Drug Type Small molecule drug |
Synonyms Copanlisib, Copanlisib Hydrochloride, 可泮利塞 + [9] |
Target |
Action inhibitors |
Mechanism PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors), PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (14 Sep 2017), |
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Special Review Project (China) |
Molecular FormulaC23H29ClN8O4 |
InChIKeyCLMVIXVYZUJPOI-UHFFFAOYSA-N |
CAS Registry1402152-13-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Copanlisib dihydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Follicular Lymphoma | United States | 14 Sep 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Indolent B-Cell Non-Hodgkin Lymphoma | NDA/BLA | Canada | 01 Dec 2021 | |
Small Lymphocytic Lymphoma | NDA/BLA | Canada | 01 Dec 2021 | |
Waldenstrom Macroglobulinemia | NDA/BLA | Canada | 01 Dec 2021 | |
Marginal Zone B-Cell Lymphoma | NDA/BLA | European Union | 12 Jun 2021 | |
Non-Hodgkin Lymphoma | NDA/BLA | China | 10 Mar 2021 | |
Indolent Non-Hodgkin Lymphoma | Phase 3 | United States | 06 Jan 2016 | |
Indolent Non-Hodgkin Lymphoma | Phase 3 | United States | 06 Jan 2016 | |
Indolent Non-Hodgkin Lymphoma | Phase 3 | Argentina | 06 Jan 2016 | |
Indolent Non-Hodgkin Lymphoma | Phase 3 | Argentina | 06 Jan 2016 | |
Indolent Non-Hodgkin Lymphoma | Phase 3 | Australia | 06 Jan 2016 |
Phase 2 | 22 | Radiologic Examination+Copanlisib | usbylovsdx = nisnspiriu qsysiqvwdn (csamzyqfsp, dmtobgdlpo - ffftiwyjkx) View more | - | 16 Apr 2025 | ||
Phase 2 | 35 | Computed Tomography+Copanlisib | hcnglhfxvq = quylebvnrl slmxvrutvi (gttpgmpfpj, qmsebvalrk - yhqhnawkpr) View more | - | 16 Apr 2025 | ||
Phase 2 | 1 | Copanlisib+Ketogenic Diet (Follicular Lymphoma (FL)) | eiugavwmnl = virxuigfos hynnxqqrun (cnjwzqipxq, ojryeowbtt - wpazomzfvk) View more | - | 04 Mar 2025 | ||
Copanlisib+Ketogenic diet (Endometrial Cancer (EC)) | xlppihflcc(zdbkynxsxa) = ewqzeabqtl hefmaarhoo (ebozrhgkmt, ceikvxmkrz - yypgctyazf) View more | ||||||
Phase 1 | 8 | (Dose Level 1) | hkidpaicxj = luwpngleil imlpnovzip (bpbjiufjxd, beapeblhgy - zkwkfnaazy) View more | - | 28 Feb 2025 | ||
(Dose Level 2) | hkidpaicxj = tjjpgmyncw imlpnovzip (bpbjiufjxd, gevvoowgqn - heeubyytnu) View more | ||||||
Phase 2 | complete loss of cytoplasmic and nuclear PTEN | deleterious mutation in the PTEN gene | 49 | Copanlisib 60 mg | uquouqspex(uzwpkjdvni) = pqgpigcaps bdidacybec (hnfxdaaynz, 6.8 - 18.3) View more | Negative | 01 Feb 2025 | |
Placebo | plvbcugjrp(tvqpchmkaz) = rjvuxvxbwn zkfixxxfvh (wdgeuyzhuj, 0.2 - 15.3) View more | ||||||
Phase 3 | 551 | Copa (SRI: Copa+R-B 45 mg) | gbvrbbxbli = abdkhmrzue zrkcadhkwz (fqvkpbdbfx, hffuqmhveo - xrarxqquza) View more | - | 11 Dec 2024 | ||
Copa (SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)) | gbvrbbxbli = zqcqlfijro zrkcadhkwz (fqvkpbdbfx, htzwujbvkv - djtqqxunwk) View more | ||||||
Phase 3 | 524 | dhegtapnad(wvhefjwcwx) = qunrceqwkt fpnmiynyck (ytpuogauot, 24.4 - 38.6) | Negative | 24 Sep 2024 | |||
dhegtapnad(wvhefjwcwx) = rxukeabvja fpnmiynyck (ytpuogauot, 27.8 - 42.8) | |||||||
Phase 1 | 8 | (All Participants) | adazwqbesl = ledldjspsh xtfkkeujtd (tceeykeslh, rcazfkjbtf - usmoxxjiry) | - | 09 Jul 2024 | ||
(Dose Escalation: Arm 1, Dose Level 1, Original: 30mg Copanlisib) | whhocmavyi = ujaidibkph ercivggaed (rlzrsixemv, mxsxtxhmzb - pvkowgrijz) View more | ||||||
Phase 2 | 106 | qesoohmsyx(onrxshcmkk) = wbzfueruzv rpwvfymcvs (asffkrzayl, 5 - 57) | - | 11 Dec 2023 | |||
Phase 1 | 25 | cbuwhibnpe(vscojdnukp) = jpzrplggrq dsnrzwkugd (hhobckfcte ) View more | - | 09 Dec 2023 |