Darzalex(daratumumab)
Darzalex (daratumumab) is an antibody pharmaceutical. Daratumumab was first approved as Darzalex on 2015-11-16. It is used to treat multiple myeloma in the USA. It has been approved in Europe to treat multiple myeloma. The pharmaceutical is active against ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Darzalex
CombinationsDarzalex faspro
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Daratumumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Darzalex | daratumumab | Johnson & Johnson | N-761036 RX | 2015-11-16 | 2 products |
Daratumumab
+
Hyaluronidase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Darzalex Faspro | daratumumab and hyaluronidase-fihj | Johnson & Johnson | N-761145 RX | 2020-05-01 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darzalex | Biologic Licensing Application | 2021-09-10 |
| darzalex darzalex iv | Biologic Licensing Application | 2025-04-15 |
| darzalex faspro | Biologic Licensing Application | 2024-08-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
| extravasation of diagnostic and therapeutic materials | — | D005119 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
daratumumab / hyaluronidase, Darzalex Faspro, Janssen Biotech, Inc. | |||
| 2028-01-15 | Orphan excl. | ||
daratumumab, Darzalex, Janssen Biotech, Inc. | |||
| 2026-09-26 | Orphan excl. | ||
Patent Expiration
No data
Clinical
Clinical Trials
404 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 15 | 48 | 20 | 1 | 2 | 83 |
| Plasma cell neoplasms | D054219 | — | — | 10 | 29 | 9 | 1 | 2 | 48 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Smoldering multiple myeloma | D000075122 | — | — | — | 5 | 1 | — | — | 6 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 2 | 5 | 1 | — | — | 6 |
| Recurrence | D012008 | — | — | — | 3 | 2 | — | — | 5 |
| Plasmacytoma | D010954 | — | C90.3 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 3 | 4 | — | — | — | 5 |
| Lymphoma | D008223 | — | C85.9 | 2 | 3 | — | — | — | 5 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 2 | — | — | — | 3 |
| Paraproteinemias | D010265 | — | D47.2 | 1 | 3 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 1 | 3 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | — | — | — | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | 1 | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 1 | — | — | — | — | 1 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 1 | — | — | — | — | 1 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Daratumumab |
| INN | daratumumab |
| Description | Daratumumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >7DUN:H|Fab heavy chain
EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYYADSVKGRFTISRDNSKNTLY
LQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPK
>7DUN:L|Fab light chain
EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP
EDFAVYYCQQRSNWPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRG |
Identifiers
| PDB | 7DHA, 7DUN, 7DUO |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743007 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09331 |
| UNII ID | 4Z63YK6E0E (ChemIDplus, GSRS) |
Target
Agency Approved
CD38
CD38
Organism
Homo sapiens
Gene name
CD38
Gene synonyms
NCBI Gene ID
Protein name
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1
Protein synonyms
2'-phospho-ADP-ribosyl cyclase, 2'-phospho-ADP-ribosyl cyclase/2'-phospho-cyclic-ADP-ribose transferase, 2'-phospho-cyclic-ADP-ribose transferase, ADP-ribosyl cyclase 1, ADPRC 1, cADPR hydrolase 1, CD38, CD38 antigen (p45), cluster of differentiation 38, Cyclic ADP-ribose hydrolase 1, ecto-nicotinamide adenine dinucleotide glycohydrolase, NAD(+) nucleosidase, T10
Uniprot ID
Mouse ortholog
Cd38 (12494)
ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 (Q8BFY8)
Alternate
No data
Variants
No data
Financial
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Darzalex – Johnson & Johnson
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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30,381 adverse events reported
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