Ibudilast is under clinical development by Kyorin Pharmaceutical 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 Ibudilast’s likelihood of approval (LoA) and phase transition for Amyotrophic Lateral Sclerosis 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 Ibudilast’s LoA and PTSR for Recurrent Glioblastoma Multiforme (GBM).

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

Ibudilast overview

Ibudilast (Ketas) is an anti-inflammatory and neuroprotective agent. It is formulated in the form of hard gelatin capsules for oral route of administration. Ketas capsule is indicated for the treatment of asthma and improvement of dizziness due to chronic cerebral circulatory disorders associated with cerebral infarction.

It is under development for the treatment of amyotrophic lateral sclerosis (ALS), primary and secondary progressive multiple sclerosis, alcohol dependence, opium withdrawal syndrome, methamphetamine addiction (drug addiction), degenerative cervical myelopathy, chemotherapy-induced peripheral neuropathy, chlorine-induced acute lung injury and acute respiratory distress syndrome in patients infected by the COVID-19 coronavirus, glaucoma, Pneumonia, retinal damage and metastatic uveal melanoma. It was also under development for chronic medication overuse headache, cerebrovascular disorders, globoid cell leukodystrophy (Krabbe Disease), neuropathic pain and post traumatic brain injury.

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 Ibudilast LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Ibudilast
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Ear Nose Throat Disorders
  • Infectious Disease
  • Oncology
  • Ophthalmology
  • Respiratory
  • Toxicology
Key Developers
  • Sponsor Company: Kyorin Pharmaceutical
  • Originator: Kyorin Pharmaceutical
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.