Kisqali

(Ribociclib)

ApprovedSmall molecule

Ribociclib is used to treat certain types of breast cancer, particularly hormone receptor-positive breast cancer in women. It works by slowing down the growth of cancer cells when used in combination with other cancer medications.[2] Kisqali is currently approved and in use across 38 indications[4].[1]

Kisqali is one of 600 small molecule programs targeting Metastatic Breast Cancer. It is currently in Approved.

Indications

143

Total Trials

Active Trials

599

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Metastatic Breast CancerRecruiting

LiposarcomaApproved

Glioblastoma MultiformeApproved

Head and Neck Squamous Cell CarcinomaApproved

Breast CarcinomaApproved

Breast NeoplasmApproved

ParagangliomaApproved

Hepatocellular CarcinomaApproved

Kidney DiseaseApproved

Childhood MedulloblastomaApproved

Metastatic Breast CancerApproved

Recruiting

LiposarcomaApproved

Approved

Glioblastoma MultiformeApproved

Approved

Head and Neck Squamous Cell CarcinomaApproved

Approved

Breast CarcinomaApproved

Approved

Breast NeoplasmApproved

Approved

ParagangliomaApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Kidney DiseaseApproved

Approved

Childhood MedulloblastomaApproved

Approved

Showing 10 of 38 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Kisqali

Novartis

Approved

63 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Blenoxane

Bristol-Myers Squibb

Preclinical

1 5

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Acupan

YYonsei University

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Preclinical

—8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Bisphosphonate

Amgen

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Abemaciclib

NCT05766410

Q4 2026

Phase 1/2Active, not recruiting

TNBC

NCT03090165

Phase 2Active, not recruiting

Breast Cancer

NCT03285412

Post-ApprovalRecruiting

Breast Cancer

NCT05452213

Phase 1Active, not recruiting

NSCLC

NCT03333343

Phase 1Active, not recruiting

Breast Cancer

NCT02608216

Clinical

Trials by Indication[1]

Breast Cancer63 trials

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Completed·—·Phase 1/2·NCT02657343·25 enrolled

Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

Recruiting·JJonsson Comprehensive Cancer Center·Phase 1/2·NCT05319873·18 enrolled

FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer

Active, not recruiting·FFondazione Sandro Pitigliani·Phase 2·NCT03944434·116 enrolled

Show 60 more trials

Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06656624·190 enrolled

Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients

Unknown status·YYonsei University·Phase 1/2·NCT03913234·95 enrolled

Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer

Completed·UUniversity of Milano Bicocca··NCT06367335·128 enrolled

Tailoring NEOadjuvant Therapy in Hormone Receptor Positive, HER2 Negative, Luminal Breast Cancer.

Active, not recruiting·BBorstkanker Onderzoek Groep·Phase 2·NCT03283384·100 enrolled

Ribociclib in Hormone Receptor-positive, HER2-negative Early Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT07400523·446 enrolled

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

Withdrawn·DDanish Breast Cancer Cooperative Group·Phase 3·NCT06585969

Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer

Not yet recruiting·YYeon Hee Park·Phase 2·NCT06849947·272 enrolled

Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

Completed·GGBG Forschungs GmbH·Phase 2·NCT03555877·56 enrolled

TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02586675·7 enrolled

Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06760637·1,020 enrolled

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Recruiting·FFondazione IRCCS Istituto Nazionale dei Tumori, Milano··NCT06805812·3,500 enrolled

A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib

Terminated· Novartis logo

Novartis·Phase 3·NCT03050398·8 enrolled

Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06587789·286 enrolled

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Terminated·TTvardi Therapeutics, Incorporated·Phase 1·NCT05384119·6 enrolled

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

Active, not recruiting·QQamar Khan·Phase 2·NCT02712723·121 enrolled

A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer

Active, not recruiting· Pfizer logo

Pfizer··NCT06495164·1 enrolled

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03822468·376 enrolled

DETECT IV - A Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).

Completed·PProf. Wolfgang Janni·Phase 2·NCT02035813·116 enrolled

Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer

Completed·—·Phase 2·NCT03477396·2 enrolled

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

Completed· Novartis logo

Novartis·Phase 3·NCT02422615·726 enrolled

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

Recruiting·KKarolinska University Hospital·Phase 2·NCT05900206·370 enrolled

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

Completed· Novartis logo

Novartis·Phase 1/2·NCT02732119·104 enrolled

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B)

Active, not recruiting· Pfizer logo

Pfizer·Phase 1/2·NCT05573555·20 enrolled

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT02278120·672 enrolled

CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT03285412·120 enrolled

Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06409390·15 enrolled

Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer

Completed· Novartis logo

Novartis··NCT05569187·76 enrolled

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03078751·54 enrolled

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer

Withdrawn· Novartis logo

Novartis·Phase 3·NCT03081234

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

Recruiting·SSOLTI Breast Cancer Research Group·Phase 2·NCT05296746·1,100 enrolled

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Recruiting· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05216432·930 enrolled

Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer

Not yet recruiting·NNagoya City University·Phase 1/2·NCT07164976·86 enrolled

A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer

Completed·—·Phase 1·NCT02599363·18 enrolled

Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)

Recruiting·CCentre Antoine Lacassagne·Phase 1/2·NCT05664893·85 enrolled

Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

Recruiting·YYale University·Phase 2·NCT06953882·140 enrolled

Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT01857193·132 enrolled

Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer

Not yet recruiting·MMedSIR·Phase 2·NCT07195227·150 enrolled

Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer.

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT03248427·106 enrolled

Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Withdrawn·EEmory University·Phase 1·NCT04585724

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

Recruiting·IInstitut fuer Frauengesundheit·Phase 4·NCT05452213·1,000 enrolled

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

Completed·—·Phase 4·NCT07487129·206 enrolled

[18F]FLT PET/CT in Rb+ Metastatic Breast Cancer

Active, not recruiting·UUniversity of Pennsylvania·Phase 1·NCT02608216·20 enrolled

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

Active, not recruiting·UUNICANCER·Phase 2·NCT05625087·162 enrolled

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT01958021·668 enrolled

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

Recruiting· Novartis logo

Novartis··NCT06905301·240 enrolled

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Completed· Relay Therapeutics logo

Relay Therapeutics·Phase 1·NCT05759949·41 enrolled

Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors

Completed· Novartis logo

Novartis··NCT05153135·4,320 enrolled

Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT03839823·222 enrolled

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04256941·4 enrolled

Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT03096847·502 enrolled

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocrine Therapy or Who Have Progressed on Endocrine Therapy in Combination With a CDK4/6 Inhibitor for Advanced Disease

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT05870579·28 enrolled

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

Recruiting· Roche logo

Roche·Phase 2·NCT07405801·80 enrolled

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

Recruiting· Roche logo

Roche·Phase 2·NCT07054190·120 enrolled

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)

Recruiting·OOlema Pharmaceuticals, Inc.·Phase 3·NCT07085767·1,000 enrolled

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

Recruiting· Novartis logo

Novartis··NCT06930859·2,766 enrolled

A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT05996107·30 enrolled

A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)

Terminated· Novartis logo

Novartis·Phase 3·NCT03439046·287 enrolled

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.

Completed· Novartis logo

Novartis·Phase 2·NCT03671330·327 enrolled

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Recruiting· Eli Lilly logo

Eli Lilly·Preclinical·NCT05768139·880 enrolled

Metastatic Breast Cancer6 trials

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 recruiting· Novartis logo

Novartis·Approved·NCT05161195·134 enrolled

A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4/6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and/or Metastatic ER Positive, HER2 Negative Breast Cancer

Active, not recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT05508906·190 enrolled

A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)

Recruiting· Roche logo

Roche·Preclinical·NCT03424005·1,132 enrolled

Show 3 more trials

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE)

Terminated·UUniversity of Utah·Phase 1·NCT04315233·12 enrolled

Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 3·NCT06377852·500 enrolled

A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial

Terminated·SSOLTI Breast Cancer Research Group·Phase 3·NCT05207709·61 enrolled

Dedifferentiated Liposarcoma3 trials

A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma

Unknown status·—·Phase 2·NCT03096912·30 enrolled

A Phase II Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma

Unknown status·HHadassah Medical Organization·Phase 2·NCT02571829·30 enrolled

Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS)

Active, not recruiting·FFox Chase Cancer Center·Phase 2·NCT03114527·48 enrolled

Ovarian Cancer3 trials

Ribociclib + PDR001 in Breast Cancer and Ovarian Cancer

Terminated·—·Phase 1·NCT03294694·33 enrolled

Ribociclib and Letrozole Treatment in Ovarian Cancer

Active, not recruiting·GGynecologic Oncology Group·Phase 2·NCT03673124·51 enrolled

Ribociclib (Ribociclib (LEE-011)) With Platinum-based Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer

Completed·RRonald Buckanovich·Phase 1·NCT03056833·35 enrolled

Advanced Breast Cancer3 trials

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Active, not recruiting· Roche logo

Roche·Phase 3·NCT06065748·1,050 enrolled

A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06380751·788 enrolled

Efficacy and Safety of First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer: A Multicenter, Nonrandomized Phase II Study With an External Control

Completed·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06375707·74 enrolled

56 more indications

Glioma2 trials

A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

Completed·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 1·NCT03834740·27 enrolled

A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)

Completed·—·Phase 1·NCT03355794·19 enrolled

Patients With Advanced Solid Tumors2 trials

Study of AVZO-021 in Patients With Advanced Solid Tumors

Recruiting·AAvenzo Therapeutics, Inc.·Phase 1/2·NCT05867251·430 enrolled

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

Active, not recruiting· Novartis logo

Novartis·Phase 1/2·NCT05358249·74 enrolled

Advanced Solid Tumors2 trials

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Terminated· Novartis logo

Novartis·Phase 1·NCT02703571·95 enrolled

(VELA) Study of BLU-222 in Advanced Solid Tumors

Terminated·BBlueprint Medicines·Phase 1·NCT05252416·50 enrolled

Neuroblastoma2 trials

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Terminated· Novartis logo

Novartis·Phase 1·NCT05429502·12 enrolled

Next Generation Personalized Neuroblastoma Therapy

Terminated·YYael P Mosse·Phase 1·NCT02780128·66 enrolled

Tics2 trials

Pharmacokinetics and Pharmacogenomics of Ribociclib in Race-based Cohorts

Terminated·GGeorgetown University·Phase 4·NCT04657679·21 enrolled

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

Withdrawn·UUniversity of Michigan Rogel Cancer Center·Phase 4·NCT05691400

Early Breast Cancer2 trials

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT03701334·5,101 enrolled

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Recruiting· Novartis logo

Novartis·Phase 3·NCT05827081·1,400 enrolled

HR+/HER2- Breast Cancer2 trials

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

Recruiting·BBeOne Medicines·Phase 3·NCT07492641·1,056 enrolled

Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia

Recruiting· Novartis logo

Novartis··NCT06797531·177 enrolled

HER2-negative Breast Cancer2 trials

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

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07647328·150 enrolled

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04964934·315 enrolled

Breast Neoplasms2 trials

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)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07174336·800 enrolled

A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life

Recruiting· Novartis logo

Novartis··NCT06830720·3,250 enrolled

Abemaciclib1 trial

A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT05766410·60 enrolled

Postmenopausal Women1 trial

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

Completed· Novartis logo

Novartis·Phase 3·NCT02941926·3,246 enrolled

TNBC1 trial

Ribociclib and Bicalutamide in AR+ TNBC

Active, not recruiting·KKari Wisinski·Phase 1/2·NCT03090165·37 enrolled

Prostate Cancer1 trial

Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1/2·NCT02555189·46 enrolled

Neoadjuvant Treatment1 trial

The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

Not yet recruiting·HHongmei Zheng, PhD·N/A·NCT06810492·40 enrolled

mCRPC1 trial

LEE011 (Ribociclib) in Combination With Docetaxel Plus Prednisone in mCRPC

Completed·RRahul Aggarwal·Phase 1/2·NCT02494921·43 enrolled

Aged1 trial

Managed Access Programs for LEE011, Ribociclib

Available· Novartis logo

Novartis··NCT05038631

Combination Therapy1 trial

Ribociclib-endocrine Combination Therapy Versus Chemotherapy as 1st Line in Visceral mBC

Terminated·SSwiss Cancer Institute·Phase 3·NCT03905343·25 enrolled

HNSCC1 trial

Ribociclib and Spartalizumab in R/M HNSCC

Unknown status·NNational Taiwan University Hospital·Phase 1·NCT04213404·13 enrolled

Malignancies1 trial

Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies

Terminated· Novartis logo

Novartis·Phase 1·NCT04000529·122 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Endometrial Cancer1 trial

Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer

Completed·MMayo Clinic·Phase 2·NCT02657928·40 enrolled

Non-Small Cell Lung Cancer1 trial

Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT02292550·27 enrolled

Temozolomide1 trial

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

Recruiting·NNationwide Children's Hospital·Phase 2·NCT05843253·120 enrolled

Neuroendocrine Tumors1 trial

Ribociclib in Treating Patients With Advanced Neuroendocrine Tumors of Foregut Origin

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02420691·21 enrolled

Radiation Therapy1 trial

A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy

Terminated·—·Phase 1/2·NCT02607124·11 enrolled

Recurrent or Refractory1 trial

Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors

Completed·PPediatric Brain Tumor Consortium·Phase 1·NCT03387020·22 enrolled

NSCLC1 trial

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT03333343·105 enrolled

Soft Tissue Sarcoma1 trial

Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery

Completed·OOHSU Knight Cancer Institute·Phase 1·NCT03009201·16 enrolled

Lymphoma1 trial

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma

Terminated·RRoswell Park Cancer Institute·Phase 1·NCT02414724·10 enrolled

Endometrial Carcinoma1 trial

A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03008408·90 enrolled

Melanoma1 trial

A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma

Terminated· Novartis logo

Novartis·Phase 1·NCT02974725·241 enrolled

Head and Neck Squamous Cell Cancer1 trial

Impact of Ribociclib on Head and Neck Squamous Cell Cancer

Terminated·FFox Chase Cancer Center·Phase 1·NCT03179956·1 enrolled

CDK4/6 Inhibitor1 trial

T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

Enrolling by invitation·ZZheng Yabing·Phase 2·NCT06481956·40 enrolled

Phase IB1 trial

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

Recruiting·FForward Pharmaceuticals Co., Ltd.·Phase 1/2·NCT07002177·196 enrolled

Chemotherapy1 trial

Adj. Marker-adjusted Personalized Therapy Comparing ET+Ribociclib vs Chemotherapy in Intermediate Risk, HR+/HER2- EBC

Active, not recruiting·WWest German Study Group·Phase 3·NCT04055493·1,684 enrolled

Advanced or Metastatic Solid Tumors1 trial

Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors

Completed·MMayo Clinic·Phase 1·NCT03237390·43 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Metastatic Melanoma1 trial

Study of Efficacy and Safety of LXH254 Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04417621·134 enrolled

Meningioma1 trial

Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients

Active, not recruiting·NNader Sanai·Phase 1·NCT02933736·48 enrolled

Glioblastoma1 trial

Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma

Unknown status·UUniversity of Virginia·Phase 1·NCT02345824·3 enrolled

Efficacy and Safety1 trial

A Phase IV Study to Collect Data on the Efficacy and Safety of RIBociclib in Older Women With Breastcancer

Completed·UUniversitaire Ziekenhuizen KU Leuven··NCT03956654·78 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Brain Tumors1 trial

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT03434262·68 enrolled

Anatomic Stage II Breast Cancer AJCC v81 trial

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low)

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT07391774·1,978 enrolled

Solid Tumor, Adult1 trial

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)

Recruiting·TTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)·Phase 1·NCT06625775·392 enrolled

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)

Recruiting· Roche logo

Roche·Preclinical·NCT04802759·316 enrolled

Advanced HR+/HER2- Breast Cancer1 trial

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors

Recruiting· Novartis logo

Novartis·Preclinical·NCT06726148·280 enrolled

Acute Lymphoblastic Leukemia (ALL)1 trial

Phase I Trial of Ribociclib in Combination With Everolimus and Dexamethasone in Children and Young Adults With Relapsed Acute Lymphoblastic Leukemia

Active, not recruiting·DDana-Farber Cancer Institute·Phase 1·NCT03740334·45 enrolled

Locally Advanced (Inoperable) or Metastatic Breast Cancer1 trial

A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04862663·893 enrolled

ER+ HER2- Advanced Breast Cancer1 trial

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT06188520·564 enrolled

Solid Tumor1 trial

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy and in Combination With Anticancer Therapies in Participants With Selected Advanced Solid Tumors

Active, not recruiting· Incyte logo

Incyte·Phase 1·NCT05238922·291 enrolled

Recurrence1 trial

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Recruiting·OOana Danciu·Phase 2·NCT05467891·200 enrolled

Pediatric Cancer1 trial

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

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Malignant Solid Tumor1 trial

MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.

Recruiting·CCentre Leon Berard·Phase 2·NCT04116541·455 enrolled

Advanced Cancer1 trial

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and as Part of Combination Therapy in Participants With Advanced Breast Cancer

Active, not recruiting·OOnKure, Inc.·Phase 1·NCT06239467·200 enrolled

Unspecified1 trial

Detect V / CHEVENDO (Chemo vs. Endo)

Active, not recruiting·PProf. Wolfgang Janni·Phase 3·NCT02344472·271 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 13, 2017

KISQALI

NDA NDA209092

Sources

References

[1]
ClinicalTrials.gov — 143 trial records for Ribociclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Kisqali drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ribociclib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ribociclib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209092). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Kisqali. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclin-Dependent Kinase 6 Inhibitor; Cyclin-Dependent Kinase 4 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Dec 17, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8324225*PEDDec 17, 2028

9416136Aug 20, 2029

8962630Dec 9, 2029

9416136*PEDFeb 20, 2030

8685980May 25, 2030

16 more patents

8962630*PEDJun 9, 2030

8685980*PEDNov 25, 2030

8415355*PEDSep 13, 2031

9868739Nov 9, 2031

9193732Nov 9, 2031

9868739*PEDMay 9, 2032

9193732*PEDMay 9, 2032

12544380Aug 7, 2034

12544379Aug 7, 2034

12544380*PEDFeb 7, 2035

12544379*PEDFeb 7, 2035

12419894Apr 14, 2036

12064434Apr 14, 2036

10799506*PEDOct 14, 2036

12064434*PEDOct 14, 2036

12419894*PEDOct 14, 2036

Kisqali

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Breast Cancer63 trials

Metastatic Breast Cancer6 trials

Dedifferentiated Liposarcoma3 trials

Ovarian Cancer3 trials

Advanced Breast Cancer3 trials

Glioma2 trials

Patients With Advanced Solid Tumors2 trials

Advanced Solid Tumors2 trials

Neuroblastoma2 trials

Tics2 trials

Early Breast Cancer2 trials

HR+/HER2- Breast Cancer2 trials

HER2-negative Breast Cancer2 trials

Breast Neoplasms2 trials

Abemaciclib1 trial

Postmenopausal Women1 trial

TNBC1 trial

Prostate Cancer1 trial

Neoadjuvant Treatment1 trial

mCRPC1 trial

Aged1 trial

Combination Therapy1 trial

HNSCC1 trial

Malignancies1 trial

Pilot Study1 trial

Endometrial Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Temozolomide1 trial

Neuroendocrine Tumors1 trial

Radiation Therapy1 trial

Recurrent or Refractory1 trial

NSCLC1 trial

Soft Tissue Sarcoma1 trial

Lymphoma1 trial

Endometrial Carcinoma1 trial

Melanoma1 trial

Head and Neck Squamous Cell Cancer1 trial

CDK4/6 Inhibitor1 trial

Phase IB1 trial

Chemotherapy1 trial

Advanced or Metastatic Solid Tumors1 trial

Trial1 trial

Metastatic Melanoma1 trial

Meningioma1 trial

Glioblastoma1 trial

Efficacy and Safety1 trial

Observational Study1 trial

Brain Tumors1 trial

Anatomic Stage II Breast Cancer AJCC v81 trial

Solid Tumor, Adult1 trial

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer1 trial

Advanced HR+/HER2- Breast Cancer1 trial

Acute Lymphoblastic Leukemia (ALL)1 trial

Locally Advanced (Inoperable) or Metastatic Breast Cancer1 trial

ER+ HER2- Advanced Breast Cancer1 trial

Solid Tumor1 trial

Recurrence1 trial

Pediatric Cancer1 trial

Malignant Solid Tumor1 trial

Advanced Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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