Announcement: Commencement of Phase II Clinical Trials for Janus Kinase Inhibitor "ROH-201" in Japan

Announcement: Commencement of Phase II Clinical Trials for Janus Kinase Inhibitor "ROH-201" in Japan

Sep 30, 2022

Company name: ROHTO Pharmaceutical Co., Ltd.
Representative name: President Masashi Sugimoto
(Code: 4527 TSE Prime)
Contact: Kazuharu Shimada, Public Relations & CSV Promotion Division

ROHTO Pharmaceutical Co., Ltd. (Head Office: Osaka, President: Masashi Sugimoto, hereinafter referred to as "ROHTO Pharmaceutical") is pleased to announce the commencement of Phase II clinical trials for ROH-201, a Janus Kinase Inhibitor (JAK) developed under our development code, for which the general name is Delgocitinib. This compound was originally discovered by Japan Tobacco Inc. (Head Office: Minato-ku, Tokyo, President & CEO: Masamichi Terabatake, hereinafter referred to as "JT Inc.").

As part of Rohto Pharmaceutical's comprehensive management vision for 2030, "Connect for Well-being," we are committed to focusing on the field of medical ophthalmic drugs to contribute to the well-being of people. As a testament to this commitment, we entered into a licensing agreement with JT Inc. in March 2018 to develop ROH-201 as a therapeutic agent in the field of ophthalmology

Janus Kinases are a type of tyrosine kinase found in cells and play a crucial role in the transmission of immune activation signals within cells. ROH-201 is expected to improve eye disorders by inhibiting this function, thus suppressing excessive immune responses. Following the completion of Phase II clinical trials, which included dry eye patients, including those with Sjogren's syndrome, we are commencing Phase II clinical trials. We will continue to advance the development of ROH-201, aiming to contribute to the well-being of patients by promoting healthy eyes, ultimately benefiting society at large.


  • Tyrosine Kinase
    Enzymes that add phosphate groups to the amino acid tyrosine, playing vital roles in cell proliferation, survival, development, and differentiation. They collectively form a group of enzymes that are crucial for transmitting immune activation signals within cells. Janus Kinases are one type of tyrosine kinase..
  • Sjogren's Syndrome
    An autoimmune disease characterized by organ-specific symptoms resulting from an imbalance in the immune system. It is designated as a rare disease. In the field of ophthalmology, it is known to exacerbate and complicate dry eye symptoms due to impaired tear and salivary gland function.

About JT Inc.

JT Inc. is a global tobacco company, and its products are sold in over 130 countries and regions. In addition to its tobacco business, the company is involved in pharmaceuticals and processed food operations, engaging in various business activities. JT Inc. primarily focuses on research and development functions in the areas of "cardiovascular, renal, and metabolic diseases," "immunity and inflammation," and "central nervous system." A group company, Torii Pharmaceutical Co., Ltd., is responsible for manufacturing and sales activities in Japan.
JT Inc. has developed Delgocitinib as a topical cream for the treatment of atopic dermatitis and received manufacturing and marketing approval in January 2020. It is marketed under the product name "CORECTIM® ointment."
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