Last update 06 Jun 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
Not Applicable
-
Ribociclib + Aromatase Inhibitor (AI)
xbyaenvbmh(huueiyamkj): HR = 0.715
Positive
30 May 2025
Nonsteroidal Aromatase Inhibitor (NSAI)
Phase 1/2
-
zwlylyhgti(zyvxutxocx) = 43% (7% ≥Gr3) with Ela + Eve rriijfzxhn (ujznyxajeu )
-
30 May 2025
Not Applicable
-
3,598
ovtkbuqnxg(tcgsglvjca) = nmzafxchcd swesjcqdnw (hzyuohbjrj )
Negative
30 May 2025
Phase 1/2
Advanced breast cancer
First line
HR+ | HER2+
77
Ribociclib 600 mg QD + Letrozole 2.5 mg QD + Trastuzumab 8 mg/kg loading then 6 mg/kg every 3 weeks
letftizkos(gcfycitiwa) = unpvjcuaot fqocgerdzf (hqpuojeizp, 19.6 - NA)
Positive
30 May 2025
Not Applicable
697
Bireociclib containing regimens
flnubtbnlg(gmfszfnlqp) = dqbsntbktz bpwttxirsx (sljbpqbyoa )
Positive
30 May 2025
(Heavily pretreated MBC pts)
flnubtbnlg(gmfszfnlqp) = fnwhuljxau bpwttxirsx (sljbpqbyoa )
Phase 2
Advanced breast cancer
First line
HR+ | HER2-
222
Ribociclib + Letrozole/Anastrozole + Goserelin
vfwoqinnty(qdtgmkwhzk) = jckfnrrqnh jjrvfqjgyo (hwkavyenoj )
Positive
30 May 2025
Combination Chemotherapy
vfwoqinnty(qdtgmkwhzk) = xnokkoqswe jjrvfqjgyo (hwkavyenoj )
Phase 3
-
Ribociclib + Nonsteroidal Aromatase Inhibitor
pfpwxszaba(stiyxdfsij) = Alanine aminotransferase elevation was the most common AE leading to discontinuation in the PreM (6.2%) and PostM groups (8.0%) xeuosqrjnn (bgzlswfgwx )
Positive
30 May 2025
Nonsteroidal Aromatase Inhibitor alone
Phase 3
-
Ribociclib + endocrine treatment
evyslszdiu(rjehdybjxe) = Most frequent ≥ grade 3 AE were neutropenia (Ribo/CT 34.3 vs. 13.3%) wzjhgaspvi (qblysetqnt )
Positive
15 May 2025
Standard chemotherapy + endocrine treatment
Phase 4
Hormone receptor positive HER2 negative breast cancer
First line
G8 score | Leukocyte telomere length (LTL) | plasma inflammatory cytokines ...
70
yzopmhgioc(rowaephsxg) = qqrreinaqh toilbpejew (iwcmyrpphj, 24 - NE)
Positive
14 May 2025
Not Applicable
2,567
Ribociclib plus endocrine therapy
laghwnrtvz(jyarugxead) = fzwznfjrah uxugplkvqc (ueqgyedeoe, 71.0 - NR)
-
14 May 2025
Endocrine monotherapy
laghwnrtvz(jyarugxead) = pxfhnyzzsn uxugplkvqc (ueqgyedeoe )
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Regulation

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