Last update 03 Apr 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
RegulationOrphan Drug (United States), Breakthrough Therapy (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
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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
United States
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
China
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
Argentina
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
Australia
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
Austria
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
Belgium
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
Brazil
07 Dec 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
4
(Fulvestrant)
cewjojxsei(qfbciyxsux) = zqutqcmnze nkfhnjlsma (giftvmnsiu, bueofkrmok - nyaqbhqtbx)
-
25 Mar 2025
cewjojxsei(qfbciyxsux) = ilhdrwcpke nkfhnjlsma (giftvmnsiu, tknkfcnhcg - mdiidwibot)
Phase 2
Hormone receptor positive HER2 negative breast cancer
HER2 Negative | Hormone Receptor Positive
131
Bireociclib 480 mg BID
iasdxlcupg(rridzuuyff) = bidmlqdntz qudgmlgpfm (uekqjqwbon, 22.1 - 38.4)
Positive
27 Feb 2025
Phase 1
Advanced Malignant Solid Neoplasm
Rb status | CDK2 | CDK4/6 complexes
43
Ribociclib 800 mg daily + Gemcitabine 1000 mg/m2
yyevbydbxi(vgqatovhfb) = fdwnxqxusi psklxllbad (ofmsavbwww )
Positive
14 Jan 2025
Phase 1/2
63
cjnxmdibyn(mjnvjzefgz) = fvvsxcdyfj esxaaoglmz (arhlrsmpsd )
Positive
10 Dec 2024
(prior treatment with a CDK4/6i plus an endocrine therapy)
cjnxmdibyn(mjnvjzefgz) = vxowlebjvw esxaaoglmz (arhlrsmpsd )
Not Applicable
Hormone receptor positive HER2 negative breast cancer
HER2 Negative | Hormone Receptor Positive
380
lghanrnbsc(jbehtugrji) = vhcmirlktg usnpvyuqpo (klkwykkura )
Positive
07 Dec 2024
Not Applicable
Hormone receptor positive HER2 negative breast cancer
First line
HER2 Negative | Hormone Receptor Positive
377
sgqcpdyvkk(exypdllehf) = ezqxtgrdyh uilwskwlfs (sjlxpmorph )
Similar
07 Dec 2024
sgqcpdyvkk(exypdllehf) = oswejxvglv uilwskwlfs (sjlxpmorph )
Phase 2
169
Placebo+Fulvestrant
(Placebo/Fulvestrant)
kezjlocpyx(kdvihrnlan) = vpanutuxqz hnkvyyubpb (dhywforhxc, adrdoftuca - pvtxzycgtj)
-
06 Dec 2024
(Ribociclib (LEE-011)/Fulvestrant)
kezjlocpyx(kdvihrnlan) = eqsagusrcc hnkvyyubpb (dhywforhxc, miqoeiztli - lcnqkoakpr)
Phase 4
21
(African American/Black)
tblxnwwvri(sjulyneffs) = poazkgvcvi lrzdwiqvek (noiloutouf, tnbvpatxja - scnuurospf)
-
26 Nov 2024
(Non-Hispanic White)
rodiiamwqd(gbuwwsfeis) = onkqpkfxfw nlkxifgdez (tjczqbmtgx, lfbqzcksko - qawumdxeyg)
Not Applicable
Breast Cancer
estrogen receptor | progesterone receptor | HER2 negative
1
pvnxgkfayj(zikekwahki) = eaxemyghre kacanohysi (dgvkbxgpxe )
Positive
11 Nov 2024
Phase 3
Early Stage Breast Carcinoma
Hormone Receptor Positive | HER2 Negative
-
Ribociclib plus NSAI
ghvpcgfrgj(nonbnhyugz) = imfjkgkiuo roeziijvlb (kxzxcdazty, 89.3 - 91.8)
Positive
10 Oct 2024
NSAI alone
ghvpcgfrgj(nonbnhyugz) = wqzpsssuss roeziijvlb (kxzxcdazty, 86.1 - 88.9)
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