loncastuximab
Trade name: Zynlonta
mAbapprovedADCOrphan Drug FDA
Approved
Apr 23, 2021
Clinical trial activity
37 trials · 29 clinical orgs · 1 marketing orgs
Phase 1
17
Phase 2
20
Phase 3
3
Phase 4
0
Earliest trial started Mar 1, 2016 (NCT02669264)
Timeline
2010s
- Jan 1, 2016
ADC Therapeutics SARL — Earliest Phase 1 Sponsor(trial)
- Jun 8, 2017
Orphan Drug Designation
- Jan 1, 2018
ADC Therapeutics SARL — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 1, 2020
ADC Therapeutics SARL — Earliest Phase 3 Sponsor(trial)
- Apr 23, 2021
ADC Therapeutics SARL — Earliest FDA Approval
- Apr 23, 2021
ADC Therapeutics SARL — Marketing Organization
- Apr 23, 2021
ADC Therapeutics SARL — NDA Secondary Org
- Apr 23, 2021
ADC Therapeutics SARL — NDA Organization
Indications
Approved for
Studied for
- Biological Products · Phase 1/Phase 2
- B-Lymphocytes · Phase 1/Phase 2
- Burkitt Lymphoma · Phase 1
- Healthy Volunteers · Early Phase 1
- Hodgkin Disease · Phase 2/Phase 3
- Inosine Triphosphate · Phase 1/Phase 2
- Kidney Diseases · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Lupus Erythematosus, Systemic · Phase 1/Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Neoplasms · Phase 2
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Recurrence · Phase 2
- Thrombocytopenia · Phase 1/Phase 2
- Transplantation · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- B-lymphocyte antigen CD19BINDING AGENT
B-lymphocyte antigen CD19 binding agent
- DNACROSS-LINKING AGENT
DNA cross-linking agent
- B-lymphocyte antigen CD19INHIBITOR
CD19 inhibitor
Approval history
- approvedPriority reviewAcceleratedApr 23, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
- Payload
- pyrrolobenzodiazepine
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5314814 ↗
- ChEMBLCHEMBL4297778 ↗
- ChEMBLCHEMBL4297238 ↗
Also known as
- adct-402
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06919939 | Phase 2 | Dec 1, 2025 | ADC Therapeutics SARL, Genmab, University of Miami |
| NCT07197307 | Phase 2 | Oct 15, 2025 | AbbVie, Swedish Orphan Biovitrum, University of Munster |
| NCT07096843 | Phase 2 | Aug 25, 2025 | Climb Bio, Inc. |
| NCT07090655 | Early Phase 1 (Phase 1) | Aug 11, 2025 | Climb Bio, Inc. |
| NCT07011043 | Phase 1 | Jul 10, 2025 | Climb Bio, Inc. |
| NCT07043946 | Phase 1/Phase 2 (Phase 2) | Jun 30, 2025 | Climb Bio, Inc. |
| NCT06788964 | Phase 2 | Mar 31, 2025 | ADC Therapeutics SARL, University of Utah |
| NCT06570434 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2025 | Tenet Medicines |
| NCT06607549 | Phase 1 | Nov 30, 2024 | ADC Therapeutics SARL, University of Utah |
| NCT05672251 | Phase 2 | Dec 28, 2023 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT05971251 | Phase 1 | Dec 18, 2023 | ADC Therapeutics SARL, University of Alabama, Birmingham |
| NCT05991388 | Phase 2/Phase 3 (Phase 3) | Oct 31, 2023 | ADC Therapeutics SARL, Cancer Research UK, Fight Kids Cancer, Regeneron, University of Birmingham, University of Cambridge |
| NCT06918912 | Phase 2 | Jun 16, 2023 | Istituto Clinico Humanitas - Rozzano (MI), Italy |
| NCT05453396 | Phase 2 | Jan 1, 2023 | University of Washington |
| NCT05658562 | Phase 1/Phase 2 (Phase 2) | Dec 31, 2022 | Mitsubishi Tanabe |
| NCT05270057 | Phase 1 | Dec 31, 2022 | Medical College of Wisconsin |
| NCT05660395 | Phase 1 | Dec 19, 2022 | ADC Therapeutics SARL |
| NCT05228249 | Phase 1 | Dec 7, 2022 | ADC Therapeutics SARL, University of Washington |
| NCT05600686 | Phase 2 | Dec 1, 2022 | ADC Therapeutics SARL, National Cancer Institute (NCI), University of California, Davis |
| NCT05464719 | Phase 2 | Sep 23, 2022 | University of Texas at Houston |
Showing 20 of 37 trials
Page 1 / 2
Organizations
Research & Development (29)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| ADC Therapeutics SARL | For profit | 22 | 12 | 4 | 2016 |
| Climb Bio, Inc. | For profit | 4 | 4 | 2 | 2025 |
| University of Miami | Academic/Hospital | 3 | 3 | 1 | 2022 |
| National Cancer Institute (NCI) | Government | 2 | 0 | 1 | 2022 |
| University of Utah | Academic/Hospital | 2 | 2 | 2 | 2024 |
| University of Washington | Academic/Hospital | 2 | 2 | 2 | 2022 |
| AbbVie | For profit | 1 | 0 | 1 | 2025 |
| ASO SS Antonio e Biagio e C Arrigo Alessandria, Italy | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Cancer Research UK | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| City of Hope National Medical Center | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Fight Kids Cancer | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Fondazione Italiana Diabete Onlus | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Genmab | For profit | 1 | 0 | 1 | 2025 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Istituto Clinico Humanitas - Rozzano (MI), Italy | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Medical College of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Mitsubishi Tanabe | For profit | 1 | 1 | 1 | 2022 |
| Regeneron | For profit | 1 | 0 | 1 | 2023 |
| Swedish Orphan Biovitrum | For profit | 1 | 0 | 1 | 2025 |
29 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ADC Therapeutics SARL | For profit | MKTG | Apr 23, 2021 |
| ADC Therapeutics SARL | For profit | NDA2 | Apr 23, 2021 |
| ADC Therapeutics SARL | For profit | NDA | Apr 23, 2021 |