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Kisqali

(Dalpiciclib)

Phase 3Small molecule

RRisen (Suzhou) Pharma Tech Co., Ltd.

Dalpiciclib is used to treat certain types of breast cancer, specifically hormone receptor-positive breast cancer in women. It works by slowing down the growth of cancer cells.[1] Kisqali is currently being investigated across 11 indications[3], with its most advanced program in Phase 3.[1]

Kisqali is one of 339 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

11

Indications

31

Total Trials

24

Active Trials

338

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Breast NeoplasmActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Liver DiseaseActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

Pancreatic CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Gastric CancerActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Active, not recruiting

Breast NeoplasmPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Liver DiseasePhase 1

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

MelanomaPhase 1

Active, not recruiting

Pancreatic CancerPhase 2

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Gastric CancerPhase 1

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Kisqali

RRisen (Suzhou) Pharma Tech Co., Ltd.

Megace

Bristol-Myers Squibb

MS Contin

Zolymbus

Methylthioninium Chloride

PProvepharm SAS

Zinecard

CChildren's Oncology Group

Effexor

WWyeth-Lederle Vaccines

Acupan

YYonsei University

Paracetamol

QS21

MMemorial Sloan Kettering Cancer Center

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Breast Cancer

NCT06613373

Phase 2Recruiting

Breast Cancer

NCT06149130

Phase 2Recruiting

Breast Cancer

NCT05594095

Phase 2Active, not recruiting

Breast Cancer

NCT05463601

Q1 2027

Phase 2Not yet recruiting

Ovarian Cancer

NCT06552858

Q2 2027

Phase 2Recruiting

Breast Cancer

NCT05759572

Clinical

Trials by Indication[1]

Breast Cancer24 trials

Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor

Not yet recruiting·—·Phase 2·NCT06556862·155 enrolled

Efficacy and Safety of Dalpiciclib in Hormone Receptor-positive Advanced Breast Cancer

Recruiting·HHebei Medical University Fourth Hospital··NCT05578053·420 enrolled

An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer

Not yet recruiting·JJiangsu Famous Medical Technology Co., Ltd.·Phase 4·NCT06613373·30 enrolled

Show 21 more trials

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06341894·1,163 enrolled

Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT06107673·144 enrolled

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Recruiting·FFudan University·Phase 2·NCT05582499·716 enrolled

Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer

Recruiting·Wwanghaibo·Phase 2·NCT07285382·120 enrolled

Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05759572·145 enrolled

Dalpiciclib Combined With Letrozole in Neoadjuvant Treatment of Stage Ⅱ-Ⅲ HR-positive/HER2-negative Breast Cancer

Unknown status·HHebei Medical University Fourth Hospital·Phase 2·NCT05512780·30 enrolled

PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05759546·200 enrolled

Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer

Enrolling by invitation·PPeking University·Phase 2·NCT06650748·100 enrolled

Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

Not yet recruiting·FFudan University·Phase 2·NCT07179939·288 enrolled

Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer

Recruiting·HHebei Medical University Fourth Hospital·Phase 2·NCT07492394·60 enrolled

Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer

Active, not recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05463601·132 enrolled

Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer

Recruiting·TTongji Hospital·Phase 2·NCT06149130·82 enrolled

SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Recruiting·FFudan University·Phase 2·NCT05594095·620 enrolled

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

Recruiting·SShengjing Hospital·Phase 2·NCT05638594·236 enrolled

Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer

Unknown status·FFudan University·Phase 1/2·NCT03772353·59 enrolled

Exploration of Dalpiciclib + Chidamide in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor: a Phase Ⅰb Study

Unknown status·—·Phase 1·NCT05586841·30 enrolled

Dalpiciclib Plus Fulvestrant With Pyrotinib in Hormone Receptor-positive, HER2-low Advanced Breast Cancer That Progressed on Previous CDK4/6i Plus AI Therapy

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05806671·30 enrolled

PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

Active, not recruiting·ZZhimin Shao·Phase 3·NCT06612814·307 enrolled

Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

Unknown status·FFudan University·Phase 1/2·NCT05574881·72 enrolled

Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower)

Unknown status·FFudan University·Phase 2·NCT05577923·126 enrolled

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

Recruiting·RRisen (Suzhou) Pharma Tech Co., Ltd.·Phase 3·NCT07207070·312 enrolled

Dalpiciclib2 trials

Dalpiciclib in HR+/HER2- ABC

Recruiting·RRenJi Hospital··NCT06301438·103 enrolled

Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC

Not yet recruiting·FFujian Medical University·N/A·NCT06711094·52 enrolled

Metastatic Colorectal Cancer1 trial

mFOLFOX6 Combined With Dalpiciclib in Patients With Metastatic Colorectal Cancer

Unknown status·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2·NCT05480280·18 enrolled

Esophageal Squamous Cell Carcinoma1 trial

Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas

Recruiting·WWest China Hospital·Phase 1·NCT06225921·6 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas

Recruiting·WWest China Hospital·Phase 1·NCT06109207·6 enrolled

2 more indications

Ovarian Cancer1 trial

Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06552858·30 enrolled

Adjuvant Therapy1 trial

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

Not yet recruiting·FFujian Cancer Hospital·Phase 2·NCT07101159·200 enrolled

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Dalpiciclib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dalpiciclib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dalpiciclib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Risen (Suzhou) Pharma Tech Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: RRisen (Suzhou) Pharma Tech Co., Ltd.

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