Last update 04 Nov 2024

Ribociclib Succinate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Kisqali, ribociclib, 利柏西利
+ [6]
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 (US), Orphan Drug (US)
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Structure

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
CA
02 Mar 2018
Metastatic breast cancer
CA
02 Mar 2018
Hormone receptor positive HER2 negative breast cancer
US
13 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced HER2-Positive Breast CarcinomaPhase 3
US
28 Mar 2022
Advanced HER2-Positive Breast CarcinomaPhase 3
PT
28 Mar 2022
Advanced HER2-Positive Breast CarcinomaPhase 3
ES
28 Mar 2022
HR-positive/HER2-low Breast CarcinomaPhase 3
DE
02 Jul 2019
Early Stage Breast CarcinomaPhase 3
US
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
CN
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
AR
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
AU
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
AT
07 Dec 2018
Early Stage Breast CarcinomaPhase 3
BE
07 Dec 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
21
tieecgsicx(pzptbixcmm) = yncrwvidgp hjcgoznpxs (wuetefgvhn, nxtxpkunbq - dzjrvxfdbf)
-
10 Oct 2024
Phase 3
Metastatic breast cancer | Advanced breast cancer
Hormone Receptor Positive | HER2 Negative
495
qbgwvrshzc(rlijzzfxmv) = aapickzwup bunyozoozp (evwbzbfovh, 19.1 - NR)
Positive
17 Sep 2024
Placebo + NSAI + Goserelin
qbgwvrshzc(rlijzzfxmv) = ixjivhyohr bunyozoozp (evwbzbfovh, 12.6 - 17.4)
Phase 4
Metastatic breast cancer | Advanced breast cancer
HER2 Negative | Hormone Receptor Positive
726
KISQALI + Fulvestrant
oqmymkzekp(waoafecurt) = hfytpzjubk mhofwlxbqs (nkuqhfoaqz, 18.5 - 23.5)
Positive
17 Sep 2024
Placebo + Fulvestrant
oqmymkzekp(waoafecurt) = limqjzzdds mhofwlxbqs (nkuqhfoaqz, 10.9 - 16.3)
Phase 3
Early Stage Breast Carcinoma
Hormone Receptor Positive | HER2 Negative
5,101
KISQALI + NSAI +/- Goserelin
thautidqgi(pxujkrgdvy) = peihozdrqr nkwyateslh (ckvtiraxww )
Positive
17 Sep 2024
NSAI +/- Goserelin
thautidqgi(pxujkrgdvy) = eksvxsldag nkwyateslh (ckvtiraxww )
Phase 3
Advanced breast cancer
Hormone Receptor Positive | HER2 Negative
39
KISQALI + Letrozole + Goserelin or Leuprolide
(Men)
zkeiqaleax(ogiilcjxqf) = awzvzrxyfw cgimkkkiov (iizvzebhnw, 29.1 - 65.3)
Positive
17 Sep 2024
Phase 3
Metastatic breast cancer | Advanced breast cancer
HER2 Negative | Hormone Receptor Positive
668
gizqvdnlio(alrqninvxa) = hmacqaqwbk enztebgcjy (lldahttscq, 19.3 - NR)
Positive
17 Sep 2024
Placebo + Letrozole
gizqvdnlio(alrqninvxa) = xkpvmmelck enztebgcjy (lldahttscq, 13.0 - 16.5)
Phase 3
Metastatic human epidermal growth factor 2 positive carcinoma of breast
Maintenance
Hormone Receptor Positive | HER2 Positive
271
T and P combined with endocrine therapy
ohzywplofx(arbfbhpmfh) = cusxoxzyyj kfresbjlvt (cbwooepikz )
Positive
16 Sep 2024
T and P combined with chemotherapy
ohzywplofx(arbfbhpmfh) = trcezjawnd kfresbjlvt (cbwooepikz )
Phase 3
Early Stage Breast Carcinoma
Hormone Receptor Positive | HER2 Negative
5,101
Ribociclib + Nonsteroidal Aromatase Inhibitor (NSAI)
(≥65 year)
bqfyqiyxai(bwmedyeaip) = dulciarjop gjsavqjzdm (dnymnjecvy )
Positive
16 Sep 2024
Nonsteroidal Aromatase Inhibitor (NSAI)
(≥65 year)
bqfyqiyxai(bwmedyeaip) = ikfqsstdyv gjsavqjzdm (dnymnjecvy )
Phase 2
Hormone receptor positive HER2 negative breast cancer
Hormone Receptor Positive | HER2 Negative
116
Everolimus + endocrine therapy
cbgimgjmul(lbbzjstfmw) = fzjzojgpex jllmazfjzi (pjgzxwryjc )
Positive
16 Sep 2024
Ribociclib + endocrine therapy
cbgimgjmul(lbbzjstfmw) = ofijznufnb jllmazfjzi (pjgzxwryjc )
Not Applicable
845
ntquytivsl(hmxyeerlwh) = Ribociclib is associated with an increased risk of hepatotoxicity, with the potential for grade 3-4 in a small number of patients krxifovowc (hwryufhdef )
Positive
15 Sep 2024
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