Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

TAK 426

Drug Profile

TAK 426

Alternative Names: PIZV; Purified inactivated Zika virus vaccine - Takeda; TAK426; Zika virus vaccine - Takeda

Latest Information Update: 28 Jan 2021

At a glance

  • Originator Takeda
  • Class Zika virus vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I Zika virus infection

Most Recent Events

  • 11 May 2021 Takeda expects approval for Zika virus infection in FY 2025 (Takeda pipeline, May 2021)
  • 28 Jan 2021 No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in Puerto Rico (IM, Injection)
  • 28 Dec 2020 No recent reports of development identified for phase-I development in Zika-virus-infection(Prevention) in USA (IM, Injection)

Development Overview

Introduction

Takeda is developing TAK 426 (also known as PIZV), an inactivated, purified, alum adjuvanted, whole virus vaccine for the prevention of Zika virus infection. The vaccine is being developed under a funding granted by Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services. Phase I development of the candidate is underway in the US.

As at December 2020, no recent reports of development had been identified for phase-I development in Zika-virus-infection (Prevention) in USA (IM, Injection).

As at January 2021, no recent reports of development had been identified for phase-I development in Zika-virus-infection (Prevention) in Puerto Rico (IM, Injection).

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

In January 2018, TAK 426 was granted fast track designation by the US FDA for the prevention of Zika virus infection [2] .

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 [3] [1] [4] .

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)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Zika virus infection - Prevention Phase I USA (fast track) IM / Injection Takeda 30 Dec 2020
Zika virus infection - Prevention No development reported (I) Puerto Rico IM / Injection Takeda 28 Jan 2021

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) 28 May 2021

Development History

Event Date Update Type Comment
11 May 2021 Regulatory Status Takeda expects approval for Zika virus infection in FY 2025 (Takeda pipeline, May 2021) Updated 28 May 2021
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) [3] (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 [3] 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

  1. Takeda to develop Zika Vaccine with up to $312 million in funding from US Government.

    Media Release
  2. Takedas Zika Vaccine Candidate Receives U.S. FDA Fast Track Designation.

    Media Release
  3. Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate.

    Media Release
  4. 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
Back to top