Duvelisib is under clinical development by Secura Bio and currently in Phase II for Natural Killer Cell Lymphomas. According to GlobalData, Phase II drugs for Natural Killer Cell Lymphomas does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Duvelisib LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Duvelisib overview

Duvelisib (Copiktra) is an isoquinolone derivative, acts as an anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Copiktra is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and follicular lymphoma after at least two prior therapies. 

Duvelisib (IPI-145, formerly known as INK1197) is under development for the treatment of melanoma, advanced relapsed and refractory hematologic cancers like chronic lymphocytic leukemia, peripheral T-Cell lymphomas (PTCL), angioimmunoblastic T-Cell lymphoma, anaplastic large cell lymphoma, natural killer cell lymphomas, T-cell lymphomas and non-hodgkin lymphomas including small lymphocytic lymphoma, follicular lymphoma. It is under development for the treatment of indolent non-hodgkin lymphomas including follicular lymphoma, marginal zone lymphoma (splenic, nodal, or extranodal).

It was under development for the treatment of head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx, Coronavirus disease 2019 (COVID-19). It was also under development for the treatment of rheumatoid arthritis (RA), acute lymphoblastic leukemia (T-ALL or B-ALL), lymphoma, nodal, extranodal, splenic marginal zone lymphoma and diffuse large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma and allergic asthma and solid tumors including esophageal cancer, gastric cancer, colorectal cancer, head and neck cancer squamous cell carcinoma.

Secura Bio overview

Secura Bio is a pharmaceutical company that develops and commercializes oncology therapies. Its product includes copiktra medicine, which is used for treating patients with chronic lymphocytic leukemia (CLL) and copiktra (duvelisib) a kinase inhibitor that is used to treat patients with relapsed or refractorysmall lymphocytic lymphoma and chronic lymphocytic leukemia. Its pipeline products include NCT03372057 PRIMO Single agent and NCT04038359 TEMPO Intermittent dosing. The company has its operations in the US and Ireland. Secura Bio is headquartered in Las Vegas, Nevada, the US.

For a complete picture of Duvelisib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.