Development Pipeline

In-house discovered and In-licensed projects(As of Nov 10, 2025)

Development Code Planned Indication Development Stage Remarks
KAR Head lice Phase Ⅲ ・In-licensed from Arbor Pharmaceuticals, LLC.(Currently, Azurity Pharmaceuticals)
・Product name in the US: Sklice
KP-001 Refractory vascular malformations Phase Ⅲ

・In-house discovered product
・Announced the topline data from the confirmatory trial

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: Lyvdelzi
ESK-001 Plaque psoriasis Phase Ⅲ ・In-licensed from Alumis Inc.
・Under global Phase Ⅲ (incl. Japan)
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
KP-910 Peripheral neuropathic pain Phase Ⅰ In-house discovered product
Tildacerfont Congenital adrenal hyperplasia Phase Ⅰ ・In-licensed from Spruce Biosciences, Inc.
・Strategy under Consideration
KP-001(USA) Refractory vascular malformations Preparing for Phase Ⅲ In-house discovered product

Note:Kaken will advance KP-723, an oral STAT6 inhibitor in preclinical development, to the completion of Phase Ⅰ clinical trials, which had entered into a licence agreement with J&J.

Other(As of Nov 10, 2025)

Development Code Planned Indication Development Stage Remarks
Sebetralstat Hereditary angioedema Authorization application

・Applied by KalVista Pharmaceuticals, Inc.
・Obtained approval in the US and Europe(Product name: Ekterly)
・Exclusive sales rights in Japan

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

Note:The medical device "Silk-Elastin Wound Healing Sheet", for which a marketing authorization application had been submitted by the licensor, Sanyo Chemical Industries, Ltd., was approved on April 21, 2025.

Status of Out-Licensed Products Overseas
(As of Nov 10, 2025)

Generic name
(domestic sales name)
Planned Indication Development Stage Out-licensed(Developing country)
Efinaconazole
(Clenafin)
Onychomycosis Approval

Almirall S.A.
(Germany: Approved in Aug 2025
※Italy:Approved in Mar 2025)

Efinaconazole
(Clenafin)
Onychomycosis Phase Ⅲ AIM(China)
Sofpironium bromide
(Ecclock)
Primary axillary hyperhidrosis Approval Dong-Wha Pharm Co., Ltd.
(Korea: Approved in Aug 2025)
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