ITOVEBI

Growth

inavolisib

NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
14

Mechanism of Action

Phosphoinositide 3-Kinase alpha Inhibitors

Pharmacologic Class:

Kinase Inhibitor

Clinical Trials (5)

NCT07405801Phase 2Recruiting

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 Mar 2026
80 enrolled
Breast Cancer
NCT07287150Phase 2Recruiting

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer

Started Mar 2026
100 enrolled
Metastatic Castration-Resistant Prostate Cancer
NCT07368998Phase 2Recruiting

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Started Feb 2026
80 enrolled
Breast Cancer
NCT07323576Phase 2Withdrawn

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
0
Colorectal Cancer
NCT07347600N/ARecruiting

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

Loss of Exclusivity

LOE Date
Jun 14, 2038
149 months away
Patent Expiry
Jun 14, 2038
Exclusivity Expiry
Oct 10, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8242104
Sep 27, 2030
SubstanceProduct
8343955
Sep 27, 2030
U-4024
9650393
Jul 1, 2036
SubstanceProduct
U-4024
11760753
Jul 1, 2036
U-4024
10851091
Jul 1, 2036
SubstanceProduct