Product Description
Darzalex (daratumumab) is the first FDA-approved monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. (Sourced from: https://www.myeloma.org/darzalex-daratumumab)
Mechanisms of Action: CD38 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous,Subcutaneous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additional Commercial Interests: Genmab
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 126
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Multiple Myeloma results on 2025-06-03 for Daratumumab
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Multiple Myeloma results on 2024-12-08 for Daratumumab
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Multiple Myeloma results on 2024-09-27 for Daratumumab
Highest Development Phases
Phase 3: Amyloidosis|Bone Cancer|Multiple Myeloma
Phase 2: Acute Lymphoid Leukemia|Alzheimer Disease|Anemia, Sickle Cell|Antiphospholipid Syndrome|Arthritis, Rheumatoid|Blood Protein Disorders|Chronic Lymphoid Leukemia|Glomerulonephritis|Heart Transplant|Kidney Diseases|Kidney Transplant|Large-Cell Immunoblastic Lymphoma|Lupus Erythematosus, Systemic|Lymphocytic Chronic B-Cell Leukemia|Monoclonal Gammopathy of Undetermined Significance|POEMS Syndrome|Paraproteinemias|Peripheral Nervous System Diseases|Plasmablastic Lymphoma|Plasmacytoma|Polyneuropathies|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Leukemia
Phase 1: Acute Myeloid Leukemia|Anemia, Aplastic|Bladder Cancer|Chronic Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Kidney Cancer|Myelodysplastic Syndrome|Myelofibrosis|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Preleukemia|Renal Cell Carcinoma|Stem Cell Transplant|Transitional Cell Carcinoma|Urologic Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| 2018-004185-34 | P2 |
Completed |
Multiple Myeloma |
2024-07-22 |
57% |
2025-07-09 |
Treatments |
| DARALUP | P2 |
Completed |
Lupus Erythematosus, Systemic |
2024-07-25 |
19% |
2025-07-09 |
Treatments |
| SUN-RAY | P2 |
Recruiting |
Anemia, Sickle Cell |
2044-09-01 |
20% |
2024-04-11 |
Primary Endpoints|Treatments |
| M15-654 | P2 |
Active, not recruiting |
Multiple Myeloma |
2031-05-01 |
74% |
2025-07-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
| MMulti-Immune HR | P2 |
Not yet recruiting |
Multiple Myeloma |
2030-04-01 |
2025-06-21 |
Primary Endpoints|Treatments |
|
| GMMG-DADA | P2 |
Recruiting |
Multiple Myeloma |
2029-12-01 |
12% |
2021-08-20 |
Primary Endpoints|Start Date |
| Iber-KDd | P2 |
Recruiting |
Multiple Myeloma |
2029-03-01 |
12% |
2024-03-02 |
Primary Endpoints|Start Date|Treatments |
| REVIVE | P2 |
Recruiting |
Multiple Myeloma |
2028-12-31 |
12% |
2024-03-02 |
Primary Endpoints|Treatments |
| 54767414AMY2009 | P2 |
Active, not recruiting |
Amyloidosis |
2028-02-18 |
12% |
2025-05-02 |
Treatments |
| EA9213 | P2 |
Recruiting |
T-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2027-06-30 |
12% |
2024-12-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| DAMOCLES | P2 |
Recruiting |
Monoclonal Gammopathy of Undetermined Significance|Paraproteinemias|Kidney Diseases|Glomerulonephritis |
2027-06-01 |
2025-03-22 |
Primary Endpoints |
|
| EMN39 | P3 |
Not yet recruiting |
Multiple Myeloma |
2036-12-01 |
85% |
2025-04-18 |
Primary Endpoints|Treatments |
| jRCT2031240014 | P3 |
Not yet recruiting |
Multiple Myeloma |
2033-10-28 |
|||
| C1071006 | P3 |
Recruiting |
Multiple Myeloma |
2031-11-29 |
54% |
2025-05-02 |
Treatments |
| OMC01/19 | P3 |
Recruiting |
Multiple Myeloma |
2031-06-01 |
2022-09-22 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
| jRCT2051210043 | P3 |
Recruiting |
Multiple Myeloma |
2031-02-15 |
|||
| IPANEMA | P3 |
Unknown status |
Multiple Myeloma |
2030-11-11 |
2022-03-13 |
Treatments |
|
| DRAMMATIC | P3 |
Recruiting |
Multiple Myeloma |
2029-07-01 |
21% |
2023-05-04 |
Primary Endpoints|Start Date|Treatments |
| 54767414MMY3030 | P3 |
Active, not recruiting |
Multiple Myeloma |
2029-01-31 |
2025-05-02 |
Treatments |
|
| 54767414MMY3019 | P3 |
Active, not recruiting |
Multiple Myeloma |
2028-10-31 |
93% |
2025-05-02 |
Treatments |
| CC-220-MM-002 | P3 |
Active, not recruiting |
Multiple Myeloma |
2028-09-11 |
2025-05-02 |
Treatments |
|
| MagnetisMM-6 | P3 |
Recruiting |
Multiple Myeloma |
2028-03-31 |
54% |
2024-09-20 |
|
| AMC-105 | P1 |
Recruiting |
Plasmablastic Lymphoma|Diffuse Large B-Cell Lymphoma|Large-Cell Immunoblastic Lymphoma |
2029-07-01 |
23% |
2025-07-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| CT-P44 3.1 | P3 |
Not yet recruiting |
Multiple Myeloma |
2027-11-15 |
90% |
2025-05-03 |
Primary Endpoints|Treatments |
| 79635322MMY1002 | P1 |
Recruiting |
Multiple Myeloma |
2028-03-31 |
23% |
2025-06-07 |
Patient Enrollment|Primary Endpoints|Treatments |