Idelalisib is under clinical development by Gilead Sciences and currently in the 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 Idelalisib’s likelihood of approval (LoA) and phase transition for Non-Small Cell Lung Cancer took place on 25 Jul 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Idelalisib overview

Idelalisib (Zydelig) drug belongs to anti-neoplastic agent. It is formulated as film-coated tablets for oral route of administration. Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. Zydelig in combination with rituximab, for the treatment of patients with  relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be  considered appropriate therapy due to other co-morbidities, for the treatment of patients with relapsed  follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior systemic therapies.

The drug candidate is under development for waldenstrom macroglobulinemia, non-small cell lung cancer and diffuse large B-cell lymphoma, follicular lymphoma.

The drug candidate was also under development for indolent B-cell non-Hodgkin lymphomas including small lymphocytic lymphoma, follicular lymphoma, lymphoblastic lymphoma, marginal zone lymphoma, mantle cell lymphoma and frontline chronic lymphocytic leukemia, mediastinal B-cell lymphoma and metastatic pancreatic ductal adenocarcinoma, primary myelofibrosis, post-essential thrombocythemia myelofibrosis, post-polycythemia vera myelofibrosis (PPV-MF), polycythemia vera,nodal marginal zone B-Cell lymphoma, extranodal marginal zone B-cell lymphoma (mucosa-associated lymphoid tissue or malt-lymphoma), splenic marginal zone B-cell lymphoma,  refractory and relapsed chronic lymphocytic leukemia.

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.

Quick View Idelalisib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Idelalisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
  • Respiratory
Key Developers
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.