Drug Type Small molecule drug |
Synonyms Dalpiciclib, 达尔西利, SHR-6390 + [1] |
Target |
Mechanism CDK4 inhibitors(Cyclin-dependent kinase 4 inhibitors), CDK6 inhibitors(Cyclin-dependent kinase 6 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date CN (31 Dec 2021), |
RegulationPriority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN) |
Molecular FormulaC25H30N6O2 |
InChIKeySGJLSPUSUBJWHO-UHFFFAOYSA-N |
CAS Registry1637781-04-4 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hormone receptor positive HER2 negative breast cancer | CN | 31 Dec 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Castration-sensitive prostate cancer | Phase 3 | CN | 18 Sep 2023 | |
HER2-negative breast cancer | Phase 3 | CN | 30 Apr 2021 | |
Hormone receptor positive breast cancer | Phase 3 | CN | 30 Apr 2021 | |
Node-positive breast cancer | Phase 3 | CN | 30 Apr 2021 | |
Advanced breast cancer | Phase 3 | CN | 13 Jun 2019 | |
HR Positive/HER2 Negative/Node positive breast cancer | Phase 3 | CN | 13 Jun 2019 | |
Breast Cancer | Phase 2 | - | 01 Aug 2024 | |
Metastatic castration-resistant prostate cancer | Phase 2 | CN | 31 Jul 2024 | |
ER-positive/HER2-negative Breast Cancer | Phase 2 | CN | 20 Dec 2023 | |
Sarcoma | Phase 2 | CN | 01 Jul 2023 |
NCT06009627 (ESMO2024) Manual | Phase 2 | 32 | pyvccjdkhl(zboxqfqwkj) = qgvhkocthn jarkhpmiiz (rrqabpinek ) | Positive | 16 Sep 2024 | ||
pyvccjdkhl(zboxqfqwkj) = rvhinftjzd jarkhpmiiz (rrqabpinek ) | |||||||
Phase 2 | Squamous Cell Carcinoma of Head and Neck p16-negative | 14 | ddrensrpla(gtpqlyhitt) = khdbtgcgzq xsotcsybel (pcemyopbij, 38.6 - 83.8) View more | Positive | 14 Sep 2024 | ||
Phase 2 | 23 | qbjalqigfp(xbilemjfkl) = nblelorzso gjoitsdtdv (jzovbzjqvd, 76.0% - 98.8) View more | Positive | 24 May 2024 | |||
Phase 2 | Advanced breast cancer HR+ | HER2-low | 30 | igxkmiwxsg(puckaddbfn) = The median PFS has not been reached vjgdgqmsih (veawjjoyzb ) View more | Positive | 24 May 2024 | ||
Phase 2 | 32 | pvzjhnlhsn(oupxhpovxi) = tzqeablvpb mssgjwoazt (vtcfxlhtkl, 10.65 - 24.15) | Positive | 24 May 2024 | |||
Phase 1 | HR Positive/HER2 Negative/Node positive breast cancer HR-positive | HER2-negative | - | Dalpiciclib 125 mg | wtmocrgxou(qnhtqzziku) = tajiqopbpx jrpkbystcm (mzychkxbmf ) View more | Positive | 01 Jan 2024 | |
wtmocrgxou(qnhtqzziku) = cjwxeyfvai jrpkbystcm (mzychkxbmf ) View more | |||||||
NCT04095390 (ASCO2023) Manual | Phase 2 | Advanced HER2-Positive Breast Carcinoma HER2 Positive | 33 | qzdwdquogv(nkaasngopm) = euksmvdtbp ncksooameq (xevgfmjddi ) View more | Positive | 31 May 2023 | |
qzdwdquogv(nkaasngopm) = czexqqkflf ncksooameq (xevgfmjddi ) View more | |||||||
Phase 2 | 48 | yimlbdenno(ggkkdvlozw) = dekevmulzo elrwabvdey (orwdsebpyo ) | Positive | 31 May 2023 | |||
Phase 2 | Advanced HER2-Positive Breast Carcinoma HER2 Positive | 40 | exauzkuiqs(ohifdbkzhx) = folcqptzvs gtxjlmlypt (slmslvttda, 7.3 - 19.3) | Positive | 26 May 2023 | ||
(HR-negative patients) | exauzkuiqs(ohifdbkzhx) = qnmgrypdkf gtxjlmlypt (slmslvttda, 7.3 - NA) | ||||||
Not Applicable | 12 | exemestane+SBRT+dalpiciclib | nmmdfnfugt(ulbwvupoym) = kbjolmyeii vxnswafqlw (abjkcvhuau, 3.5 - 46.0) Met View more | Positive | 26 May 2023 |