Drug · Small Molecule

Inavolisib

CI-DRUG-00000301Explore in graph →NCIt C132166 CHEMBL4650215 CIViC Approved

Regulatory

Approvals (5)

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-dpdRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as ITOVEBI (DIN 02555476) under ATC L01EM06 INAVOLISIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 10, 2025	health-canada-dpd
CA Health Canada	—	Marketed in Canada as ITOVEBI (DIN 02555484) under ATC L01EM06 INAVOLISIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 10, 2025	health-canada-dpd

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 18 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 3	23	14	5	27	5	CA, EU, US	Oct 10, 2024	Dec 13, 2016
Malignant Breast Neoplasm	Approved	Phase 3	13	9	4	14	2	EU, US	Oct 10, 2024	Dec 13, 2016
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	2	1	0	2	0	—	—	Oct 20, 2021
Malignant Ovarian Neoplasm	Phase2	Phase 2	1	0	0	1

Curated evidence

Clinical evidence (8)

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

civicCuratedShowing 1–8 of 8 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 E453A + PIK3CA E453D + PIK3CA E453G + PIK3CA E453K + PIK3CA E453Q + PIK3CA E453V1

Clinical trials

Trials with this intervention (28)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–28 of 28 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
NCT05646862	A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy(INAVO121)	recruiting	Phase 3	420	Hoffmann-La RocheINDUSTRY	20	Sep 28, 2026	clinicaltrials
NCT07054190	A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer

Molecule

Record

Kind: Small Molecule
Mechanism: PI3-kinase p110-alpha subunit inhibitor
Targets: 1 gene
UNII: L4C1UY2NYH
Aliases: GDC 0077, GDC-0077, GDC0077, Inavolisib, Itovebi, ITOVEBI, PI3K Inhibitor GDC0077, RG 6114, RG-6114, RG6114, RO 7113755, RO-7113755, RO7113755

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (6)

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

System	Code	Label
ATC (WHO)	L01EM06	INAVOLISIB
DIN (Health Canada)	02555476	ITOVEBI
DIN (Health Canada)