BLAINJECTIONINJECTABLEPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARZALEX (daratumumab) is a CD38-directed monoclonal antibody approved in November 2015 for treating multiple myeloma. It works by binding to CD38 on plasma cells, triggering immune-mediated cell death through multiple mechanisms including ADCP, ADCC, and CDC. The drug is currently at peak lifecycle stage with established market presence.
$0.016BPart D
PeakEstablished peak-stage asset generating substantial Part D volume with significant commercial infrastructure, suggesting stable team sizing and mature go-to-market execution.
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)
A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis
Started Jan 2027
260 enrolled
Light Chain (AL) Amyloidosis
Study to Evaluate Change in Disease Activity and Adverse Events of Subcutaneous Etentamig Compared With Daratumumab Plus Cyclophosphamide Plus Bortezomib Plus Dexamethasone (Dara-CyBorD) in Adults With Amyloid Light Chain (AL) Amyloidosis
Started Nov 2026
370 enrolled
Amyloid Light Chain (AL) Amyloidosis
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
Started Sep 2026
1,000 enrolled
Multiple Myeloma
A Study Comparing Treatment With Teclistamab and Talquetamab Versus Daratumumab and Lenalidomide in Patients With Multiple Myeloma After Stem Cell Transplant Who Still Have Detectable Disease
Started Sep 2026
248 enrolled
Multiple Myeloma (MM)
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Started Sep 2026
500 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.