Drugs / PCV21
PCV21
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Capvaxive | — | 2025-03-24 | europa.eu ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07712575 | Aug 2026 → Jun 2028 expected | — | Merck Sharp & Dohme LLC | Not yet recruiting | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07247188 | Jan 2026 → Jan 2027 expected | sickle cell disease | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT07348692 | Jan 2026 → Jun 2027 expected | — | Sanofi | Recruiting | No outcome recorded |
| Phase 3 | NCT06975878 | May 2025 → Aug 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06838000 | Feb 2025 → Dec 2026 expected | pneumococcal infection | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06824194 | Feb 2025 → Oct 2027 expected | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06736041 | Dec 2024 → May 2027 expected | — | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07135453 | Jul 2026 → Mar 2027 expected | pneumococcal infection | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 4 | NCT06271681 | Jan 2026 → Jan 2027 expected | immunodeficiency disease | VA Sierra Nevada Health Care System | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07284654 Comparator | Dec 2025 → Jan 2027 expected | — | Vaxcyte, Inc. | Active not recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-12-23 | Sanofi | Press Release: Sanofi initiates phase 3 program for PCV21 and expands collaboration with SK bioscience for next-generation pneumococcal conjugate vaccines sanofi.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PCV21 | “Will receive PCV21” NCT07135453 ↗ |
| Known as | 21-valent pneumococcal conjugate vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06271681 ↗ |
| Known as | CAPVAXIVE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07712575 ↗ |
| Modality | Vaccine | “21-valent pneumococcal conjugate vaccine” NCT06271681 ↗ |
| Route | Intramuscular | “Route of administration:Intramuscular” NCT06736041 ↗ |