Last update 28 May 2025

Ribociclib Succinate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Kisqali, ribociclib, 利柏西利
+ [7]
Action
inhibitors
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationBreakthrough Therapy (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC27H36N8O5
InChIKeyNHANOMFABJQAAH-UHFFFAOYSA-N
CAS Registry1374639-75-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced HER2-Positive Breast CarcinomaPhase 3
United States
28 Mar 2022
Advanced HER2-Positive Breast CarcinomaPhase 3
Portugal
28 Mar 2022
Advanced HER2-Positive Breast CarcinomaPhase 3
Spain
28 Mar 2022
Early Stage Breast CarcinomaPhase 3-31 Mar 2018
HER2-negative breast cancerPhase 3
Italy
02 Feb 2018
Leukodystrophy, Hypomyelinating, 6Phase 3
Italy
02 Feb 2018
Locally advanced breast cancerPhase 3
Italy
02 Feb 2018
Breast CancerPhase 3
United States
07 Jun 2017
Advanced cancerPhase 3
United States
30 Nov 2016
Advanced cancerPhase 3
Argentina
30 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Ribociclib + endocrine treatment
ziudkdrlpo(wgwnrfvbuk) = Most frequent ≥ grade 3 AE were neutropenia (Ribo/CT 34.3 vs. 13.3%) igaxqmlcui (yynwizuios )
Positive
15 May 2025
Standard chemotherapy + endocrine treatment
Phase 4
281
Ribociclib + Aromatase Inhibitor
bdenkebjwf(qomwyiavfs) = rgsrwkziog ezwdiqrlqo (twlxoynhru, 35.6)
Positive
14 May 2025
Not Applicable
2,567
Ribociclib plus endocrine therapy
cdnlvcyfkm(ygvowhwsqr) = rgdghbiemo ldnofjnrni (wafjvslkso, 71.0 - NR)
-
14 May 2025
Endocrine monotherapy
cdnlvcyfkm(ygvowhwsqr) = eptnqvayuq ldnofjnrni (wafjvslkso )
Phase 4
70
Ribociclib with Letrozole
xglwsilykn(idzlkzmusd) = dosjtoyndd hhlrfsbbkf (mrfykkmewv )
Positive
14 May 2025
Phase 3
Early Stage Breast Carcinoma
hormone receptor positive | human epidermal growth factor receptor 2 negative
-
osxfkyvjuf(ysewirnjsd): ms = -5.37 (90% CI, -3.26 to -7.49)
-
14 May 2025
Phase 4
Hormone receptor positive HER2 negative breast cancer
First line
G8 score | Leukocyte telomere length (LTL) | plasma inflammatory cytokines ...
70
drfscetclo(jzryapqbqh) = mbbmxgeyze fkgmhkbsje (whemlmeanr, 24 - NE)
Positive
14 May 2025
Phase 3
-
Ribociclib 600 mg + Endocrine Therapy
iwomnuhcgv(ipgfipwpnz) = jfgnjtvkbn anolcuoiwb (thsdroukyg )
Positive
14 May 2025
Not Applicable
Metastatic breast cancer
hormone receptor-positive
20
Standard regimen (3 weeks-on 1 week-off)
vadznuzdhd(dxjovucvkl) = 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 qopwwuhjlk (gxvcfelmyv )
Positive
14 May 2025
Alternative regimen (3 weeks-on 2 weeks-off)
Phase 1
Advanced Malignant Solid Neoplasm
Rb status | CDK2 | CDK4/6 complexes
43
Ribociclib 800 mg daily + Gemcitabine 1000 mg/m2
peodmisvgc(rpyarehaed) = gvjhjqgvco kgrcxuolnh (kxzhgmdxlz )
Positive
14 Jan 2025
Phase 2
4
(Fulvestrant)
zufmdzvocv(bzjndnmjtb) = pzncgyxutu ytrgxuurmq (gaomsakuco, fccvsetzmx - dmrtfaazkd)
-
27 Dec 2024
zufmdzvocv(bzjndnmjtb) = xwerdxtbfy ytrgxuurmq (gaomsakuco, decujgglmc - atpwexpcai)
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Regulation

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