TAK 426
Alternative Names: PIZV; Purified inactivated Zika virus vaccine - Takeda; TAK-426; Zika virus vaccine - TakedaLatest Information Update: 27 Mar 2024
At a glance
- Originator Takeda
- Class Zika virus vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Discontinued Zika virus infection
Most Recent Events
- 13 Mar 2024 Takeda terminates a phase II trial in Zika virus infection (Prevention) in USA prior to enrolment (IM, Injection) (NCT05469802)
- 28 Jan 2024 No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in USA (IM, Injection)
- 30 Jun 2023 Discontinued - Phase-I for Zika virus infection (Prevention) in Puerto Rico (IM) (Takeda pipeline; February 2024)
Development Overview
Introduction
Takeda was developing TAK 426 (also known as PIZV), an inactivated, purified, alum adjuvanted, whole virus vaccine for the prevention of Zika virus infection. The vaccine was developed under a funding granted by Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services. Clinical development of the candidate was underway in the US and Puerto Rico, however, as of June 2023, company discontinued development.
Company Agreements
Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services has provided an initial funding of $US19.8 million for the development of this vaccine upto Phase I and a potential funding of up to $US312 million if BARDA exercises all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application (BLA) in the US [1] .
Key Development Milestones
As of June 2023, Takeda discontinued the development of TAK 426 (Takeda pipeline; February 2024).
In January 2018, TAK 426 was granted fast track designation by the US FDA for the prevention of Zika virus infection [2] .
In March 2024, Takeda terminate a phase II trial prior to enrolment which was designed to evaluate the safety and immunogenicity of the purified inactivated zika virus vaccine (PIZV) administered on days 1 and 29 in healthy participants aged 18 to 49 years (NCT05469802; ZIK-201). The double-blind, randomized was initiated in January 2024 [3] .
In November 2020, Takeda completed a phase I trial that assessed the safety, tolerability and immunogenicity of two doses of TAK 426 in flavivirus naive and primed healthy adults (ZIK-101; U1111-1201-5778; NCT03343626). The trial was initiated in November 2017 and enrolled 271 volunteers is underway in the US and Puerto Rico. The trial is being conducted under a US IND application.Based on the results from the trial, the company plans to conduct a phase II trial [4] [1] [5] .
In September 2016, Takeda announced that the Biomedical Advanced Research and Development Authority (BARDA), has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. As a part of the first stage of work, the company is planning to complete pre-clinical studies [1] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class Zika virus vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
D06B-B (Antivirals)
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E (Viral Vaccines)
Table of Contents
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Zika virus infection | - | Prevention | Discontinued (I) | Puerto Rico, USA (fast track) | IM / Injection | Takeda | 30 Jun 2023 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Zika virus infection |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Takeda | Originator | Japan |
| Takeda | Owner | Japan |
| Biomedical Advanced Research and Development Authority | Funder | USA |
| US Department of Health and Human Services | Funder | USA |
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2025 | Regulatory Status | Takeda expects approval for Zika virus infection in FY 2025 (Takeda pipeline, May 2021) | 24 Mar 2024 |
| 27 Sep 2022 | Trial Update | Takeda plans a phase II trial for Zika virus infection (Prevention) (IM, Injection) in September 2022 (NCT05469802) (700354758) | 27 Mar 2024 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 13 Mar 2024 | Trial Update | Takeda terminates a phase II trial in Zika virus infection (Prevention) in USA prior to enrolment (IM, Injection) (NCT05469802) Updated 27 Mar 2024 |
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in USA (IM, Injection) Updated 28 Jan 2024 |
| 30 Jun 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Zika virus infection (Prevention) in Puerto Rico (IM) (Takeda pipeline; February 2024) Updated 27 Feb 2024 |
| 30 Jun 2023 | Phase Change - Discontinued(I) | Discontinued - Phase-I for Zika virus infection (Prevention) in USA (IM) (Takeda pipeline; February 2024) Updated 27 Feb 2024 |
| 22 Jul 2022 | Trial Update | Takeda plans a phase II trial for Zika virus infection (Prevention) (IM, Injection) in September 2022 (NCT05469802) Updated 27 Mar 2024 |
| 11 May 2021 | Regulatory Status | Takeda expects approval for Zika virus infection in FY 2025 (Takeda pipeline, May 2021) Updated 24 Mar 2024 |
| 28 Jan 2021 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in Puerto Rico (IM, Injection) Updated 28 Jan 2021 |
| 30 Dec 2020 | Phase Change - I | Phase-I clinical trials in Zika virus infection (Prevention) in USA (IM) (NCT03343626) Updated 30 Dec 2020 |
| 28 Dec 2020 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in USA (IM, Injection) Updated 28 Dec 2020 |
| 24 Nov 2020 | Trial Update | Takeda completes a phase I trial in Zika virus infection (Prevention) in USA (IM) (NCT03343626) Updated 30 Dec 2020 |
| 29 Jan 2018 | Regulatory Status | TAK 426 receives Fast Track designation for Zika virus infection [IM,Injection] (Prevention) in USA [2] Updated 31 Jan 2018 |
| 28 Nov 2017 | Phase Change - I | Phase-I clinical trials in Zika virus infection (Prevention) in USA (IM, Injection) [4] (NCT03343626) Updated 30 Nov 2017 |
| 28 Nov 2017 | Trial Update | Takeda plans a phase II trial for Zika virus infection based on the clinical data of the phase I trial [4] Updated 30 Nov 2017 |
| 15 Nov 2017 | Trial Update | Takeda plans a phase I trial for Zika virus infections (Prevention) in USA and Puerto Rico (NCT03343626) Updated 24 Nov 2017 |
| 13 Nov 2017 | Phase Change - I | Phase-I clinical trials in Zika virus infection (Prevention) in Puerto Rico (IM) (NCT03343626) Updated 30 Dec 2020 |
| 01 Sep 2016 | Company Involvement | Takeda receives funding from BARDA for development of vaccine for Zika virus infection (prevention) [1] Updated 06 Sep 2016 |
| 01 Sep 2016 | Phase Change | Early research in Zika virus infection in Japan (unspecified route) Updated 06 Sep 2016 |
References
-
Takeda to develop Zika Vaccine with up to $312 million in funding from US Government.
Media Release -
Takedas Zika Vaccine Candidate Receives U.S. FDA Fast Track Designation.
Media Release -
A Randomized, Observer-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Safety and Immunogenicity of the Purified Inactivated Zika Virus Vaccine (PIZV) Administered on Days 1 and 29 in Healthy Participants Aged 18 to 49 Years in the US
ctiprofile -
Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate.
Media Release -
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine (PIZV) Candidate in Flavivirus Naive and Primed Healthy Adults Aged 18 to 49 Years
ctiprofile
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