daratumumab
Trade name: darzalex
mAbapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Nov 16, 2015
Daratumumab, sold under the brand name Darzalex among others, is an anti-cancer monoclonal antibody medication. It binds to CD38, which is overexpressed in multiple myeloma cells. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. — Wikipedia
Clinical trial activity
331 trials · 214 clinical orgs · 2 marketing orgs
Phase 1
94
Phase 2
248
Phase 3
62
Phase 4
6
Earliest trial started Mar 1, 2008 (NCT00574288)
Timeline
2000s
- Jan 1, 2008
Johnson and Johnson — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
- May 6, 2013
Orphan Drug Designation
- Jan 1, 2014
Johnson and Johnson — Earliest Phase 3 Sponsor(trial)
- Nov 16, 2015
Janssen Pharmaceutica NV — Earliest FDA Approval
- Nov 16, 2015
Johnson and Johnson — Marketing Organization
- Nov 16, 2015
Janssen Pharmaceutica NV — NDA Organization
- Nov 16, 2015
Johnson and Johnson — NDA Secondary Org
Indications
Approved for
Studied for
- Allergy and Immunology · Phase 1/Phase 2
- Alzheimer Disease · Phase 2
- Amyloid · Phase 2
- Amyloidosis · Phase 2
- Anemia, Aplastic · Phase 1
- Anemia, Hemolytic · Phase 1
- Anemia, Sickle Cell · Phase 2
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis · Phase 3
- Autoimmune Diseases · Phase 1/Phase 2
- Blood Protein Disorders · Phase 1/Phase 2
- Blood Transfusion · Phase 1
- Breast Neoplasms · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 1/Phase 2
- Carcinoma, Renal Cell · Early Phase 1
- Carcinoma, Transitional Cell · Early Phase 1
- Chromosome Disorders · Phase 2
- Colorectal Neoplasms · Phase 2
- Corneal Diseases · Phase 1/Phase 2
- Drugs, Investigational · Phase 2
- Glioblastoma · Phase 1/Phase 2
- Glomerulonephritis · Phase 2
- Glomerulonephritis, Membranoproliferative · Phase 2
- Graft Rejection · Phase 2
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 1
- Heart Transplantation · Phase 2
- Hemangioma, Cavernous, Central Nervous System · Early Phase 1
- Hematologic Diseases · Phase 1
- Hematologic Neoplasms · Early Phase 1
- Hematology · Phase 1/Phase 2
- Hematopoietic Stem Cell Transplantation · Phase 2
- Hemophilia A · Phase 4
- Hodgkin Disease · Phase 1
- Immunoglobulin Light-chain Amyloidosis · Phase 3
- Immunotherapy · Phase 1/Phase 2
- Inosine Triphosphate · Phase 2
- Kidney Neoplasms · Early Phase 1
- Kidney Transplantation · Phase 1/Phase 2
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia, Lymphoid · Phase 2
- Leukemia, Monocytic, Acute · Phase 1
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Early Phase 1
- Leukemia, Myeloid · Phase 1
- Leukemia, Myeloid, Acute · Phase 2
- Leukemia, Plasma Cell · Phase 2
- Lung Neoplasms · Phase 2
- Lupus Erythematosus, Systemic · Phase 2
- Lupus Nephritis · Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 1
- Lymphoma, B-Cell, Marginal Zone · Phase 1
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2/Phase 3
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 1/Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 2
- Lymphoma, Primary Effusion · Phase 2
- Lymphoma, T-Cell · Phase 2
- Malaria, Falciparum · Phase 1
- Monoclonal Gammopathy of Undetermined Significance · Phase 2
- Mycosis Fungoides · Phase 1
- Myelodysplastic Syndromes · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasm, Residual · Phase 1/Phase 2
- Neoplasms, Plasma Cell · Phase 1/Phase 2
- Nephrotic Syndrome · Phase 2
- Neuromyelitis Optica · Phase 2/Phase 3
- Pancreatic Neoplasms · Phase 2
- Paraproteinemias · Phase 2
- Peripheral Nervous System Diseases · Phase 2
- Plasma · Phase 1/Phase 2
- Plasmablastic Lymphoma · Phase 2
- Plasmacytoma · Phase 2
- POEMS Syndrome · Phase 2
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2/Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Myelofibrosis · Early Phase 1
- Prostatic Neoplasms · Phase 2
- Purpura, Thrombocytopenic, Idiopathic · Phase 2
- Recurrence · Phase 2
- Renal Insufficiency · Phase 2
- Smoldering Multiple Myeloma · Phase 3
- Stevens-Johnson Syndrome · Phase 1/Phase 2
- Testosterone · Phase 1
- Therapeutics · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
- Lymphocyte differentiation antigen CD38BINDING AGENT
CD38 binding agent
CD38 inhibitor
- Lymphocyte differentiation antigen CD38Supplementation
CD38 supplementation
Approval history
- approvedAcceleratedFast trackBreakthroughNov 16, 2015
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaDaratumumab ↗
- NCATS4Z63YK6E0E ↗
- ChEMBLCHEMBL2109269 ↗
- ChEMBLCHEMBL1743007 ↗
Also known as
- 3003-005
- 3003-005
- dararumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- daratumumab
- darzalex
- darzalex
- darzalex
- darzalex
- humax-cd38
- humax-cd38
- humax-cd38
- humax-cd38
- jnj-54767414
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07285239 | Phase 3 | May 31, 2026 | GlaxoSmithKline, Mayo Clinic, PrECOG, LLC. |
| NCT07247097 | Phase 2 | Apr 15, 2026 | Harvard University, Pfizer |
| NCT07029776 | Phase 2 | Apr 1, 2026 | University of Arkansas |
| NCT07221032 | Phase 1 | Mar 31, 2026 | Medical College of Wisconsin |
| NCT07072585 | Phase 2/Phase 3 (Phase 3) | Mar 30, 2026 | National Cancer Institute (NCI) |
| NCT07222761 | Phase 3 | Jan 29, 2026 | Regeneron |
| NCT07191379 | Phase 4 | Jan 1, 2026 | Region Syddanmark, University of Southern Denmark |
| NCT07297563 | Phase 2 | Dec 31, 2025 | China Academy of Chinese Medical Sciences |
| NCT07287228 | Phase 1/Phase 2 (Phase 2) | Dec 10, 2025 | China Academy of Chinese Medical Sciences |
| NCT07234019 | Phase 2 | Nov 30, 2025 | China Academy of Chinese Medical Sciences |
| NCT07095452 | Phase 2/Phase 3 (Phase 3) | Nov 12, 2025 | AbbVie, Program for the Study and Treatment of Haematological Malignances |
| NCT07110844 | Phase 2 | Nov 7, 2025 | Columbia University, Janssen Pharmaceutica NV |
| NCT07274462 | Phase 4 | Nov 1, 2025 | University Hospital, Martin |
| 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 |
| NCT06932562 | Phase 3 | Oct 31, 2025 | Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista, Erasmus University Rotterdam, European Myeloma Network, Regeneron |
| NCT07110662 | Phase 1/Phase 2 (Phase 2) | Oct 29, 2025 | Johnson and Johnson, University of Lyon |
| NCT07075510 | Phase 1/Phase 2 (Phase 2) | Oct 23, 2025 | Johnson and Johnson, University of Maryland |
| NCT07018050 | Phase 2 | Sep 12, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT07063199 | Phase 2 | Aug 31, 2025 | China Academy of Chinese Medical Sciences |
| NCT06952478 | Phase 3 | Aug 12, 2025 | Celltrion |
Showing 20 of 331 trials
Page 1 / 17
Organizations
Research & Development (214)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Janssen Pharmaceutica NV | For profit | 85 | 9 | 4 | 2014 |
| Johnson and Johnson | For profit | 48 | 32 | 5 | 2008 |
| National Cancer Institute (NCI) | Government | 27 | 5 | 3 | 2017 |
| Mayo Clinic | Academic/Hospital | 17 | 14 | 3 | 2017 |
| Celgene | For profit | 16 | 7 | 3 | 2014 |
| Bristol-Myers Squibb | For profit | 13 | 5 | 4 | 2012 |
| Takeda | For profit | 11 | 4 | 2 | 2018 |
| China Academy of Chinese Medical Sciences | Academic/Hospital | 10 | 10 | 3 | 2023 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 10 | 8 | 2 | 2017 |
| European Myeloma Network | Academic/Hospital | 9 | 9 | 2 | 2017 |
| University of Texas at Houston | Academic/Hospital | 8 | 8 | 2 | 2017 |
| AbbVie | For profit | 7 | 5 | 3 | 2018 |
| GlaxoSmithKline | For profit | 7 | 4 | 2 | 2020 |
| Harvard University | Academic/Hospital | 7 | 5 | 1 | 2012 |
| City of Hope National Medical Center | Academic/Hospital | 6 | 5 | 3 | 2018 |
| Genentech | For profit | 6 | 3 | 2 | 2016 |
| Hellenic Society of Hematology | Academic/Hospital | 6 | 6 | 1 | 2018 |
| Ohio State University | Academic/Hospital | 6 | 5 | 2 | 2017 |
| PETHEMA Foundation | Academic/Hospital | 6 | 5 | 2 | 2018 |
| Roche | For profit | 6 | 3 | 1 | 2015 |
214 organizations
Page 1 / 11
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Janssen Pharmaceutica NV | For profit | NDA | Nov 16, 2015 |
| Johnson and Johnson | For profit | MKTG | Nov 16, 2015 |
| Johnson and Johnson | For profit | NDA2 | Nov 16, 2015 |