Difamilast is under clinical development by Otsuka Pharmaceutical and currently in the 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 Difamilast’s likelihood of approval (LoA) and phase transition for Atopic Dermatitis (Atopic Eczema) took place on 23 Nov 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.

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

Difamilast overview

Difamilast (Moizerto) is acts by targeting phosphodiesterase-4 (PDE4). It is formulated as ointment for topical administration. Moizerto is indicated for the treatment of atopic dermatitis.

Difamilast (OPA-15406) is under development for the treatment of atopic dermatitis. It is a small molecule and formulated as an ointment and applied topically. It targets phosphodiesterase-4 (PDE4).

Otsuka Pharmaceutical overview

Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment. The company develops formulations for diagnosis and treatment of central nervous system, oncology, cardiovascular and renal, gastrointestinal, ophthalmology disorders and infectious diseases through its pharmaceutical business. It’s nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. OPC is investigating drugs for psychiatry and neurology; oncology; cardiovascular and other therapeutic indications in collaboration with academia and venture companies. The company operates branch offices, research facilities and factories in Japan. OPC is headquartered in Chiyoda-ku, Tokyo, Japan.

Quick View Difamilast LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Difamilast
Administration Pathway
  • Topical
Therapeutic Areas
  • Dermatology
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.