Ripasudil hydrochloride hydrate

①Glaucoma and ocular hypertension [GLANATEC® ophthalmic solution 0.4%]

This drug is an eye drop preparation with a novel mechanism of action, the first of its kind in the world, for treating glaucoma.
The drug lowers intraocular pressure by inhibiting rho-kinase, a type of protein kinase, and promoting the outflow of aqueous humor from the main collector channel via the trabecular meshwork/Schlemm’s canal.

In 2002, DWTI out-licensed the rights to the drug to Kowa Co., Ltd., which then moved ahead with development and launched the drug in Japan under the brand name Ripasudil hydrochloride hydrate in December 2014.
*Because all rights in Japan and worldwide relating to Ripasudil hydrochloride hydrate have been out-licensed to Kowa, the following two drugs are also being developed by Kowa.

②Fuchs endothelial corneal dystrophy [K-321]

Since Ripasudil hydrochloride hydrate is a rho-kinase inhibitor, it has been suggested that the compound may also act on other kinases in the eye, leading to investigations of its applicability to other ophthalmic diseases. As part of these efforts, development of the compound as a treatment for Fuchs endothelial corneal dystrophy (FECD) is underway.
FECD is a disease in which corneal edema and opacity occur as a result of damage to corneal endothelial cells, resulting in diminished acuity of vision.
Although there are few patients suffering from FECD in Japan, it is a common disease in Europe and the U.S.
There is currently no effective drug treatment for FECD, which is often treated with corneal transplant surgery. We hope that our compound will become a new drug for treating FECD.

③Glaucoma and ocular hypertension [Fixed combination eye drop (Ripasudil hydrochloride hydrate and Brimonidine tartrate); K-232]

This drug is being developed as the first fixed combination eye drop containing Ripasudil hydrochloride hydrate.
Since the standard treatment for glaucoma involves the use of multiple drugs, we are seeking to improve the quality of life for glaucoma patients by providing a combination drug.

①Glaucoma and ocular hypertension
[GLANATEC® ophthalmic solution 0.4%]
in Vietnam
in Korea,
Singapore,
Malaysia and
Thailand
in Japan
②Fuchs endothelial corneal dystrophy[K-321]
in U.S.
③Glaucoma and ocular hypertension
[Fixed combination eye drop
(Ripasudil hydrochloride hydrate and Brimonidine tartrate);
K-232]
in Japan
Clinical indication ①Glaucoma and ocular hypertension
②Fuchs endothelial corneal dystrophy
③Glaucoma and ocular hypertension
Development process ①Launched (Japan); Approved(Asia); Application(Vietnam)
②Phase II clinical trials (U.S.) started
③Application (Japan) filed
Licensee Kowa Co., Ltd.

Development Progress

①Glaucoma and ocular hypertension [GLANATEC® ophthalmic solution 0.4%]

  • 2020.08
    Approved of new drug application (Thailand)
  • 2020.07
    Approved of new drug application (Malaysia)
  • 2020.03
    Approved of new drug application (Singapore)
  • 2019.02
    Approved of new drug application (Korea)
  • 2014.12
    Launched (Japan)
  • 2014.09
    Acquired marketing approval (Japan)
  • 2006.07
    Phase I clinical trials (Japan) started
  • 2002.09
    Licensed out all rights in Japan and worldwide relating to Ripasudil hydrochloride hydrate to Kowa Company, Ltd.

②Fuchs endothelial corneal dystrophy [K-321]

  • 2019.08
    Phase II clinical trials (U.S.)

③Fixed combination eye drop (Ripasudil hydrochloride hydrate and Brimonidine tartrate) [K-232]

  • 2021.11
    Application (Japan) filed
  • 2020.02
    Phase III clinical trials (Japan)