Difamilast is a Small Molecule owned by Otsuka Pharmaceutical, and is involved in 5 clinical trials, of which 1 was completed, 3 are ongoing, and 1 is planned.

Difamilast (OPA-15406) is an inhibitor of PDE4 (phosphodiesterase-4). PDE4 promotes inflammation by degrading intracellular levels of cyclic adenosine monophosphate (cAMP), a naturally occurring second messenger that helps maintain immune homeostasis. With PDE4 inhibition and the resulting increases in cAMP levels in immune and non-immune cell types, expression of a network of pro-inflammatory and anti-inflammatory mediators.

The revenue for Difamilast is expected to reach a total of $404m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Difamilast NPV Report.

Difamilast was originated by Otsuka Holdings and is currently owned by Otsuka Pharmaceutical. Otsuka Holdings is the other company associated in development or marketing of Difamilast.

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 Holdings Overview

Otsuka Holdings (Otsuka) is a holding company, which operates various businesses such as pharmaceuticals, nutraceuticals, consumer products and other businesses through its subsidiaries. It focuses on the research and development, manufacture, and sale of medicines for the treatment of cancer, cardiovascular diseases, central nervous system disorders, ophthalmic diseases, gastrointestinal and respiratory diseases, infectious diseases, dermatological conditions and allergies. The company’s product portfolio includes pharmaceutical products, cosmetics, functional foods and beverages, alcoholic beverages, fine chemicals, electronic equipment, functional chemicals, medical devices and OTC products. It markets its products in North America, Europe, and Asia. Otsuka is headquartered in Chiyoda-ku, Tokyo, Japan.

The company reported revenues of (Yen) JPY1,498,276 million for the fiscal year ended December 2021 (FY2021), an increase of 5.3% over FY2020. In FY2021, the company’s operating margin was 10.3%, compared to an operating margin of 13.8% in FY2020. In FY2021, the company recorded a net margin of 8.4%, compared to a net margin of 10.4% in FY2020. The company reported revenues of JPY451,811 million for the third quarter ended September 2022, an increase of 4.1% over the previous quarter.

Quick View – Difamilast

Report Segments
  • Innovator (NME)
Drug Name
  • Difamilast
Administration Pathway
  • Topical
Therapeutic Areas
  • Dermatology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.