Clinical development pipeline progress
First written in FY2017. 10 of 16 entries say "Advanced", first in FY2018. Latest entry: 2026-11-09.
8 other companies' latest entry also says "Advanced".
- FY2026DroppedAnnual report
「Tildacerfont, a treatment for congenital adrenal hyperplasia licensed from SpringWorks Biosciences, has been discontinued.」
The discontinuation of development of tildacerfont was explicitly stated. - FY2026AdvancedAnnual report
「ESK-001, a treatment for plaque psoriasis licensed from アルミス社, achieved its primary endpoint in an international joint Phase III trial, conducted by アルミス社, including Japan. The company also began a domestic Phase III trial for generalised pustular psoriasis and erythrodermic psoriasis. Navenibart is undergoing an international joint Phase III trial.」
ESK-001 achieved its primary endpoint in an international joint Phase III trial and began a domestic Phase III trial for additional indications. Navenibart continues its international joint Phase III trial, and multiple clinical development products have progressed to late-stage development. - 2026-05-15AdvancedOther Disclosures
「本剤は 2026 年 3 月 19 日に厚生労働省より希少疾病用医薬品の指定を受けています。」
KP-001について、希少疾病用医薬品の指定を受けたうえで製造販売承認申請に進んだことが示された。 - FY2025-H1DroppedAnnual report
「The company transferred the intellectual property for NM26 (development code: NM26-2198) to シーラグ社, an affiliate of J&J, and removed it from the development project.」
NM26-2198 was removed from the Group's development projects and clinical development pipeline. Rights to revenues and other interests related to development by J&J remain separately in place. - FY2024-Q3RestatedAnnual report
「Nexobrid, an agent for removing necrotic tissue, was launched in August 2023.」
The domestic launch of NexoBrid has been reconfirmed, but no progress to a new development stage has been reported. - FY2024-Q2AdvancedAnnual report
「In August 2023, the company launched NexoBrid, a debridement agent. NexoBrid is a topical product indicated for the removal of eschar in deep partial-thickness or full-thickness burns, providing a new treatment option.」
NexoBrid progressed from the development stage to the manufacturing and marketing and launch stages, and its indications were also specified. - FY2022WorsenedAnnual report
「Lenabasum, a treatment for systemic sclerosis and dermatomyositis licensed from Corbus, failed to achieve its primary endpoints in Corbus's respective Phase III trials. The company will discuss future development with Corbus before making a final decision. Following the results of the Phase II trial of its in-house-discovered KP-607 for onychomycosis, the company decided to withdraw its development of KP-607 as a treatment for onychomycosis from the development pipeline.」
Lenabasum failed to achieve its primary endpoints in the Phase III trial and has reached the stage of discussing and deciding on its future development policy. Based on the results of the Phase II trial, KP-607 was withdrawn from the development pipeline as a treatment for onychomycosis. - FY2022-Q3AdvancedAnnual report
「In the pharmaceuticals business, ARTham Therapeutics株式会社, which became a consolidated subsidiary during the nine-month period ended December 31, is conducting Phase II trials for ART-001, a treatment for refractory vascular malformations, and ART-648, a treatment for bullous pemphigoid.」
Following the consolidation of ARTham Therapeutics株式会社 as a subsidiary, two development products, ART-001 and ART-648, were added to the pipeline, and both are undergoing Phase II trials. The company also states its policy of pursuing global expansion by taking over subsequent Phase III clinical trials and other activities aimed at obtaining approval in Japan, the United States and Europe if the trials are successful. - FY2022-Q2RestatedAnnual report
「We are conducting clinical trials with the safety of patients and trial sites and the reduction of their burden as our top priorities. Although delays in trial-related activities and other issues have occurred at some medical institutions, there are currently no significant delays in the schedule.」
Regarding clinical trials conducted during the COVID-19 pandemic, the company continues to explain that although some delays have occurred, there are no significant delays to the schedule at this point. - FY2021AdvancedAnnual report
「The treatment for primary axillary hyperhidrosis licensed from Brickell Biotech obtained marketing approval in Japan as Ecloc Gel 5% in September 2020 and was launched in November 2020. In the United States, Brickell Biotech is conducting a Phase III trial.」
The treatment for primary axillary hyperhidrosis obtained approval and reached the launch stage. KMW-1 is in Phase III, KAR is being prepared for Phase III, KP-607 is in Phase II, lenabasum is at the Phase III stage, and BBI-4000 is being prepared for Phase I. - FY2019AdvancedAnnual report
「BBI-4000, a treatment for primary axillary hyperhidrosis, and KMW-1, a debridement agent for burn eschar, are undergoing Phase III trials, while KP-607, a treatment for onychomycosis, is undergoing a Phase I trial.」
BBI-4000 and KMW-1 progressed to ongoing Phase III trials, while KP-607 progressed to an ongoing Phase I trial. Lenabasum also reached the Phase III stage, and KAR was being prepared for clinical trials. Meanwhile, the co-development agreement for KAG-308 with its co-development partner was terminated. - FY2018AdvancedAnnual report
「BBI-4000, a treatment for primary focal hyperhidrosis being co-developed with Brickell Biotech, is being prepared for Phase III trials in Japan by the company and in the United States by Brickell Biotech. KMW-1, a debridement agent for burn eschar licensed from MediWound, is being prepared for a Phase III trial. KAG-308, a treatment for ulcerative colitis, has completed its Phase II trial, and the company is discussing future development plans with its co-development partner. KP-607, a treatment for onychomycosis discovered in-house, is undergoing a Phase I trial.」
BBI-4000 and KMW-1 are being prepared for Phase III trials, KAG-308 has completed Phase II, and KP-607 is undergoing Phase I, providing specific updates on the development stages of multiple products. - FY2017First statedAnnual report
「The ulcerative colitis treatment KAG-308 is undergoing a Phase II trial. BBI-4000, a treatment for primary focal hyperhidrosis being co-developed with Brickell Biotech, is undergoing a Phase II trial in Japan. In the United States, Brickell Biotech has completed its Phase II trial and is conducting a Phase II confirmatory trial to verify the safety and efficacy of the commercial formulation. For KMW-1, a debridement agent for burn eschar licensed from MediWound, the company has held regulatory consultations in preparation for starting clinical trials.」
The development stages of KAG-308, BBI-4000 and KMW-1 are described by product, including Phase II trials and regulatory consultations.