Wednesday, July 8, 2026

Drug profile · INN

ribociclib succinate

ribociclib succinate (KISQALI) is a cyclin-dependent kinase 4 inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 7
News articles 0
Drug details — ribociclib succinate
US status
approved
Class
Route
ORAL
Patents
0
Programs
7
Data quality
0.84

Quick answer

ribociclib succinate (KISQALI) is a cyclin-dependent kinase 4 inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN ribociclib succinate
Brand KISQALI
Mechanism Cyclin-dependent kinase 4 inhibitor
Target Cyclin-dependent kinase 4
Route ORAL
Formulation TABLET

Mechanism of action

Cyclin-dependent kinase 4 inhibitor

Primary target: Cyclin-dependent kinase 4

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. CO44657 Phase 3 · HOFFMANN-LA ROCHE · Estrogen receptor (ER)-positive, HER2-negative advanced brea
  2. ABCSG 63 Phase 2 · Shanghai Zerun Biotechnology · endocrine-responsive HER2-negative early breast cancer
  3. BO45853 Phase 2 · HOFFMANN-LA ROCHE · Early-Stage, PIK3CA-Mutated Breast Cancer (BC)
  4. CO40115 Phase 2 · HOFFMANN-LA ROCHE · Metastatic breast cancer, including triple negative breast c
  5. GIM35-RIBOSIL Phase 2 · Telethon Foundation · hormone receptor positive, HER2-negative breast cancer
  6. GEICAM/2023-09 Approved · Ningbo Cancer Hospital · Early Breast Cancer
  7. RIBOCICLIB, Kisqali 200 mg film-coated tablets Approved · George Institute for · Hormone receptor–positive (HRpos)/human epidermal growth fac

Related & competitor drugs

  1. abemaciclib Antineoplastic and immunomodulating agents (L01)
  2. ribociclib Antineoplastic and immunomodulating agents (L01)
  3. trilaciclib dihydrochloride Cyclin-dependent kinase 4 inhibitor

Frequently asked questions

What is ribociclib succinate?

ribociclib succinate (KISQALI) is a cyclin-dependent kinase 4 inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for ribociclib succinate?

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

What is the US approval status of ribociclib succinate?

ribociclib succinate 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.