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 | 2024-01-22 |
| darzalex faspro | Biologic Licensing Application | 2023-11-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple myeloma | — | D009101 | C90.0 |
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
335 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 | 68 | 123 | 45 | 4 | 11 | 222 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | — | — | — | 1 | — | 1 |
| Pneumococcal infections | D011008 | EFO_0000772 | J13 | — | — | — | 1 | — | 1 |
| Febrile neutropenia | D064147 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | 4 | 6 | 1 | — | 1 | 9 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 2 | 6 | 2 | — | — | 8 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | 1 | — | — | 3 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 8 | — | — | — | 9 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 5 | — | — | — | 7 |
| Paraproteinemias | D010265 | — | D47.2 | 2 | 3 | — | — | 1 | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 1 | — | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | — | — | — | 3 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 3 | 2 | — | — | — | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | — | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 2 | — | — | — | 2 |
| Plasma cell leukemia | D007952 | — | C90.1 | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart transplantation | D016027 | EFO_0010673 | — | 2 | — | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Hemolytic anemia | D000743 | — | D55-D59 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Patient satisfaction | D017060 | — | — | — | — | — | — | 1 | 1 |
| Personal satisfaction | D010549 | — | — | — | — | — | — | 1 | 1 |
| Patient preference | D057240 | — | — | — | — | — | — | 1 | 1 |
| Leukapheresis | D007937 | — | — | — | — | — | — | 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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11,846 adverse events reported
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