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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
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
cardiovascular diseasesD002318
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Darzalex
Combinations
Darzalex 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
DarzalexdaratumumabJohnson & JohnsonN-761036 RX2015-11-16
2 products
Daratumumab
+
Hyaluronidase
Tradename
Proper name
Company
Number
Date
Products
Darzalex Fasprodaratumumab and hyaluronidase-fihjJohnson & JohnsonN-761145 RX2020-05-01
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
darzalex fasproBiologic Licensing Application2023-05-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple myeloma—D009101C90.0
Agency Specific
FDA
EMA
Expiration
Code
daratumumab / hyaluronidase, Darzalex Faspro, Janssen Biotech, Inc.
2028-01-15Orphan excl.
daratumumab, Darzalex, Janssen Biotech, Inc.
2026-09-26Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FC: Cd38 (clusters of differentiation 38) inhibitors
— L01FC01: Daratumumab
HCPCS
Code
Description
J9144
Injection, daratumumab, 10 mg and hyaluronidase-fihj
J9145
Injection, daratumumab, 10 mg
Clinical
Clinical Trials
258 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.053993627174
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AmyloidosisD000686EFO_1001875E85151——6
Smoldering multiple myelomaD000075122—21——3
Neuromyelitis opticaD009471EFO_0004256G36.0—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immunoglobulin light-chain amyloidosisD00007536346———7
NeoplasmsD009369C8056———7
Myeloid leukemia acuteD015470C92.044———6
Non-hodgkin lymphomaD008228C85.941———4
ParaproteinemiasD010265D47.223———3
Hematologic diseasesD006402EFO_0005803D75.932———3
Myelodysplastic syndromesD009190D46—2———2
Plasma cell leukemiaD007952C90.111———2
RecurrenceD012008—2———2
Hodgkin diseaseD006689C8121———2
Show 27 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Heart transplantationD016027EFO_00106732————2
Breast neoplasmsD001943EFO_0003869C501————1
Mycosis fungoidesD009182C84.01————1
Myeloid leukemiaD007951C921————1
B-cell lymphomaD0163931————1
Renal cell carcinomaD0022921————1
Kidney neoplasmsD007680EFO_0003865C641————1
Healthy volunteers/patients—1————1
AdenocarcinomaD0002301————1
Hemolytic anemiaD000743D55-D591————1
Show 2 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Patient satisfactionD017060————11
Personal satisfactionD010549————11
Patient preferenceD057240————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDARATUMUMAB
INNdaratumumab
Description
Daratumumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)DARATUMUMAB
Structure (InChI/SMILES or Protein Sequence)
>7DUN:H|Fab heavy chain EVQLLESGGGLVQPGGSLRLSCAVSGFTFNSFAMSWVRQAPGKGLEWVSAISGSGGGTYYADSVKGRFTISRDNSKNTLY LQMNSLRAEDTAVYFCAKDKILWFGEPVFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVT VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPK >7DUN:L|Fab light chain EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP EDFAVYYCQQRSNWPPTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRG
Identifiers
PDB7DHA, 7DUN, 7DUO
CAS-ID945721-28-8
RxCUI1721947
ChEMBL IDCHEMBL1743007
ChEBI ID—
PubChem CID—
DrugBankDB09331
UNII ID4Z63YK6E0E (ChemIDplus, GSRS)
Target
Agency Approved
CD38
CD38
Organism
Homo sapiens
Gene name
CD38
Gene synonyms
NCBI Gene ID
952
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
Q96HY4
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
$
€
£
₣
Mock data
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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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