Development of ropinirole hydrochloride as an ALS treatment and preparations for a Phase III clinical trial
First written in FY2023-Q3. 6 of 13 entries say "Restated". Latest entry: 2026-08-19.
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- 2026-08-19AdvancedInvestor presentation
「KP2011 (ALS* domestic): Preparations for Phase III are progressing smoothly * Advancing preparations for PMDA pre-consultation and submission of the clinical trial notification」
The company described PMDA pre-consultation and preparations for submitting the clinical trial notification as concrete progress toward a domestic Phase III trial. - FY2026-H1RestatedAnnual report
「For the ALS development pipeline, in Japan we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues preparations with Alfresa Pharma Corporation for a Phase III trial for the ALS treatment using ropinirole hydrochloride. - FY2025AdvancedAnnual report
「Alfresa Pharma Corporation announced on 25 December 2025 on the Clinical Research and Trials Information Submission and Publication System (Japan Registry of Clinical Trials, commonly known as jRCT) that it had completed the Phase I clinical trial of KA-2301, its code name for the extended-release granule formulation.」
The licensee reported concrete progress: completion of the Phase I clinical trial for the ALS treatment using ropinirole hydrochloride. - 2026-03-04AdvancedGeneral Meetings of Shareholders
「アルフレッサ ファーマ株式会社 announced on 25 December 2025 through the Clinical Research and Trials Information System (Japan Registry of Clinical Trials, commonly known as jRCT) that it had completed the Phase I clinical trial of KA-2301 (Note 2).」
The completion of the Phase I clinical trial for KA-2301 was indicated, marking progress to the preparation stage for a confirmatory clinical trial (Phase III trial). - FY2025-H1RestatedAnnual report
「For the ALS development pipeline, we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues preparations with Alfresa Pharma Corporation for a Phase III trial for the ALS program involving ropinirole hydrochloride. - FY2024RestatedAnnual report
「For the ALS development pipeline, we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues preparations with Alfresa Pharma Corporation for a Phase III trial for the ALS treatment using ropinirole hydrochloride. - FY2024-H1RestatedAnnual report
「For the ALS development pipeline, we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues preparations with Alfresa Pharma Corporation for a Phase III trial for the ALS program involving ropinirole hydrochloride. - FY2024-Q1RestatedAnnual report
「For the ALS development pipeline, we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues preparations with Alfresa Pharma Corporation for a Phase III trial for the ALS program involving ropinirole hydrochloride. - FY2023RestatedAnnual report
「For the ALS development pipeline, we are proceeding with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company continues development, manufacturing and marketing in Japan of ropinirole hydrochloride with Alfresa Pharma Corporation and preparations for the Phase III trial. - FY2023-Q3First statedAnnual report
「For the ALS development pipeline, on 1 March 2023 we entered into an Agreement for a License of Development, Manufacturing and Marketing Rights for an ALS Treatment Using Ropinirole Hydrochloride with Alfresa Pharma Corporation, and will proceed with preparations with Alfresa Pharma Corporation for the confirmatory clinical trial (Phase III trial) in order to deliver the treatment to patients as soon as possible.」
The company entered into the license agreement on 1 March 2023 and is preparing for the Phase III trial.