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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Case Study: Multiple Myeloma
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Commercial
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
darzalex faspro | Biologic Licensing Application | 2023-05-26 |
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
258 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 5 | 1 | — | — | 6 |
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 |
---|---|---|---|---|---|---|---|---|---|
Immunoglobulin light-chain amyloidosis | D000075363 | 4 | 6 | — | — | — | 7 | ||
Neoplasms | D009369 | C80 | 5 | 6 | — | — | — | 7 | |
Myeloid leukemia acute | D015470 | C92.0 | 4 | 4 | — | — | — | 6 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 4 | 1 | — | — | — | 4 | |
Paraproteinemias | D010265 | D47.2 | 2 | 3 | — | — | — | 3 | |
Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 3 | 2 | — | — | — | 3 |
Myelodysplastic syndromes | D009190 | D46 | — | 2 | — | — | — | 2 | |
Plasma cell leukemia | D007952 | C90.1 | 1 | 1 | — | — | — | 2 | |
Recurrence | D012008 | — | 2 | — | — | — | 2 | ||
Hodgkin disease | D006689 | C81 | 2 | 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 | 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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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 | 945721-28-8 |
RxCUI | 1721947 |
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
Clinical Variant
No data
Financial
Darzalex - Johnson & Johnson
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,819 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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9,439 adverse events reported
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