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Darvadstrocel
Alofisel (darvadstrocel) is a cell pharmaceutical. Darvadstrocel was first approved as Alofisel on 2018-03-23. It has been approved in Europe to treat rectal fistula.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AX: Other immunosuppressants in atc
— L04AX08: Darvadstrocel
HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Crohn diseaseD003424EFO_0000384K50115129
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rectal fistulaD012003HP_0010447K60.311———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDARVADSTROCEL
INNdarvadstrocel
Description
Darvadstrocel, sold under the brand name Alofisel, is a medication used to treat complex perianal fistulas in adults with non-active/mildly active luminal Crohn's disease when fistulas have shown an inadequate response to at least one conventional or biologic therapy. It contains mesenchymal stem cells from fat tissue of adult donors.
Classification
Cell
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4298180
ChEBI ID—
PubChem CID—
DrugBankDB16581
UNII ID31W7R94KYT (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Alofisel - Takeda
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 193 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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310 adverse events reported
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