cosibelimab
Trade name: Unloxcyt
mAbapproved
Approved
Dec 13, 2024
Clinical trial activity
3 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
1
Phase 3
1
Phase 4
0
Earliest trial started Sep 20, 2017 (NCT03212404)
Timeline
2010s
- Jan 1, 2017
Fortress Biotech — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2021
Fortress Biotech — Earliest Phase 3 Sponsor(trial)
- Dec 13, 2024
Fortress Biotech — Earliest FDA Approval
- Dec 13, 2024
Fortress Biotech — NDA Organization
- Dec 13, 2024
Fortress Biotech — Marketing Organization
Indications
Approved for
Studied for
- Carcinoma, Merkel Cell · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinoma, Renal Cell · Phase 1
- Carcinoma, Small Cell · Phase 1
- Carcinoma, Squamous Cell · Phase 1
- Carcinoma, Transitional Cell · Phase 1
- Endometrial Neoplasms · Phase 1
- Head and Neck Neoplasms · Phase 1
- Hodgkin Disease · Phase 1
- Lung Neoplasms · Phase 1
- Lymphoma, Non-Hodgkin · Phase 1
- Melanoma · Phase 1
- Mesothelioma · Phase 1
- Pancreatic Neoplasms · Phase 1
- Small Cell Lung Carcinoma · Phase 3
Mechanism of action
- Programmed cell death 1 ligand 1INHIBITOR
Programmed cell death 1 ligand 1 inhibitor
Approval history
- approvedDec 13, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4297729 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06981806 | Phase 1 | Jan 31, 2026 | Cedars-Sinai Medical Center |
| NCT04786964 | Phase 3 | Sep 30, 2021 | Fortress Biotech |
| NCT03212404 | Phase 1 | Sep 20, 2017 | Fortress Biotech, Novotech |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Fortress Biotech | For profit | 2 | 2 | 2 | 2017 |
| Cedars-Sinai Medical Center | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Novotech | For profit | 1 | 0 | 1 | 2017 |
3 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Fortress Biotech | For profit | NDA | Dec 13, 2024 |
| Fortress Biotech | For profit | MKTG | Dec 13, 2024 |