teclistamab
Trade name: Tecvayli
mAbapprovedMulti-specificOrphan Drug FDABreakthrough Therapy FDA
Approved
Oct 25, 2022
Clinical trial activity
43 trials · 38 clinical orgs · 1 marketing orgs
Phase 1
9
Phase 2
29
Phase 3
6
Phase 4
2
Earliest trial started May 16, 2017 (NCT03145181)
Timeline
2010s
- Jan 1, 2017
Johnson and Johnson — Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
- Nov 24, 2020
Orphan Drug Designation
- Jan 1, 2021
Earliest Phase 3 Sponsor(trial)
- Oct 25, 2022
Johnson and Johnson — Earliest FDA Approval
- Oct 25, 2022
Johnson and Johnson — Marketing Organization
- Oct 25, 2022
Johnson and Johnson — NDA Secondary Org
- Oct 25, 2022
Johnson and Johnson — NDA Organization
Indications
Approved for
Mechanism of action
- T cell surface glycoprotein CD3BINDING AGENT
T cell surface glycoprotein CD3 binding agent
Directs cytotoxic T-cells to tumours
- Tumor necrosis factor receptor superfamily member 17BINDING AGENT
Tumor necrosis factor receptor superfamily member 17 binding agent
Directs cytotoxic T-cells to tumours
- T-cell surface glycoprotein CD3 epsilon chainCHELATING AGENT
CD3E chelating agent
Approval history
- approvedAcceleratedBreakthroughOct 25, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- ChEMBLCHEMBL4594505 ↗
Also known as
- jnj-64007957
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07029776 | Phase 2 | Apr 1, 2026 | University of Arkansas |
| NCT07258511 | Phase 3 | Feb 20, 2026 | — |
| NCT07110844 | Phase 2 | Nov 7, 2025 | Columbia University, Janssen Pharmaceutica NV |
| NCT06880601 | Phase 2 | Nov 1, 2025 | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| NCT06948084 | Phase 2 | Oct 31, 2025 | ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI) |
| 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 |
| NCT07105059 | Phase 1 | Aug 8, 2025 | Bristol-Myers Squibb, Johnson and Johnson, Memorial Sloan-Kettering Cancer Center |
| NCT06465316 | Phase 1 | Jul 8, 2025 | Harvard University, National Cancer Institute (NCI) |
| NCT07079423 | Phase 2 | Jun 28, 2025 | Chinese Academy of Medical Sciences |
| NCT07030517 | Phase 4 | May 22, 2025 | Johnson and Johnson |
| NCT06935162 | Phase 2 | May 21, 2025 | Chinese Academy of Medical Sciences |
| NCT06649695 | Phase 2 | Mar 31, 2025 | European Myeloma Network, Janssen Pharmaceutica NV, University of Limoges |
| NCT06758375 | Phase 2 | Mar 3, 2025 | Universidad Autonoma de Nuevo Leon |
| NCT06588660 | Phase 1 | Feb 1, 2025 | Simcha, University of Washington |
| NCT06352866 | Phase 2 | Jan 1, 2025 | Case Western Reserve University |
| NCT06699394 | N/A | Dec 1, 2024 | Peking University |
| NCT06251076 | Phase 4 | Oct 15, 2024 | Janssen Pharmaceutica NV, University of Toronto |
| NCT06577025 | Phase 2 | Aug 20, 2024 | — |
| NCT06171685 | Phase 2 | Jul 31, 2024 | Multiple Myeloma Research Consortium, Multiple Myeloma Research Foundation |
Showing 20 of 43 trials
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Organizations
Research & Development (38)
38 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Oct 25, 2022 |
| Johnson and Johnson | For profit | NDA2 | Oct 25, 2022 |
| Johnson and Johnson | For profit | NDA | Oct 25, 2022 |