Overview
Ribociclib is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably. Ribociclib was approved by the U.S. FDA in March, 2017 as Kisqali.
Indication
用于联合芳香酶抑制剂或氟维司群治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的晚期或转移性乳腺癌成人患者。
Associated Conditions
- Advanced Breast Cancer
- Metastatic Breast Cancer
Research Report
A Comprehensive Scientific Monograph on Ribociclib (Kisqali®)
Executive Summary
Ribociclib, marketed under the brand name Kisqali®, is a highly selective, orally bioavailable small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6).[1] Developed through a collaboration between Novartis and Astex Pharmaceuticals, Ribociclib has emerged as a transformative therapy and a cornerstone in the management of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, the most common subtype of the disease.[4] Its therapeutic action is rooted in its ability to interrupt a fundamental pathway that drives cancer cell proliferation.
The core mechanism of Ribociclib involves the targeted inhibition of the cyclin D-CDK4/6-retinoblastoma (Rb) protein pathway. By preventing the phosphorylation of the Rb protein, Ribociclib effectively halts the cell cycle in the G1 phase, inducing a state of cytostasis and thereby suppressing tumor growth.[2] This precise mechanism of action underpins its significant efficacy in HR+ breast cancer, where this pathway is frequently dysregulated.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/25 | Not Applicable | Not yet recruiting | |||
2025/07/08 | Not Applicable | Recruiting | |||
2025/06/03 | Phase 1 | Not yet recruiting | Forward Pharmaceuticals Co., Ltd. | ||
2025/05/01 | Phase 2 | Recruiting | |||
2025/04/16 | N/A | Not yet recruiting | |||
2025/04/01 | N/A | Not yet recruiting | |||
2025/02/03 | N/A | Recruiting | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | ||
2025/01/28 | N/A | Not yet recruiting | |||
2025/01/07 | Phase 3 | Recruiting | |||
2024/12/10 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Novartis Pharmaceuticals Corporation | 0078-0860 | ORAL | 200 mg in 1 1 | 9/2/2021 | |
| Novartis Pharmaceuticals Corporation | 0078-0867 | ORAL | 200 mg in 1 1 | 9/2/2021 | |
| Novartis Pharmaceuticals Corporation | 0078-0874 | ORAL | 200 mg in 1 1 | 9/2/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| KISQALI FILM-COATED TABLET 200MG | SIN15407P | TABLET, FILM COATED | 200mg | 1/22/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| KISQALI ribociclib 200 mg (as succinate) film coated tablet blister pack | 280246 | Medicine | A | 10/23/2017 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| KISQALI 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1171221001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized | |
| KISQALI 200 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 1171221005IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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