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Drug

Daratumumab

Approved · EMA
ClassLymphocyte differentiation antigen CD38 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Darzalex, Darzalex Faspro.

5
Research papers
104
Active clinical trials
CD38
Primary target
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Daratumumab
Aliases & brands
DarzalexDarzalex Faspro
RxNorm CUI
1721947
ChEMBL ID
CHEMBL1743007
ATC codes
L01FC01
UNII
4Z63YK6E0E
Primary mechanism
Lymphocyte differentiation antigen CD38 inhibitor
Regulatory jurisdictions
mhraema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORLymphocyte differentiation antigen CD38 inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-05-20
Latest approval
2016-05-20
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2016-05-20Accelerated approval
Accelerated approval: Darzalex (EMA)
Indication: Multiple Myeloma  Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisoneShow full indication

Multiple Myeloma  Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5.1). in as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. Smouldering multiple myeloma Darzalex as monotherapy is indicated for the treatment of adult patients with smouldering multiple myeloma at high risk of developing multiple myeloma. Light chain (AL) amyloidosis Darzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. Darzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2019-08-19Safety communicationSafety
Drug Safety Update: Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

198 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
198
registered trials across all phases
LATEST COMPLETION 2026
104
Active studies
52
Recruiting
45
Late-stage (III+)
57
Completed
37
Discontinued
PHASE DISTRIBUTIONn = 198
Phase 131Phase 1 / 226Phase 296Phase 2 / 36Phase 333Phase 44Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182024
Most influential
Recent papers
Major research themes8
Antibodies, Monoclonal1Antineoplastic Combined Chemotherapy Protocols1Bortezomib1Dexamethasone1Immunotherapy, Adoptive1Multiple Myeloma1Stem Cell Transplantation1Thalidomide1
Journals, researchers & institutions
Top journals
  • The Lancet. Oncology2
  • Frontiers in immunology1
  • Journal of hematology & oncology1
  • Lancet (London, England)1
Leading researchers
  • Arnulf B3
  • Avet-Loiseau H3
  • Belhadj K3
  • Benboubker L3
  • Broijl A3
  • Caillon H3
  • Caillot D3
  • Corre J3
Leading institutions
free-text, unnormalised
  • Biochemistry Laboratory3
  • Centre Hospitalier Annecy Genevois3
  • Centre Hospitalier Départemental Vendée3
  • Institut Curie Paris3
  • Institut Jules Bordet3
  • Northwest Clinics3

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across the same disease area as Daratumumab in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.