respiratory syncytial virus vaccine

Trade name: ABRYSVO

VaccineapprovedBreakthrough Therapy FDA

Approved

May 31, 2023

Clinical trial activity

6 trials · 7 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
5
Phase 3
4
Phase 4
1

Earliest trial started Nov 13, 2024 (NCT06642558)

Timeline

2020s

  1. May 31, 2023

    Pfizer — Earliest FDA Approval

  2. May 31, 2023

    Pfizer — NDA Secondary Org

  3. May 31, 2023

    Pfizer — NDA Organization

  4. Jan 1, 2024

    Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2025

    Pfizer — Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedBreakthroughMay 31, 2023

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07232706Phase 3Jan 31, 2026CH Annecy, University of Paris
NCT07296120Phase 4Jan 1, 2026Rowan University
NCT07272434Phase 3Oct 22, 2025Government of China, MAXVAX Biotechnology Limited Liability Company
NCT07041190Phase 3Sep 30, 2025PENTA Foundation
NCT06890416Phase 3Apr 4, 2025Pfizer
NCT06642558Phase 1/Phase 2 (Phase 2)Nov 13, 2024Government of China, MAXVAX Biotechnology Limited Liability Company
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Government of ChinaGovernment2022024
MAXVAX Biotechnology Limited Liability CompanyFor profit2222024
CH AnnecyAcademic/Hospital1112026
PENTA FoundationAcademic/Hospital1112025
PfizerFor profit1112025
Rowan UniversityAcademic/Hospital1012026
University of ParisAcademic/Hospital1012026
7 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDA2May 31, 2023
PfizerFor profitNDAMay 31, 2023