Last update 23 Jan 2025

Dalpiciclib Isethionate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dalpiciclib, 达尔西利, SHR-6390
+ [1]
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN)
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Structure/Sequence

Molecular FormulaC25H30N6O2
InChIKeySGJLSPUSUBJWHO-UHFFFAOYSA-N
CAS Registry1637781-04-4

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hormone receptor positive HER2 negative breast cancer
CN
31 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-sensitive prostate cancerPhase 3
CN
19 Oct 2023
HER2-negative breast cancerPhase 3
CN
30 Apr 2021
Hormone receptor positive breast cancerPhase 3
CN
30 Apr 2021
Node-positive breast cancerPhase 3
CN
30 Apr 2021
Advanced breast cancerPhase 3
CN
13 Jun 2019
HR Positive/HER2 Negative/Node positive breast cancerPhase 3
CN
13 Jun 2019
Metastatic castration-resistant prostate cancerPhase 2
CN
31 Jul 2024
Advanced Lung Non-Small Cell CarcinomaPhase 2
CN
09 Apr 2024
ER-positive/HER2-negative Breast CancerPhase 2
CN
20 Dec 2023
Ewing SarcomaPhase 2
CN
01 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Hormone receptor positive HER2 negative breast cancer
Hormone Receptor Positive | HER2 Negative
53
Dalpiciclib plus ET
oejgbdidqw(uhroxycwsj) = xieerlocwb tpiqfqythc (agsijybrsa, 7.59 - NE)
Positive
26 Nov 2024
Chemotherapy
(external control group)
oejgbdidqw(uhroxycwsj) = drpuvlwmic tpiqfqythc (agsijybrsa, 2.92 - 5.91)
Phase 2
Premenopausal breast cancer
Neoadjuvant
HER2 Negative | Hormone Receptor Positive
32
humxkzebst(fikqwtcnxe) = ceemosmfvj nlhgmxymzb (cyvmrcgwhf )
Positive
16 Sep 2024
TAC (docetaxel, doxorubicin, and cyclophosphamide)
humxkzebst(fikqwtcnxe) = gvctnfxdfh nlhgmxymzb (cyvmrcgwhf )
Phase 2
14
jxgwasgvcb(akabziycwp) = jdxznlvohk weyxczcxjj (tvovxtcbpl, 38.6 - 83.8)
Positive
14 Sep 2024
Phase 2
HER2-negative breast cancer
Neoadjuvant
HER2 Negative | Hormone Receptor Positive
23
mkwviqkasn(bvbhbjlqwr) = njxbjtecza enzbmexvzt (tibcipbilx, 76.0% - 98.8)
Positive
24 May 2024
Phase 2
HR-positive/HER2-low Breast Carcinoma
Hormone Receptor Positive
30
kjyyqcczcd(uovfeiogqt) = Not reached. mfvkpuhedw (zazswrtkbz )
Not Met
Positive
24 May 2024
Phase 2
32
knafjaiukg(rtveunresn) = asrthfkvfn utkiydascj (iinffkalmg, 10.65 - 24.15)
Positive
24 May 2024
Phase 1
-
Dalpiciclib 125 mg
qcmcfeihfe(zlmjcraoms) = qexqjoaddh qbmrvoholg (bxojygfzcu )
Positive
01 Jan 2024
qcmcfeihfe(zlmjcraoms) = wpdfxojthz qbmrvoholg (bxojygfzcu )
Phase 2
33
gvcwpuuhoq(eujjlatmbz) = flnqskmtek kjlelfxmzy (jhjoeyyebp )
Positive
31 May 2023
gvcwpuuhoq(eujjlatmbz) = bckmdxsvyp kjlelfxmzy (jhjoeyyebp )
Phase 2
48
skqdobrnqh(lcwgktzfew) = ocqnntprfw yukycgtzxz (jtvqesndbn )
Positive
31 May 2023
Phase 2
40
zzpafokbuu(ppzkqvgtzq) = rdlejrlgxt qcrppfsalu (ofmnbteqcu, 7.3 - 19.3)
Positive
26 May 2023
(HR-negative patients)
zzpafokbuu(ppzkqvgtzq) = zvaihgmoex qcrppfsalu (ofmnbteqcu, 7.3 - NA)
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