Drugs / Duvelisib
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Duvelisib

Small molecule targets PIK3CD, PIK3CG via inhibition

Developed for
chronic lymphocytic leukemia/small lymphocytic lymphoma · follicular lymphoma · peripheral T-cell lymphoma, not otherwise specified · lymphoma · T-cell non-Hodgkin lymphoma · B-cell chronic lymphocytic leukemia · COVID-19 · diffuse large B-cell lymphoma
+30 more · enteropathy-associated T-cell lymphoma · head and neck squamous cell carcinoma · hematopoietic and lymphoid cell neoplasm · indolent B-cell non-Hodgkin lymphoma · monomorphic epitheliotropic intestinal T-cell lymphoma · Nodal T-follicular helper cell lymphoma, follicular type · primary cutaneous T-cell lymphoma · Richter transformation · T-cell large granular lymphocyte leukemia · T-cell prolymphocytic leukemia · acute lymphoblastic leukemia · adult T-cell leukemia/lymphoma · ALK-positive anaplastic large cell lymphoma · angioimmunoblastic T-cell lymphoma · cancer · chronic lymphoproliferative disorder of NK-cells · extranodal nasal NK/T cell lymphoma · hepatosplenic T-cell lymphoma · Hodgkins lymphoma · leukemia · lymphoid leukemia · marginal zone lymphoma · melanoma · mycosis fungoides · nodal marginal zone B-cell lymphoma · non-Hodgkin lymphoma · plasma cell myeloma · rheumatoid arthritis · splenic marginal zone lymphoma · asthma
Investigated by
SecuraBio · National Cancer Institute (NCI) · Infinity Pharmaceuticals, Inc. · Dana-Farber Cancer Institute · Memorial Sloan Kettering Cancer Center · Washington University School of Medicine
+39 more · AbbVie · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · City of Hope Medical Center · Emory University · Verastem, Inc. · Alliance for Clinical Trials in Oncology · Anhui Provincial Cancer Hospital · Beijing Tongren Hospital · Bristol-Myers Squibb · CSPC Ouyi Pharmaceutical Co., Ltd. · David Bond, MD · Genentech, Inc. · Glenn J. Hanna · H. Lee Moffitt Cancer Center and Research Institute · Institute of Hematology & Blood Diseases Hospital, China · John Kirkwood · Jonsson Comprehensive Cancer Center · Liling Zhang · M.D. Anderson Cancer Center · Nanfang Hospital, Southern Medical University · Narendranath Epperla · National Heart, Lung, and Blood Institute (NHLBI) · Novartis · Peking University People's Hospital · Peking University Third Hospital · Ruijin Hospital · SCRI Development Innovations, LLC · Stanford University · Sun Yat-sen University · The First Affiliated Hospital of Anhui Medical University · The First Affiliated Hospital of Nanchang University · The First Affiliated Hospital of Soochow University · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital of Zhengzhou University · The First Hospital of Jilin University · The Foundation for Barnes-Jewish Hospital · The Second Affiliated Hospital of Harbin Medical University · West China Hospital · Wuhan TongJi Hospital

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Copiktra 2026-02-16 europa.eu
Approved EU (EMA) Copiktra 2021-05-19 europa.eu
Approved US (FDA) COPIKTRA 2018-09-24 fda.gov

Trials 53 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04890236 Jan 2022 → Mar 2024 diffuse large B-cell lymphoma Emory University Completed No outcome recorded
Phase 120 trials
Phase 1 NCT07714187 Jan 2027 → Oct 2028 expected mycosis fungoides SecuraBio Not yet recruiting No outcome recorded
Phase 1 NCT07001384 Aug 2025 → Aug 2031 expected ALK-positive anaplastic large cell lymphoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT04639843 Nov 2022 adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, extranodal nasal NK/T cell lymphoma, hepatosplenic T-cell lymphoma +1 National Cancer Institute (NCI) Withdrawn No outcome recorded
Phase 1 NCT04836832 Jul 2022 → Dec 2023 follicular lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma Narendranath Epperla Withdrawn No outcome recorded
Phase 1 NCT05044039 Feb 2022 → Jan 2026 overdue acute lymphoblastic leukemia Washington University School of Medicine Active not recruiting No outcome recorded
Phase 1 NCT05065866 Nov 2021 → Jan 2024 Hodgkins lymphoma, lymphoid leukemia, non-Hodgkin lymphoma, plasma cell myeloma H. Lee Moffitt Cancer Center and Research Institute Completed No outcome recorded
Phase 1 NCT04652960 Oct 2021 → Dec 2026 expected primary cutaneous T-cell lymphoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 1 NCT05010005 Aug 2021 → Aug 2027 expected T-cell large granular lymphocyte leukemia, T-cell prolymphocytic leukemia Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT03892044 Nov 2019 → Feb 2024 Richter transformation, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma David Bond, MD Completed No outcome recorded
Phase 1 NCT02640833 Jul 2016 → Jan 2020 chronic lymphocytic leukemia/small lymphocytic lymphoma AbbVie Withdrawn No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT06810778 May 2025 → Jun 2030 expected T-cell prolymphocytic leukemia, primary cutaneous T-cell lymphoma Jonsson Comprehensive Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT05675813 Feb 2023 → Jul 2026 overdue peripheral T-cell lymphoma, not otherwise specified Ruijin Hospital Recruiting No outcome recorded
Phase 1/2 NCT05508659 Sep 2022 → Sep 2024 cancer CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT04688658 Oct 2021 → Feb 2024 melanoma John Kirkwood Terminated No outcome recorded
Phase 1/2 NCT04193293 Jun → Dec 2020 head and neck squamous cell carcinoma SecuraBio Terminated No outcome recorded
Phase 1/2 NCT03534323 Jul 2018 → Dec 2024 overdue B-cell chronic lymphocytic leukemia, Richter transformation Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1/2 NCT02391545 Dec 2014 → Jan 2017 follicular lymphoma SecuraBio Terminated No outcome recorded
Phase 1/2 NCT02158091 Jun 2014 → Oct 2017 overdue B-cell chronic lymphocytic leukemia Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 219 trials
Phase 2 NCT07293403 Jun 2026 → Nov 2027 expected Nodal T-follicular helper cell lymphoma, follicular type, peripheral T-cell lymphoma, not otherwise specified City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT06530550 Aug 2024 → Aug 2026 overdue T-cell large granular lymphocyte leukemia, chronic lymphoproliferative disorder of NK-cells Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2 NCT05976997 May 2023 → Oct 2026 expected peripheral T-cell lymphoma, not otherwise specified Liling Zhang Recruiting No outcome recorded
Phase 2 NCT05057247 Oct 2021 → Oct 2023 head and neck squamous cell carcinoma Glenn J. Hanna Completed No outcome recorded
Phase 2 NCT04803201 Oct 2021 → May 2027 Nodal T-follicular helper cell lymphoma, follicular type, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma +1 Alliance for Clinical Trials in Oncology Suspended No outcome recorded
Phase 2 NCT04487886 Nov 2020 → Jun 2021 COVID-19 Emory University Completed No outcome recorded
Phase 2 NCT04372602 Oct 2020 → Feb 2022 COVID-19 Washington University School of Medicine Completed No outcome recorded
Phase 2 NCT04209621 Jul 2020 → Jan 2021 chronic lymphocytic leukemia/small lymphocytic lymphoma National Heart, Lung, and Blood Institute (NHLBI) Terminated No outcome recorded
Phase 2 NCT04331119 Jul 2020 → Apr 2026 T-cell non-Hodgkin lymphoma Washington University School of Medicine Terminated No outcome recorded
Phase 2 NCT03961672 May 2020 → Jul 2023 overdue chronic lymphocytic leukemia/small lymphocytic lymphoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 35 trials
Phase 3 NCT06522737 May 2025 → Feb 2028 expected lymphoma SecuraBio Recruiting No outcome recorded
Phase 3 NCT02576275 Dec 2015 → Nov 2016 chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, marginal zone lymphoma SecuraBio Withdrawn No outcome recorded
Phase 3 NCT02204982 Sep 2014 → Dec 2016 follicular lymphoma SecuraBio Terminated No outcome recorded
Phase 3 NCT02049515 Dec 2013 → Jun 2020 chronic lymphocytic leukemia/small lymphocytic lymphoma SecuraBio Completed No outcome recorded
Phase 3 NCT02004522 Nov 2013 → May 2017 chronic lymphocytic leukemia/small lymphocytic lymphoma SecuraBio Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT01653756 Comparator Jul 2012 → Aug 2014 asthma SecuraBio Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2014-09-03 AbbVie Infinity And AbbVie Announce Global Strategic Collaboration To Develop And Commercialize Duvelisib (IPI-145) In Oncology abbvie.com

Evidence & citations 14 cited values

Every value below carries the sentence it was read from. 57 sources stand behind the page.

FieldValueCited text
Known as Duvelisib “A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)” NCT07001384
41

“Linperlisib 80mg QD orally, or Duvelisib 25mg BID orally” NCT06530550

NCT05057247

NCT03961672

NCT03534323

NCT04707079

NCT02004522

NCT04639843

NCT04803201

NCT04372602

NCT02783625

NCT04890236

NCT04193293

NCT06810778

NCT02711852

NCT03892044

NCT04331119

NCT04688658

NCT04038359

NCT02204982

NCT05044039

NCT02598570

NCT03370185

NCT06522737

NCT02576275

NCT01882803

NCT02640833

NCT05065866

NCT02605694

NCT05976997

NCT04487886

NCT05508659

NCT01476657

NCT04836832

NCT03372057

NCT05675813

NCT04652960

NCT05010005

NCT02391545

NCT04209621

NCT07293403

NCT07714187

Known as Copiktra ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as Duv “the dual phosphatidylinositol 3-kinase-δ/γ (PI3K-δ/γ) inhibitor duvelisib (Duv) and the Bcl-2 inhibitor venetoclax (Ven)” PMID 33786583 Jun 2021
Known as Duvelisib (as hydrate) ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as Duvelisib hydrate ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as DUVELISIB MONOHYDRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as INK-1147 ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as INK-1197 ChEMBL registry synonym — accepted as the source's own label CHEMBL3039502
Known as IPI-145 “Duvelisib (IPI-145) is an oral inhibitor of phosphatidylinositol 3-kinase (PI3K)-δ/γ isoforms currently in clinical development.” PMID 29233821 Dec 2017
12

NCT02158091

NCT02049515

NCT01851707

NCT01871675

NCT01925911

NCT01947777

NCT02292225

NCT02028039

NCT01653756

NCT01836861

NCT02095587

NCT01549106

Action Inhibit “Duvelisib (IPI-145) is an oral inhibitor of phosphatidylinositol 3-kinase (PI3K)-δ/γ isoforms currently in clinical development.” PMID 29233821 Dec 2017
2

“PI3-kinase p110-gamma subunit inhibitor” CHEMBL3039502

“PI3-kinase p110-delta subunit inhibitor” CHEMBL3039502

Modality Small molecule CHEMBL3039502
Route Oral “IPI-145 is administered orally as a capsule formulation.” NCT01476657
Target PIK3CD “PI3-kinase p110-delta subunit inhibitor” CHEMBL3039502
Target PIK3CG “PI3-kinase p110-gamma subunit inhibitor” CHEMBL3039502