NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
14
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 20h ago
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 (14)
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
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer
Started Feb 2026
0Colorectal Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Started Jan 2026
500 enrolled
Locally Advanced Breast CancerMetastatic 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.