Drug Profile

Ribociclib - Novartis Oncology

Alternative Names: Kisqali; LEE-011; LEE-011A

Latest Information Update: 24 Jun 2025

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At a glance

Originator Astex Therapeutics; Mount Sinai Health System
Developer Array BioPharma; Cedars-Sinai Medical Center; Cincinnati Children's Hospital Medical Center; Cliniques Universitaires Saint Luc; Dana-Farber Cancer Institute; Georgetown University; Gynecologic Oncology Group; Hadassah Medical Organization; Mayo Clinic; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA); National Taiwan University Hospital; Novartis; Novartis Oncology; Roswell Park Cancer Institute; Seagen; SOLTI Breast Cancer Research Group; St Josephs Hospital and Medical Center; Thomas Jefferson University; UNICANCER; University of Texas M. D. Anderson Cancer Center; University of Texas Southwestern Medical Center; Virginia Mason Research Center
Class Amides; Aminopyridines; Antineoplastics; Piperazines; Pyrimidines; Pyrroles; Small molecules
Mechanism of Action Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Marketed Breast cancer; HER2 negative breast cancer
Phase II Cancer; Malignant melanoma; Neuroendocrine tumours; Ovarian cancer; Peritoneal cancer
Phase I/II Liposarcoma; Neuroblastoma; Pancreatic cancer; Triple negative breast cancer
Phase I Glioma; Medulloblastoma; Rhabdoid tumour; Rhabdomyosarcoma
No development reported Lymphoma; Non-small cell lung cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer
Discontinued Endometrial cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Meningioma; Prostate cancer; Teratoma

18 Jun 2025 Health Canada has granted a Notice of Compliance for KISQALI®
31 May 2025 Novartis Pharmaceuticals terminates a phase-I/II trial in Neuroblastoma (In adolescents, In adults, In children, In infants, Second-line therapy or greater, Combination therapy) in Germany, Italy, United Kingdom and USA (PO), due to high toxicity risk identified by the BHLRM model and failure to determine a recommended Phase 2 dose in Phase 1-Part A (NCT05429502)
31 Jan 2025 Novartis settles lcompound patent litigation with generic manufacturer

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