nirsevimab
Trade name: Beyfortus
mAbapprovedFast Track FDA
Approved
Jul 17, 2023
Clinical trial activity
14 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
8
Phase 3
7
Phase 4
1
Earliest trial started Apr 1, 2014 (NCT02114268)
Timeline
2010s
- Jan 1, 2014
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2016
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2019
AstraZeneca — Earliest Phase 3 Sponsor(trial)
2020s
- Jul 17, 2023
AstraZeneca — Earliest FDA Approval
- Jul 17, 2023
AstraZeneca — Marketing Organization
- Jul 17, 2023
AstraZeneca — NDA Secondary Org
- Jul 17, 2023
AstraZeneca — NDA Organization
Indications
Mechanism of action
- RSV F-proteinANTAGONIST
RSV F-protein antagonist
- Fusion glycoprotein F0INHIBITOR
Fusion glycoprotein F0 inhibitor
Approval history
- approvedFast trackJul 17, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4297575 ↗
Also known as
- medi8897
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07232706 | Phase 3 | Jan 31, 2026 | CH Annecy, University of Paris |
| NCT07041190 | Phase 3 | Sep 30, 2025 | PENTA Foundation |
| NCT07106918 | Early Phase 1 (Phase 1) | Aug 17, 2025 | China National Biotec Group Co., Ltd |
| NCT07109297 | Phase 4 | Jul 31, 2025 | Sanofi |
| NCT06042049 | Phase 3 | Jul 27, 2023 | AstraZeneca, IQVIA |
| NCT05437510 | Phase 3 | Aug 8, 2022 | AstraZeneca, Sanofi, Sanofi-Aventis |
| NCT05110261 | Phase 3 | Nov 5, 2021 | AstraZeneca, IQVIA |
| NCT04840849 | Phase 1 | Jun 22, 2021 | AstraZeneca, IQVIA |
| NCT04484935 | Phase 2 | Aug 19, 2020 | AstraZeneca, IQVIA |
| NCT03979313 | Phase 3 | Jul 26, 2019 | AstraZeneca |
| NCT03959488 | Phase 2/Phase 3 (Phase 3) | Jul 26, 2019 | AstraZeneca |
| NCT02878330 | Phase 2 | Nov 3, 2016 | MedImmune |
| NCT02290340 | Phase 1 | Jan 1, 2015 | MedImmune |
| NCT02114268 | Phase 1 | Apr 1, 2014 | MedImmune |
Showing 14 of 14 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 7 | 6 | 3 | 2019 |
| IQVIA | For profit | 4 | 0 | 3 | 2020 |
| MedImmune | For profit | 3 | 3 | 2 | 2014 |
| Sanofi | For profit | 2 | 1 | 2 | 2022 |
| CH Annecy | Academic/Hospital | 1 | 1 | 1 | 2026 |
| China National Biotec Group Co., Ltd | For profit | 1 | 1 | 1 | 2025 |
| PENTA Foundation | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Sanofi-Aventis | For profit | 1 | 1 | 1 | 2022 |
| University of Paris | Academic/Hospital | 1 | 0 | 1 | 2026 |
9 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | Jul 17, 2023 |
| AstraZeneca | For profit | NDA2 | Jul 17, 2023 |
| AstraZeneca | For profit | NDA | Jul 17, 2023 |