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idelalisib

Generic: IDELALISIB·Brand: IDELALISIB, ZYDELIG, Zydelig

idelalisib: developed by 1 company · 5 clinical trials tracked · 1 FDA decision.

idelalisib evidence translation

What we can confirm

1 FDA record · 5 tracked trials

What it means

Source-backed records connect idelalisib to GILD; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could idelalisib → GILD affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 3 study sponsors
Development Pipeline (1)
CompanyPhase
GILEAD SCIENCES, INC. (GILD)Approved
Clinical Trials (5)

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

NCT07218341·Phase 4·LLY
Recruiting

Primary endpoint: Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)

Interventionalopen150 targetStarted 2026-03Completion 2032-1250 sites · Australia, Austria, Belgium, Canada…Eli Lilly and Company

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

NCT06846671·Phase 3·ONC
Recruiting

Primary endpoint: Progression-Free Survival (PFS) by Independent Review Committee (IRC)

InterventionalRandomizedopen250 targetStarted 2025-04Completion 2030-0250 sites · Argentina, Australia, Brazil, United StatesBeOne Medicines

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)

NCT04666038·Phase 3·LOXO
Active, not recruiting

Primary endpoint: Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

InterventionalRandomizedopen238 targetStarted 2021-03Completion 2027-0550 sites · Australia, United StatesLoxo Oncology, Inc.

A Phase I/Randomized Phase II Trial of Idelalisib and Lenalidomide in Patients With Relapsed/Refractory Mantle Cell Lymphoma

NCT01838434·Phase 1
Completed

Primary endpoint: Maximum tolerated dose (MTD) of idelalisib and lenalidomide, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

InterventionalRandomizedopen106 enrolledStarted 2013-10Completion 2017-054 sites · United StatesAlliance for Clinical Trials in Oncology

A Phase I Trial of Lenalidomide and Idelalisib in Recurrent Follicular Lymphoma

NCT01644799·Phase 1
Completed

Primary endpoint: MTD based on the incidence of dose-limiting toxicity (DLT) assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Interventionalopen8 enrolledStarted 2013-08Completion 2017-056 sites · United StatesAlliance for Clinical Trials in Oncology
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbi(GILD)FDA ↗
NDA205858Type 1 - New Molecular EntityOrphan DrugStandardOralTablet

Frequently asked questions

Who is developing idelalisib?

idelalisib is being developed by GILEAD SCIENCES, INC..

How many clinical trials involve idelalisib?

BioSniper tracks 5 clinical trials involving idelalisib.

What is idelalisib's latest FDA decision?

The most recent tracked FDA decision for idelalisib is Approval for 1 INDICATIONS AND USAGE Zydelig is indicated, in combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities. Zydelig is a kinase inhibitor indicated for the treatment of patients with: Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbi, dated July 23, 2014.