NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
6/8 — Strong
Priority Review
ITOVEBI (inavolisib) by Roche is phosphoinositide 3-kinase alpha inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2024.
Drug data last refreshed 17h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ITOVEBI (inavolisib) is an oral small-molecule phosphoinositide 3-kinase alpha inhibitor approved by the FDA on October 10, 2024. It is a kinase inhibitor tablet developed by Roche for oncology indications. The drug works by selectively inhibiting PI3K-alpha signaling pathways implicated in cancer cell proliferation.
Growth11.7 years to LOE
Recently approved asset in growth phase presents entry opportunity for brand teams; commercial infrastructure and promotional strategy are being built out.
Mechanism of Action
Phosphoinositide 3-Kinase alpha Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Started Oct 2026
40 enrolled
Breast CancerDiabetes Type II
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
Started Jun 2026
160 enrolled
Breast Cancer
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Started Apr 2026
80 enrolled
Breast Cancer
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Started Mar 2026
100 enrolled
Metastatic Castration-Resistant Prostate Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
Started Feb 2026
80 enrolled
Breast Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.