Parsaclisib is under clinical development by Incyte and currently in the Phase II and Phase III 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 Parsaclisib’s likelihood of approval (LoA) and phase transition for Refractory Chronic Lymphocytic Leukemia (CLL) took place on 17 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Parsaclisib overview

Parsaclisib is under development for the treatment of indolent/aggressive B-cell non-Hodgkin's lymphoma, mantle cell lymphoma, hairy cell leukemia, Waldenstrom macroglobulinemia, Hodgkin's lymphoma, follicular lymphoma, relapsed/refractory chronic lymphocytic leukemia/ small lymphocytic lymphoma, salivary gland cancer, marginal zone lymphoma including extranodal, nodal, and splenic subtypes, newly diagnosed triple negative breast cancer, and primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis and autoimmune hemolytic anemia. It is a small molecule administered orally in the form of tablet. It acts by targeting phosphoinositide 3-kinase delta (PI3Kdelta).

The therapeutic candidate was also under development for HER2-positive breast cancer, endometrial cancer, gastric cancer, small cell lung cancer, triple negative breast cancer, ureter cancer, bladder, urethral cancer, head and neck cancer squamous cell carcinoma, melanoma, colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple-negative breast cancer, transitional cell carcinoma, pemphigus vulgaris and Sjogren's syndrome. It was under development for the treatment of relapsed and refractory diffuse large B-cell lymphoma, peripheral t-cell lymphoma, including peripheral t-cell lymphoma, unspecified type, anaplastic large cell lymphoma (ALK negative or positive), angioimmunoblastic T-cell lymphoma, enteropathy related T-cell lymphoma, hepatosplenic T-cell lymphoma, γ/δ T-cell lymphoma, NK/T-cell lymphoma.

Incyte overview

Incyte is a biopharmaceutical company, which discovers, develops and commercializes proprietary cancer therapeutics. The company’s lead product, Jakafi (ruxolitinib) is marketed in the US for the treatment of patients with high-risk myelofibrosis; and polycythemia vera who are intolerant to hydroxyurea. The company distributes Jakafi through a network of specialty pharmacy providers and wholesalers. In collaboration with Incyte, Novartis International Pharmaceutical Ltd (Novartis) develops and commercializes ruxolitinib outside the US for hematologic and cancer indications under the name Jakavi. The company’s pipeline portfolio encompasses drugs for the treatment of lung cancer, graft versus host disease, non-small cell lung cancer, b-cell malignancies, solid tumors, glioblastoma, liver cancer, and advanced malignancies. Incyte is headquartered in Wilmington, Delaware, the US.

Quick View Parsaclisib LOA Data

Report Segments
  • Innovator
Drug Name
  • Parsaclisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Hematological Disorders
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Filing rejected/Withdrawn

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.