Duvelisib is under clinical development by Secura Bio and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Duvelisib’s likelihood of approval (LoA) and phase transition for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma) took place on 05 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

In addition, the same event on 05 Dec 2022 decreased Duvelisib’s LoA and PTSR for Nodal Marginal Zone B-Cell Lymphoma, and decreased LoA and PTSR for Splenic Marginal Zone B-Cell Lymphoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Duvelisib Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 Coronavirus disease 2019 (COVID-19), melanoma, advanced relapsed and refractory hematologic cancers like chronic lymphocytic leukemia, relapsed and refractory chronic lymphocytic leukemia (second line), peripheral T-Cell lymphomas (PTCL), angioimmunoblastic T-Cell lymphoma, anaplastic large cell lymphoma, natural killer cell lymphomas, T-cell lymphomas, cutaneous T-cell lymphoma and non-hodgkin lymphomas including small lymphocytic lymphoma, follicular lymphoma, relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and relapsed or refractory follicular lymphoma. 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.

It is under development for the treatment of indolent non-hodgkin lymphomas including follicular lymphoma, marginal zone lymphoma (splenic, nodal, or extranodal), and SLL.

It was under development for the treatment of head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.

Secura Bio overview

Secura Bio is a pharmaceutical company that develops innovative therapies and drugs. Its product portfolio includes FARYDAK (panobinostat) capsules, which are used for treating patients with multiple myeloma. Secura Bio is headquartered in Las Vegas, Nevada, the US.

Quick View Duvelisib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Duvelisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Immunology
  • Infectious Disease
  • Oncology
  • Respiratory
Key Developers
  • Sponsor Company: Secura Bio
  • Originator: Intellikine
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.