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copanlisib

Trade name: aliqopa

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Sep 14, 2017

Copanlisib, developed by Bayer, is a phosphoinositide 3-kinase (PI3K) inhibitor with potential antineoplastic activity. Copanlisib inhibits the activation of the PI3K signaling pathway, which may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations. Activation of the PI3K signaling pathway is frequently associated with tumorigenesis and dysregulated PI3K signaling may contribute to tumor resistance to a variety of antineoplastic agents. Copanlisib is currently under Phase II/III clinical trials for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. — NCATS

Clinical trial activity

69 trials · 37 clinical orgs · 1 marketing orgs

Phase 1
45
Phase 2
41
Phase 3
3
Phase 4
0

Earliest trial started Nov 1, 2009 (NCT00962611)

Timeline

2000s

  1. Jan 1, 2009

    Bayer — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Bayer — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    Bayer — Earliest Phase 3 Sponsor(trial)

  3. Feb 5, 2015

    Orphan Drug Designation

  4. Sep 14, 2017

    Bayer — Earliest FDA Approval

  5. Sep 14, 2017

    Bayer — NDA Secondary Org

  6. Sep 14, 2017

    Bayer — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackSep 14, 2017

Chemistry & pharmacology

Loading structure…

SMILES

COc1c(OCCCN2CCOCC2)ccc2c1N=C(NC(=O)c1cnc(N)nc1)N1CCN=C21.Cl.Cl
Mol. weight
553.45 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • 2-amino-n-(7-methoxy-8-(3-morpholinopropoxy)-2,3-dihydroimidazo(1,2-c)quinazolin-4-yl)pyrimidine-5-carboxamide
  • aliqopa
  • aliqopa
  • bay 80-6946
  • bay 80-6946
  • bay 80-6946
  • bay-80-6946
  • bay-80-6946
  • copanlisib
  • copanlisib
  • copanlisib
  • copanlisib
  • copanlisib
  • copanlisib
  • copanlisib
  • copanlisib dihydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06218667Phase 1/Phase 2 (Phase 2)Jan 11, 2024Memorial Sloan-Kettering Cancer Center
NCT05687721Phase 1/Phase 2 (Phase 2)Jan 1, 2024Bayer, Department of Veteran Affairs
NCT05295589Phase 2Jun 30, 2022National Cancer Institute (NCI), NRG Oncology
NCT05082025Phase 2Feb 28, 2022Bayer, University of Texas at Houston
NCT04939272Phase 1/Phase 2 (Phase 2)Dec 15, 2021City of Hope National Medical Center, National Cancer Institute (NCI)
NCT04933617Phase 1Dec 7, 2021National Cancer Institute (NCI)
NCT05010096Phase 1Dec 2, 2021University of Texas at Houston
NCT04572763Phase 1/Phase 2 (Phase 2)Sep 30, 2021AbbVie, Bayer, Harvard University
NCT04803123Early Phase 1 (Phase 1)Jun 21, 2021Bayer, Duke University
NCT04895579Phase 1May 12, 2021Bayer, University of Kentucky
NCT04685915Phase 2Apr 30, 2021Bayer, Harvard University
NCT04750941Phase 2Mar 31, 2021Bayer, Columbia University
NCT05387616Phase 2Oct 19, 2020Bayer, Ludwig Maximilians University, Roche
NCT04345913Phase 1/Phase 2 (Phase 2)Oct 16, 2020Duke University, National Cancer Institute (NCI)
NCT04433182Phase 2Aug 1, 2020Fondazione Italiana Diabete Onlus
NCT04462471Phase 1Jun 26, 2020Memorial Sloan-Kettering Cancer Center
NCT04431635Phase 1Jun 15, 2020Big Ten Cancer Research Consortium, University of Michigan
NCT04317105Phase 1/Phase 2 (Phase 2)May 6, 2020National Cancer Institute (NCI), University of Texas at Houston
NCT04253262Phase 1/Phase 2 (Phase 2)Apr 30, 2020Bayer, Brown University, Clovis Oncology, Rhode Island Hospital
NCT04263584Phase 2Mar 31, 2020Bayer, University of Munster
Showing 20 of 69 trials
Page 1 / 4

Organizations

Research & Development (37)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit392142009
National Cancer Institute (NCI)Government191522016
University of Texas at HoustonAcademic/Hospital7322018
Duke UniversityAcademic/Hospital4122018
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital4422018
Cancer Trials IrelandAcademic/Hospital2212016
City of Hope National Medical CenterAcademic/Hospital2222019
Columbia UniversityAcademic/Hospital2222020
ECOG-ACRIN Cancer Research GroupAcademic/Hospital2012018
Harvard UniversityAcademic/Hospital2212021
NRG OncologyAcademic/Hospital2112016
University of WashingtonAcademic/Hospital2222019
AbbVieFor profit1012021
Big Ten Cancer Research ConsortiumAcademic/Hospital1112020
Bristol-Myers SquibbFor profit1012019
Brown UniversityAcademic/Hospital1112020
Chonnam National UniversityAcademic/Hospital1112017
Clovis OncologyFor profit1012020
Consortium for Improving Survival of LymphomaAcademic/Hospital1012017
Department of Veteran AffairsGovernment1112024
37 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
BayerFor profitNDA2Sep 14, 2017
BayerFor profitNDASep 14, 2017