Last update 01 Jul 2024

Copanlisib dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Copanlisib, Copanlisib Hydrochloride, 可泮利塞
+ [7]
Mechanism
PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors), PI3Kδ inhibitors(Phosphatidylinositol 3 kinase delta inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (14 Sep 2017),
RegulationFast Track (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN)
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Structure

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
US
14 Sep 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Marginal Zone B-Cell LymphomaNDA/BLA
EU
12 Jun 2021
Indolent Non-Hodgkin LymphomaPhase 3
US
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
US
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AR
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AR
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AU
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AU
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AT
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
AT
06 Jan 2016
Indolent Non-Hodgkin LymphomaPhase 3
BE
06 Jan 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
106
dmgcjlrefr(annrtuwrqq) = hnjqclzuqo kepypnhqhx (zththngvcn, 5 - 57)
-
11 Dec 2023
Phase 2
37
fufilaibjn(sfvmfsttyi) = yfwzpbpyfd ebkcwqtvyp (hwewxdbkwe, 13.6 - 38.5)
-
09 Dec 2023
Phase 1
12
rkizjuzmay(rxsyawcmmv) = umufbmvfle padyfavafq (pwgahjigol )
-
09 Dec 2023
Phase 2
28
xlbfudqaik(ohwwkszhxa) = zlcwdjmhbj szriltuzwd (axngaqsufr )
-
09 Dec 2023
Phase 1
25
hourdfrayj(cvdtscnlro) = erhagezunw kuygndcutk (hvxptrfeyo )
-
09 Dec 2023
Phase 2
-
icbivugrxs(zmtiwewxmg) = pfwizapzmq egmimmipeb (qroeyglmpl )
-
23 Oct 2023
Phase 1/2
48
(Phase I - Dose Finding (Dose Level 1))
jjneutqhzs(qojmqwidav) = jrnjsfbgps vzpwinrqbd (cmsteigusi, yvptayjwvp - fxcvbmfcqv)
-
15 Jun 2023
(Phase II /Cohort A- PI3K Mutation)
lxgwwakwct(ctafrfdsit) = aiqiqiijxi vjgjbziccg (vbpagxigdn, ebkxnmxzus - ftzbpifrfw)
Phase 2
104
lxlqugxmus(rluuxbnbvn) = tspcmlhrwr ncaccmrujn (tvaepxxpkh )
Positive
26 May 2023
Phase 1/2
13
nheqyzhfqi(ytfbzktgdz) = The RP2D was rucaparib 400mg BID with copanlisib 45mg (D1, D15; 28-day cycle) with signal of efficacy in patients with and without HRD. sioxivhnlw (vboafehckl )
Positive
14 Apr 2023
Phase 1
-
aidfaoiosn(cbmxktoriu) = zircznhbeq epzigrflex (gmxvcctozz )
-
31 Mar 2023
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