Development Pipeline

In-house discovered and In-licensed projects(As of Augasut 7, 2026)

Development Code Planned Indication Development Stage Remarks
KAR Head lice Authorization application ・In-licensed from Arbor Pharmaceuticals, LLC.(Currently, Azurity Pharmaceuticals)
・Product name in the US: Sklice
・Filed a Marketing Authorization in June 2026
・Presented PIII trial results at the 125th Annual Meeting of the Japanese Dermatological Association
KP-001 Refractory vascular malformations Authorization application ・In-house discovered product
・Announced the topline data from the confirmatory trial
・Presented PIII trial results at the 22nd Annual Meeting of the Japanese Society for the Study of Vascular Anomalies
・The long-term trial is ongoing
・Generic Name︓serabelisib
KC-8025 Primary biliary cholangitis Phase Ⅲ ・In-licensed from CymaBay Therapeutics, Inc.(Currently, Gilead Sciences, Inc.)
・Product name in US,UK,CA: Livdelzi
・Product name in EU,CA: Lyvdelzi
ESK-001 Plaque psoriasis Phase Ⅲ ・In-licensed from Alumis Inc.
・Announced the top line data from global PIII trial (incl. Japan)
・The long-term trial is ongoing
・Generic Name︓envudeucitinib
Generalized pustular psoriasis
/Erythrodermic psoriasis
Phase Ⅲ ・Generic Name︓envudeucitinib
Navenibart Hereditary angioedema Phase Ⅲ ・In-licensed from Astria Therapeutics, Inc.
・Under global Phase Ⅲ (incl. Japan)
KP-483 Solid tumors
(immuno-oncology)
Phase Ⅰ ・In-house discovered product
・Presented PI trial results at ASCO 2026
KP-910 Peripheral neuropathic pain Phase Ⅰ In-house discovered product
KP-001(USA) Refractory vascular malformations Phase Ⅲ ・In-house discovered product
・Clinical trial countries:US, CA, Taiwan, Korea
・Generic Name︓serabelisib

Note:Kaken will advance KP-723, an oral STAT6 inhibitor, to the completion of PⅠ trials, which had entered into a license agreement with J&J.
*The development stage includes the preparatory period for clinical trials.
*In-house is defined as pipelines acquired prior to obtaining POC and the company holds development rights.

Other(As of August 7, 2026)

Development Code Planned Indication Development Stage Remarks
gMSC1 Knee osteoarthritis with a focal defect Preparing for Phase Ⅲ ・Allogenic synovial mesenchymal stem cell-derived three-dimensional artificial tissue
・Development by the licensor, TWOCELLS Co., Ltd.
・Joint development and exclusive sales rights in the area of orthopedics in Japan
NM-26 Atopic dermatitis Phase Ⅱ ・Clinical trial underway by J&J after IP transfer
・Option rights to negotiate a sales partnership agreement in Japan
・PⅡb trial discontinued, as announced by J&J (December 26, 2025)

Note: The medical device “Silk-Elastin Wound Healing Sheet” for the treatment of wounds, including refractory wounds, is under preparation for its launch.

Status of Out-Licensed Products Overseas
(As of August 7, 2026)

Generic name
(domestic sales name)
Planned Indication Development Stage Out-licensed(Developing country)
Efinaconazole
(Clenafin)
Onychomycosis Authorization application AIM(China)

Note: Efinaconazole (overseas product name: Jublia), which was out-licensed to Almirall, was launched in Germany in May 2026.

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