Friday, July 10, 2026

Drug profile · INN

duvelisib

duvelisib (COPIKTRA) is a pi3-kinase p110-gamma subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: withdrawn Antineoplastic and immunomodulating agents (L01) L01EM04
US status approved
Patents linked 0
Pipeline programs 1
News articles 0
Drug details — duvelisib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
1
Data quality
0.84

Quick answer

duvelisib (COPIKTRA) is a pi3-kinase p110-gamma subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN duvelisib
Brand COPIKTRA
Mechanism PI3-kinase p110-gamma subunit inhibitor
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation CAPSULE
ATC code L01EM04

Mechanism of action

PI3-kinase p110-gamma subunit inhibitor

Approval history

Authority Status Date
FDA approved
EMA withdrawn

Pipeline programs

  1. SBI-0145-304 Phase 3 · Secura Bio · relapsed/refractory nodal T cell lymphoma with T follicular

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is duvelisib?

duvelisib (COPIKTRA) is a pi3-kinase p110-gamma subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for duvelisib?

COPIKTRA is a marketed brand name for duvelisib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of duvelisib?

duvelisib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.