|Drug class||PI3-kinase inhibitor|
|Main uses||Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), follicular lymphoma|
|Side effects||Diarrhea, low blood cells, rash, tiredness, fever, liver problems, muscle pains|
|By mouth (capsules)|
|Onset of action||1-2 hours after initial administration|
|Typical dose||25 mg BID|
|Metabolism||mainly metabolized by CYP3A4|
|Elimination half-life||5.2 to 10.9 hours|
|Excretion||Feces (79%), urine (14%)|
|Chemical and physical data|
|Molar mass||416.87 g·mol−1|
|3D model (JSmol)|
Duvelisib, sold under the brand name Copiktra, is a medication used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma. It is used when other treatments have failed. It is taken by mouth.
Common side effects include diarrhea, low blood cells, rash, tiredness, fever, liver problems, and muscle pains. Other serious side effects include inflammation of the lungs, infertility, and infections. Use in pregnancy may harm the baby. It is a dual inhibitor of PI3Kδ and PI3Kγ.
It is used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma after other treatments have failed. Further trials are ongoing to confirm benefits as of 2019.
It is taken at a dose of 25 mg twice per day.
Mechanism of action
Duvelisib is a Phosphoinositide 3-kinase inhibitor, specifically of the delta and gamma isoforms of PI3K. This class of compounds works by preventing PI3K from playing its role in transducing signals from outside of cells into various intracellular pathways involved in cell cycle regulation, apoptosis, DNA repair, senescence, angiogenesis and cell metabolism, including the PI3K/AKT/mTOR pathway.
Duvelisib, also known as IPI-145, was discovered by Intellikine, a company founded in September 2007 based on biochemistry research from the lab of Kevan Shokat at the University of California San Francisco.
In mid-June 2016, Infinity announced results of Phase II clinical trial of duvelisib.
In November 2016, Infinity exclusively licensed the worldwide rights to duvelisib to Verastem Oncology for little money compared to earlier deals; the deal included no upfront payment, a $6 million milestone for success in a Phase 3 trial in chronic lymphocytic leukemia, a $22 million payment for an FDA approval, and royalties.
In September 2020, Duvelisib was sold by Verastem to Secura Bio, Inc. for $70 million and additional payments based on milestones and royalties. 
Society and culture
In April 2018, Verastem filed a New Drug Application (NDA) for duvelisib for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for relapsed or refractory follicular lymphoma (FL). The FDA approved the application in September 2018.
Duvelisib is intended to be used in patients who have received at least two prior systemic therapies, and carries a black box warning due to the risk of fatal/serious toxicities: infections, diarrhea or colitis, cutaneous reactions and pneumonitis.
On 25 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Copiktra, intended for the treatment of adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) and refractory follicular lymphoma (FL). The applicant for this medicinal product is Verastem Europe GmbH.
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