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Drug

Duvelisib

Regulatory activity · EMA
Late-stage development

Also known as Copiktra.

9
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma

Clinical trial2026-06-02Results expected Q4 2027 · ClinicalTrials.gov

Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas

Clinical trial2026-04-09Results expected Q3 2027 · ClinicalTrials.gov

Market withdrawal: Copiktra (EMA)

Regulatory2026-02-16EMA

Profile

Identifiers & mechanism

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

Canonical name
Duvelisib
Aliases & brands
Copiktra
RxNorm CUI
2058509
ChEMBL ID
CHEMBL3039502
UNII
610V23S0JI
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
2026-02-16Market withdrawalMarket
Market withdrawal: Copiktra (EMA)
Indication: Copiktra monotherapy is indicated for the treatment of adult patients with:  Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.Show full indication

Copiktra monotherapy is indicated for the treatment of adult patients with:  Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies.  Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.

Evidence ↗

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

Clinical trials

37 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
37
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
5
Recruiting
4
Late-stage (III+)
13
Completed
15
Discontinued
PHASE DISTRIBUTIONn = 37
Early Phase 11Phase 111Phase 1 / 26Phase 215Phase 34

Late-stage studies

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

Recent completions

Trials that read out recently, adding to the completed evidence base.

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.