Wednesday, July 8, 2026

Drug profile · INN

ribociclib

ribociclib (KISQALI) is a cyclin-dependent kinase 6 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antineoplastic and immunomodulating agents (L01) L01EF02
US status approved
Patents linked 1
Pipeline programs 22
News articles 1
Drug details — ribociclib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
1
Programs
22
Data quality
0.84

Quick answer

ribociclib (KISQALI) is a cyclin-dependent kinase 6 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ribociclib
Brand KISQALI
Mechanism Cyclin-dependent kinase 6 inhibitor
Target Cyclin-dependent kinase 4
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation TABLET
ATC code L01EF02

Mechanism of action

Cyclin-dependent kinase 6 inhibitor

Primary target: Cyclin-dependent kinase 4

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Recent coverage

Pipeline programs

  1. C4391024 Phase 3 · First Biotech (Australia) · Advanced/Metastatic Breast Cancer
  2. CLEE011O12001 Phase 3 · Novartis India · HR-positive HER-2- negative Breast Cancer
  3. CLEE011O12301C Phase 3 · Novartis India · hormone receptor (HR)-positive, HER2-negative, early breast
  4. CO44657 Phase 3 · HOFFMANN-LA ROCHE · Estrogen receptor (ER)-positive, HER2-negative advanced brea
  5. D8534C00001 Phase 3 · AstraZeneca · Estrogen Receptor-Positive, HER-2 negative Advanced Breast C
  6. D9722C00001 Phase 3 · AstraZeneca · Advanced Breast Cancer
  7. J6M-MC-JSGD Phase 3 · Eli Lilly and · Neoplasm Metastasis, Breast Neoplasms
  8. OP-1250-302 Phase 3 · Olema Pharmaceuticals · ER+, HER2- Advanced Breast Cancer

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)
  1. US 9018244

    Benzopyran compounds, compositions and uses thereof

    Expires Mon Apr 23 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is ribociclib?

ribociclib (KISQALI) is a cyclin-dependent kinase 6 inhibitor. Associated with Novartis Pharmaceuticals. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ribociclib?

KISQALI is a marketed brand name for ribociclib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of ribociclib?

ribociclib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.