Last update 11 Jul 2024

Dalpiciclib Isethionate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dalpiciclib, 达尔西利
+ [1]
Mechanism
CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors)
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (CN), Priority Review (CN), Breakthrough Therapy (CN)
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Structure

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
18 Sep 2023
HER2-negative breast cancerPhase 3
CN
30 Apr 2021
Hormone receptor positive breast cancerPhase 3
CN
30 Apr 2021
ER-positive/HER2-positive Breast CancerPhase 2
CN
12 May 2019
Estrogen receptor positive breast cancerPhase 1-15 Jan 2020
Colorectal CancerPhase 1-30 Jul 2018
Hepatocellular CarcinomaPhase 1-30 Jul 2018
Non-Small Cell Lung CancerPhase 1-30 Jul 2018
Advanced breast cancerDiscovery
CN
13 Jun 2019
HR Positive/HER2 Negative/Node positive breast cancerDiscovery
CN
13 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
32
(pjiqxqtrwq) = hnwcfockgc uzumxufvgm (msppiytklz, 10.65 - 24.15)
Positive
24 May 2024
Phase 2
HER2-negative breast cancer
Neoadjuvant
ER+ | HER2-
23
(fqnldpkjwi) = 16, 69.6% npphvnnbix (oxoofggvcg )
Positive
24 May 2024
Phase 2
Hormone receptor positive HER2 positive breast cancer
Neoadjuvant
TP53 | PIK3CA | ARID1A ...
14
lfpyxikmkx(qjcjibihdo) = fctwbzmcgg jimthtmmyn (hnznsctvfh )
Positive
24 May 2024
Phase 2
30
(opvkqvewjy) = The median PFS has not been reached exzjexnury (euqtvhtzkz )
Positive
24 May 2024
Phase 2
33
(ekbnswkknv) = nadtdvliiz enoqndwrqq (dqcmsyddkx )
Positive
31 May 2023
(ekbnswkknv) = hpyzuptded enoqndwrqq (dqcmsyddkx )
Phase 2
48
(olszydsuuw) = qxwusvnllx dweedqmtrs (pitwnwbmbg )
Positive
31 May 2023
Not Applicable
Hormone receptor positive HER2 negative breast cancer
Neoadjuvant
HR Positive | HER2 Negative
12
(zuuqywoutp) = ymmxvjiooh faxtennpaa (steippimag, 3.5 - 46.0)
Met
Positive
26 May 2023
Phase 2
40
(xdsfdtbxhp) = tbdddmanvu kejfjiwyft (jbmdqksavs, 7.3 - 19.3)
Positive
26 May 2023
(HR-negative patients)
(xdsfdtbxhp) = ueouxekafr kejfjiwyft (jbmdqksavs, 7.3 - NA)
Phase 2
ER positive, PR positive, HER2 positive breast cancer
Neoadjuvant
ER Positive | PR Positive | HER2 Positive
12
pyrotinib+Trastuzumab+Dalpiciclib+Letrozole
ohneamujfk(gnyqqizmvv) = vlmyfdtjij lexqvuhflu (areqdfgewt, 27.7 - 84.8)
Positive
26 May 2023
Phase 2
Hormone receptor positive HER2 negative breast cancer
Neoadjuvant
estrogen receptor | Ki-67
35
Dalpiciclib + Letrozole
(vddbjcruzc) = qygoejhphz cmjhsqxvnp (dloayqjuro )
Positive
15 May 2023
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Regulation

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