KISQALI

Peak

ribociclib

NDAORALTABLETPriority Review
Approved
Mar 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
73

Mechanism of Action

cyclin-dependent kinase (CDK) 4 and 6. These kinases are activated upon binding to D-cyclins and are downstream of signaling pathways which lead to cell cycle progression and cellular proliferation. The cyclin D-CDK4/6 complex regulates cell cycle progression through phosphorylation of the…

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
NCT06905301N/ARecruiting

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Started Jan 2026
240 enrolled
Breast Cancer
NCT06930859N/ARecruiting

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

Started Dec 2025
2,766 enrolled
Breast Cancer
NCT07237256Phase 3Recruiting

Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib

Started Dec 2025
3,902 enrolled
Breast Cancer
NCT07243002N/ARecruiting

Real-world Evaluation of Patient Outcomes and Experiences With Ribociclib Early Adopters.

Started Dec 2025
3,000 enrolled
Breast Cancer

Loss of Exclusivity

LOE Date
Apr 14, 2036
123 months away
Patent Expiry
Apr 14, 2036
Exclusivity Expiry
Sep 17, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
8324225
Jun 17, 2028
SubstanceProduct
9416136
Aug 20, 2029
U-3975
8962630
Dec 9, 2029
U-3975
8685980
May 25, 2030
SubstanceProduct
8415355
Mar 13, 2031
SubstanceProduct