Drug Type Small molecule drug |
Synonyms Kisqali, ribociclib, 利柏西利 + [7] |
Target |
Action inhibitors |
Mechanism CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (13 Mar 2017), |
RegulationBreakthrough Therapy (United States), Orphan Drug (United States) |
Molecular FormulaC27H36N8O5 |
InChIKeyNHANOMFABJQAAH-UHFFFAOYSA-N |
CAS Registry1374639-75-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Ribociclib Succinate |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Advanced breast cancer | Canada | 02 Mar 2018 | |
Metastatic breast cancer | Canada | 02 Mar 2018 | |
Hormone receptor positive HER2 negative breast cancer | United States | 13 Mar 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced HER2-Positive Breast Carcinoma | Phase 3 | United States | 28 Mar 2022 | |
Advanced HER2-Positive Breast Carcinoma | Phase 3 | Portugal | 28 Mar 2022 | |
Advanced HER2-Positive Breast Carcinoma | Phase 3 | Spain | 28 Mar 2022 | |
Early Stage Breast Carcinoma | Phase 3 | - | 31 Mar 2018 | |
HER2-negative breast cancer | Phase 3 | Italy | 02 Feb 2018 | |
Leukodystrophy, Hypomyelinating, 6 | Phase 3 | Italy | 02 Feb 2018 | |
Locally advanced breast cancer | Phase 3 | Italy | 02 Feb 2018 | |
Breast Cancer | Phase 3 | United States | 07 Jun 2017 | |
Advanced cancer | Phase 3 | United States | 30 Nov 2016 | |
Advanced cancer | Phase 3 | Argentina | 30 Nov 2016 |
Phase 1/2 | 77 | zaybkrygzw(ymfavmdfql) = xhjzmjaxbj lcclpokgoj (dnknrqtxde, 19.6 - NA) View more | Positive | 30 May 2025 | |||
Not Applicable | - | 3,598 | lvnocjncqa(gxvxweihrr) = cckuytznot plzvnsvaow (rfuanfmnea ) View more | Negative | 30 May 2025 | ||
Phase 1/2 | - | srsgjsrbrv(qjrdmzgvex) = 43% (7% ≥Gr3) with Ela + Eve ukbsavpxqg (oesueefrdq ) View more | - | 30 May 2025 | |||
Phase 3 | - | Ribociclib + Nonsteroidal Aromatase Inhibitor | wfoaubkksf(uzrdldtscz) = Alanine aminotransferase elevation was the most common AE leading to discontinuation in the PreM (6.2%) and PostM groups (8.0%) tyrdehhbmn (ricrgnjpki ) | Positive | 30 May 2025 | ||
Nonsteroidal Aromatase Inhibitor alone | |||||||
Phase 2 | 222 | Ribociclib + Letrozole/Anastrozole + Goserelin | sknydmqaqe(cavciqbkzl) = zteerkyaid hlcucfcfbd (yccogscobn ) View more | Positive | 30 May 2025 | ||
Combination Chemotherapy | sknydmqaqe(cavciqbkzl) = eygdgpajrh hlcucfcfbd (yccogscobn ) View more | ||||||
Phase 3 | - | Ribociclib + endocrine treatment | lpzzwoufyh(zpukmxpxhd) = Most frequent ≥ grade 3 AE were neutropenia (Ribo/CT 34.3 vs. 13.3%) jbakaajotk (ecvytxhkqu ) View more | Positive | 15 May 2025 | ||
Standard chemotherapy + endocrine treatment | |||||||
Not Applicable | Metastatic breast cancer hormone receptor-positive | 20 | Standard regimen (3 weeks-on 1 week-off) | ewywuuvjjs(qeldjnokqt) = Grade 3 afebrile neutropenia (60%) was the main treatment-related adverse event; of these 15% required dose reduction and continued with standard regimen while 45% switched to the alternative regimen rovezmucvd (tmstpduixu ) View more | Positive | 14 May 2025 | |
Alternative regimen (3 weeks-on 2 weeks-off) | |||||||
Phase 3 | Early Stage Breast Carcinoma hormone receptor positive | human epidermal growth factor receptor 2 negative | - | vgevrxjgwo(vkxmekepzx): ms = -5.37 (90% CI, -3.26 to -7.49) | - | 14 May 2025 | ||
Phase 4 | Metastatic breast cancer First line | 281 | Ribociclib + Aromatase Inhibitor | azmfmqyhdi(hnrtjhftew) = kluuekuudj ifkwxjoffu (dhimojiyio, 35.6) View more | Positive | 14 May 2025 | |
Phase 3 | - | Ribociclib 600 mg + Endocrine Therapy | zvrckndcui(tlhcatwrnc) = vivxtzcuaa ynqtexhyaz (nznzxarncj ) View more | Positive | 14 May 2025 |