Drugs / Duvelisib
Duvelisib
also known as
IPI-145 · Copiktra · Duv · Duvelisib (as hydrate) · Duvelisib hydrate · DUVELISIB MONOHYDRATE · INK-1147 · INK-1197
Small molecule targets PIK3CD, PIK3CG via inhibition
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed follicular lymphoma, susceptibility to 3 milestones | |||||
| Filed | EU (EMA) | COPIKTRA | follicular lymphoma, susceptibility to | 2019-11-25 | “submission of a Marketing Authorization Application to the European Medicines Agency (EMA) for COPIKTRA® (duvelisib)” verastem.com ↗ |
| Filed | US (FDA) | — | follicular lymphoma, susceptibility to | 2018-02-07 | “today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) seeking full approval for its lead product candidate duvelisib” verastem.com ↗ “In April, the U.S. Food and Drug Administration ( FDA ) accepted with Priority Review Verastem Oncology’s New Drug Application for duvelisib” verastem.com ↗ “Verastem has submitted a New Drug Application (NDA) requesting the full approval of duvelisib” verastem.com ↗ “Duvelisib NDA accepted by FDA with priority review” verastem.com ↗ |
| Filed | China (NMPA) | COPIKTRA | follicular lymphoma, susceptibility to | — | “APPLICATION FOR MARKETING APPROVAL OF “DUVELISIb CAPSULES ” ACCEPTED bY NMPA” irasia.com ↗ |
| Withdrawn Indication not stated 3 milestones | |||||
| Withdrawn | EU (EMA) | Copiktra | — | 2026-02-16 | europa.eu ↗ |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
News releases announcing trial results or a regulatory action · 41
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | Secura Bio, Inc. | Results Secura Bio Announces Journal of Clinical Oncology Publication of Final Results of Duvelisib PRIMO Phase 2 Trial in Relapsed/Refractory Peripheral T-cell Lymphoma securabio.com ↗
The trial demonstrated an overall response rate (ORR) of 48.0%, a complete response rate (CRR) of 33.3%, median progression-free survival (mPFS) of 3.4 months, and median overall survival (mOS) of 12.4 months. |
| 2025-12-07 | Secura Bio, Inc. | Results Secura Bio Presents Extended Follow Up Analyses from Phase 2 PRIMO Trial in Patients with Relapsed/Refractory peripheral T-cell lymphoma at the 2025 American Society of Hematology Meeting securabio.com ↗
The results continue to show that duvelisib delivers meaningful clinical activity with a manageable safety profile, even in heavily pretreated patients, underscoring its potential role across a broad PTCL population. |
| 2024-12-09 | Secura Bio, Inc. | Results Secura Bio Presented New Data from its Phase 2 PRIMO Trial of Copiktra® (Duvelisib) in Relapsed or Refractory Peripheral T-cell Lymphoma and Announced Plans for its Phase 3 TERZO Trial at the 2024 American Society of Hematology Meeting securabio.com ↗
Results from the expansion arm demonstrated an overall response rate (ORR) of 48%, a complete response (CR) rate of 33%, and a median duration of response (DOR) of 7.89 months. |
| 2024-12-09 | Secura Bio, Inc. | Results New Combination Data of Secura Bio’s COPIKTRA® (duvelisib) Presented at the 2024 American Society of Hematology Meeting securabio.com ↗
Results demonstrated an overall response rate (ORR) of 45%, complete response rate (CR) of 22%, and partial response (PR) rate of 22% |
| 2023-01-09 | Secura Bio, Inc. | Regulatory Secura Bio, Inc. Receives Orphan Drug Designation in Europe for Duvelisib for the Treatment of Patients with Peripheral T-cell Lymphoma securabio.com ↗
Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announces that the European Commission (EC) issued an Orphan Drug Designation for duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL). |
| 2022-03-18 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - "DUVELISIB CAPSULES" OBTAINS DRUG REGISTRATION APPROVAL irasia.com ↗ |
| 2021-04-19 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - APPLICATION FOR MARKETING APPROVAL OF "DUVELISIB CAPSULES" ACCEPTED BY NMPA irasia.com ↗
has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China and granted the qualification of conditional marketing approval and priority review. |
| 2020-06-22 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Preclinical Data Supporting the Combination of VS-6766 and Defactinib in Metastatic Uveal Melanoma verastem.com ↗
The dual PI3K-δ/PI3K-γ inhibitor duvelisib inhibits signaling and proliferation of solid tumor cells expressing PI3K-δ and/or PI3K-γ |
| 2019-12-07 | Verastem, Inc. | Results Verastem Oncology Presents Phase 2 PRIMO Study Data Evaluating Duvelisib in Relapsed or Refractory Peripheral T-Cell Lymphoma at the American Society of Hematology 2019 Annual Meeting verastem.com ↗
Duvelisib Achieves Overall Response Rate of 62% in Patients with Relapsed or Refractory PTCL with Manageable Safety Profile in Initial Phase of PRIMO Trial |
| 2019-11-25 | Verastem, Inc. | Regulatory Verastem Oncology Announces Submission of a Marketing Authorization Application to the European Medicines Agency for COPIKTRA® (duvelisib) verastem.com ↗ |
| 2019-10-23 | Verastem, Inc. | Results Verastem Oncology Announces COPIKTRA™ (Duvelisib) Presentations at the Lymphoma & Myeloma 2019 International Congress verastem.com ↗
“Findings from the DUO study demonstrated that patients taking duvelisib who have received two or more prior therapies experienced improved clinical outcomes and a manageable safety profile,” states Matthew S. Davids , MD, Associate Director, Center for Chronic Lymphocytic Leukemia at Dana-Farber Cancer Institute . |
| 2019-10-03 | Verastem, Inc. | Regulatory Verastem Oncology Receives Orphan Drug Designation from FDA for COPIKTRA for the Treatment of T-Cell Lymphoma verastem.com ↗
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced duvelisib (COPIKTRA TM ) has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of T-Cell lymphoma. |
| 2019-10-03 | Verastem, Inc. | Results Verastem Oncology Presents New Preclinical Duvelisib Data at the 5th International Conference on New Concepts in Lymphoid Malignancies verastem.com ↗
Accordingly, the data show superior anti-cancer activity of the dual PI3K-delta/gamma inhibitor duvelisib compared to the PI3K-delta inhibitor idelalisib in these preclinical MCL models. |
| 2019-06-21 | Verastem, Inc. | Results Verastem Oncology Presents COPIKTRA™ (Duvelisib) Data in Peripheral T-Cell Lymphoma at the 2019 International Conference on Malignant Lymphoma verastem.com ↗
Data from Two Phase 1 Studies Show Response Rates of 44-57%, Including Complete Response Rates of 15-22% |
| 2019-06-17 | Verastem, Inc. | Results Verastem Oncology Presents COPIKTRA™ (Duvelisib) Data at the European Hematology Association 2019 Annual Meeting verastem.com ↗
In CLL/SLL Patients in the DUO Study, Duvelisib Treatment Rapidly Increased Lymphocytes and Resulted in Shrinkage of Lymph Nodes, With 86% of Patients Achieving a Lymph Node Response |
| 2019-05-15 | Verastem, Inc. | Results Verastem Oncology to Present New COPIKTRA™ (Duvelisib) Dose Modification Data from Patients Treated in the Phase 3 DUO Study verastem.com ↗
Dose Interruptions of a Median 15 days Do Not Significantly Impact Response or PFS |
| 2019-03-07 | Verastem, Inc. | Results Verastem Oncology Presents Further COPIKTRA™ (Duvelisib) Data at the 23rd Annual International Congress on Hematologic Malignancies verastem.com ↗
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, today announced that three COPIKTRA (duvelisib) abstracts were presented at the 23 rd Annual International Congress on Hematologic Malignancies (ICHM), which took place February 28 – March 3, 2019 , in Miami, FL. |
| 2019-03-04 | Verastem, Inc. | Results Verastem Oncology Presents Phase 3 DUO™ Data Evaluating COPIKTRA™ (Duvelisib) in Patients with CLL/SLL Who Have Progressed Following Two Prior Lines of Therapy verastem.com ↗
COPIKTRA Demonstrates Progression-Free Survival of 16.4 Months and an Overall Response Rate of 78% in Adult Patients with CLL/SLL After At Least Two Prior Therapies |
| 2019-02-14 | Verastem, Inc. | Results Verastem Oncology Announces Publication of the Phase 2 DYNAMO Study Results in Indolent Non-Hodgkin Lymphoma in the Journal of Clinical Oncology verastem.com ↗ |
| 2018-12-04 | Verastem, Inc. | Results Verastem Oncology Presents Duvelisib Development Program Data at the American Society of Hematology 2018 Annual Meeting verastem.com ↗
New Preclinical Research Suggests Duvelisib Overcomes Ibrutinib Resistance in CLL Models through Elimination of Malignant B Cells and Disruption of the Supportive Tumor Microenvironment |
| 2018-12-03 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Updated Duvelisib Combination Clinical Data in Peripheral T-Cell Lymphoma at the American Society of Hematology 2018 Annual Meeting verastem.com ↗
The response rate observed to date from the combination is compelling considering that PTCL is an aggressive type of non-Hodgkin lymphoma for which new therapies are desperately needed. |
| 2018-11-06 | Verastem, Inc. | Results Verastem Oncology Announces Presentation of Preclinical Data Supporting Dual PI3K-delta and PI3K-gamma Inhibition in Combination with Immunotherapy at the Society for Immunotherapy of Cancer’s 33rd Annual Meeting verastem.com ↗
Results to be presented at SITC’s 33 rd Annual Meeting demonstrated that duvelisib shows strong anti-tumor synergy with PD-1 or OX40 antibodies. |
| 2018-10-04 | Verastem, Inc. | Results Verastem Oncology Announces Publication of the Phase 3 DUO Study Results in the Journal Blood verastem.com ↗
Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, today announced that the results of the Phase 3 DUO™ study, which evaluated COPIKTRA™ (duvelisib) capsules versus ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), was published online in the peer-reviewed journal Blood . |
| 2018-09-24 | Verastem, Inc. | Regulatory Verastem Oncology Receives FDA Approval of COPIKTRA™ (duvelisib) Capsules verastem.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has approved COPIKTRA™, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma. |
| 2018-06-16 | Verastem, Inc. | Results Verastem Oncology Presents Duvelisib Data at EHA 2018 Annual Meeting verastem.com ↗
Phase Ib/II study of duvelisib in combination with FCR (dFCR) achieves ORR of 94% and 76% bone marrow MRD negativity in frontline therapy in younger CLL patients |
| 2018-06-04 | Verastem, Inc. | Results Verastem Oncology Presents Data on Two Lead Drug Candidates at ASCO 2018 Annual Meeting verastem.com ↗
Duvelisib demonstrates robust clinical activity with 73% ORR and a median of 15 month PFS in the DUO crossover study of patients who became relapsed/refractory to ofatumumab in DUO™ |
| 2018-05-17 | Verastem, Inc. | Results Verastem Oncology to Present Duvelisib Data at EHA 2018 Annual Meeting verastem.com ↗
dFCR was observed to be a highly active regimen, achieving ORR of 97% and 81% bone marrow MRD negativity |
| 2018-05-16 | Verastem, Inc. | Results Verastem Oncology to Present Data on Two Lead Drug Candidates at ASCO 2018 Annual Meeting verastem.com ↗
Results from the DUO™ crossover study with duvelisib demonstrate superior ORR and PFS compared to prior ofatumumab treatment and consistent with ORR in patients who were initially treated with duvelisib in the DUO™ Study |
| 2018-05-03 | Verastem, Inc. | Results Verastem Oncology Reports on Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma Opportunity, Landscape and Advancements in Pre-Commercial Initiatives at Analyst and Investor Day verastem.com ↗ |
| 2018-04-09 | Verastem, Inc. | Regulatory FDA Accepts New Drug Application for Duvelisib and Grants Priority Review verastem.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib. |
| 2018-02-07 | Verastem, Inc. | Regulatory Verastem Submits New Drug Application to U.S. FDA for Duvelisib for the Treatment of Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma verastem.com ↗
Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to improve the survival and quality of life of cancer patients, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) seeking full approval for its lead product candidate duvelisib, a first-in-class oral dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). |
| 2018-01-26 | Verastem, Inc. | Results Verastem Presents Preclinical Data at ASCO-SITC Highlighting the Synergistic Effects of Duvelisib in Combination with Immune Checkpoint or Co-Stimulatory Antibodies in B Cell Lymphoma Model verastem.com ↗
When duvelisib and anti-OX40 were combined, tumor regression was observed which correlated with strong reduction of tumor Tregs, M2 macrophages and myeloid-derived suppressor cells. |
| 2017-12-11 | Verastem, Inc. | Results Verastem Announces the Presentation of Phase 1 Duvelisib Combination Data in T-Cell Lymphomas at the ASH 2017 Annual Meeting verastem.com ↗
Combination of Duvelisib and Romidepsin Achieves 60% Overall Response Rate Including a 27% Complete Response Rate in these patient populations |
| 2017-12-10 | Verastem, Inc. | Results Verastem Announces Clinical Data from the Pivotal Phase 3 DUO™ Study: Duvelisib Significantly Improves Progression Free Survival in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma verastem.com ↗
The DUO Study Achieves Primary Endpoint, Demonstrating Statistically Significant Improvement in PFS for Duvelisib Versus Ofatumumab (HR=0.52, p<0.0001) |
| 2017-10-31 | Verastem, Inc. | Regulatory Verastem Announces Regulatory Strategy for Duvelisib New Drug Application Following Guidance from FDA verastem.com ↗ |
| 2017-09-06 | Verastem, Inc. | Regulatory Verastem Expands Duvelisib Development Program to Include Peripheral T-Cell Lymphoma verastem.com ↗
Duvelisib has been granted Fast Track designation by the U.S. Food & Drug Administration ( FDA ) for the treatment of patients with PTCL who have received at least one prior therapy. |
| 2017-09-06 | Verastem, Inc. | Results Verastem Announces Positive Top-line Data from the Pivotal Phase 3 DUO™ Study in Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma verastem.com ↗
Median PFS in the subset of patients with 17p deletion randomized to duvelisib was also significantly higher (12.7 months compared to 9.0 months for ofatumumab; HR of 0.41, p=0.0011). |
| 2017-06-24 | Verastem, Inc. | Results Verastem Reports Phase 2 Long-Term Follow-Up Data for Duvelisib in Patients with Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma at the 22nd Congress of the European Hematology Association verastem.com ↗
Notably, 83% of evaluable patients with FL treated with duvelisib had a reduction in the size of their target lymph nodes. |
| 2017-06-07 | Verastem, Inc. | Results Verastem to Present Long-Term Follow-Up Data from the DYNAMO™ Study at the 14th International Conference on Malignant Lymphoma verastem.com ↗
Duvelisib Monotherapy Treatment Demonstrates 47% ORR in Patients with Double-Refractory Indolent Non-Hodgkin Lymphoma |
| 2016-12-05 | Verastem, Inc. | Results Verastem Presents Phase 2 DYNAMO® Clinical Data at ASH 2016 Annual Meeting verastem.com ↗
The overall response rate (ORR) was 46% as determined by independent review committee (IRC; p=0.0001; 95% CI 0.37-0.55). |
| 2014-11-17 | AbbVie | Results AbbVie to Present Data on Investigational Oncology Compounds at the 56th American Society of Hematology Annual Meeting abbvie.com ↗
Duvelisib (IPI-145), a PI3K-δ,γ Inhibitor, Is Clinically Active in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia; |
All press releases naming this drug 61 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 57 sources stand behind the page.
| Field | Value | Cited 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 ↗ |
| 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 |
| Action | Inhibit | “Duvelisib (IPI-145) is an oral inhibitor of phosphatidylinositol 3-kinase (PI3K)-δ/γ isoforms currently in clinical development.” PMID 29233821 ↗ Dec 20172“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 ↗ |