Talquetamab
Trade name: Talvey
mAbapprovedBi-specificOrphan Drug FDABreakthrough Therapy FDA
Approved
Aug 9, 2023
Clinical trial activity
29 trials · 27 clinical orgs · 1 marketing orgs
Phase 1
10
Phase 2
18
Phase 3
3
Phase 4
0
Earliest trial started Dec 16, 2017 (NCT03399799)
Timeline
2010s
- Jan 1, 2017
Johnson and Johnson — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2021
Earliest Phase 2 Sponsor(trial)
- May 3, 2021
Orphan Drug Designation
- Aug 9, 2023
Johnson and Johnson — Earliest FDA Approval
- Aug 9, 2023
Johnson and Johnson — Marketing Organization
- Aug 9, 2023
Johnson and Johnson — NDA Secondary Org
- Aug 9, 2023
Johnson and Johnson — NDA Organization
Indications
Approved for
Mechanism of action
CD3E activator
- T cell surface glycoprotein CD3BINDING AGENT
T cell surface glycoprotein CD3 binding agent
Directs cytotoxic T-cells to tumours
- G-protein coupled receptor family C group 5 member DBINDING AGENT
G-protein coupled receptor family C group 5 member D binding agent
Directs cytotoxic T-cells to tumours
Approval history
- approvedPriority reviewAcceleratedBreakthroughAug 9, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes (Bi-specific)
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL4594503 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07029776 | Phase 2 | Apr 1, 2026 | University of Arkansas |
| NCT07032714 | Phase 1 | Dec 16, 2025 | Celgene, Harvard University, Johnson and Johnson |
| NCT07093554 | Phase 1 | Dec 1, 2025 | Medical College of Wisconsin |
| NCT07107529 | Phase 2 | Oct 31, 2025 | Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, European Myeloma Network, HOVON - Dutch Haemato-Oncology Association, Janssen Pharmaceutica NV, Nordic Myeloma Study Group, PETHEMA Foundation, University of Oslo, University of Salamanca |
| NCT06993675 | Phase 2 | Aug 21, 2025 | Johnson and Johnson, Yale University |
| NCT06827860 | Phase 2 | Feb 28, 2025 | Icahn School of Medicine at Mount Sinai |
| NCT06572605 | Phase 1/Phase 2 (Phase 2) | Dec 15, 2024 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06461988 | Phase 2 | Nov 30, 2024 | Janssen Pharmaceutica NV, Stanford University |
| NCT06550895 | Phase 2 | Sep 16, 2024 | — |
| NCT06500884 | Phase 2 | Aug 26, 2024 | — |
| NCT06577025 | Phase 2 | Aug 20, 2024 | — |
| NCT06348108 | Phase 1 | Jul 1, 2024 | Bristol-Myers Squibb, Celgene, University of California, San Francisco |
| NCT06505369 | Phase 2 | Jun 19, 2024 | Janssen Pharmaceutica NV, North Estonia Medical Centre Foundation |
| NCT06353022 | Phase 2 | Apr 20, 2024 | Janssen Pharmaceutica NV, University of Nantes |
| NCT06208150 | Phase 3 | Jan 22, 2024 | — |
| NCT06100237 | Phase 2 | Dec 4, 2023 | Janssen Pharmaceutica NV, University of Miami |
| NCT05849610 | Phase 2 | Nov 30, 2023 | Clinica Universidad de Navarra, Janssen Pharmaceutica NV, PETHEMA Foundation, Universidad Complutense de Madrid, University of Barcelona, University of Salamanca |
| NCT06066346 | Phase 2 | Sep 27, 2023 | Janssen Pharmaceutica NV, Memorial Sloan-Kettering Cancer Center |
| NCT05461209 | Phase 3 | Oct 20, 2022 | — |
| NCT05455320 | Phase 3 | Oct 13, 2022 | — |
Showing 20 of 29 trials
Page 1 / 2
Organizations
Research & Development (27)
27 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Aug 9, 2023 |
| Johnson and Johnson | For profit | NDA2 | Aug 9, 2023 |
| Johnson and Johnson | For profit | NDA | Aug 9, 2023 |