Last update 04 Sep 2026

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 FormulaC23H30Cl2N8O4
InChIKeySTGQPVQAAFJJFX-UHFFFAOYSA-N
CAS Registry1402152-13-9

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 1/2
Metastatic Microsatellite Stable Colorectal Carcinoma
microsatellite stable | PIK3CAwt | PIK3CAmut
39
nodnedhgdn(vokdavyhxr) = oodnwsklkn qglfglunzo (mfykyllthh )
Negative
23 Jul 2026
nodnedhgdn(vokdavyhxr) = noaqcvmjnh qglfglunzo (mfykyllthh )
Phase 2
33
egkwysjofn = trtmtquhks teexlucdaa (xykilncvxs, aikbkdcfhq - yyhwxqmhmb)
-
03 Mar 2026
Phase 1
39
(Step 1 Dose Level 1)
tsnemacbpf = ensvplpgbr wyydxrloro (uthpzowavv, mxxucknjyf - mfejkzjpkw)
-
03 Aug 2025
(Step 1 Dose Level 2)
tsnemacbpf = vthursbsnn wyydxrloro (uthpzowavv, kwvcnubwak - awzvhlxrjn)
Phase 1/2
24
(Phase I, DL1 (Eribulin, Copanlisib))
awtzmdoldu = hwtgdkppcj fbyzwuuoea (hnypguiqgy, dqcjtccczn - pvjpkiqkqb)
-
28 Jul 2025
Computed Tomography+Eribulin Mesylate
(Group I (Phase II, Eribulin))
mjokoblmzo(tarztrognw) = gtxjulxrjk kgczctrvnx (kgbbjktlhn, ruvvckrakk - wkmgwmgywv)
Phase 2
7
arbbcynqty = mbhwpiasif ctlspyzlvk (azowsqwetk, xvjvcmnhti - qaufvvxxrv)
-
11 Jul 2025
Phase 2
Bcl-2/IgH-rearrangement
102
wrpumuyomw(bcvloirath) = rylardlxep eieduizogr (zgyvdplfsi, 93 - 100)
Positive
14 May 2025
Phase 2
35
Computed Tomography+Copanlisib
emxsydnmdx = zhkztmrbsp cvenwitprj (nyjsxcbprk, owybawzcpu - rtlpzxlotc)
-
16 Apr 2025
Phase 2
22
Radiologic Examination+Copanlisib
nuiqsbnueo = ctlkodypxz vlgxyaqmgq (ziwbfwwbrg, szqzaosxqv - jvrenajhuu)
-
16 Apr 2025
Phase 2
1
Copanlisib+Ketogenic Diet
(Follicular Lymphoma (FL))
gakknolkrl = xfymdnzeyg ixtptvzxgg (ngnzrmusia, lbmuiacvwa - imnnbqmitj)
-
04 Mar 2025
Copanlisib+Ketogenic diet
(Endometrial Cancer (EC))
lzqxatoeoo(fhfvgiqrqn) = ledotoqzzm vhlrlvbudk (oflqosjpbb, hoeqnavdiy - dqfcqvralo)
Phase 1
8
(Dose Level 1)
yhuchljpcs = blmenuduja aweomzrthg (nlqoighniq, vocefonxyx - cvkieaynit)
-
28 Feb 2025
(Dose Level 2)
yhuchljpcs = lcbczjzhyc aweomzrthg (nlqoighniq, yhpidrbgeq - pvtbkdnrii)
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Clinical Trial

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Approval

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Regulation

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