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Drug

Ribociclib

Approved · FDA
ClassCyclin-dependent kinase 6 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Kisqali, Kisqali (200 mg daily-dose), Kisqali (400 mg daily-dose), Kisqali (600 mg daily-dose).

RxNorm1873916ChEMBLCHEMBL3545110UNIITK8ERE8P56
3
Research papers
63
Active clinical trials
2
Protein targets
16
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Clinical trial2026-07-30Results expected Q2 2029 · ClinicalTrials.gov

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer

Clinical trial2026-07-16Results expected Q3 2027 · ClinicalTrials.gov

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Clinical trial2026-07-10Results expected Q2 2029 · ClinicalTrials.gov

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Clinical trial2026-07-10Results expected Q1 2031 · ClinicalTrials.gov

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

Clinical trial2026-07-10Results expected Q1 2029 · ClinicalTrials.gov

Indication expansion: RIBOCICLIB (NDA209092)

Regulatory2026-07-01FDA

Supplemental approval: RIBOCICLIB (NDA209092)

Regulatory2025-09-16FDA

Label change: RIBOCICLIB (NDA209092)

Regulatory2025-07-28FDA

Label change: RIBOCICLIB (NDA209092)

Regulatory2025-02-11FDA

Inhibiting CDK4/6 in Breast Cancer with Palbociclib, Ribociclib, and Abemaciclib: Similarities and Differences.

Research2020-12-28Drugs

Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.

Research2019-12-11The New England journal of medicine

Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.

Research2016-10-07The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ribociclib
Aliases & brands
KisqaliKisqali (200 mg daily-dose)Kisqali (400 mg daily-dose)Kisqali (600 mg daily-dose)
RxNorm CUI
1873916
ChEMBL ID
CHEMBL3545110
UNII
TK8ERE8P56
Primary mechanism
Cyclin-dependent kinase 6 inhibitor
Regulatory jurisdictions
fda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Cyclin-dependent kinase 6
CDK6 · Q00534
INHIBITORCyclin-dependent kinase 6 inhibitor
Cyclin-dependent kinase 4
CDK4 · P11802
INHIBITORCyclin-dependent kinase 4 inhibitor

Regulatory timeline

16 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-03-13
Latest approval
2026-07-01
Authorities
FDA
Total events
16
fdaU.S. Food and Drug Administration· 16 events
2026-07-01Indication expansion
Indication expansion: RIBOCICLIB (NDA209092)
Evidence ↗
2025-09-16Supplemental approval
Supplemental approval: RIBOCICLIB (NDA209092)
Evidence ↗
2025-07-28Label change
Label change: RIBOCICLIB (NDA209092)
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

120 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
120
registered trials across all phases
LATEST COMPLETION 2025
63
Active studies
38
Recruiting
29
Late-stage (III+)
30
Completed
27
Discontinued
PHASE DISTRIBUTIONn = 120
Early Phase 13Phase 135Phase 1 / 220Phase 233Phase 323Phase 45Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Active, not recruitingPH IVNovartis Pharmaceuticalsn=1342030

Phase IV Multi-arm Study of CDK4/6 Pharmacokinetics in Healthy Volunteers With Known CYP3A4*22 Genotype

WithdrawnPH IVUniversity of Michigan Rogel Cancer Center2027

CAPTOR-BC: Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

RecruitingPH IVKey trialInstitut fuer Frauengesundheitn=1,0002026

Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt

CompletedPH IVBeni-Suef Universityn=2062025

evaLuation of Variations pharmacokinEtics and phArmacogeNOmics of Ribociclib in rAce-based Cohorts: The LEANORA Study

TerminatedPH IVGeorgetown Universityn=212023

Recent completions

Trials that read out recently, adding to the completed evidence base.

Clinical and Pharmacoeconomic Assessment of CDK4/6 Inhibitors for Treatment of Breast Cancer in Egypt

CompletedPH IVBeni-Suef Universityn=2062025

Phase II Randomized, Double-blind, Placebo-controlled Study of LEE011(Ribociclib) or Placebo in Combination With Endocrine Therapy for the Treatment of Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer, Including a Subset With Pharmacokinetic Analysis.

CompletedPH IINovartis Pharmaceuticalsn=3272025

A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors

CompletedPH IRelay Therapeutics, Inc.n=412025

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

CompletedPH IINovartis Pharmaceuticalsn=3762024

Molecularly-Driven Doublet Therapy for All Children With Refractory or Recurrent CNS Malignant Neoplasms and Young Adults With Refractory or Recurrent SHH Medulloblastoma

CompletedPH ISt. Jude Children's Research Hospitaln=682024

DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

CompletedPH IIProf. Wolfgang Jannin=1162024

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20162021
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
  • Drugs1
Leading researchers
  • Nusch A2
  • Petrakova K2
  • Sonke GS2
  • Alba E1
  • André F1
  • Arteaga CL1
  • Bachelot T1
  • Beck JT1
Leading institutions
free-text, unnormalised
  • Department of Hospital Pharmacy1
  • Erasmus University MC Cancer Institute1
  • From the David Geffen School of Medicine at UCLA1
  • From the University of Texas M.D. Anderson Cancer Center1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas
Breast Neoplasms2

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Abemaciclib

Acts on the same molecular target as Ribociclib, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper
Palbociclib

Acts on the same molecular target as Ribociclib, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper
Fulvestrant

Studied across the same disease area as Ribociclib in the shared literature.

1 shared disease1 shared paper
Letrozole

Studied across the same disease area as Ribociclib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.