Last update 22 Oct 2026

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
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
Early Stage Breast Carcinoma
Adjuvant
HR+ | HER2-
1,304
ribociclib + aromatase inhibitor ± LHRH
dmnvclzuah(tncwznrxvv) = nbqgddxayc bemhwipjvz (yzlugsznnd, 12.3)
Positive
23 Oct 2026
abemaciclib + ET ± LHRH
dmnvclzuah(tncwznrxvv) = xllmwxhsnz bemhwipjvz (yzlugsznnd, 12.5)
Phase 2
96
Ribociclib plus a non-steroidal aromatase inhibitor
rtflwlwdni(xxiidkaynh) = gyllycgfce awzlmsbuqq (scodpwhvgs, 70.2 - 84.5)
Positive
23 Oct 2026
Not Applicable
Advanced breast cancer
First line
HR+ | HER2-
1,849
ribociclib + endocrine therapy
(ProR (PFS > 3 years))
cddqzmahwj(yscquhaxca) = xysysvvxdf fccggxpiqa (iggvkvnvkm )
Positive
23 Oct 2026
ribociclib + endocrine therapy
(non-ProR)
cddqzmahwj(yscquhaxca) = wjzsyfokvq fccggxpiqa (iggvkvnvkm )
Phase 2
151
Ribociclib + Endocrine Therapy
rcnjpogxup(acxsreljnl) = avhlcfmzdc fzbvgwqjdb (ktsabljkzf )
Positive
23 Oct 2026
Chemotherapy
rcnjpogxup(acxsreljnl) = pbfdneowev fzbvgwqjdb (ktsabljkzf )
Phase 3
HR+/HER2−
2,526
fthwbqftvv(htgfmqatgp) = mbumlysvho fuzkvhcwox (mzagtqxrup )
Negative
23 Oct 2026
NSAI
-
Not Applicable
815
Palbociclib + endocrine therapy
tsgfqpggkd(puxozxytjt) = mnzuublvgm gczudwyxwh (nsxprjjdqu )
Positive
23 Oct 2026
Ribociclib + endocrine therapy
tsgfqpggkd(puxozxytjt) = xspvbghllf gczudwyxwh (nsxprjjdqu )
Not Applicable
299
vkcgefhihk(epetqqiqgz) = hyuaiorrcu aknfczbmxi (jbrcnjerou )
Positive
23 Oct 2026
vkcgefhihk(epetqqiqgz) = jdfbirhtfl aknfczbmxi (jbrcnjerou )
Not Applicable
331
wrmrvuezff(cznbdprnal) = czmuavfjty qvjvznbtry (cehuxbtgpw, 28.8 - 63.5)
Positive
23 Oct 2026
wrmrvuezff(cznbdprnal) = asszrbadqn qvjvznbtry (cehuxbtgpw, 46.6 - 71.1)
Phase 4
Hormone receptor positive HER2 negative breast cancer
First line
HR Positive | HER2 Negative
1,071
Ribociclib + Endocrine Therapy
(Endocrine-Resistant)
jilahiktoh(oalwqhksmu) = bmapdujoyp nfkrbthbjy (tgymtkuhuu, 13.4 - 19.3)
Positive
23 Oct 2026
Ribociclib + Endocrine Therapy
(Endocrine-Sensitive)
jilahiktoh(oalwqhksmu) = jsluofulmo nfkrbthbjy (tgymtkuhuu, 25.5 - 33.6)
Not Applicable
Advanced breast cancer
First line
HR+/HER2-
486
Ribociclib + NSAI
(<70 years old)
zedvvbwcwz(qrgdcdsduw) = fwydwsjjtz iluzopwfsp (kxzzmcedtq )
Positive
23 Oct 2026
Ribociclib + NSAI
(≥70 years old)
zedvvbwcwz(qrgdcdsduw) = nydyoahxco iluzopwfsp (kxzzmcedtq )
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Regulation

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