Bimiralisib — drug · CancerIndex

Regulatory

Approvals (0)

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

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

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	Trials	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	10	—	—	2014-01
Malignant Breast Neoplasm	Phase2	Phase 2	1	—	—	Mar 28, 2016
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	3	—	—	2015-07
Non-Hodgkin Lymphoma	Phase2	Phase 2	3

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
NOTCH1 Loss-of-function1
Bimiralisib	Head and Neck Squamous Cell Carcinoma

Clinical trials

Trials with this intervention (10)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–10 of 10 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
NCT06319794	Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis	completed	Phase 2	46	TORQURINDUSTRY	1	Jul 18, 2025	clinicaltrials
NCT03740100	Single-arm Study With Bimiralisib in Patients With HNSCC Harboring NOTCH1 Loss of Function Mutations(HNSCC)	terminated