Research & Development Division

R&D Pipeline

KAKEN’s drug discovery research focuses on such areas of strength as inflammation, immunity, allergies and pain relief in addition to its core competence of fungal infection disease. KAKEN invest substantial financial and human resources into such research activities with the aim of developing new drugs that are both effective and safe. To create new drugs that can compete in the world market, we maintain an active program of drug discovery research, spearheaded by outstanding research professionals and techniques refined over many years of experience in pharmaceutical development.

Code Indication Stage
BBI-4000 Primary focal hyperhidrosis PIII
KMW-1 Removal of eschar with thermal burns PIII
KP-607 Onychomycosis PI
KAR Ivermectin Head Lice infestation Preparing for clinical trial

KAKEN’s Innovation Product for Regeneration

Fiblast® (Recombinant human basic fibroblast growth factor, rh bFGF)

Fiblast Spray is the world’s first marketed product for regenerative medicine treatment containing recombinant human basic Fibroblast Growth Factor (bFGF). Present in almost all tissue in the human body, bFGF is released from the extracellular matrix once tissue is damaged, and then acts on various cells and tissues to stimulate tissue regeneration. While bFGF has a wide variety of functions, its most prominent features are its powerful ability to stimulate cellular proliferation and its capacity to promote neovascularization.

In 1988, KAKEN obtained exclusive licensing rights for recombinant human bFGF (trafermin) in Asia from Scios Inc., of the United States. Following this, KAKEN has pushed forward with its own R&D efforts, and subsequently obtained marketing approval for Fiblast Spray for the treatment of pressure ulcers and other skin ulcers (burn ulcers and leg ulcers) in June 2001. Further, after completing reexamination in 2010, Fiblast Spray has been re-acknowledged as a highly reliable drug. It is now used with confidence at a number of hospitals throughout Japan.

Not only effective for regenerating skin tissue, trafermin has also demonstrated the ability to promote the proliferation and regeneration of both periodontal and bone tissues. In the field of dentistry, trafermin is known for its ability to promote the regeneration of periodontal ligaments, cementum, and alveolar bone. KAKEN has completed phase III clinical trial for this drug, and are currently in the process of preparing to file a new drug application for trafermin to be used in the treatment of periodontitis.

In March 2005, KAKEN acquired the worldwide rights to develop, manufacture, and market for all therapeutic purposes. In June 2007, KAKEN entered a licensing agreement with Sunstar Inc. regarding the development and marketing of trafermin for dental applications in Europe and North America. Further, in November 2009, KAKEN entered a licensing agreement with Olympus Corporation in relation to the development and marketing of trafermin for wound healing in Europe and North America. KAKEN also entered licensing agreements regarding the development and marketing of Fiblast Spray with a Chinese pharmaceutical company in December 2005 and with a South Korean company in December 2006.

Going forward, KAKEN will continue to expand the presence of trafermin in the global medical market. In this undertaking, KAKEN will collaborate with our overseas business partners and fully utilize the wealth of knowledge we have accumulated regarding trafermin.

Kaken’s specialty -topical antifungal agent-

Clenafin® (Topical onychomycosis treatment)

Clenafin (efinaconazole) discovered by KAKEN’s scientists is the world’s first triazole compound for a topical medication for onychomycosis. This drug has potent antifungal activity and is effective against a wide spectrum of fungi. Also, its effectiveness decreased only slightly compared to other existing antifungal agents in the presence of keratin, the main component of nails. This means that the drug has superior nail penetrating properties, thereby demonstrating that it can maintain its therapeutic effect in nails thickened by fungal infection or on the underside of such nails. Clenafin has also shown antifungal activity in various animal models of infections and, in particular, greater effectiveness than other treatment options in a guinea pig model for onychomycosis. For these reasons, Clenafin is a promising new topical treatment for persistent onychomycosis, which has been primarily treated through oral medications in the past.

In 2006, KAKEN concluded a licensing agreement with U.S. company Dow Pharmaceutical Sciences, Inc. (DPS), granting it the development and marketing rights for Clenafin in Europe and the Americas. After Canadian company Valeant Pharmaceuticals International, Inc., acquired DPS in 2009, it has continued to conduct joint clinical development activities with KAKEN. In two multinational pivotal studies (phase III) in patients with mild to moderate onychomycosis of the toenails, this topical investigational drug was found to be clinically and statistically superior to a vehicle for all primary and secondary endpoints. The efficacy of this drug is also competitive when compared to that of existing oral medications, and it has demonstrated its efficacy as a topical agent with fewer side effects.

In 2014, KAKEN was granted manufacturing and marketing approval for Clenafin in Japan, and it was subsequently launched that year, making it the first topical medication for onychomycosis in the country. In the nearly one year since its release, Clenafin has an exceptional reputation among dermatologists. In addition, Valeant acquired marketing approval for this drug in the United States and Canada during 2014, and this drug is being marketed under the trade name Jublia in these countries.

KAKEN will continue to work with overseas partners to get approval for this drug’s use as a treatment for onychomycosis in the global market.