Last update 12 Aug 2025

Copanlisib dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Copanlisib, Copanlisib Hydrochloride, 可泮利塞
+ [9]
Action
inhibitors
Mechanism
PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors), PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Originator 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)
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Structure/Sequence

Molecular FormulaC23H29ClN8O4
InChIKeyCLMVIXVYZUJPOI-UHFFFAOYSA-N
CAS Registry1402152-13-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Follicular Lymphoma
United States
14 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Indolent B-Cell Non-Hodgkin LymphomaNDA/BLA
Canada
01 Dec 2021
Small Lymphocytic LymphomaNDA/BLA
Canada
01 Dec 2021
Waldenstrom MacroglobulinemiaNDA/BLA
Canada
01 Dec 2021
Marginal Zone B-Cell LymphomaNDA/BLA
European Union
12 Jun 2021
Non-Hodgkin LymphomaNDA/BLA
China
10 Mar 2021
Indolent Non-Hodgkin LymphomaPhase 3
United States
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
United States
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
Argentina
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
Argentina
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
Australia
06 Jan 2016
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Clinical Result

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

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