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Drug

Idelalisib

Approved · EMA
Emerging researchLate-stage development

Also known as 5-Fluoro-3-phenyl-2-((S)-1-(9H-purin-6-ylamino)-propyl)-3H-quinazolin-4-one, Zydelig.

RxNorm1544460ChEMBLCHEMBL2216870UNIIYG57I8T5M0
2
Research papers
7
Active clinical trials
3
Regulatory events
Latest activity
beta

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

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

Clinical trial2026-07-09Results expected Q2 2028 · ClinicalTrials.gov

A Phase II Study of Anti-PD-1 Antibody (MK-3475) in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Other Low Grade B Cell Non-Hodgkin Lymphoma (NHL)

Clinical trial2026-06-24Results posted · ClinicalTrials.gov

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical trial2026-06-23Results expected Q2 2030 · ClinicalTrials.gov

A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Clinical trial2026-06-03Results expected Q1 2029 · ClinicalTrials.gov

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

Clinical trial2026-05-11Results posted · ClinicalTrials.gov

A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

Clinical trial2026-04-24Results posted · ClinicalTrials.gov

A Phase Ib Study of ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed Chronic Lymphocytic Leukemia

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Phase 1b study to investigate the safety and tolerability of idelalisib in Japanese patients with relapsed/refractory follicular lymphoma and chronic lymphocytic leukemia.

Research2020-12-01Japanese journal of clinical oncology

Drug Safety Update: Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection

Regulatory2016-09-15MHRA

Drug Safety Update: Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials

Regulatory2016-05-10MHRA

Approval: Zydelig (EMA)

Regulatory2014-09-18EMA

PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma.

Research2014-01-22The New England journal of medicine

Profile

Identifiers & mechanism

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

Canonical name
Idelalisib
Aliases & brands
5-Fluoro-3-phenyl-2-((S)-1-(9H-purin-6-ylamino)-propyl)-3H-quinazolin-4-oneZydelig
RxNorm CUI
1544460
ChEMBL ID
CHEMBL2216870
UNII
YG57I8T5M0
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

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.

Earliest approval
2014-09-18
Latest approval
2014-09-18
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2014-09-18Approval
Approval: Zydelig (EMA)
Indication: Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):… Show full indication

Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2016-09-15Safety communicationSafety
Drug Safety Update: Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection
Evidence ↗
2016-05-10Safety communicationSafety
Drug Safety Update: Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials
Evidence ↗

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

53 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
53
registered trials across all phases
LATEST COMPLETION 2024
7
Active studies
4
Recruiting
16
Late-stage (III+)
18
Completed
28
Discontinued
PHASE DISTRIBUTIONn = 53
Phase 114Phase 1 / 24Phase 219Phase 314Phase 42

Late-stage studies

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

Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

RecruitingPH IVEli Lilly and Companyn=1502032

An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

TerminatedPH IVGilead Sciencesn=32017

A Global Phase 3, Randomized, Open-label, Multi-center Trial Designed to Compare the Efficacy and Safety of Lisocabtagene Maraleucel vs Investigator's Choice Options (Idelalisib + Rituximab or Bendamustine + Rituximab) in Adult Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Whose Disease Has Failed Treatment With Both BTKi and BCL2i Targeted Therapies (A Double Class Exposed Population)

WithdrawnPH IIIJuno Therapeutics, Inc., a Bristol-Myers Squibb Company2031

A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab or Venetoclax Plus Rituximab Retreatment) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors

RecruitingPH IIIBeOne Medicinesn=2502030

A Phase 3, Open-Label, Randomized, Multicenter Study to Evaluate Anti-tumor Efficacy of DZD8586 Versus Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

RecruitingPH IIIDizal Pharmaceuticalsn=2502029

Recent completions

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

1630GCC: A Pilot Study of Zydelig in Patients With B-cell Malignancies as Post-Autologous Transplant Remission Maintenance

CompletedPH IIUniversity of Maryland, Baltimoren=172024

An Open Label Non-randomized Phase II Study Exploring "Chemo-free " Treatment Association With Idelalisib + Obinutuzumab in Patient With Relapsed/Refractory Waldenstrom's Macroglobulinemia

CompletedPH IIFrench Innovative Leukemia Organisationn=502023

A Phase II Study of Anti-PD-1 Antibody (MK-3475) in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Other Low Grade B Cell Non-Hodgkin Lymphoma (NHL)

CompletedPH IIMayo Clinicn=652022

A Phase II, Two-Cohort, Open-Label, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of MOR00208 Combined With Idelalisib or Venetoclax in Patients With Relapsed or Refractory CLL/SLL Previously Treated With Bruton's Tyrosine Kinase (BTK) Inhibitor

CompletedPH IIMorphoSys AGn=242021

A Phase II Trial of Idelalisib in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

CompletedPH IINordic Lymphoma Groupn=362021

A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (GS-4059) and Idelalisib With and Without Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia

CompletedPH IIGilead Sciencesn=352021

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20142020
Major research themes1
Phosphoinositide-3 Kinase Inhibitors1
Journals, researchers & institutions
Top journals
  • Japanese journal of clinical oncology1
  • The New England journal of medicine1
Leading researchers
  • Bhargava P1
  • Blum KA1
  • Dansey RD1
  • Davies AJ1
  • de Vos S1
  • Dreyling M1
  • Flinn IW1
  • Flowers CR1
Leading institutions
free-text, unnormalised
  • Aichi Cancer Center Hospital1
  • Clinical Research Center1
  • National Cancer Center Hospital1
  • Tohoku University Graduate School of Medicine1
  • Toranomon Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.