RSVPreF3
Trade name: Arexvy
Vaccineapproved
Approved
May 3, 2023
Clinical trial activity
39 trials · 10 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
34
Phase 3
24
Phase 4
0
Earliest trial started Jul 1, 2015 (NCT02491463)
Timeline
2010s
- Jan 1, 2015
GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- May 3, 2023
GlaxoSmithKline — Earliest FDA Approval
- May 3, 2023
GlaxoSmithKline — NDA Secondary Org
- May 3, 2023
GlaxoSmithKline — NDA Organization
Indications
Mechanism of action
- RSV F-proteinImmunity, active
RSV F-protein immunity, active
- Respiratory syncytial virusImmunity, active
Respiratory syncytial virus immunity, active
Approval history
- approvedMay 3, 2023
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- gsk3389245a
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07050732 | Phase 2 | Dec 31, 2025 | GlaxoSmithKline, Johns Hopkins University |
| NCT07220109 | Phase 3 | Oct 31, 2025 | GlaxoSmithKline |
| NCT07092865 | Phase 2 | Aug 6, 2025 | GlaxoSmithKline |
| NCT06866405 | Phase 3 | Apr 8, 2025 | Pfizer |
| NCT06843317 | Phase 1 | Mar 21, 2025 | Clover Biopharmaceuticals |
| NCT06593210 | Phase 3 | Oct 31, 2024 | University of Toronto |
| NCT06614725 | Phase 3 | Oct 1, 2024 | GlaxoSmithKline |
| NCT06597916 | Phase 2 | Sep 19, 2024 | GlaxoSmithKline, Medical University of Vienna |
| NCT06556147 | Phase 1 | Aug 13, 2024 | Sunshine Coast University, Australia, Veritas Research., Corp., Vicebio |
| NCT06551181 | Phase 3 | Aug 5, 2024 | GlaxoSmithKline |
| NCT06534892 | Phase 3 | Aug 1, 2024 | GlaxoSmithKline |
| NCT06473519 | Phase 3 | Jun 24, 2024 | Pfizer |
| NCT06389487 | Phase 3 | Apr 29, 2024 | GlaxoSmithKline |
| NCT06374394 | Phase 3 | Apr 29, 2024 | GlaxoSmithKline |
| NCT05921903 | Phase 2 | Jul 28, 2023 | GlaxoSmithKline |
| NCT05966090 | Phase 3 | Jul 28, 2023 | GlaxoSmithKline |
| NCT05900154 | Phase 3 | Jun 22, 2023 | Pfizer |
| NCT05886777 | Phase 2 | Jun 5, 2023 | Pfizer |
| NCT05879107 | Phase 3 | May 26, 2023 | GlaxoSmithKline |
| NCT05842967 | Phase 3 | May 11, 2023 | Pfizer |
Showing 20 of 39 trials
Page 1 / 2
Organizations
Research & Development (10)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 26 | 24 | 3 | 2015 |
| Pfizer | For profit | 10 | 9 | 3 | 2020 |
| Clover Biopharmaceuticals | For profit | 1 | 1 | 1 | 2025 |
| hVIVO Services Limited | For profit | 1 | 1 | 1 | 2020 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Medical University of Vienna | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Sunshine Coast University, Australia | Academic/Hospital | 1 | 0 | 1 | 2024 |
| University of Toronto | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Veritas Research., Corp. | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Vicebio | For profit | 1 | 1 | 1 | 2024 |
10 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | May 3, 2023 |
| GlaxoSmithKline | For profit | NDA | May 3, 2023 |