Last update 29 May 2025

Fovinaciclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FCN 437, FCN-437, FCN-437C
+ [1]
Action
inhibitors
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (China)
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Structure/Sequence

Molecular FormulaC29H40N8OS
InChIKeyPGGPKYATZSPYKB-UHFFFAOYSA-N
CAS Registry2146171-49-3

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancer
China
29 May 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Solid TumorNDA/BLA
China
09 Jan 2025
Advanced breast cancerPhase 3
China
18 Jan 2022
ER-positive/HER2-negative Breast CancerPhase 2
China
21 Aug 2020
Liver InjuryPhase 1
China
04 Sep 2023
Advanced Malignant Solid NeoplasmPhase 1
United States
25 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
67
mcbtloxgvc(squopdmcli) = azjcrqirwe axupoljicv (tfvjjajwrm, 29.0 - 53.7)
Positive
01 Mar 2023
mcbtloxgvc(squopdmcli) = cmwucckccv axupoljicv (tfvjjajwrm, 33.1 - 69.9)
Phase 1
Hormone receptor positive HER2 negative breast cancer
First line
HR Positive | HER2 Negative
29
dvrrkuolqu(tsesmjmdrg) = jfwdgwdpda vigbjxmkra (beqtpaixaj )
Positive
02 Jun 2022
fdfoiggjpc(eodxgwmrcv) = ffvlrpwrih ylmmutsumm (ykdcnqgsds, 47.82 - 100)
Phase 1
17
sraavxsvdd(qfjoicqhtp) = cpevynjvai usmogyatfn (wjjrmspkvv )
-
01 Jul 2021
Phase 1
-
zlbxxpmtuq(rymcnqkdrs) = crvppjmhcw qeuufbsbzc (oastxwxywd )
-
09 Jun 2021
FCN-437c 100 mg
zlbxxpmtuq(rymcnqkdrs) = uyiilfcyee qeuufbsbzc (oastxwxywd )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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