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 Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 127
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|Plasmablastic Lymphoma|Plasmacytoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Stevens-Johnson Syndrome|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 ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04139304 |
AMC-105 | P1 |
Recruiting |
Large-Cell Immunoblastic Lymphoma|Diffuse Large B-Cell Lymphoma|Plasmablastic Lymphoma |
2029-07-01 |
50% |
2025-07-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06398457 |
J2450 | P1 |
Recruiting |
Myelodysplastic Syndrome|Myelofibrosis|Acute Lymphoid Leukemia|Chronic Myeloid Leukemia|Anemia, Aplastic|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Chronic Lymphoid Leukemia|Stem Cell Transplant|Acute Myeloid Leukemia|Multiple Myeloma|Preleukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia |
2026-09-01 |
12% |
2024-09-26 |
Primary Endpoints|Start Date |
NCT06142396 |
54767414MMY2095 | P1 |
Recruiting |
Multiple Myeloma|Kidney Diseases |
2025-11-01 |
50% |
2025-02-22 |
Primary Endpoints|Start Date |
NCT03473730 |
NCI-2018-00800 | P1 |
Completed |
Renal Cell Carcinoma|Transitional Cell Carcinoma|Urologic Cancer|Bladder Cancer|Kidney Cancer |
2025-01-27 |
67% |
2025-01-31 |
|
NCT06358638 |
SUN-RAY | P2 |
Recruiting |
Anemia, Sickle Cell |
2044-09-01 |
12% |
2025-08-27 |
Primary Endpoints|Start Date|Treatments |
NCT07110662 |
NET-CD38 | P2 |
Not yet recruiting |
Stevens-Johnson Syndrome |
2028-10-29 |
12% |
2025-08-08 |
|
NCT04396496 |
NCT04396496 | P2 |
Completed |
POEMS Syndrome |
2023-08-29 |
37% |
2023-11-14 |
Primary Endpoints |
NCT05289687 |
EA9213 | P2 |
Recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Leukemia|Acute Lymphoid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
2027-06-30 |
12% |
2024-12-13 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06889948 |
DAMOCLES | P2 |
Recruiting |
Kidney Diseases|Paraproteinemias|Glomerulonephritis|Monoclonal Gammopathy of Undetermined Significance |
2027-06-01 |
2025-03-22 |
Primary Endpoints |
|
NCT04827979 |
ATTAIN | P2 |
Recruiting |
Kidney Transplant |
2027-03-31 |
12% |
2025-08-27 |
Primary Endpoints |
NCT04166565 |
EMN19 | P2 |
Active, not recruiting |
Multiple Myeloma|Plasmacytoma |
2027-03-01 |
12% |
2024-01-31 |
Primary Endpoints|Treatments |
NCT04915248 |
FIL_DALYA | P2 |
Recruiting |
Plasmablastic Lymphoma|Large-Cell Immunoblastic Lymphoma |
2026-01-01 |
12% |
2025-07-17 |
|
NCT03236428 |
NCT03236428 | P2 |
Active, not recruiting |
Multiple Myeloma|Monoclonal Gammopathy of Undetermined Significance|Paraproteinemias |
2026-10-04 |
12% |
2022-09-22 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05300451 |
NCT05300451 | P2 |
Enrolling by invitation |
Heart Transplant |
2026-08-01 |
12% |
2025-10-31 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2021-006669-40 |
CURACTA | P2 |
Active, not recruiting |
Arthritis, Rheumatoid |
2026-01-31 |
|||
NCT05671757 |
DARE-APS | P2 |
Recruiting |
Antiphospholipid Syndrome |
2026-06-24 |
12% |
2024-11-30 |
|
NCT05280275 |
EAE 120 | P2 |
Recruiting |
Multiple Myeloma|Paraproteinemias|Blood Protein Disorders |
2026-03-15 |
49% |
2023-12-02 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT04270175 |
NCT04270175 | P2 |
Active, not recruiting |
Amyloidosis |
2026-01-01 |
12% |
2025-10-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2021-000962-14 |
DARALUP | P2 |
Completed |
Lupus Erythematosus, Systemic |
2024-07-25 |
19% |
2025-07-09 |
Treatments |
NCT03734198 |
IDA53 | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia |
2023-06-17 |
37% |
2024-11-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04070378 |
DARZAD | P2 |
Completed |
Alzheimer Disease |
2023-06-08 |
29% |
2023-11-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-507143-11-00 |
54767414SMM3001 | P3 |
Active, not recruiting |
Bone Cancer |
2025-12-10 |
2025-05-02 |
Treatments |
|
NCT06932562 |
EMN39 | P3 |
Not yet recruiting |
Multiple Myeloma |
2036-12-01 |
85% |
2025-04-18 |
Primary Endpoints|Treatments |
NCT07095452 |
M25-586 | P3 |
Not yet recruiting |
Multiple Myeloma |
2042-01-01 |
69% |
2025-08-01 |
|
jRCT2031240014 |
jRCT2031240014 | P3 |
Not yet recruiting |
Multiple Myeloma |
2033-10-28 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/13/2025 |
News Article |
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