HelpAcademyLoginJoin us as a Member

PCV21

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Sanofi SNY SNYNF · Pneumococcal Infections; Sickle Cell Disease

Sign in to save PCV21 to a watchlist Sign in to set an alert for PCV21

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Sanofi SNY SNYNF Source: Company record for Sanofi (opens in a new tab)
Indications
Pneumococcal Infections; Sickle Cell Disease Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 28 Feb 20252 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for PCV21. Editors add each one with its source.

Filed application

No filed application is on record for PCV21. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for PCV21.

Clinical trials

Trials linked to PCV21
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07247188ClinicalTrials.gov record for NCT07247188 (opens in a new tab)Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell DiseasePhase 3Recruiting100 (estimated)7 Jan 2027 (estimated) No
NCT06838000ClinicalTrials.gov record for NCT06838000 (opens in a new tab)Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and AdolescentsPhase 3Active, not recruiting1,268 (actual)1 Dec 2026 (estimated) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

Loading trial quality…

FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as PCV21.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.