Izorlisib — 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	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	1	0	0	4	0	—	—	2010-08
Malignant Breast Neoplasm	Phase2	Phase 2	1	0	0	1	0	—	—	May 24, 2023

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (2)

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

civicCuratedShowing 1–2 of 2 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 E542K1
Izorlisib	Malignant Breast Neoplasm

Clinical trials

Trials with this intervention (4)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–4 of 4 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
NCT05810870	PIK3CA/PTEN-altered Advanced Breast Cancer Treated With MEN1611 Monotherapy or in Combination With Eribulin(SABINA)	active not recruiting	Phase 2	14	MedSIROTHER	1	Mar 10, 2026	clinicaltrials
NCT03767335	MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer(B-PRECISE-01)