Copiktra

(Duvelisib)

ApprovedSmall molecule

Copiktra is a small molecule that works as a PI3-Kinase P110-Gamma Subunit Inhibitor; PI3-Kinase P110-Delta Subunit Inhibitor.[2] It is being used across 20 indications, with its most advanced program in Approved.[1]

Copiktra is one of 426 small molecule programs targeting Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

425

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LeukemiaApproved

ArthritisApproved

Hematopoietic and Lymphoid Cell NeoplasmApproved

Liver DiseaseApproved

Head and Neck Squamous Cell CarcinomaApproved

Lymphoid LeukemiaApproved

Rheumatoid ArthritisApproved

Unspecified Peripheral T-Cell LymphomaApproved

Non-Hodgkins LymphomaApproved

AsthmaApproved

LeukemiaApproved

Approved

ArthritisApproved

Approved

Hematopoietic and Lymphoid Cell NeoplasmApproved

Approved

Liver DiseaseApproved

Approved

Head and Neck Squamous Cell CarcinomaApproved

Approved

Lymphoid LeukemiaApproved

Approved

Rheumatoid ArthritisApproved

Approved

Unspecified Peripheral T-Cell LymphomaApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

AsthmaApproved

Approved

Showing 10 of 20 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Copiktra

SSecuraBio

Approved

11 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 5

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 6

Nuvigil

NNuvo Research GmbH

Preclinical

1 7

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—8

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Chronic Lymphocytic Leukemia

NCT03961672

Phase 1Active, not recruiting

Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC V8

NCT04652960

Q2 2027

Phase 2Recruiting

Angioimmunoblastic T-Cell Lymphoma

NCT04803201

Q3 2027

Phase 1Recruiting

T - Cell Lymphoma

NCT05010005

Q4 2027

Phase 2Recruiting

Follicular Helper T-Cell Lymphoma

NCT07293403

Not yet recruiting

Lymphoma

NCT05923502

Clinical

Trials by Indication[1]

Lymphoma11 trials

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Completed·SSecuraBio·Phase 2·NCT03372057·156 enrolled

Doxorubicin, CC-(486) (5-azacitidine), Romidepsin, and Duvelisib (hARD) for T-cell Lymphoma

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT04639843

Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02783625·114 enrolled

Show 8 more trials

Acalabrutinib and Duvelisib for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

Withdrawn·NNarendranath Epperla·Phase 1·NCT04836832

A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype

Recruiting·SSecuraBio·Phase 3·NCT06522737·124 enrolled

A Study of Duvelisib in Combination With Rituximab and Bendamustine vs Placebo in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma (BRAVURA)

Withdrawn·SSecuraBio·Phase 3·NCT02576275

A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

Completed·SSecuraBio·Phase 2·NCT01882803·129 enrolled

(CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)

Not yet recruiting·RRuijin Hospital··NCT05923502·200 enrolled

Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT04331119·17 enrolled

Study Evaluating Duvelisib in Japanese Subjects With Relapsed or Refractory Lymphoma

Completed· AbbVie logo

AbbVie·Phase 1·NCT02598570·7 enrolled

A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Participants With Indolent Non-Hodgkin Lymphoma

Completed·SSecuraBio·Phase 2·NCT04038359·103 enrolled

Follicular Lymphoma5 trials

A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

Terminated·SSecuraBio·Phase 1/2·NCT02391545·55 enrolled

Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

Terminated·SSecuraBio·Phase 3·NCT02204982·13 enrolled

Duvelisib With Rituximab vs R-CHOP in Subjects With Relapsed/Refractory Follicular Lymphoma (FRESCO)

Withdrawn·SSecuraBio·Phase 2·NCT02605694

Show 2 more trials

A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma

Unknown status· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 2·NCT04707079·24 enrolled

Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma

Completed·—·Phase 1·NCT03892044·7 enrolled

Chronic Lymphocytic Leukemia3 trials

A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

Withdrawn· AbbVie logo

AbbVie·Phase 1·NCT02640833

Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

Withdrawn·SSecuraBio·Phase 2·NCT03370185

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting·—·Phase 2·NCT03961672·15 enrolled

Relapsed or Refractory2 trials

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

Completed·SSecuraBio·Phase 3·NCT02004522·319 enrolled

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

Active, not recruiting·—·Phase 1/2·NCT03534323·55 enrolled

Metastatic1 trial

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Completed·GGlenn J. Hanna·Phase 2·NCT05057247·26 enrolled

18 more indications

Effectiveness1 trial

Observational Trial of Real-World Treatment Utilization and Effectiveness of PI3K-inhibitors in CLL/SLL and FL

Terminated·SSecuraBio··NCT04342117·2 enrolled

Head and Neck Cancer1 trial

A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Terminated·SSecuraBio·Phase 1/2·NCT04193293·2 enrolled

Malignancy1 trial

Duvelisib in Combination With BMS-986345 in Lymphoid Malignancy

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT05065866·14 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study

Completed·EEmory University·Phase 1·NCT04890236·4 enrolled

COVID-191 trial

Duvelisib to Combat COVID-19

Completed·WWashington University School of Medicine·Phase 2·NCT04372602·28 enrolled

Hematologic Malignancies1 trial

A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)

Completed·SSecuraBio·Phase 2·NCT02711852·19 enrolled

Melanoma1 trial

Duvelisib in Combination With Nivolumab in Patients With Advanced Unresectable Melanoma

Terminated·JJohn Kirkwood·Phase 1/2·NCT04688658·13 enrolled

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT04209621·3 enrolled

Chimeric Antigen Receptor T-cell1 trial

Duvelisib Following Chimeric Antigen Receptor T-Cell Therapy

Active, not recruiting·WWashington University School of Medicine·Phase 1·NCT05044039·42 enrolled

Anaplastic Large Cell Lymphoma1 trial

A Study of Alectinib and Duvelisib in People With Anaplastic Lymphoma Kinase-Positive Anaplastic Large Cell Lymphoma (ALK+ALCL)

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07001384·30 enrolled

Advanced Solid Tumors1 trial

A Study of Duvelisib Combined With SG001 Injection in Patient With Advanced Solid Tumors

Unknown status· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1/2·NCT05508659·128 enrolled

Pneumonia1 trial

Duvelisib Ameliorates Manifestations of Pneumonia in Established Novel Coronavirus Infection (COVID-19)

Completed·EEmory University·Phase 2·NCT04487886·47 enrolled

T - Cell Lymphoma1 trial

Phase I Multicenter Study of Ruxolitinib and Duvelisib in Relapsed or Refractory T- or NK-Cell Lymphomas

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT05010005·70 enrolled

Angioimmunoblastic T-Cell Lymphoma1 trial

A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT04803201·170 enrolled

Follicular Helper T-Cell Lymphoma1 trial

A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma

Recruiting·CCity of Hope Medical Center·Phase 2·NCT07293403·25 enrolled

Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v81 trial

A Phase I Study With an Expansion Cohort of Duvelisib and Nivolumab in Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04652960·38 enrolled

Mycosis Fungoides1 trial

A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides

Not yet recruiting·SSecuraBio·Phase 1·NCT07714187·30 enrolled

T-Cell Prolymphocytic Leukemia1 trial

Phase I/II Study of Duvelisib and Venetoclax in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Recruiting·JJonsson Comprehensive Cancer Center·Preclinical·NCT06810778·12 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 24, 2018

COPIKTRA

NDA NDA211155

Sources

References

[1]
ClinicalTrials.gov — 40 trial records for Duvelisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Duvelisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Duvelisib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211155). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Copiktra. U.S. Food & Drug Administration.
[6]
SEC EDGAR — SecuraBio company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Gamma Subunit Inhibitor; PI3-Kinase P110-Delta Subunit Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SSecuraBio

Patent Landscape[5]

Patent Cliff

Jan 5, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9216982Jan 5, 2029

8193182Feb 13, 2030

9840505Jan 10, 2032

11312718Jan 10, 2032

RE46621May 17, 2032

1 more patents

12213983Apr 26, 2035

Copiktra

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Lymphoma11 trials

Follicular Lymphoma5 trials

Chronic Lymphocytic Leukemia3 trials

Relapsed or Refractory2 trials

Metastatic1 trial

Effectiveness1 trial

Head and Neck Cancer1 trial

Malignancy1 trial

Diffuse Large B-Cell Lymphoma1 trial

COVID-191 trial

Hematologic Malignancies1 trial

Melanoma1 trial

Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma1 trial

Chimeric Antigen Receptor T-cell1 trial

Anaplastic Large Cell Lymphoma1 trial

Advanced Solid Tumors1 trial

Pneumonia1 trial

T - Cell Lymphoma1 trial

Angioimmunoblastic T-Cell Lymphoma1 trial

Follicular Helper T-Cell Lymphoma1 trial

Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v81 trial

Mycosis Fungoides1 trial

T-Cell Prolymphocytic Leukemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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