Wednesday, July 8, 2026

Drug profile · INN

daratumumab

daratumumab (DARZALEX) is a lymphocyte differentiation antigen cd38 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Antineoplastic and immunomodulating agents (L01) L01FC01
US status approved
Patents linked 0
Pipeline programs 50
News articles 0
Drug details — daratumumab
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
INJECTION
Patents
0
Programs
50
Data quality
0.84

Quick answer

daratumumab (DARZALEX) is a lymphocyte differentiation antigen cd38 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN daratumumab
Brand DARZALEX
Mechanism Lymphocyte differentiation antigen CD38 inhibitor
Target ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route INJECTION
Formulation INJECTABLE
ATC code L01FC01

Mechanism of action

Lymphocyte differentiation antigen CD38 inhibitor

Primary target: ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. 207503 Phase 3 · GSK Glaxo Smith · Multiple Myeloma
  2. 214828 Phase 3 · GSK Glaxo Smith · Multiple myeloma
  3. 54767414MMY3019 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  4. 64007957MMY3005 Phase 3 · Janssen-Cilag International N.V · Multiple Myeloma
  5. 64407564MMY3002 Phase 3 · Janssen-Cilag International N.V · Relapsed or Refractory Multiple Myeloma
  6. 68284528MMY3002 Phase 3 · Janssen-Cilag International N.V · Relapsed and Lenalidomide-Refractory Multiple Myeloma
  7. BB2121-MM-003 Phase 3 · Celgene · Multiple myeloma (MM) with at least 2 prior therapies includ
  8. C1071005 Phase 3 · First Biotech (Australia) · MULTIPLE MYELOMA

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is daratumumab?

daratumumab (DARZALEX) is a lymphocyte differentiation antigen cd38 inhibitor. Associated with Janssen-Cilag Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for daratumumab?

DARZALEX is a marketed brand name for daratumumab. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of daratumumab?

daratumumab has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.