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Drug

Darvadstrocel

Withdrawn from market
1
Regulatory events

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Darvadstrocel
RxNorm CUI
2273276
ChEMBL ID
CHEMBL4298180
ATC codes
L04AX08
UNII
31W7R94KYT
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-12-13Market withdrawalMarket
Market withdrawal: Alofisel (EMA)
Indication: Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown anShow full indication

Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. Alofisel should be used after conditioning of fistula.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

4 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
4
registered trials across all phases
LATEST COMPLETION 2024
4
Late-stage (III+)
2
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 4
Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.