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: None *
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: Multiple Myeloma | Stem Cell Transplant
Known Adverse Events: Anemia | Thrombocytopenia | Neutropenia | Cross Infection | Contraception | Dyspnea | Asthenia | Diarrhea | Edema
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal 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, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 153
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|Heart Transplant|Kidney Diseases|Kidney Transplant|Large-Cell Immunoblastic Lymphoma|Leukemia, Plasma Cell|Lupus Erythematosus, Systemic|Lymphocytic Chronic B-Cell Leukemia|Lymphoid Leukemia|Monoclonal Gammopathy of Undetermined Significance|Myelodysplastic Syndrome|POEMS Syndrome|Paraproteinemias|Peripheral Nervous System Diseases|Plasmablastic Lymphoma|Plasmacytoma|Polyneuropathies|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Stem Cell Transplant|T-Cell Leukemia|T-Cell Lymphoma|T-Cell Peripheral Lymphoma|Waldenstrom Macroglobulinemia
Phase 1: Acute Myeloid Leukemia|Anemia, Aplastic|Bladder Cancer|Chronic Myeloid Leukemia|Diffuse Large B-Cell Lymphoma|Kidney Cancer|Myelofibrosis|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Preleukemia|Renal Cell Carcinoma|Transitional Cell Carcinoma|Urologic Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SUN-RAY | P2 |
Recruiting |
Anemia, Sickle Cell |
2044-09-01 |
|
| jRCT2031240014 | P3 |
Not yet recruiting |
Multiple Myeloma |
2033-10-28 |
|
| OMC01/19 | P3 |
Recruiting |
Multiple Myeloma |
2031-06-01 |
|
| jRCT2051210043 | P3 |
Recruiting |
Multiple Myeloma |
2031-02-15 |