Data updated: Jun 28, 2026
Arexvy (respiratory syncytial virus vaccine, adjuvanted) · GSK
Approved 2023-05-02
1
Indication
--
Phase 3 Trials
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2023-05-02
- Patent Cliff
- 2035
- Routes
- Intramuscular
- Dosage Forms
- For Injection
Arexvy Approval History
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
May 2023 ORIGINAL
Update · CBER biologic (Purple Book)
What Arexvy Treats
1 FDA approvalsOriginally approved for its first indication in 2023 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2023)
GSK's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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OJJAARA
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1 designation
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1 designation
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JEMPERLI
2021 DOSTARLIMAB-GXLY
3 designations
KRINTAFEL
2018 TAFENOQUINE SUCCINATE
3 designations
ZEJULA
2017 NIRAPARIB TOSYLATE
4 designations
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06194318 | CLO-SCB-1019-001 | Ph 1 | completed | First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults |
| NCT06843317 | CLO-SCB-1019-002 | Ph 1 | recruiting | Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy 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.
Arexvy FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.