Wednesday, July 8, 2026

Drug profile · INN

idelalisib

idelalisib (ZYDELIG) is a pi3-kinase p110-delta subunit inhibitor. Associated with Gilead Sciences Pty Limited. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01XX47
US status approved
Patents linked 0
Pipeline programs 3
News articles 0
Drug details — idelalisib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
3
Data quality
0.84

Quick answer

idelalisib (ZYDELIG) is a pi3-kinase p110-delta subunit inhibitor. Associated with Gilead Sciences Pty Limited. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN idelalisib
Brand ZYDELIG
Mechanism PI3-kinase p110-delta subunit inhibitor
Target Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01XX47

Mechanism of action

PI3-kinase p110-delta subunit inhibitor

Primary target: Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. BGB-16673-302 Phase 3 · BEONE MEDICINES AUS · Chronic lymphotic leukemia and Small Lymphocytic lymphoma
  2. DZ2024B0002 Phase 3 · Anaxis Pharma · Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymph
  3. LOXO-BTK-20020 Phase 3 · Createrna Science and · Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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 idelalisib?

idelalisib (ZYDELIG) is a pi3-kinase p110-delta subunit inhibitor. Associated with Gilead Sciences Pty Limited. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for idelalisib?

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

What is the US approval status of idelalisib?

idelalisib 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.