BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
DARZALEX (daratumumab) by Johnson & Johnson is cd38-directed antibody interactions [moa]. Approved for cd38-directed cytolytic antibody [epc]. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARZALEX (daratumumab) is a CD38-directed monoclonal antibody approved in November 2015 for the treatment of multiple myeloma and other CD38-positive hematologic malignancies. It functions as a cytolytic antibody that binds to CD38 antigen on plasma cells, triggering immune-mediated cell death through multiple mechanisms including antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). DARZALEX is a foundational therapy in the modern myeloma treatment paradigm and is used across multiple lines of therapy, from newly diagnosed to relapsed/refractory disease.
$0.0BPart D
Mechanism of Action
CD38-directed Antibody Interactions
Pharmacologic Class:
CD38-directed Cytolytic Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started May 2026
500 enrolled
Multiple Myeloma
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
Started Apr 2026
160 enrolled
Multiple MyelomaNewly Diagnosed Multiple MyelomaTransplant Ineligible+1 more
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
Started Mar 2026
270 enrolled
High Risk Smoldering Multiple Myeloma (HR-SMM)
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
Started Mar 2026
102 enrolled
Multiple Myeloma
A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
Started Jan 2026
660 enrolled
Multiple Myeloma
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.