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Tradipitant - Vanda Pharmaceuticals

Drug Profile

Tradipitant - Vanda Pharmaceuticals

Alternative Names: LY-686017; VLY 686

Latest Information Update: 04 May 2020

At a glance

  • Originator Eli Lilly and Company
  • Developer Eli Lilly and Company; National Institute on Alcohol Abuse and Alcoholism; Vanda Pharmaceuticals
  • Class Anti-inflammatories; Antipruritics; Anxiolytics; Chlorobenzenes; Gastrokinetics; Pyridines; Small molecules; Triazoles
  • Mechanism of Action Neurokinin 1 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Atopic dermatitis; COVID 2019 infections; Gastroparesis; Motion sickness
  • Phase II Pruritus
  • Discontinued Alcoholism; Social phobia

Most Recent Events

  • 14 Apr 2020 Vanda Pharmaceuticals initiates enrolment in the phase III ODYSSEY trial for pneumonia in COVID-2019 infections in USA (NCT04326426)
  • 02 Apr 2020 Phase-III clinical trials in COVID-2019 infections in USA (PO)
  • 26 Feb 2020 Phase-III clinical trials in Motion sickness in USA (PO) prior to February 2020 (Vanda Pharmaceuticals pipeline, February 2020)

Development Overview

Introduction

Tradipitant is a small molecule neurokinin 1 (NK1) receptor antagonist, being developed by Vanda Pharmaceuticals for the oral treatment of gastroparesis, pruritus, atopic dermatitis and motion sickness. Tradipitant blocks substance P from acting on NK1 receptors in the brain. Substance P is released in response to stress and gives rise to anxiety. Blocking the NK1 receptor from Substance P may be useful in treating a variety of conditions, including anxiety, substance dependence, nausea and vomiting, pruritus and heterotopic ossification. Clinical development for atopic dermatitis, gastroparesis, COVID-2019 infections, pruritus and motion sickness is underway in the US and Germany.

As of February 2019, the US FDA placed a partial clinical hold on Vanda Pharmaceuticals's studies of tradipitant. Vanda Pharmaceuticals in return filed a complaint against the US FDA requesting the court to lift the partial clinical hold [1]

Tradipitant was undergoing phase II development with Eli Lilly, as LY 686017, for the treatment of alcoholism and social phobia. However, development was discontinued and the rights were transferred to Vanda for further development. No recent reports of development had been identified for pruritus in Switzerland.

Company Agreements

In April 2012, Vanda Pharmaceuticals acquired an exclusive worldwide license to develop and commercialise tradipitant for all human indications from Eli Lilly. Under the terms of the agreement, Vanda paid an initial license fee of $US1.0 million and will be responsible to pay for all development costs. Eli Lilly will be eligible for payments based upon achievement of specified development and commercialisation milestones as well as tiered-royalties on net sales. These milestones include $US4.0 million for pre-NDA approval milestones and up to $US95.0 million for future regulatory approval and sales milestones [2] .

Key Development Milestones

In April 2019, Vanada declared that additional chronic toxicity studies demanded by the FDA in order to lift the partial clinical hold were unjustified, and the company has already submitted the required information, in accordance with applicable law and FDA regulations, regarding the safety of tradipitant, to the FDA to support the continued study of tradipitant in patients beyond 12 weeks. The company has announced this, when even after the re-evaluation, the US FDA indicated that partial clinical hold will continue, until the company provides data from chronic toxicity studies in canines, monkeys or minipigs. Followed by a lawsuit filed by Vanda, in February 2019, against the FDA in the United States District Court, for the District of Columbia (DC District Court), challenging the FDA's legal authority to issue the partial clinical hold, and seeking an order to set it aside, the US FDA had filed a motion for voluntary remand to the agency and for a stay of the case. In March 2019 the DC District Court had approved the FDA's request for voluntary remand and returned the matter to the FDA for further consideration. Thus, again in April 2019, Vanda and the FDA filed a Joint Motion for extension of time to propose a scheduling order for this matter, and in response, the DC District Court has granted the motion, thereby extending the deadline until May 3, 2019, for the FDA and Vanda to file proposals regarding a scheduling order [1] [3] .

Atopic Dermatitis

In October 2019, Vanda Pharmaceuticals initiated the phase III EPIONE 2 trial to evaluate the efficacy of tradipitant in patients with atopic dermatitis (VP-VLY-686-3102; NCT04140695). The randomised, double-blind, placebo-controlled trial is enrolling approximately 350 patients in the US [4] [5] .

In February 2020, Vanda Pharmaceuticals completed the EPIONE 1 phase III trial that evaluated the efficacy of tradipitant in patients with atopic dermatitis (VP-VLY-686-3101; NCT03568331). The primary outcome of the study was reduction of worst itch in atopic dermatitis measured by Numerical Rating Scale at week 8.The multi-center, randomised, double-blind, placebo-controlled study was initiated in June 2018 and recruited 375 patients in the US [5] [6] . In the same month, the company released efficacy data of tradipitant which failed to meet the primary endpoint of reduction of pruritus in patients with atopic dermatitis [7] .

Alcoholism

Eli Lilly and the National Institute on Alcohol Abuse and Alcoholism (NIAAA) conducted a phase II trial to evaluate tradipitant in 75 patients with alcohol dependence (NCT00310427). Patients were randomised to receive either 50mg of tradipitant or placebo every morning for 28 days. In the last week of the study, patients underwent functional magnetic resonance imaging (fMRI) to evaluate blood flow to brain structures thought to be involved in craving and anxiety. Craving for alcohol was also evaluated using rating scales and the Trier Social Stress Test.

COVID-2019 infections

In April 2020, Vanda Pharmaceuticals initiated the phase III ODYSSEY trial and enrolled first patient to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-2019 infections (NCT04326426; VLY-686-3501). The study intends to enrol approximately 300 patients aged 18-90 with severe COVID-2019 infection who are suffering from pneumonia in the US. Earlier, Vanda received the US FDA permission to proceed with the study for the treatment and prevention of pneumonia associated with COVID-2019 [8] [9] [10] .

Gastroparesis

In July 2019, Vanda Pharmaceuticals initiated a phase III trial to investigate the safety and efficacy of tradipitant versus placebo in relieving symptoms of gastroparesis (NCT04028492; VP-VLY-686-3301). The randomised, double-blind, placebo-controlled trial intends to enrol approximately 250 patients in the US [11] . Earlier, in May 2019, Vanda Pharmaceuticals conducted a meeting with the US FDA to confirm the pathway for regulatory approval of tradipitant for the treatment of gastroparesis [12] .

In December 2018, Vanda Pharmaceuticals presented positive efficacy and safety results from a phase II study and announced that tradipitant met the primary endpoint of nausea, the significant increase in nausea free days, and the reported overall symptom improvement in patients with gastroparesis (VP-VLY-686-2301; NCT02970968). The randomised study enrolled 141 patients in the US. Results from the study showed that tradipitant was well tolerated with comparable rates of adverse events between the tradipitant and placebo groups [13] [14] [15] [16] . In April 2018, Vanda had submitted a protocol amendment to the FDA, proposing a 52-week open-label extension (OLE) period for patients who had completed a phase II study in gastroparesis. On the basis of the feedback from the FDA, in May 2018, Vanda amended the protocol limiting the duration of treatment in the study to a total of three months, while continuing to seek further dialogue with the FDA on extending the study duration to 52-weeks. In September 2018, Vanda submitted a new follow-on 52-week OLE protocol to the FDA (2302) for patients who had completed a phase II study and no patients were enrolled in any study beyond 12 weeks [3] . In October 2019, the company presented the efficacy data at the 27th United European Gastroenterology Week (UEGW-2019) [17] .

Motion sickness

Prior to February 2020, Vanda Pharmaceuticals initiated a phase III trial in motion sickness (Vanda Pharmaceuticals pipeline, February 2020). The company also announced the intention to complete a phase III trial, with a plan to file a new drug application (NDA) with the US FDA in 2020 [18] [19] [20] .

In January 2019, Vanda Pharmaceuticals initiated a phase II Motion Sifnos trial to evaluate the efficacy of tradipitant in patients with motion sickness (VP-VLY-686-2401; NCT03772340). This randomised, double-blinded trial intends to enrol approximately 250 patients in the US [21] . In July 2019, positive results from the trial were released by Vanda Pharmaceuticals [20] .

Pruritus

In September 2017, Vanda Pharmaceuticals completed a phase II trial that evaluated the safety and efficacy of tradipitant, in patients with treatment-resistant chronic pruritus associated with atopic dermatitis (Study-2102; VP-VLY-686-2102; NCT02651714). Patients received tradipitant 85 mg or placebo orally twice daily. The randomised, double-blind, placebo-controlled trial was initiated in January 2016, and enrolled 168 patients in the US [22] [23] . In September 2017, Vanda Pharmaceuticals released results for the trial, which demonstrated that tradipitant improved itch, and disease severity in atopic dermatitis patients [24] . In February 2018, the company presented interim results of the study at the 76th Annual Meeting of the American Academy of Dermatology (AAD-2018) [25] .

In September 2017, Vanda intends to meet with the FDA to further define and confirm the clinical development path towards registration of tradipitant in the treatment of patients with atopic dermatitis. The company plans to hold an end of Phase II meeting with the US FDA in the first quarter of 2018 [26] [24] .

The primary endpoint defined as overall effect of the pre-defined dose of tradipitant on itch, as measured by a 100mm visual analogue scale was not met in a phase II trial (VP-VLY686-2101; EudraCT2013-002931-25; NCT02004041). In March 2015, Vanda completed the randomised, double-blind, placebo-controlled, proof-of-concept phase II trial, assessing the efficacy of tradipitant in patients with treatment-resistant pruritus associated with atopic dermatitis. The trial that was initiated in November 2013, enrolled 68 patients in Germany [27] [28] [29] [30] . Top-line results were released in March 2015 [31] .

Vanda initiated a randomised, double-blind, placebo-controlled, crossover phase I trial in August 2013, to investigate the efficacy of tradipitant in preventing or reducing pruritus in healthy male volunteers after intradermal injections with Substance P (VP-VLY686-1101; NCT01919944). The primary endpoints were itch severity scores on the Verbal Rating Scale and Visual Analogue Scale, 20 minutes after challenge. The trial enrolled 12 subjects in Switzerland, and was completed in November 2013 [32] .

In August 2014, Vanda filed an IND application with the US FDA [33] .

Social phobia

Eli Lilly completed a phase II trial in the US to test the efficacy of tradipitant compared with paroxetine in the treatment of social anxiety disorder (NCT00191022). The primary endpoint of the study was superiority, defined as a statistically greater reduction from baseline to week 12 in the Liebowitz Social Anxiety Scale (LSAS) total score. The study was initiated in December 2004.

Phase I trials

In February 2016, Vanda Pharmaceuticals completed a phase I trial that assessed the effect of multiple doses of tradipitant, on CYP3A4 using midazolam as a substrate in healthy volunteers (VP-VLY-686-1102; NCT02621385). The pharmacokinetics, single-group, open-label trial was initiated in November 2015 and enrolled 24 volunteers in Switzerland and the US [34] .

Financing information

In August 2013, Vanda Pharmaceuticals announced the sale of shares of common stock, with net proceeds expected to total approximately $US48.3 million. Vanda intends to use the proceeds for commercial launch activities for tasimelteon [see separate profile], research and development activities and for general corporate purposes [35] .

Patent Information

The patent protection covering new chemical entity patent for tradipitant expires in June 2029 in the US based on an anticipated Hatch-Waxman patent term extension, and April 2023 elsewhere. Lilly owns patent applications for polymorphic forms of, and methods of making tradipitant worldwide (Vanda pharmaceuticals form 10-k, March 2017) [2] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Capsule, unspecified
  • Class Anti-inflammatories, Antipruritics, Anxiolytics, Chlorobenzenes, Gastrokinetics, Pyridines, Small molecules, Triazoles
  • Target Neurokinin 1 receptor
  • Mechanism of Action Neurokinin 1 receptor antagonists
  • WHO ATC code

    D04A-X (Other antipruritics)

    J05 (Antivirals for Systemic Use)

    N05B (Anxiolytics)

    N07B-B (Drugs used in alcohol dependence)

  • EPhMRA code

    D4A (Anti-Pruritics, Including Topical Antihistamines, Anaesthetics, etc)

    J5 (Antivirals for Systemic Use)

    N5B (Hypnotics/Sedatives)

    N7E (Drugs Used In Alcohol Dependence)

  • Chemical name 1-[2-[1-[3,5-Bis(trifluoromethyl)benzyl]-5-(4-pyridyl)-1H-1,2,3-triazol-4-yl]pyridin-3-yl]-1-(2-chlorophenyl)-methanone
  • Molecular formula C28 H16 Cl F6 N5 O
  • SMILES C1C=C(C=CN=1)C1=C(N=NN1CC1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F)C1C(=CC=CN=1)C(=O)C1C=CC=CC=1Cl
  • Chemical Structure
  • CAS Registry Number 622370-35-8

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

pruritus

Outcome Measure

tachykinin receptor 1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Tradipitant - Vanda Pharmaceuticals Carbohydrate-deficient transferrin Outcome Measure
tachykinin receptor 1 Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Alcoholism - - Discontinued (II) USA PO / Capsule Eli Lilly and Company, National Institute on Alcohol Abuse and Alcoholism 01 Oct 2009
Atopic dermatitis - - Phase III USA PO / Capsule Vanda Pharmaceuticals 01 Jun 2018
COVID 2019 infections pneumonia due to COVID-19 infections - Phase III USA PO / unspecified Vanda Pharmaceuticals 02 Apr 2020
Gastroparesis In patients with Gastroparesis, Idiopathic and Diabetic Gastroparesis - Phase III USA PO / Capsule Vanda Pharmaceuticals 23 Jul 2019
Motion sickness - - Phase III USA PO / Capsule Vanda Pharmaceuticals 26 Feb 2020
Pruritus - Treatment-experienced Phase II Germany, USA PO / Capsule Vanda Pharmaceuticals 01 Jan 2016
Pruritus - In volunteers No development reported (I) Switzerland PO / Capsule Vanda Pharmaceuticals 04 Nov 2017
Social phobia - - Discontinued (II) USA PO / Capsule Eli Lilly and Company 01 Oct 2009

Commercial Information

Involved Organisations

Organisation Involvement Countries
Eli Lilly and Company Originator USA
Eli Lilly and Company Owner USA
Vanda Pharmaceuticals Licensee World
National Institute on Alcohol Abuse and Alcoholism Collaborator USA

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
Alcohol Dependence Wrld (50% US) - Development Stopped - - - - 02 Apr 2020

Scientific Summary

Pharmacokinetics

A significant correlation between blood levels of tradipitant and the VAS change from baseline (p < 0.05) was seen during a phase II trial in pruritus. A separate analysis of the time of pruritus assessment revealed that approximately half the patients in the study came in for morning visits for their pruritus assessments and these patients also had higher blood levels of tradipitant than those who came in the afternoon. Patients with a VAS score of greater than 70mm were randomized to receive either 100mg of tradipitant (n = 34) or placebo (n = 35) once a day in the evening, for four weeks in the double-blind trial [36] .

Adverse Events

In a phase II trial, tradipitant was safe and well tolerated with minimal adverse events recorded. The 8-week, randomised 1:1, double-blind trial is designed to investigate the safety and efficacy of tradipitant 85mg bid in 168 patients with treatment-resistant pruritus associated with atopic dermatitis [24] [23] .

Tradipitant 100 mg was safe and well-tolerated and indicated an adverse event profile that was mild and similar to placebo. Patients with a VAS score of greater than 70mm were randomized to receive either 100mg of tradipitant (n = 34) or placebo (n = 35) once a day in the evening, for four weeks in the double-blind trial [36] .

In VLY-686-2301 study, treatment with tradipitant was well tolerable in patients with gastroparesis. Improvements in core gastroparesis symptoms were observed including nausea, vomiting, bloating, and fullness after meals consistent with an overall improvement. No worsening of any of the core symptoms were observed. Results were reported from a randomised placebo-controlled phase II study [13] [16] .

Therapeutic Trials

Updated results of the randomised, double-blind, phase II trial of tradipitant demonstrated a clinically meaningful and statistically significant improvement in measures of itch, disease severity and quality of life in 168 patients with with chronic pruritus associated with atopic dermatitis, refractory to treatment with antihistamines or corticosteroids. Patients receiving tradipitant observed improvment in the Worst Itch VAS scale, when compared with placebo (-44.2 versus -30.6, p = 0.019), the total SCORAD index (-21.3 versus -13.6, p = 0.008), objective SCORAD (-13.3 versus -7.2, p=0.005), the Clinician Global Impression of Change (CGI-C) scale (2.6 versus 3.3, p = 0.007), the Patient Global Impression of Change (PGI-C) scales for itch (2.6 versus 3.2, p = 0.025), Patient Global Impression of Change (PGI-C) scales for disease (2.7 versus 3.5, p = 0.007) and the Patient Benefit Index (PBI) scale (1.7 versus 1.2, p = 0.038). Improvements favouring tradipitant were also observed for Average Itch VAS, subjective SCORAD, and SKINDEX 16, but the differences did not reach significance for these measures [25] . Interim results demonstrated that tradipitant treatment caused significant and clinically meaningful improvement in the intensity of the worst itch patients experienced, and atopic dermatitis disease severity. Tradipitant also exhibited significant effects in a responder analysis for Worst Itch in patients who achieved improvements of ≥ 40 points improvement from baseline in Worst Itch VAS scores (p = 0.037) or ≥ 30 points (p = 0.049). On the pre-specified primary endpoint of Average Itch VAS, tradipitant demonstrated improvement over placebo, which was not significant due to high placebo effect and the lack of sensitivity of this measure. Consistent with the observed improvements in Worst Itch, which is associated with scratching behaviour, tradipitant also showed disease modifying properties by showing significant improvement in the total SCORAD scale (p = 0.008) and objective SCORAD scale (p = 0.005). Tradipitant showed significant improvements in several clinical features of severity of atopic dermatitis, including excoriation, erythema, oozing and dryness. In sub-population of 23 patients who had filaggrin (FLG) loss-of-function (LOF) variant mutation, 3/9 (33%) patients treated with tradipitant responded to the treatment (p = 0.047) [37] [24] [23] .

In VLY-686-2301 study, treatment with tradipitant in patients with gastroparesis showed significant improvements in the primary endpoint of change of nausea score as measured by patient daily diaries (-1.2 for tradipitant versus -0.7 for placebo, p = 0.0099). The drug also met the endpoint (p = 0.0160) of improvement in the number of nausea free days. Improvement in the number of nausea free days was 28.8% in tradipitant group while 15.0% in placebo group. Patients receiving tradipitant had a significant decrease in their average nausea score compared with placebo with LS mean difference (95% CI) of -0.53 (-0.92, -0.13, p=0.0099). A clinically meaningful response of 1-point or more improvement on the GCSI total score was observed in 46.0% of patients on tradipitant compared with 24.2% of patients on placebo. Tradipitant also showed significant improvement in scales reflecting overall gastroparesis symptoms including the Gastroparesis Symptom Index (GCSI) (p = 0.0223); Patients Assessment of Upper Gastrointestinal Disorders–Symptoms (PAGI-SYM) (p = 0.0497); and Patient Global Impression of Change (PGI-C) (p = 0.0429) as well as a Clinician Global Impression of Severity (CGI-S) (p = 0.0207). In a subgroup analysis of patients that experienced both nausea and vomiting at baseline (n = 101), tradipitant showed highly significant effects on the primary endpoint of change in nausea score (change of -1.4 for tradipitant versus -0.4 for placebo, p = 0.00002) as well as the number of nausea free days (an addition of 32.3% for tradipitant versus 7.6% for placebo, p = 0.0003). Results were reported from a randomised placebo-controlled phase II study [13] [16] .

In the phase II Motion Sifnos trial in participants with prior history of motion sickness, significantly fewer patients on tradipitant vomited than those on placebo. In the overall population (n=126), 39.7% of participants experienced vomiting in the placebo arm as compared to 17.5% of tradipitant arm (p = 0.0039). The Motion Sickness Severity Scale (MSSS) Worst score endpoint was favorable to tradipitant, but the difference did not reach statistical significance, 3.75 versus 3.4, (p= 0.293). In an exploratory analysis under the rough sea condition (n=19), 15.8% of tradipitant arm participants experienced vomiting as compared to 72.2% of the placebo treated arm (p = 0.0009). A significant effect was also seen under the rough sea conditions in the MSSS Worst score of 3.19 for tradipitant arm and 4.57 for placebo (p = 0.0235). Under the calm sea condition (n=44), 18.2% of participants experienced vomiting compared to 26.7% of placebo arm. A similar MSSS Worst score was seen between the two groups, 3.32 and 3.40, for placebo and tradipitant respectively (not significant) [20] [21] .

Tradipitant did not meet the primary endpoint of overall effect on itch, as measured by a 100mm visual analogue scale due to a large placebo effect, during a phase II trial in pruritus. Improvement from baseline for tradipitant was 40.5nm, compared with 36.5nm seen in the placebo arm (p < 0.0001). Analysis of patients who came in for morning visits indicated VAS change was -54mm in the tradipitant arm, compared with -30.3 in the placebo arm (p < 0.01) and VRS change was -1.46, compared with -0.67 (p < 0.05). CGC-C and PBI values were 2.46 and 1.47, relative to 3.61 and 0.73, respectively (p < 0.05). SCORAD subjective analysis in the tradipitant and placebo arms were -9.58 and -4.36, respectively (p < 0.01). Patients with a VAS score of greater than 70mm were randomized to receive either 100mg of tradipitant (n = 34) or placebo (n = 35) once a day in the evening, for four weeks in the double-blind trial [36] .

In the phase III EPIONE 1 trial, treatment with tradipitant demonstrated improvement in pruritus as measured by the Worst Itch Numeric Rating Scale (WI-NRS), in patients with atopic dermatitis. The magnitude of improvement were reported to be greater with tradipitant than placebo. A significant interaction was reported between baseline disease severity (IGA 1-4) and treatment (p=0.0004). A significantly larger improvement in WI-NRS was reported with tradipitant at the pre-specified endpoint of Week 8 in the full trial population (p=0.0217). Similar effects were reported throughout the treatment periods at all post-randomisation visits comprising weeks 2, 4, 6 and 8. Also a subgroup analysis reported that patients with mild disease severity (23% of study patients, IGA 1, 2) reported the largest improvement over placebo. A 72.5% of tradipitant patients reported clinically meaningful response as compared to 33.3% of placebo patients, as per categorical WI-NRS responder analysis (>4 point improvement [7] [6] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Regulatory Status Vanda Pharmaceuticals announces intention to file an NDA with the US FDA for Motion sickness in 2020 [20] 28 Feb 2020
31 Mar 2020 Trial Update Vanda plans a second phase III trial for Atopic dermatitis in the first quarter of 2020 [3] 15 Feb 2019
31 Dec 2019 Trial Update Vanda Pharmaceuticals plans a phase III trial in Motion Sickness in 2019 [12] 13 May 2020
30 Jun 2019 Regulatory Status Vanda plans a meeting with the US FDA to define and confirm the approval path of Tradipitant for Gastroparesis in the second quarter of 2019 [3] 02 Aug 2019
30 Jun 2019 Trial Update Vanda plans a phase III trial for Gastroparesis in the second quarter of 2019 [3] 02 Aug 2019
30 Jun 2018 Trial Update Vanda Pharmaceuticals plans a phase III trial for Atopic dermatitis in USA in the first half of 2018 [26] 04 Jul 2018

Development History

Event Date Update Type Comment
14 Apr 2020 Trial Update Vanda Pharmaceuticals initiates enrolment in the phase III ODYSSEY trial for pneumonia in COVID-2019 infections in USA (NCT04326426) [8] Updated 17 Apr 2020
02 Apr 2020 Financial Update Credit Suisse financial data update Updated 11 Apr 2020
02 Apr 2020 Phase Change - III Phase-III clinical trials in COVID-2019 infections in USA (PO) [9] Updated 08 Apr 2020
26 Feb 2020 Phase Change - III Phase-III clinical trials in Motion sickness in USA (PO) prior to February 2020 (Vanda Pharmaceuticals pipeline, February 2020) Updated 28 Feb 2020
25 Feb 2020 Scientific Update Efficacy data from the phase III EPIONE trial in Atopic dermatitis released by Vanda Pharmaceuticals [7] Updated 28 Feb 2020
01 Feb 2020 Trial Update Vanda Pharmaceuticals completes the phase III EPIONE trial in Atopic dermatitis in USA (PO, Capsule) (NCT03568331) Updated 04 May 2020
21 Oct 2019 Trial Update Vanda Pharmaceuticals initiates the phase III EPIONE 2 trial for Atopic dermatitis in USA [5] Updated 15 Nov 2019
19 Oct 2019 Scientific Update Efficacy data from a phase II trial in Gastroparesis presented at the 27th United European Gastroenterology Week (UEGW-2019) [17] Updated 26 Feb 2020
30 Sep 2019 Trial Update Vanda Pharmaceuticals completes enrolment in the phase III EPIONE 1 trial for Atopic dermatitis in USA [5] Updated 15 Nov 2019
31 Jul 2019 Trial Update Vanda Pharmaceuticals plans a phase III trial in Motion Sickness in 2019 [12] Updated 13 May 2020
23 Jul 2019 Phase Change - III Phase-III clinical trials in Gastroparesis in USA (PO) (NCT04028492) Updated 29 Jul 2019
16 Jul 2019 Regulatory Status Vanda Pharmaceuticals announces intention to file an NDA with the US FDA for Motion sickness in 2020 [20] Updated 28 Feb 2020
16 Jul 2019 Scientific Update Efficacy data from a phase II Motion Sifnos trial in Motion sickness released by Vanda Pharmaceuticals [20] (NCT03772340) Updated 18 Jul 2019
30 Apr 2019 Regulatory Status Vanda and the US FDA files a Joint Motion for extension of time to propose a scheduling order for partial clinical hold of tradipitant Updated 08 May 2019
26 Apr 2019 Regulatory Status The US FDA continues with the partial clinical hold on clinical studies of tradipitant after re-evaluation Updated 08 May 2019
13 Feb 2019 Regulatory Status Vanda plans a meeting with the US FDA to define and confirm the approval path of Tradipitant for Gastroparesis in the second quarter of 2019 [3] Updated 02 Aug 2019
13 Feb 2019 Trial Update Vanda plans a phase III trial for Gastroparesis in the second quarter of 2019 [3] Updated 02 Aug 2019
13 Feb 2019 Regulatory Status Vanda plans to submit NDA to the US FDA for Gastroparesis [3] Updated 15 Feb 2019
13 Feb 2019 Trial Update Vanda plans a second phase III trial for Atopic dermatitis in the first quarter of 2020 [3] Updated 15 Feb 2019
05 Feb 2019 Regulatory Status Vanda Pharmaceuticals files a complaint against the US FDA for partial clinical hold on clinical studies of tradipitant [1] Updated 07 Feb 2019
31 Dec 2018 Phase Change - II Phase-II clinical trials in Motion sickness (In adults, In the elderly) in USA (PO) (NCT03772340) Updated 19 Dec 2018
19 Dec 2018 Regulatory Status US FDA imposes a partial clinical hold on Vanda Pharmaceuticals studies of tradipitant [1] [3] Updated 07 Feb 2019
03 Dec 2018 Scientific Update Efficacy and adverse events data from a phase II trial in Gastroparesis released by Vanda Pharmaceuticals [13] Updated 07 Dec 2018
30 Sep 2018 Trial Update Vanda Pharmaceuticals completes enrolment in a phase II trial in Gastroparesis in USA [14] Updated 15 Nov 2018
24 Jun 2018 Biomarker Update Biomarkers information updated Updated 31 Aug 2018
01 Jun 2018 Phase Change - III Phase-III clinical trials in Atopic dermatitis in USA (PO, Capsule) (NCT03568331) Updated 04 Jul 2018
16 Feb 2018 Scientific Update Interim efficacy data from a phase II trial in Pruritus presented at the 76th Annual Meeting of the American Academy of Dermatology (AAD-2018) [25] Updated 08 May 2018
07 Nov 2017 Trial Update Vanda Pharmaceuticals plans a phase III trial for Atopic dermatitis in USA in the first half of 2018 [26] Updated 04 Jul 2018
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for phase-I development in Pruritus(In volunteers) in Switzerland (PO, Capsule) Updated 04 Nov 2017
13 Sep 2017 Scientific Update Efficacy and adverse events data from a phase II trial in Pruritus released by Vanda Pharmaceuticals [24] Updated 15 Sep 2017
01 Sep 2017 Trial Update Vanda Pharmaceuticals completes a phase II trial in Pruritus (Treatment-resistant) in USA (PO) (NCT02651714) Updated 14 Nov 2017
29 Mar 2017 Patent Information Eli lilly has patent protection for tradipitant worldwide (Vanda pharmaceuticals form 10-k, March 2017) Updated 07 Apr 2017
29 Mar 2017 Patent Information Eli lilly has patents pending for tradipitant worldwide (Vanda pharmaceuticals form 10-k, March 2017) Updated 07 Apr 2017
01 Nov 2016 Phase Change - II Phase-II clinical trials in Gastroparesis in USA (PO) (NCT02970968) Updated 20 Dec 2016
27 Jul 2016 Trial Update Vanda Pharmaceuticals plans a phase II trial in Gastroparesis [15] Updated 01 Aug 2016
01 Feb 2016 Trial Update Vanda Pharmaceuticals completes a pharmacokinetics phase I trial in Healthy volunteers in Switzerland and USA (PO) (NCT02621385) Updated 04 May 2016
01 Jan 2016 Phase Change - II Phase-II clinical trials in Pruritus (Treatment-resistant) in USA (PO) (NCT02651714) Updated 24 Feb 2016
01 Dec 2015 Trial Update Vanda Pharmaceuticals plans a phase II trial for Pruritus (Treatment resistant) in USA (NCT02651714) Updated 27 Jan 2016
01 Nov 2015 Trial Update Vanda Pharmaceuticals initiates a pharmacokinetics phase I trial in Healthy volunteers in Switzerland and USA (PO) (NCT02621385) Updated 08 Dec 2015
29 Jul 2015 Trial Update Vanda Pharmaceuticals plans a phase II trial for Pruritus (in patients with Atopic dermatitis) [22] Updated 06 Aug 2015
05 Mar 2015 Scientific Update Efficacy, safety and pharmacokinetics data from a phase II trial in pruritus released by Vanda Pharmaceuticals [36] Updated 29 Mar 2015
04 Mar 2015 Trial Update Vanda Pharmaceuticals completes a phase II trial in Pruritis (Treatment resistant) in Germany Updated 10 Mar 2015
28 Oct 2014 Regulatory Status Vanda Pharmaceuticals files an IND application with the US FDA for Puritis [33] Updated 15 Nov 2014
19 Nov 2013 Trial Update Vanda Pharmaceuticals completes a phase I trial in Pruritus in Switzerland (NCT01919944) Updated 26 Nov 2013
05 Nov 2013 Phase Change - II Phase-II clinical trials in Pruritus (treatment-resistant) in Germany (PO) Updated 18 Nov 2013
05 Nov 2013 Trial Update Vanda Pharmaceuticals completes enrolment in its phase I trial for Pruritis in Switzerland (NCT01919944) Updated 11 Nov 2013
06 Aug 2013 Phase Change - I Phase-I clinical trials in Pruritus in Switzerland (PO) Updated 12 Aug 2013
04 Apr 2013 Trial Update Vanda Pharmaceuticals plans a phase II trial for an unspecified indication Updated 30 Apr 2013
16 Apr 2012 Licensing Status Tradipitant licensed to Vanda Pharmaceuticals worldwide [2] Updated 17 Apr 2012
01 Oct 2009 Phase Change - Discontinued(II) Discontinued - Phase-II for Alcoholism in USA (PO) Updated 21 Jan 2010
01 Oct 2009 Phase Change - Discontinued(II) Discontinued - Phase-II for Social phobia in USA (PO) Updated 21 Jan 2010
31 Mar 2006 Phase Change - II Phase-II clinical trials in Alcoholism in USA (PO) Updated 19 Sep 2008
31 Dec 2004 Phase Change - II Phase-II clinical trials in Social phobia in USA (PO) Updated 19 Sep 2008

References

  1. Vanda Pharmaceuticals Takes a Stand Against Unnecessary Animal Research.

    Media Release
  2. Vanda Pharmaceuticals Acquires Rights to NK-1 Receptor Antagonist from Eli Lilly and Company.

    Media Release
  3. Vanda Pharmaceuticals Reports Fourth Quarter 2018 and Full Year 2018 Financial Results.

    Media Release
  4. A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY STUDY OF THE NEUROKININ-1 RECEPTOR ANTAGONIST VLY-686 IN PATIENTS WITH ATOPIC DERMATITIS

    ctiprofile
  5. Vanda Pharmaceuticals Reports Third Quarter 2019 Financial Results.

    Media Release
  6. A Randomized, Double-Blind, Placebo-Controlled Efficacy Study of The Neurokinin-1 Receptor Antagonist VLY-686 in Patients With Atopic Dermatitis

    ctiprofile
  7. Vanda Reports results from the EPIONE study of Tradipitant in the treatment of Pruritus in Atopic Dermatitis.

    Media Release
  8. Vanda Pharmaceuticals, Northwell Health Conduct ODYSSEY Trial In Patients With Severe COVID-19 Pneumonia.

    Media Release
  9. Vanda Pharmaceuticals Announces the Initiation of ODYSSEY, an FDA Approved Clinical Study of Tradipitant in Hospitalized Patients with Severe COVID-19 Pneumonia.

    Media Release
  10. ODYSSEY: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Treating Inflammatory Lung Injury and Improving Clinical Outcomes Associated With Severe or Critical COVID-19 Infection

    ctiprofile
  11. VP-VLY-686-3301: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study To Assess The Efficacy Of Tradipitant In Relieving Symptoms Of Gastroparesis

    ctiprofile
  12. Vanda Pharmaceuticals Reports Second Quarter 2019 Financial Results.

    Media Release
  13. Vanda Announces Positive Phase II Study Results for Tradipitant in Patients with Gastroparesis.

    Media Release
  14. Vanda Pharmaceuticals Reports Third Quarter 2018 Financial Results.

    Media Release
  15. Vanda Pharmaceuticals Reports Second Quarter 2016 Financial Results.

    Media Release
  16. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Efficacy of VLY-686 (Tradipitant) in Relieving Symptoms of Gastroparesis

    ctiprofile
  17. Carlin J, Lieberman V, Dahal A, Keefe M, Xiao C, Birznieks G, et al. Tradipitant, a Novel Nk-1 Receptor Antagonist, Significantly Improved Nausea and Other Symptoms of Gastroparesis in a Phase II Trial. UEGW-2019 2019; abstr. OP137.

    Available from: URL: http://www.professionalabstracts.com/ueg2019/iplanner/#/grid/1571443200
  18. Motion Syros: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Tradipitant in the Treatment of Motion Sickness

    ctiprofile
  19. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results.

    Media Release
  20. Tradipitant Effective in Preventing Motion Sickness.

    Media Release
  21. Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

    ctiprofile
  22. Vanda Pharmaceuticals Reports Second Quarter 2015 Financial Results.

    Media Release
  23. A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Tradipitant in Treatment-resistant Pruritus Associated With Atopic Dermatitis

    ctiprofile
  24. Vanda's Tradipitant Improves Itch and Disease Severity in Patients with Atopic Dermatitis.

    Media Release
  25. Heitman A, Xiao C, Cho Y, Polymeropoulos C, Birznieks G, Polymeropoulos M. Tradipitant Improves Worst Itch and Disease Severity in Patients with Chronic Pruritus Related to Atopic Dermatitis. AAD-2018 2018; abstr. 7788.

    Available from: URL: https://www.aad.org/eposters/view/Abstract.aspx?id=7788
  26. Vanda Pharmaceuticals Reports Third Quarter 2017 Financial Results.

    Media Release
  27. Vanda Pharmaceuticals Reports Fourth Quarter 2014 and Full Year 2014 Financial Results.

    Media Release
  28. Vanda Pharmaceuticals Reports First Quarter 2013 Results.

    Media Release
  29. Vanda Pharmaceuticals Reports Second Quarter 2014 Results.

    Media Release
  30. A randomized, double-blind, placebo-controlled, proof of concept, antipruritic study of the neurokinin-1 receptor antagonist VLY-686 in subjects with treatment-resistant pruritus associated with atopic dermatitis.

    ctiprofile
  31. Affimed Announces Financial Results for Fourth Quarter and Year End 2014.

    Media Release
  32. A Randomized, Double-Blind, Placebo-Controlled, Four-Way Crossover Study on Itch Control by VLY-686 Administration in Healthy Volunteers After Intradermal Injections of Substance P

    ctiprofile
  33. Vanda Pharmaceuticals Reports Third Quarter 2014 Financial Results.

    Media Release
  34. An Open-label, Single-sequence Study to Assess the Effect of Multiple Doses of Tradipitant on Cytochrome P450 3A4 Using Midazolam as a Substrate in Healthy Subjects.

    ctiprofile
  35. Vanda Pharmaceuticals Inc. Prices Public Offering of Common Stock.

    Media Release
  36. Vanda Pharmaceuticals Announces Tradipitant Phase II Proof of Concept Study Results for Chronic Pruritus in Atopic Dermatitis.

    Media Release
  37. Smieszek S, Xiao D, Welsh S, Polymeropoulos C, Birznieks G, Polymeropoulos M. Tradipitant Response in Atopic Dermatitis patients with Filaggrin Loss-of-Function variants. AAD-2019 2019; abstr. 10098.

    Available from: URL: https://www.aad.org/eposters/view/Abstract.aspx?id=10098
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