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Drug ReportsDarvadstrocel
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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Events Timeline
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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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)
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Labels
FDA
EMA
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Indications
FDA
EMA
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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
15 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_0000384K502251412
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K5111———1
Rectal fistulaD012003HP_0010447K60.311———1
Rectovaginal fistulaD012006—N82.311———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—
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4298180
ChEBI ID—
PubChem CID—
DrugBankDB16581
UNII ID31W7R94KYT (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Alofisel – Takeda
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 543 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4 adverse events reported
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