Ozmosi | Daratumumab Drug Profile

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 Indications: None

Known Adverse Events: None

Company: Johnson & Johnson
Company Location: Eastern America
Company Founding Year: 1886
Additional Commercial Interests: Genmab

Clinical Description

Map of Global Clinical Trials for Daratumumab

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

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT04139304	AMC-105	P1	Recruiting	Plasmablastic Lymphoma\|Diffuse Large B-Cell Lymphoma\|Large-Cell Immunoblastic Lymphoma	2029-07-01	50%	2025-07-01	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments\|Trial Status
NCT06398457	J2450	P1	Recruiting	Chronic Lymphoid Leukemia\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|Myelodysplastic Syndrome\|Myelofibrosis\|Anemia, Aplastic\|Chronic Myeloid Leukemia\|Acute 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\|Urologic Cancer\|Kidney Cancer\|Transitional Cell Carcinoma\|Bladder 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
NCT07075510	2513GCCC	P2	Recruiting	Multiple Myeloma\|Conduct Disorder\|Amyloidosis	2030-10-01	12%	2025-10-30	Primary Endpoints\|Start Date\|Treatments\|Trial Status
NCT07110662	NET-CD38	P2	Not yet recruiting	Stevens-Johnson Syndrome	2028-10-29	12%	2025-08-08
NCT05289687	EA9213	P2	Recruiting	Precursor T-Cell Lymphoblastic Leukemia-Lymphoma\|Precursor Cell Lymphoblastic Leukemia-Lymphoma\|T-Cell Leukemia\|Acute Lymphoid Leukemia	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	Active, not recruiting	Kidney Transplant	2027-03-31	12%	2026-01-21	Patient Enrollment\|Primary Endpoints\|Treatments\|Trial Status
NCT04166565	EMN19	P2	Active, not recruiting	Plasmacytoma\|Multiple Myeloma	2027-03-01	12%	2024-01-31	Primary Endpoints\|Treatments
NCT04270175	NCT04270175	P2	Active, not recruiting	Amyloidosis\|Alzheimer Disease	2027-01-01	12%	2026-02-28
NCT03236428	NCT03236428	P2	Active, not recruiting	Monoclonal Gammopathy of Undetermined Significance\|Paraproteinemias\|Multiple Myeloma	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
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
2021-006669-40	CURACTA	P2	Active, not recruiting	Arthritis, Rheumatoid	2026-01-31
NCT04915248	FIL_DALYA	P2	Recruiting	Large-Cell Immunoblastic Lymphoma\|Plasmablastic Lymphoma	2026-01-01	12%	2025-07-17
2021-000962-14	DARALUP	P2	Completed	Lupus Erythematosus, Systemic	2024-07-25	19%	2025-07-09	Treatments
NCT04396496	NCT04396496	P2	Completed	POEMS Syndrome	2023-08-29	37%	2023-11-14	Primary Endpoints
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
2023-507143-11-00	54767414SMM3001	P3	Active, not recruiting	Bone Cancer	2025-12-10		2025-05-02	Treatments
2025-520897-21-00	M25-586	P3	Not yet recruiting	Multiple Myeloma	2042-02-28
NCT07095452	M25-586	P3	Recruiting	Multiple Myeloma	2042-01-01	62%	2026-01-28	Primary Completion Date\|Primary Endpoints
NCT06932562	EMN39	P3	Recruiting	Multiple Myeloma	2036-12-01	54%	2025-12-06	Primary Endpoints\|Start Date\|Treatments\|Trial Status

Recent News Events

Date	Type	Title
03/06/2026	News Article	U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma
03/05/2026	News Article	Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
02/16/2026	News Article	Click n' Close to Deploy Dara by Sagent to Power Core, Consumer, and Default Servicing
02/16/2026	News Article	The coffee industry already knows the World's 100 Best Coffee Shops

Did PRYZM just deliver the data you were looking for?
Did you try our Excel download too?

Now that you've used PRYZM, we hope you're able to see for yourself that it was designed and developed by people who actually use this data for a living. By applying next-generation technology for aggregating and curating this info across multiple key sources PRYZM delivering the latest information at your fingertips just the way you need it and with industry leading speed and cost effectiveness.

Our subscribers enjoy unlimited searches and receive this data on their own secure instance so they can overlay any additional internal/proprietary data on top of the search results and blend that data with real-time industry intel from PRYZM. Discover how you can continue to uncover the competitive landscape and drive strategy.

Suggestions

Session Expiring Soon

Daratumumab

Alternative Names: daratumumab, jnj-54767414, dara, darzalex, jnj54767414, jnj 54767414 Clinical Status: Active Latest Update: 2026-03-05 Latest Update Note: News Article