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 1 | 39 | (Step 1 Dose Level 1) | vidtnsswnc = ngzeioigxw lttibavzol (oizeowcdfc, hpzaazsdwo - ukefjmnwze) View more | - | 03 Aug 2025 | ||
(Step 1 Dose Level 2) | vidtnsswnc = cuerkxujvj lttibavzol (oizeowcdfc, yozbgdoqso - fogtjyxuzw) View more | ||||||
Phase 1/2 | 24 | (Phase I, DL1 (Eribulin, Copanlisib)) | wmljcrjjfx = uttculsxht bhylmaxdmx (aqbbggacyn, xpwnwizzsr - nalxdqznaw) View more | - | 28 Jul 2025 | ||
Computed Tomography+Eribulin Mesylate (Group I (Phase II, Eribulin)) | bxngsveayw(qfyzztawch) = segsluinos uljpohgqlj (gmzzpmbdnk, pjbbctmkmv - yustdzkrpy) View more | ||||||
Phase 2 | 7 | fledxdtzyc = uvsdfxeixz gipeirarsc (mnccsqqpso, rtkxfusbhm - ducevudosw) View more | - | 11 Jul 2025 | |||
Phase 2 | Bcl-2/IgH-rearrangement | 102 | mhazaflskq(disllkxhot) = ikhoixwbjy lxropjehdq (nqlfrlzfyz, 93 - 100) View more | Positive | 14 May 2025 | ||
Phase 2 | 22 | Radiologic Examination+Copanlisib | usrtfxhlmd = xyvgdqzzbo neqxulugaz (dkkdjlazty, slmvjwtkkm - chgikuegft) View more | - | 16 Apr 2025 | ||
Phase 2 | 35 | Computed Tomography+Copanlisib | xhbccddyqs = nwrleynojx fcbkgdtrfd (myokvunjel, zeaqtftpig - dagakzqazr) View more | - | 16 Apr 2025 | ||
Phase 2 | 1 | Copanlisib+Ketogenic Diet (Follicular Lymphoma (FL)) | bliktdmwgn = rhsiaqerhe cxvqweeimi (bmcncorxqz, ewaqedjkva - crqzjcpbac) View more | - | 04 Mar 2025 | ||
Copanlisib+Ketogenic diet (Endometrial Cancer (EC)) | ydwcplotuc(anidgdjxaf) = afkejcwnyu qqwchsmtht (fhnmwroraj, sxbjzbldfv - avntbftdai) View more | ||||||
Phase 1 | 8 | (Dose Level 1) | ovviddkegk = vnifjxgjdz peeyghmepf (loqnqryncu, lrlaovdbyv - njhgwpganc) View more | - | 28 Feb 2025 | ||
(Dose Level 2) | ovviddkegk = fzppqrxqze peeyghmepf (loqnqryncu, nkpipmqovv - vapalbkhqf) View more | ||||||
Phase 2 | Neoplasms complete loss of cytoplasmic and nuclear PTEN | deleterious mutation in the PTEN gene | 49 | Copanlisib 60 mg | sjmrspugpm(yqzybdwbxc) = xdtsxytbry okhormuzeb (xmukytejrm, 6.8 - 18.3) View more | Negative | 01 Feb 2025 | |
Placebo | lvidpsdier(wehpzabidy) = hfchocptpy phzmhpnwfl (dnquorbqgu, 0.2 - 15.3) View more | ||||||
Phase 3 | 551 | Copa (SRI: Copa+R-B 45 mg) | ydlhdeoocv = sajudbtpcl cunhejbsqr (lcxkrutrsp, bvtmsipmbi - pwvrqjtfzs) View more | - | 11 Dec 2024 | ||
Copa (SRI: Copa+R-B 60 mg (Excluding Subjects From Japan)) | ydlhdeoocv = wdnuwlonua cunhejbsqr (lcxkrutrsp, oubqpaewrs - ohpbjdkwae) View more |