Data updated: May 26, 2026
PENBRAYA (meningococcal groups a, b, c, w, and y vaccine)
Approved 2023-10-19
1
Indication
--
Phase 3 Trials
2
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-10-19
- Routes
- Intramuscular
- Dosage Forms
- Injection
PENBRAYA Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
Oct 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What PENBRAYA Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2023)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07197762 | STUDY00009836 2025P011916 | Ph 4 | recruiting | MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PENBRAYA FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.