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A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2018

At a glance

  • Drugs Baloxavir-marboxil (Primary) ; Oseltamivir
  • Indications Influenza virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CAPSTONE 1
  • Sponsors Shionogi
  • Most Recent Events

    • 24 Oct 2018 According to a Roche media release, the U.S. FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older, based on results from this phase III CAPSTONE-1 study and phase II study in otherwise healthy people with the flu (JapicCTI153090).
    • 07 Oct 2018 Results presented at the IDWeek 2018
    • 27 Sep 2018 According to a Shionogi media release, data from the study will be presented compounds at IDWeek™ 2018.

Trial Overview

Outcome

Primary endpoint met - positive

Purpose

The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.

Comments

According to a Roche media release, the U.S. FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older, based on results from this phase III CAPSTONE-1 study and phase II study in otherwise healthy people with the flu (JapicCTI153090) (as of 24 Oct 2018).
According to Shionogi media release,company Filed for the New Drug Application of Baloxavir Marboxil in Taiwan for the Treatment of Influenza( as of 2 Jul 2018).
Based on the results from this study , XOFLUZATM (baloxavir marboxil) tablets 10mg/20mg has been approved in Japan by the Ministry of Health, Labour and Welfare for the treatment of Influenza Types A and B (as of 23 Feb 2018).

Primary Endpoints

Met on 24 Jul 2017

Time to alleviation of symptoms

safety_issue: No
description: Time to alleviation of symptoms is defined as the time between the initiation of the study treatment and the alleviation of influenza symptoms. The alleviation of influenza symptoms is defined as the time when all of 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) have been assessed by the patient as being alleviated at each prespecified time point.
time_frame: From Day 1 pretreatment (baseline) up to Day 14 [1]

Other Endpoints

Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9.
time_frame: Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9.
time_frame: Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9.
time_frame: Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Influenza virus RNA was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9.
time_frame: Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods.
If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL).
time_frame: Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Change From Baseline in Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods.
If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL).
time_frame: Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA is measured by reverse transcription polymerase chain reaction (RT-PCR).
time_frame: Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA was measured by reverse transcription polymerase chain reaction (RT-PCR).
time_frame: Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9

Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to Baloxavir or Placebo

description: This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method.
time_frame: Day 1 to Day 9

Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Adults Randomized to Baloxavir or Oseltamivir

description: This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method.
time_frame: Day 1 to Day 9

Area Under the Curve (AUC) Adjusted by Baseline of Influenza Virus RNA in Participants Randomized to Baloxavir or Placebo

description: This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method.
time_frame: Day 1 to Day 9

Area Under the Curve (AUC) Adjusted by Baseline of Influenza Virus RNA in Adults Randomized to Baloxavir or Oseltamivir

description: This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method.
time_frame: Day 1 to Day 9

Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to Baloxavir or Placebo

description: Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀[TCID₅₀/mL]). The median and 95% confidence interval (CI) for time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point.
time_frame: Day 1 to Day 9

Time to Cessation of Viral Shedding Determined by Virus Titer in Adults Randomized to Baloxavir or Oseltamivir

description: Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀[TCID₅₀/mL]). The time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point.
time_frame: Day 1 to Day 9

Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to Baloxavir or Placebo

description: Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA was below the limit of detection measured by RT-PCR.
Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point.
time_frame: Day 1 to Day 9

Time to Cessation of Viral Shedding Determined by Virus RNA in Adults Randomized to Baloxavir or Oseltamivir

description: Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA was below the limit of detection measured by RT-PCR.
Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point.
time_frame: Day 1 to Day 9

Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1) .
time_frame: 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment

Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1) .
time_frame: 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment

Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to Baloxavir or Placebo

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point.
time_frame: Initiation of study treatment up to Day 14

Time to Alleviation of the Four Systemic Symptoms in Adults Randomized to Baloxavir or Oseltamivir

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point.
time_frame: Initiation of study treatment up to Day 14

Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to Baloxavir or Placebo

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.
Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point.
time_frame: Initiation of study treatment up to Day 14

Time to Alleviation of the Three Respiratory Symptoms in Adults Randomized to Baloxavir or Oseltamivir

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.
Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point.
time_frame: Initiation of study treatment up to Day 14

Change From Baseline in Composite Symptom Score at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant at each time point.
time_frame: Day 1 pretreatment (Baseline) and 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment.

Change From Baseline in Composite Symptom Score at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant at each time point.
time_frame: Day 1 pretreatment (Baseline) and 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment.

Time to Resolution of Fever in Participants Randomized to Baloxavir or Placebo

description: Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours.
Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point.
time_frame: Initiation of study treatment up to Day 14

Time to Resolution of Fever in Adults Randomized to Baloxavir or Oseltamivir

description: Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours.
Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point.
time_frame: Initiation of study treatment up to Day 14

Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment.
time_frame: 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment

Percentage of Participants Reporting Normal Temperature at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment.
time_frame: 12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment

Body Temperature at Each Time Point in Participants Randomized to Baloxavir or Placebo

description: Participant's self-measured axillary temperature using an electronic thermometer.
time_frame: 12, 24, 36, 48, 72, 96 and 120 hours after the initial dose of study treatment

Body Temperature at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir

description: Participant's self-measured axillary temperature using an electronic thermometer.
time_frame: 12, 24, 36, 48, 72, 96 and 120 hours after the initial dose of study treatment

Time to Alleviation of Individual Symptoms in Participants Randomized to Baloxavir or Placebo

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
time_frame: Initiation of study treatment up to Day 14

Time to Alleviation of Individual Symptoms in Adults Randomized to Baloxavir or Oseltamivir

description: Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).
Time to alleviation of each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.
time_frame: Initiation of study treatment up to Day 14

Time to Return to Preinfluenza Health Status in Participants Randomized to Baloxavir or Placebo

description: Participants were asked to record their preinfluenza health status on a scale from 0 (worst possible health) to 10 (normal health [for someone your age and your health condition]), and their health status every day after initiation of study treatment on the same scale. Return to preinfluenza health status was defined as time from the initiation of the study treatment to the first time when the health status score was equal to or higher than the preinfluenza health status score.
Time to return to preinfluenza health status was analyzed using KM methods; participants with a smaller number on the scale for health status by the last observation time point were censored at that time point.
time_frame: Initiation of study treatment up to Day 14

Time to Return to Preinfluenza Health Status in Adults Randomized to Baloxavir or Oseltamivir

description: Participants were asked to record their preinfluenza health status on a scale from 0 (worst possible health) to 10 (normal health [for someone your age and your health condition]), and their health status every day after initiation of study treatment on the same scale. Return to preinfluenza health status was defined as time from the initiation of the study treatment to the first time when the health status score was equal to or higher than the preinfluenza health status score.
Time to return to preinfluenza health status was analyzed using KM methods; participants with a smaller number on the scale for health status by the last observation time point were censored at that time point.
time_frame: Initiation of study treatment up to Day 14

Percentage of Participants With Influenza-related Complications in Participants Randomized to Baloxavir or Placebo

description: The percentage of participants who experienced each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an adverse event after the initiation of the study treatment.
time_frame: Initiation of study treatment up to Day 14

Percentage of Participants With Influenza-related Complications in Adults Randomized to Baloxavir or Oseltamivir

description: The percentage of participants who experienced each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an adverse event after the initiation of the study treatment.
time_frame: Initiation of study treatment up to Day 14

Percentage of Participants With Adverse Events (AEs)

time_frame: From first dose of study drug to Day 22 [2]

Diseases Treated

Indication Qualifiers Patient Segments
Influenza virus infections treatment acute

Subjects

  • Subject Type patients
  • Number

    Planned: 1494

    Actual: 1436

  • Sex male & female
  • Age Group 12-64 years; adolescent; adult; child

Patient Inclusion Criteria

1. Patients who are able to understand the study and comply with all study procedures, and willing to provide written informed consent/assent prior to the predose examinations appropriately. As for adolescent patients, informed consent/assent of voluntary participation should be obtained in accordance with local requirements 2. Male or female patients aged ≥ 12 to ≤ 64 years at the time of signing the informed consent/assent form. 3. Patients with a diagnosis of influenza virus infection confirmed by all of the following: 1. Fever ≥ 38ºC (axillary) in the predose examinations or > 4 hours after dosing of antipyretics if they were taken 2. At least one of the following general systemic symptoms associated with influenza are present with a severity of moderate or greater - Headache - Feverishness or chills - Muscle or joint pain - Fatigue 3. At least one of the following respiratory symptoms associated with influenza are present with a severity of moderate or greater - Cough - Sore throat - Nasal congestion 4. The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either: 1. Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature) 2. Time when the patient experiences at least one general or respiratory symptom 5. Women of childbearing potential who agree to use a highly effective method of contraception for 3 months after the first dose of study drug

Patient Exclusion Criteria

1. Patients with severe influenza virus infection requiring inpatient treatment. 2. Patients aged ≥ 20 years with known allergy to oseltamivir (Tamiflu®). 3. Patients with any of the following risk factors 1. Women who are pregnant or within 2 weeks post-partum 2. Residents of long-term care facilities (eg, welfare facilities for the elderly, nursing homes) 3. Chronic respiratory diseases including bronchial asthma 4. Neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (eg, cerebral palsy, epilepsy [seizure disorders], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury) 5. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms) 6. American Indians and Alaskan natives 7. Blood disorders (such as sickle cell disease) 8. Endocrine disorders (including diabetes mellitus) 9. Kidney disorders 10. Liver disorders 11. Metabolic disorders 12. Compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer or human immunodeficiency virus [HIV] infection) 13. Morbid obesity (body mass index [BMI] ≥ 40) 4. Patients unable to swallow tablets or capsules. 5. Patients who have previously received Baloxavir Marboxil. 6. Patients weighing < 40 kg 7. Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations. 8. Women who are breastfeeding or have a positive pregnancy test in the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test in the predose examinations: 1. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women 2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation 9. Patients with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the predose examinations. 10. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir, or amantadine within 30 days prior to the predose examinations. 11. Patients who have received an investigational monoclonal antibody for a viral disease in the last year. 12. Patients with severe underlying diseases. 13. Patients with known creatinine clearance ≤ 60 mL/min. 14. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Trial Details

Identifiers

Identifier Owner
NCT02954354 ClinicalTrials.gov: US National Institutes of Health
1601T0831 -

Organisations

  • Sponsors Shionogi
  • Affiliations Genentech; Roche; Shionogi

Trial Dates

  • Initiation Dates

    Planned : 01 Nov 2016

    Actual : 08 Dec 2016

  • Primary Completion Dates

    Planned : 01 May 2017

    Actual : 04 Apr 2017

  • End Dates

    Planned : 01 Oct 2017

    Actual : 24 Apr 2017

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location Japan; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
Baloxavir-marboxilPrimary Drug Oral Tablet
Oseltamivir Oral Capsule

Adolescents: Baloxavir Marboxil

Participants aged 12 to 19 years will receive two or four baloxavir marboxil 20 mg tablets on Day 1. Drug: Baloxavir Marboxil (2 to4 X 20-mg tablets taken orally) Other Name: S-033188

Adults: Baloxavir Marboxil

Participants aged 20 to 64 years will receive two or four 20 mg baloxavir marboxil tablets orally on Day 1 and one oseltamivir placebo capsule orally twice a day (BID) on Days 1 to 5. Drug: Baloxavir Marboxil (2 to4 X 20-mg tablets taken orally) Other Name: S-033188 Drug: Placebo to Oseltamivir (Placebo capsules matching oseltamivir 75 mg capsules)

Adolescents: Placebo

Participants aged 12 to 19 years will receive two or four baloxavir marboxil placebo tablets on Day 1. Drug: Placebo to Baloxavir Marboxil (2 to4 X 20-mg tablets taken orally)

Adults: Placebo

Participants aged 20 to 64 years will receive two or four baloxavir marboxil placebo tablets on Day 1 and one oseltamivir placebo capsule orally twice a day on Days 1 to 5. Drug: Placebo to Baloxavir Marboxil (2 to4 X 20-mg tablets taken orally) Drug: Placebo to Oseltamivir (Placebo capsules matching oseltamivir 75 mg capsules)

Adults: Oseltamivir

Participants aged 20 to 64 years will receive 75 mg oseltamivir twice a day on Days 1 to 5 and two or four baloxavir marboxil placebo tablets on Day 1. Drug: Placebo to Baloxavir Marboxil (2 to4 X 20-mg tablets taken orally) Drug: Oseltamivir (75 mg capsules taken orally) Other Name: Tamiflu®

Results

Therapeutic efficacy

Phase III: Baloxavir marboxil, compared with placebo, significantly reduced time to alleviation of symptoms (TTAS) (p < 0.001) in otherwise healthy patients with influenza infections in the phase III CAPSTONE-1 trial. The median TTAS was 53.7 hours (p < 0.001) in baloxavir marboxil group, compared with 53.8 hours (p = 0.7560) in oseltamivir group and 80.2 hours in placebo group, respectively. TTAS was similar between baloxavir marboxil and oseltamivir groups [3] . Significant improvement compared with placebo or oseltamivir for important virological endpoints was seen. The percentage of patients determined to be positive for influenza virus titer was significantly lower in the baloxavir marboxil group in comparison with the oseltamivir group at one, two and four days from the start of treatment. Additionally, the time to cessation of viral shedding was significantly decreased to 24 hours (p < 0.0001) in the baloxavir marboxil as compared with the 72 hours (p < 0.0001) in oseltamivir group and 96 hours in placebo group. Significant reduced fever by 24 hours (p < 0.0001) compared with 42 hours in placebo. The results were reported from 1 436 patients enrolled in the study [4] [5] [1] .

Adverse events

Phase III: Baloxavir marboxil was well tolerated with a numerically lower overall incidence of adverse events (20.7%) compared with placebo (24.6%) or oseltamivir (24.8%) in patients with influenza infections in the phase III CAPSTONE-1 trial. The incidence of treatment-related adverse events were comparable to that of placebo arm. Baloxavir marboxil showed a statistically significant decrease in the incidence of treatment-related adverse events compared to oseltamivir (p = 0.0088). The most common adverse events reported were diarrhea (3.0%), bronchitis (2.6%), nausea (1.3%) and sinusitis (1.1%), and all of these adverse events occurred at a lower frequency than placebo. The incidence of nausea was less frequent in patients treated with S 033188, compared to oseltamivir. The results were reported from 1 436 patients enrolled in the study [4] [5] [1] .

Publications

  1. Shionogi. Shionogi Announces Positive Top-Line Results for S-033188 Phase 3 Study (CAPSTONE-1) in Otherwise Healthy Influenza Patients. Media-Rel 2017;.

    Media Release
  2. Shionogi. S-033188 Phase 3 CAPSTONE-1 Study Results for Treatment of Influenza Presented at the European Scientific Working Group on Influenza Conference. Media-Rel 2017;.

    Media Release
  3. Shionogi. Shionogi To Present S-033188 Phase 3 CAPSTONE-1 Study Results For Treatment Of Influenza At IDWeek 2017. Media-Rel 2017;.

    Media Release
  4. Kawaguchi K, Portsmouth S, Shishido T, Uehara T, Hayden F. Exploring Clinical and Antiviral Efficacy of Baloxavir Marboxil in a Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study of Otherwise Healthy Adults/Adolescents in Seasonal Influenza: Impact on Regional Participants, Treatment Time and Influenza Type B Virus Infection (CAPSTONE-1 Study). IDW-2018 2018; abstr. 1645.

    Available from: URL: https://idsa.confex.com/idsa/2018/webprogram/Paper71167.html
  5. Portsmouth S, Kawaguchi K, Arai M, Tsuchiya K, Uehara T. Cap-Dependent Endonuclease Inhibitor S-033188 for the Treatment of Influenza: Results from a Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study in Otherwise Healthy Adolescents and Adults with Seasonal Influenza. IDW-2017 2017; abstr. LB-2.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper67519.html
  6. Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N-Engl-J-Med 2018;379(10):913-923.

    PubMed | CrossRef Fulltext

Authors

Author Total Publications First Author Last Author
Arai M 2 - -
de Jong MD 1 - -
Hayden F 1 - 1
Hayden FG 1 1 -
Hirotsu N 1 - -
Hurt AC 1 - -
Ishida T 1 - -
Kawaguchi K 3 1 -
Lee N 1 - -
Portsmouth S 3 1 -
Sekino H 1 - -
Shionogi 3 3 3
Shishido T 2 - -
Sugaya N 1 - -
Tsuchiya K 2 - -
Uehara T 3 - 1
Watanabe A 1 - 1
Yamada K 1 - -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Shionogi Clinical Trials Administrator Clinical Support Help Line
800-849-9707
Shionogiclintrials-admin@shionogi.co.jp
show details
Shionogi
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Centres

Centre Name Location Trial Centre Country
Shionogi
-
-
Shionogi Research Site Addison, Texas USA
Shionogi Research Site Akashi-shi, Hyogo Japan
Shionogi Research Site Amagasaki-city, Hyogo Japan
Shionogi Research Site Amagasaki-shi, Hyogo Japan
Shionogi Research Site Athens, Alabama USA
Shionogi Research Site Austin, Texas USA
Shionogi Research Site Avon, Indiana USA
Shionogi Research Site Baytown, Texas USA
Shionogi Research Site Bellevue, Nebraska USA
Shionogi Research Site Berlin, New Jersey USA
Shionogi Research Site Birmingham, Alabama USA
Shionogi Research Site Boynton Beach, Florida USA
Shionogi Research Site Bozeman, Montana USA
Shionogi Research Site Brampton, Ontario Canada
Shionogi Research Site Brooklyn, New York USA
Shionogi Research Site Canoga Park, California USA
Shionogi Research Site Canton, Ohio USA
Shionogi Research Site Carrollton, Texas USA
Shionogi Research Site Centennial, Colorado USA
Shionogi Research Site Centerville, Ohio USA
Shionogi Research Site Channelview, Texas USA
Shionogi Research Site Charleston, South Carolina USA
Shionogi Research Site Charlotte, North Carolina USA
Shionogi Research Site Chikushino City, Fukuoka Japan
Shionogi Research Site Chofu-shi, Tokyo Japan
Shionogi Research Site Chuo-ku, Tokyo Japan
Shionogi Research Site Cincinnati, Ohio USA
Shionogi Research Site Clearwater, Florida USA
Shionogi Research Site Columbus, Georgia USA
Shionogi Research Site Corpus Christi, Texas USA
Shionogi Research Site Costa Mesa, California USA
Shionogi Research Site Dallas, Texas USA
Shionogi Research Site Dayton, Ohio USA
Shionogi Research Site Decatur, Georgia USA
Shionogi Research Site Denver, Colorado USA
Shionogi Research Site DeSoto, Texas USA
Shionogi Research Site Diamond Bar, California USA
Shionogi Research Site Doral, Florida USA
Shionogi Research Site Draper, Utah USA
Shionogi Research Site Edogawa-ku, Tokyo Japan
Shionogi Research Site Ellensburg, Washington USA
Shionogi Research Site Evansville, Indiana USA
Shionogi Research Site Fayetteville, North Carolina USA
Shionogi Research Site Fort Lauderdale, Florida USA
Shionogi Research Site Fort Myers, Florida USA
Shionogi Research Site Franklin, Tennessee USA
Shionogi Research Site Fukui City, Fukui Japan
Shionogi Research Site Fukuoka Japan
Shionogi Research Site Fukuoka City, Fukuoka Japan
Shionogi Research Site Fukuoka-shi, Fukuoka Japan
Shionogi Research Site Fukutsu-shi, Fukuoka Japan
Shionogi Research Site Fukuyama City, Hiroshima Japan
Shionogi Research Site Funabashi City, Chiba Japan
Shionogi Research Site Gainesville, Florida USA
Shionogi Research Site Garden City, New York USA
Shionogi Research Site Gold River, California USA
Shionogi Research Site Greenbrae, California USA
Shionogi Research Site Gulf Shores, Alabama USA
Shionogi Research Site Gunma Japan
Shionogi Research Site Hakodate City, Hokkaido Japan
Shionogi Research Site Hakodate-city, Hokkaido Japan
Shionogi Research Site Harleysville, Pennsylvania USA
Shionogi Research Site Hawaiian Gardens, California USA
Shionogi Research Site Hialeah, Florida USA
Shionogi Research Site Hickory, North Carolina USA
Shionogi Research Site Higashi-ku, Fukuoka Japan
Shionogi Research Site Hino City, Tokyo Japan
Shionogi Research Site Hiroshima Japan
Shionogi Research Site Hiroshima-shi, Hiroshima Japan
Shionogi Research Site Houston, Texas USA
Shionogi Research Site Huntington Beach, California USA
Shionogi Research Site Huntsville, Alabama USA
Shionogi Research Site Hyogo Japan
Shionogi Research Site Ichikawa-city, Chiba Japan
Shionogi Research Site Ishikawa Japan
Shionogi Research Site Jackson, Tennessee USA
Shionogi Research Site Jacksonville, Florida USA
Shionogi Research Site Johnston, Rhode Island USA
Shionogi Research Site Kagoshima Japan
Shionogi Research Site Kagoshima City, Kagoshima Japan
Shionogi Research Site Kagoshima-shi, Kagoshima Japan
Shionogi Research Site Kalamazoo, Michigan USA
Shionogi Research Site Kanazawa-city, Ishikawa Japan
Shionogi Research Site Kasuga-shi, Fukuoka Japan
Shionogi Research Site Kasugai City, Aichi Japan
Shionogi Research Site Kawaguchi, Saitama Japan
Shionogi Research Site Kawasaki City, Kanagawa Japan
Shionogi Research Site Kisarazu City, Chiba Japan
Shionogi Research Site Kissimmee, Florida USA
Shionogi Research Site Kitakyushu City, Fukuoka Japan
Shionogi Research Site Kitakyuusyu City, Fukuoka Japan
Shionogi Research Site Kohriyama City, Fukushima Japan
Shionogi Research Site Kokubunji-shi, Tokyo Japan
Shionogi Research Site Koriyama City, Fukushima Japan
Shionogi Research Site Kumamoto Japan
Shionogi Research Site Kyoto Japan
Shionogi Research Site La Crosse, Wisconsin USA
Shionogi Research Site Lake Charles, Louisiana USA
Shionogi Research Site Lake Worth, Florida USA
Shionogi Research Site Lauderdale Lakes, Florida USA
Shionogi Research Site Lexington, North Carolina USA
Shionogi Research Site Little Rock, Arkansas USA
Shionogi Research Site Lomita, California USA
Shionogi Research Site Long Beach, California USA
Shionogi Research Site Los Angeles, California USA
Shionogi Research Site Matsudo-shi, Chiba Japan
Shionogi Research Site McAllen, Texas USA
Shionogi Research Site Metairie, Louisiana USA
Shionogi Research Site Miami, Florida USA
Shionogi Research Site Mishawaka, Indiana USA
Shionogi Research Site Miyagi Japan
Shionogi Research Site Mooresville, North Carolina USA
Shionogi Research Site Morganton, North Carolina USA
Shionogi Research Site Musashino City, Tokyo Japan
Shionogi Research Site Nagoya, Aichi Japan
Shionogi Research Site Naha City, Okinawa Japan
Shionogi Research Site Nakano-ku, Tokyo Japan
Shionogi Research Site Nashville, Tennessee USA
Shionogi Research Site Nerima-Ku, Tokyo Japan
Shionogi Research Site New Orleans, Louisiana USA
Shionogi Research Site New Tazewell, Tennessee USA
Shionogi Research Site Newmarket, Ontario Canada
Shionogi Research Site Nonoichi City, Ishikawa Japan
Shionogi Research Site Norco, California USA
Shionogi Research Site North Hollywood, California USA
Shionogi Research Site Northglenn, Colorado USA
Shionogi Research Site Norwalk, California USA
Shionogi Research Site Oita City, Oita Japan
Shionogi Research Site Oita-shi, Oita Japan
Shionogi Research Site Oklahoma City, Oklahoma USA
Shionogi Research Site Omaha, Nebraska USA
Shionogi Research Site Onojo City, Fukuoka Japan
Shionogi Research Site Orlando, Florida USA
Shionogi Research Site Osaka Japan
Shionogi Research Site Osaka City, Osaka Japan
Shionogi Research Site Osaka-shi, Osaka Japan
Shionogi Research Site Osaki City, Miyagi Japan
Shionogi Research Site Ota City, Gunma Japan
Shionogi Research Site Otsu City, Shiga Japan
Shionogi Research Site Oxnard, California USA
Shionogi Research Site Oxon Hill, Maryland USA
Shionogi Research Site Palos Verdes, California USA
Shionogi Research Site Paramount, California USA
Shionogi Research Site Pembroke Pines, Florida USA
Shionogi Research Site Pharr, Texas USA
Shionogi Research Site Phoenix, Arizona USA
Shionogi Research Site Plano, Texas USA
Shionogi Research Site Rapid City, South Dakota USA
Shionogi Research Site Rialto, California USA
Shionogi Research Site Saitama Japan
Shionogi Research Site Salt Lake City, Utah USA
Shionogi Research Site San Angelo, Texas USA
Shionogi Research Site San Antonio, Texas USA
Shionogi Research Site San Diego, California USA
Shionogi Research Site San Marino, California USA
Shionogi Research Site San Ramon, California USA
Shionogi Research Site Sandy Springs, Georgia USA
Shionogi Research Site Sapporo City, Hokkaido Japan
Shionogi Research Site Sarnia, Ontario Canada
Shionogi Research Site Scottdale, Pennsylvania USA
Shionogi Research Site Sendai City, Miyagi Japan
Shionogi Research Site Setagaya-ku, Tokyo Japan
Shionogi Research Site Shinagawa-ku, Tokyo Japan
Shionogi Research Site Shinkuju-ku, Tokyo Japan
Shionogi Research Site Shizuoka City, Shizuoka Japan
Shionogi Research Site Smithfield, Pennsylvania USA
Shionogi Research Site Smyrna, Tennessee USA
Shionogi Research Site Stockton, California USA
Shionogi Research Site Sugar Land, Texas USA
Shionogi Research Site Suita City, Osaka Japan
Shionogi Research Site Suita-shi, Osaka Japan
Shionogi Research Site Tampa, Florida USA
Shionogi Research Site Tokyo Japan
Shionogi Research Site Tomigusuku City, Okinawa Japan
Shionogi Research Site Toronto, Ontario Canada
Shionogi Research Site Toshima, Tokyo Japan
Shionogi Research Site Troy, Michigan USA
Shionogi Research Site Tsuchiura City, Ibaraki Japan
Shionogi Research Site Tsukuba City, Ibaraki Japan
Shionogi Research Site Tucson, Arizona USA
Shionogi Research Site Tulsa, Oklahoma USA
Shionogi Research Site Tuscumbia, Alabama USA
Shionogi Research Site Upland, California USA
Shionogi Research Site Urasoe City, Okinawa Japan
Shionogi Research Site Wauconda, Illinois USA
Shionogi Research Site West Columbia, South Carolina USA
Shionogi Research Site West Covina, California USA
Shionogi Research Site West Palm Beach, Florida USA
Shionogi Research Site Westminster, California USA
Shionogi Research Site Wichita, Kansas USA
Shionogi Research Site Winston-Salem, North Carolina USA
Shionogi Research Site Worcester, Massachusetts USA
Shionogi Research Site Yanagawa City, Fukuoka Japan
Shionogi Research Site Yokohama City, Kanagawa Japan
Shionogi Research Site Yokohama-city, Kanagawa Japan
Shionogi Research Site Yokohama-shi, Kanagawa Japan
Shionogi Research Site Yukuhashi City, Fukuoka Japan

Trial History

Event Date Event Type Comment
21 Dec 2018 Other trial event Last checked against ClinicalTrials.gov record. Updated 21 Dec 2018
24 Oct 2018 Other trial event According to a Roche media release, the U.S. FDA has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older, based on results from this phase III CAPSTONE-1 study and phase II study in otherwise healthy people with the flu (JapicCTI153090). Updated 31 Oct 2018
07 Oct 2018 Results Results presented at the IDWeek 2018 Updated 08 Nov 2018
27 Sep 2018 Other trial event According to a Shionogi media release, data from the study will be presented compounds at IDWeek™ 2018. Updated 05 Oct 2018
06 Sep 2018 Results Results published in the New England Journal of Medicine Updated 11 Sep 2018
17 Jul 2018 Other trial event According to a Shionogi media release, the company expects that, the US FDA will approve this drug by 24 Dec 2018. Updated 18 Jul 2018
02 Jul 2018 Other trial event According to Shionogi media release,company Filed for the New Drug Application of Baloxavir Marboxil in Taiwan for the Treatment of Influenza. Updated 06 Jul 2018
25 Jun 2018 Other trial event According to a Genentech media release, the US FDA has accepted the New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA is based on results from this trial. Updated 02 Jul 2018
23 Feb 2018 Other trial event According to a Shionogi media release, based on the results from this study , XOFLUZATM (baloxavir marboxil) tablets 10mg/20mg has been approved in Japan by the Ministry of Health, Labour and Welfare for the treatment of Influenza Types A and B. Updated 27 Feb 2018
11 Jan 2018 Other trial event Canada was the planned location for this trial. Updated 31 Oct 2018
08 Oct 2017 Results Results assessing clinical and virologic outcomes of S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection, were presented at the IDWeek 2017. Updated 30 Oct 2017
05 Oct 2017 Results Results presented in a Shionogi Media Release. Updated 10 Oct 2017
28 Sep 2017 Other trial event According to a Shionogi media release, data will be presented at IDWeek 2017. Updated 05 Oct 2017
13 Sep 2017 Results Results presented in the Shionogi Media Release Updated 25 Oct 2017
13 Sep 2017 Results According to a Shionogi media release, results from this trial were released at the 6th European Scientific Working Group on Influenza Conference (ESWI) 2017. Updated 15 Sep 2017
24 Jul 2017 Other trial event According to a Shionogi media release, based on the results from CAPSTONE-1, Shionogi plans to submit a New Drug Application (NDA) to the PMDA in Japan later this year. Updated 26 Jul 2017
24 Jul 2017 Endpoint met Primary endpoint has been met. (Time to alleviation of symptoms), according to a Shionogi media release. Updated 26 Jul 2017
24 Jul 2017 Results Top-line results published in a Shionogi media release. Updated 26 Jul 2017
08 May 2017 Status change - completed Status changed from active, no longer recruiting to completed. Updated 13 May 2017
30 Mar 2017 Other trial event Planned locations for this trial also included Singapore, South Korea and Thailand. Updated 31 Oct 2018
30 Mar 2017 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 03 Apr 2017
28 Feb 2017 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 07 Mar 2017
14 Nov 2016 New trial record New trial record Updated 14 Nov 2016

References

  1. Shionogi. Shionogi Announces Positive Top-Line Results for S-033188 Phase 3 Study (CAPSTONE-1) in Otherwise Healthy Influenza Patients. Media-Rel 2017;.

    Media Release
  2. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  3. Shionogi. S-033188 Phase 3 CAPSTONE-1 Study Results for Treatment of Influenza Presented at the European Scientific Working Group on Influenza Conference. Media-Rel 2017;.

    Media Release
  4. Genentech. FDA Grants Priority Review to Genentech's Baloxavir Marboxil for the Treatment of Influenza. Media-Rel 2018;.

    Media Release
  5. Shionogi. Shionogi To Present S-033188 Phase 3 CAPSTONE-1 Study Results For Treatment Of Influenza At IDWeek 2017. Media-Rel 2017;.

    Media Release
  6. Shionogi. Shionogi Announces FDA Approval of XOFLUZATM (Baloxavir Marboxil). Media-Rel 2018;.

    Media Release
  7. Kawaguchi K, Portsmouth S, Shishido T, Uehara T, Hayden F. Exploring Clinical and Antiviral Efficacy of Baloxavir Marboxil in a Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study of Otherwise Healthy Adults/Adolescents in Seasonal Influenza: Impact on Regional Participants, Treatment Time and Influenza Type B Virus Infection (CAPSTONE-1 Study). IDW-2018 2018; abstr. 1645.

    Available from: URL: https://idsa.confex.com/idsa/2018/webprogram/Paper71167.html
  8. Roche. Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza. Media-Rel 2018;.

    Media Release
  9. Shionogi. Shionogi Announces Positive Top-Line Results for Baloxavir Marboxil Phase III Study (CAPSTONE-2) in Individuals at High Risk for Influenza-Related Complications. Media-Rel 2018;.

    Media Release
  10. Genentech. Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza. Media-Rel 2018;.

    Media Release
  11. Roche. FDA grants Priority Review to Roche's baloxavir marboxil for the treatment of influenza. Media-Rel 2018;.

    Media Release
  12. Portsmouth S, Kawaguchi K, Arai M, Tsuchiya K, Uehara T. Cap-Dependent Endonuclease Inhibitor S-033188 for the Treatment of Influenza: Results from a Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study in Otherwise Healthy Adolescents and Adults with Seasonal Influenza. IDW-2017 2017; abstr. LB-2.

    Available from: URL: https://idsa.confex.com/idsa/2017/webprogram/Paper67519.html
  13. Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N-Engl-J-Med 2018;379(10):913-923.

    PubMed | CrossRef Fulltext
  14. Shionogi. FDA Accepts Baloxavir Marboxil New Drug Application and Grants Priority Review for the Treatment of Influenza. Media-Rel 2018;.

    Media Release
  15. Shionogi. XOFLUZATM (Baloxavir Marboxil) Tablets 10mg/20mg Approved for the Treatment of Influenza Types A and B in Japan. Media-Rel 2018;.

    Media Release
  16. Shionogi. Shionogi To Highlight Research On Cefiderocol (S-649266), A Siderophore Cephalosporin, And S-033188, A Cap-Dependent Endonuclease Inhibitor For Treatment Of Influenza, At IDWeek 2017. Media-Rel 2017;.

    Media Release
  17. Shionogi. Shionogi to Present Data on Cefiderocol and Baloxavir Marboxil at IDWeek 2018. Media-Rel 2018;.

    Media Release
  18. Food and Drug Administration. FDA approves new drug to treat influenza. Media-Rel 2018;.

    Media Release
  19. Shionogi. Shionogi Filed for the New Drug Application of Baloxavir Marboxil in Taiwan for the Treatment of Influenza. Media-Rel 2018;.

    Media Release
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