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duvelisib

Trade name: copiktra

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Sep 24, 2018

Duvelisib (IPI-145), is an orally available, small-molecule, selective dual inhibitor of phosphatidylinositol 3 kinase (PI3K) δ and γ isoforms originated by Intellikine (owned by Takeda) and developed by Infinity Pharmaceuticals. Orally administered duvelisib was rapidly absorbed, with a dose-proportional increase in exposure. The compound produced a half-life of approximately 7-12 hours, following 14 days of dosing. Duvelisib exerts profound effects on adaptive and innate immunity by inhibiting B and T cell proliferation, blocking neutrophil migration, and inhibiting basophil activation. Duvelisib blockade of PI3K-δ and PI3K-γ potentially lead to significant therapeutic effects in multiple inflammatory, autoimmune, and hematologic diseases. The molecule is in phase III development as a combination therapy for patients with haematological malignancies such as chronic lymphocytic leukemia and follicular lymphoma. — NCATS

Clinical trial activity

54 trials · 38 clinical orgs · 2 marketing orgs

Phase 1
29
Phase 2
33
Phase 3
5
Phase 4
0

Earliest trial started Aug 1, 2011 (NCT01549106)

Timeline

2010s

  1. Jan 1, 2011

    Verastem, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Verastem, Inc. — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2013

    Verastem, Inc. — Earliest Phase 3 Sponsor(trial)

  4. Apr 15, 2013

    Orphan Drug Designation

  5. Sep 24, 2018

    Verastem, Inc. — Earliest FDA Approval

  6. Sep 24, 2018

    Secura — Marketing Organization

  7. Sep 24, 2018

    Verastem, Inc. — NDA Secondary Org

  8. Sep 24, 2018

    Verastem, Inc. — NDA Organization

  9. Sep 24, 2018

    Secura — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackSep 24, 2018

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H](NC1=NC=NC2=C1N=CN2)C3=CC4=C(C(Cl)=CC=C4)C(=O)N3C5=CC=CC=C5
Mol. weight
416.863 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 8-chloro-2-phenyl-3-((1s)-1-(9h-purin-6-ylamino)ethyl)-1(2h)-isoquinolinone
  • duvelisib
  • duvelisib
  • duvelisib
  • duvelisib
  • duvelisib
  • duvelisib
  • ink-1147
  • ink-1147
  • ink-1197
  • ink-1197
  • ipi-145
  • ipi-145
  • ipi-145
  • ipi-145

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07293403Phase 2Jun 7, 2026City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07001384Phase 1Aug 8, 2025Genentech, Memorial Sloan-Kettering Cancer Center, Secura
NCT06810778Phase 1/Phase 2 (Phase 2)Mar 1, 2025University of California, Los Angeles
NCT06522737Phase 3Dec 31, 2024Secura
NCT06151106Phase 2Nov 22, 2023Fujian Medical University, Huizhou People's Central Hospital, Nanjing Medical University, Shanxi Medical University, Sun Yat-Sen University, Xiamen University
NCT05976997Phase 2May 8, 2023Huazhong University of Science and Technology, Yiling Pharmaceutical Inc.
NCT05675813Phase 1/Phase 2 (Phase 2)Jan 15, 2023Huazhong University of Science and Technology, Jiao Tong University, Peking University, Sichuan University, Southern Medical University, Sun Yat-Sen University
NCT05508659Phase 1/Phase 2 (Phase 2)Sep 20, 2022Shijiazhuang Pharma Group (CSPC)
NCT04890236Early Phase 1 (Phase 1)Feb 1, 2022Emory University, National Cancer Institute (NCI), Novartis, Secura
NCT05057247Phase 2Jan 31, 2022Harvard University, Secura
NCT05044039Phase 1Nov 30, 2021Secura, Washington University in St. Louis
NCT04836832Phase 1Nov 30, 2021Ohio State University
NCT05065866Phase 1Sep 22, 2021Secura, University of South Florida
NCT05010005Phase 1Aug 12, 2021Memorial Sloan-Kettering Cancer Center
NCT04803201Phase 2Jul 30, 2021National Cancer Institute (NCI), Washington University in St. Louis
NCT04652960Phase 1Mar 12, 2021National Cancer Institute (NCI), Yale University
NCT04688658Phase 1/Phase 2 (Phase 2)Jan 31, 2021University of Pittsburgh, Verastem, Inc.
NCT04639843Phase 1Jan 8, 2021National Cancer Institute (NCI)
NCT04487886Phase 2Nov 18, 2020Emory University, University of Pennsylvania, Verastem, Inc.
NCT04331119Phase 2Jul 31, 2020Verastem, Inc., Washington University in St. Louis
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (38)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Verastem, Inc.For profit282232011
National Cancer Institute (NCI)Government6322019
SecuraFor profit6132021
Harvard UniversityAcademic/Hospital4322014
Infinity Pharmaceuticals, Inc.For profit4022013
Pharmaceutical Research Associates, Inc. (PRA)For profit4012013
Washington University in St. LouisAcademic/Hospital4322020
AbbVieFor profit2212015
City of Hope National Medical CenterAcademic/Hospital2212019
Emory UniversityAcademic/Hospital2222020
Huazhong University of Science and TechnologyAcademic/Hospital2112023
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212021
Ohio State UniversityAcademic/Hospital2212019
Shijiazhuang Pharma Group (CSPC)For profit2212019
Sun Yat-Sen UniversityAcademic/Hospital2012023
Clinical Pharmacology of MiamiFor profit1012014
Cornell UniversityAcademic/Hospital1112016
Fujian Medical UniversityAcademic/Hospital1012023
GenentechFor profit1012025
Huizhou People's Central HospitalAcademic/Hospital1012023
38 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
SecuraFor profitMKTGSep 24, 2018
SecuraFor profitNDA2Sep 24, 2018
Verastem, Inc.For profitNDA2Sep 24, 2018
Verastem, Inc.For profitNDASep 24, 2018