Drug · Small Molecule

Idelalisib

CI-DRUG-00000294Explore in graph →NCIt C78825 CHEMBL2216870 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory4 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ZYDELIG (DIN 02438798) under ATC L01EM01 IDELALISIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 21, 2015	health-canada-dpd
CA Health Canada	—	Marketed in Canada as ZYDELIG (DIN 02438801) under ATC L01EM01 IDELALISIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 21, 2015	health-canada-dpd
EU EMA	—	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.

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 6 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	7	4	14	53	4	CA, EU, US	Jul 23, 2014	2008-06
Leukemia	Phase4	Phase 4	4	2	10	29	0	—	—	2008-06
Non-Hodgkin Lymphoma	Phase4	Phase 4	2	1	4	30	0	—	—	2008-06
Hodgkin Lymphoma	Phase2	Phase 2	0	0	0	2	0	—	—

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA P471L1
Idelalisib	Merkel Cell Carcinoma

Clinical trials

Trials with this intervention (57)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–57 of 57 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01732913	Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas(Yosemite)	terminated	Phase 3	295	Gilead SciencesINDUSTRY	19	Nov 16, 2018	clinicaltrials
NCT01732926	Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Molecule

Record

Kind: Small Molecule
Mechanism: PI3-kinase p110-delta subunit inhibitor
Targets: 1 gene
UNII: YG57I8T5M0
Aliases: 5-Fluoro-3-phenyl-2-((S)-1-(9H-purin-6-ylamino)-propyl)-3H- Quinazolin-4-one, CAL 101, CAL-101, CAL101, CAL-101 (GS-1101), GS 1101, GS-1101, GS1101, Gs-11cal-101, Idelalisib, IDELALISIBCT-CAL101IDEALISIBCAL-101CAL 101GS-1101GS 1101ZYDELIGA-1138CAL101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig, ZYDELIG

Data updated 9 hours agoSource updated unknown

Identifiers

Codes (7)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EM01	IDELALISIB
ATC (WHO)	L01XX47	Antineoplastic agents; Other antineoplastic agents