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Ribociclib - Novartis Oncology

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Drug Profile

Ribociclib - Novartis Oncology

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

Latest Information Update: 13 Jul 2026

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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

Highest Development Phases

  • 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
  • No development reported Glioma; Lymphoma; Medulloblastoma; Non-small cell lung cancer; Rhabdoid tumour; Rhabdomyosarcoma; Soft tissue sarcoma; Solid tumours; Squamous cell cancer
  • Discontinued Endometrial cancer; Fallopian tube cancer; Head and neck cancer; Liver cancer; Meningioma; Prostate cancer; Teratoma

Most Recent Events

  • 13 Jul 2026 Pharmacodynamic data from a phase II trial in Breast cancer cancer presented at 117th Annual Meeting of the American Association for Cancer Research (AACR-2026)
  • 06 Jul 2026 SOLTI Breast Cancer Research Group and Novartis terminates a phase III trial for Breast cancer (First line therapy, Late stage therapy, Combination therapy) in USA, Spain and Portugal (PO) due to enrollment was significantly delayed compared with the original projections due to the evolving therapeutic landscape (NCT05207709)
  • 29 May 2026 Pharmacodynamics data from a phase III NATALEE trial in Breast cancer presented at the 62nd Annual Meeting of the American Society of Clinical Oncology (ASCO-2026)

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