Tipelukast is under clinical development by Kyorin Pharmaceutical 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 Tipelukast’s likelihood of approval (LoA) and phase transition for Idiopathic Pulmonary Fibrosis took place on 07 Feb 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.

In addition, the same event on 07 Feb 2022 increased Tipelukast’s LoA and PTSR for Non-Alcoholic Steatohepatitis (NASH).

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

Tipelukast overview

Tipelukast (KCA-757) is under development for the treatment of non-alcoholic steatohepatitis, non-alcoholic fatty liver disease, idiopathic pulmonary fibrosis (IPF) and metabolic syndrome. It is administered orally in the form of tablet. The drug candidate targets leukotriene (LT) receptor, phosphodiesterases 3, 4, phospholipase C, 5-lipoxygenase and thromboxane A2. It was also under development for the treatment of bronchial asthma and interstitial cystitis.

Kyorin Pharmaceutical overview

Kyorin Pharmaceutical (Kyorin), a subsidiary of Kyorin Holdings Inc, is a pharmaceutical company that manufactures and markets prescription medicines. It offers Ketas, a phosphodiesterase inhibitor agent for treating bronchial asthma and cerebro-vascular disorders. Kyorin provides Kipres, a bronchial asthma and allergic rhinitis therapeutic drug; and Pentasa an agent for ulcerative colitis and chrohn’s disease. The company’s various ethical drugs include lasvic, mucodyne, pentasa, uritos, flutiform, desalex, nasonex and beova and lasvic. It offers consumer healthcare products such as over-the-counter drugs. Kyorin provides Milton brand to offer baby bottle disinfectant products. The company collaborates with other companies to develop new medicine. It has operations in the US and Germany. Kyorin is headquartered in Chiyoda, Tokyo, Japan.

Quick View Tipelukast LOA Data

Report Segments
  • Innovator
Drug Name
  • Tipelukast
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Metabolic Disorders
  • Respiratory
Key Developers
Highest Development Stage
  • Phase II

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.