Last update 25 Mar 2025

Lerociclib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
G1T38, G1t38 free base, Lerociclib (USAN)
+ [6]
Action
inhibitors
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Originator Organization
Drug Highest PhaseNDA/BLA
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC26H34N8O
InChIKeyYPJRHEKCFKOVRT-UHFFFAOYSA-N
CAS Registry1628256-23-4

External Link

KEGGWikiATCDrug Bank
D11455--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancerNDA/BLA
China
28 Mar 2023
Hormone receptor positive HER2 negative breast cancerNDA/BLA
China
28 Mar 2023
Endometrial Endometrioid AdenocarcinomaPhase 3-18 Apr 2023
Recurrent Endometrial CancerPhase 3-18 Apr 2023
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
China
14 Jan 2022
Locally advanced breast cancerPhase 3
China
10 Sep 2021
Advanced breast cancerPhase 2
United States
21 Dec 2021
Advanced breast cancerPhase 2
Belgium
21 Dec 2021
Advanced breast cancerPhase 2
Georgia
21 Dec 2021
Advanced breast cancerPhase 2
Italy
21 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Hormone receptor positive HER2 negative breast cancer
Hormone Receptor Positive | HER2 Negative
275
kzcnlzgzcm(udjonvtipw) = vblkbirtzh iqclvgeozw (ttoteckejn, 9.23 - NR)
Positive
16 Jan 2025
Placebo + Fulvestrant
kzcnlzgzcm(udjonvtipw) = litxabdyir iqclvgeozw (ttoteckejn, 3.81 - 7.36)
Phase 3
Hormone receptor positive HER2 negative breast cancer
First line
HER2 Negative | Hormone Receptor Positive
279
hrrmqbqvkm(lhprsuedpr) = nsuwhuudqw cevyzcobkf (xunkyqabsc )
Positive
24 May 2024
Placebo + Letrozole
hrrmqbqvkm(lhprsuedpr) = zipmanwtpv cevyzcobkf (xunkyqabsc )
Phase 1/2
30
(Part 1: Cohort 1 Lerociclib at 200 mg QD)
jdlyawpqoy = kuauaiqbfn avxbwlkcwo (ywoxkvkrvd, bleuetofbv - lczrmaqisf)
-
01 May 2023
(Part 1: Cohort 2 Lerociclib at 300 mg QD)
jdlyawpqoy = wiamxwwmgf avxbwlkcwo (ywoxkvkrvd, mxlprnujme - beeuwrcznf)
Phase 2
110
(200–650 mg once daily and 100–250 mg twice daily (BID))
korejohqbv(zrkyvjtkkn) = neutropenia(30%) bzkmtfolmv (gtombdltvh )
Positive
17 Sep 2020
Phase 1
24
nyvrwgtsaf(zsmubtqkcf) = cytopenias and GI AEs esknhhhjth (ntbkqtfaxc )
Positive
02 Jun 2018
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Regulation

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