Efficient Advancement of Clinical Trials for Development Programs and Early Approval
First written in FY2016. 33 of 43 entries say "Advanced", first in FY2017-Q1. Latest entry: 2026-07-31.
0 other companies' latest entry also says "Advanced".
- 2026-07-31AdvancedFinancial results presentation
「In May 2026, for olutasidenib (generic name), which we in-licensed from Rigel Pharmaceuticals (US), we submitted an application in Japan for marketing authorisation for the indication of relapsed or refractory acute myeloid leukaemia with an IDH1 gene mutation, and granted Orient EuroPharma (Taiwan) development and sales rights in Taiwan.」
The in-licensed olutasidenib advanced to the marketing-authorisation application stage in Japan, marking progress toward early approval. - FY2026AdvancedAnnual report
「The domestic late Phase II clinical trial for Matsupexole, our internally discovered treatment for Parkinson's disease (generic name; development code: KDT-3594), was unblinded in March 2026 and achieved its primary endpoint. Following the start of a domestic Phase I clinical trial for KSP-0914, a treatment for Graves' disease (development code), in August 2025, we began a domestic Phase I clinical trial for KSP-0576, a treatment for overactive bladder/interstitial cystitis and bladder pain syndrome (development code), in February 2026, and a domestic Phase I clinical trial for KSP-0930, a treatment for narcolepsy (development code), in March 2026.」
In addition to achieving the primary endpoint in a late Phase II trial, we began Phase I clinical trials for 3 products, making concrete progress in clinical development. - FY2026-H1AdvancedAnnual report
「Following the start of a domestic Phase I clinical trial for Olutasidenib, a treatment for acute myeloid leukemia, in July 2025, we began a domestic Phase I clinical trial for KSP-0914, our internally discovered treatment for Graves' disease, in August of the same year, continuing to advance our research and development programs through the stages.」
Domestic Phase I clinical trials began for Olutasidenib and KSP-0914, representing concrete progress in advancing the development programs through the clinical stage. - FY2025AdvancedAnnual report
「The Company-originated product linzagolix (generic name; development code: KLH-2109) was submitted for marketing approval in Japan for uterine fibroids in February 2025, and domestic Phase III clinical trials were commenced in March 2025 toward obtaining an additional indication for endometriosis. In addition, domestic additional Phase III clinical trials of lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, commenced in March 2025.」
The filing of a marketing application and an additional-indication trial for linzagolix, together with the start of an additional Phase III trial for troriluzole, advanced the development stages toward approval. - FY2025-H1AdvancedAnnual report
「Linzagolix, a treatment for uterine fibroids and endometriosis discovered by us (generic name; development code: KLH-2109), met the primary endpoints in 2 domestic Phase III clinical trials for uterine fibroids, and we began preparations for filing a marketing application.」
For linzagolix, the primary endpoints were achieved in 2 domestic Phase III trials, and the product progressed to the stage of preparing a marketing application. - FY2024SoftenedAnnual report
「For troriluzole, a treatment for spinocerebellar degeneration (generic name; development code: KPS-0373), we withdrew the marketing application for the time being in July 2023 and are considering whether to conduct additional clinical trials.」
KPS-0373 changed from the post-application approval stage to the stage of considering whether to conduct additional clinical trials following withdrawal of the application. - FY2024AdvancedAnnual report
「For CG0070, a treatment for non-muscle-invasive bladder cancer (development code), we are participating in an international joint Phase III clinical trial led by CG Oncology (US), the licensor, and clinical trials are underway in Japan. Linzagolix, a treatment for uterine fibroids and endometriosis discovered by us (generic name; development code: KLH-2109), is also undergoing a domestic Phase III clinical trial for uterine fibroids.」
The clinical trial for CG0070 in Japan and the domestic Phase III clinical trial for linzagolix remain ongoing. - FY2024-Q3AdvancedAnnual report
「In December 2023, we launched KORSUVA IV Injection for Dialysis Syringe, a treatment for pruritus in dialysis patients that we co-developed with 丸石製薬株式会社.」
The co-developed MR13A9 progressed through obtaining marketing approval and preparing for launch to its launch in December 2023. - FY2024-Q2SoftenedAnnual report
「Lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration, had its marketing approval application temporarily withdrawn in July of this year, and the Company is considering the feasibility of conducting additional clinical trials.」
The status changed from the application stage toward approval to the stage of temporarily withdrawing the marketing application and considering whether to conduct additional clinical trials. - FY2024-Q2AdvancedAnnual report
「As part of its R&D activities in the pharmaceutical business, the Company obtained marketing approval in September of this year for difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients for which 丸石製薬株式会社, its co-development partner, submitted an application for marketing approval in September last year. The Company is preparing to launch it after inclusion in the National Health Insurance drug price list under the product name Korsuva Injection Syringes for Dialysis 17.5 μg, 25.0 μg and 35.0 μg.」
MR13A9 progressed from the marketing-application stage to the stage of obtaining marketing approval and preparing for launch, representing concrete progress toward early approval. - FY2024-Q1SoftenedAnnual report
「Regarding the spinal and cerebellar degeneration treatment rovatirelin (generic name; development code: KPS-0373), we temporarily withdrew the application for approval in July this year and are considering the feasibility of conducting additional clinical trials.」
The status changed from the application stage toward approval to the stage of withdrawing the application for the time being and considering whether to conduct additional clinical trials. - FY2023-Q3AdvancedAnnual report
「As we obtained marketing approval in December last year for fostamatinib, a treatment for chronic idiopathic thrombocytopenic purpura (generic name; development code: R788) licensed in from Rigel Pharmaceuticals (US), for which we filed a marketing application last April, we are conducting medical information activities under the product name Tavalisse Tablets 100 mg/150 mg, led by the Rare Disease Project, which specializes in marketing in rare disease areas, in preparation for launch after inclusion in the National Health Insurance drug price list.」
R788 progressed from the marketing-application stage to the stage of obtaining marketing approval and preparing for launch, representing concrete progress toward early approval. - FY2023-Q2AdvancedAnnual report
「Regarding R&D in the pharmaceutical business, the Company submitted an application for marketing approval in April of this year for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. In September of this year, 丸石製薬株式会社 submitted an application for marketing approval for difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients that it is co-developing with the Company. The Company also commenced domestic Phase III clinical trials of its originated product linzagolix (generic name; development code: KLH-2109), a treatment for uterine fibroids and endometriosis, for uterine fibroids as the indication.」
R788 and MR13A9 progressed to the marketing-application stage, while linzagolix progressed to the stage of starting a domestic Phase III clinical trial. - FY2023-Q1AdvancedAnnual report
「Regarding R&D in the pharmaceutical business, the Company submitted an application for marketing approval in April of this year for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. It also commenced domestic Phase III clinical trials of linzagolix (generic name; development code: KLH-2109), a Company-originated treatment for uterine fibroids and endometriosis, for uterine fibroids as the indication.」
The filing of a marketing application for R788 and the start of a domestic Phase III clinical trial for linzagolix represented concrete progress toward approval of the late-stage development products. - FY2022AdvancedAnnual report
「The Company submitted an application for marketing approval in December last year for lovotirelin (generic name; development code: KPS-0373), a treatment for spinocerebellar degeneration licensed in from Shionogi & Co.,Ltd., and in April of this year submitted an application for marketing approval for fostamatinib (generic name; development code: R788), a treatment for chronic primary immune thrombocytopenia licensed in from Rigel Pharmaceuticals, Inc. In addition, difelikefalin (generic name; development code: MR13A9), a treatment for pruritus in dialysis patients co-developed with 丸石製薬株式会社, achieved its primary endpoint in domestic Phase III clinical trials.」
KPS-0373 and R788 progressed to the marketing-application stage, while MR13A9 achieved the primary endpoint in its Phase III trial. - FY2022-Q3AdvancedAnnual report
「For troriluzole, a treatment for spinocerebellar degeneration (generic name; development code: KPS-0373), which we licensed in from Shionogi & Co.,Ltd., we filed a marketing application last December. For fostamatinib, a treatment for chronic idiopathic thrombocytopenic purpura (generic name; development code: R788), which we licensed in from Rigel Pharmaceuticals (US), and difelikefalin, a treatment for pruritus in dialysis patients (generic name; development code: MR13A9), which we are co-developing with 丸石製薬株式会社, the primary endpoints were achieved in their respective domestic Phase III clinical trials.」
KPS-0373 progressed to the marketing-application stage, while R788 and MR13A9 achieved the primary endpoints in their respective domestic Phase III clinical trials, representing concrete progress. - FY2022-Q2AdvancedAnnual report
「Regarding R&D activities in the pharmaceutical business, the Company obtained marketing approval in September of this year for avacopan (generic name; development code: CCX168), a treatment for microscopic polyangiitis and granulomatosis with polyangiitis licensed in from Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland), for which it submitted an application for marketing approval in February of this year. The Company is preparing to launch it under the product name Tavneos Capsules 10 mg after its inclusion in the National Health Insurance drug price list. In addition, in May of this year, EAファーマ株式会社 submitted an application for marketing approval for carotegrast methyl (generic name; development code: AJM300), a treatment for ulcerative colitis that it is co-developing with the Company.」
CCX168 progressed to the approval and launch-preparation stage, while AJM300 progressed to the marketing-application stage, representing concrete progress toward approval of the late-stage development products. - FY2022-Q1AdvancedAnnual report
「In May of this year, EAファーマ株式会社 submitted an application for marketing approval for carotegrast methyl (generic name; development code: AJM300), a treatment for ulcerative colitis that it is co-developing with the Company.」
AJM300 progressed to the marketing-application stage, representing concrete progress toward approval of the late-stage development product. - FY2021-Q3AdvancedAnnual report
「CCX168, a treatment for microscopic polyangiitis and granulomatosis with polyangiitis (development code; generic name: avacopan), which was licensed in from Vifor Fresenius Medical Care Renal Pharma Ltd. (Switzerland), has completed Phase III clinical trials, and preparations for submission of a marketing approval application are under way.」
CCX168 progressed from completion of its Phase III clinical trial to the stage of preparing a marketing application, representing concrete progress toward early approval. - FY2021-Q2AdvancedAnnual report
「For MR13A9, a treatment for pruritus in dialysis patients that we are co-developing with 丸石製薬株式会社 (development code; generic name: difelikefalin), we began a domestic Phase III clinical trial. We are also continuing research and development across our programs and seeking to advance them through the development stages.」
MR13A9 progressed to the stage of starting a domestic Phase III clinical trial, representing concrete progress in advancing the development program. - FY2021-Q1RestatedAnnual report
「Regarding R&D in the pharmaceutical business, the Company continues to advance R&D for each project and seeks to progress projects through the development stages. In addition, the Phase III clinical trial of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin), has been completed. The Company is conducting detailed analyses of the results obtained in the trials, including subgroup analyses by severity, while continuing consultations with the regulatory authorities.」
We are continuing research and development across our programs, including post-trial analysis and discussions with the authorities for KPS-0373. - FY2020AdvancedAnnual report
「We have established a research and development pipeline capable of supporting the planned launch of 6 products over the next 5 years, including 4 products particularly in rare disease areas.」
The company states that it has established a research and development pipeline capable of supporting the planned launch of 6 products over the next 5 years, including 4 products in rare disease areas, demonstrating the concrete development platform being built toward approval and launch. - FY2020-Q3AdvancedAnnual report
「For Minirin Melt OD Tablets 25 µg and OD Tablets 50 µg, a treatment for nocturia caused by nocturnal polyuria in men, for which we entered into a co-promotion agreement in Japan with Ferring Pharmaceuticals Co., Ltd., we have been conducting medical information activities since September last year. In addition, we launched in November last year the renal anemia treatment Darbepoetin Alfa BS Injection JCR, co-developed with JCR Pharmaceuticals Co., Ltd.」
JCR Darbepoetin Alfa BS Injection, a follow-on product to JR-131, progressed to launch, representing progress in the post-approval market introduction of the late-stage development product. - FY2020-Q2AdvancedAnnual report
「JR-131, a biosimilar of darbepoetin alfa (generic name), a treatment for renal anemia, was submitted for marketing approval by JCRファーマ株式会社, the Company’s co-development partner, in September last year. Following the grant of marketing approval in September of this year, the Company is preparing to launch it under the product name Darbepoetin Alfa BS Injection JCR after its inclusion in the National Health Insurance drug price list. In addition, the Company entered into an agreement with Rigel Pharmaceuticals, Inc. (U.S.) to acquire exclusive development and commercialization rights in Japan, China, South Korea and Taiwan for R788, a treatment for chronic primary immune thrombocytopenia (development code; generic name: fostamatinib), and has now commenced domestic Phase III clinical trials.」
JR-131 progressed to the stage of preparing for launch following receipt of marketing approval, while R788 progressed to the stage of starting a domestic Phase III clinical trial. - FY2020-Q1AdvancedAnnual report
「JCR Pharmaceuticals Co., Ltd., our co-development partner, filed a marketing application last September for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), and preparations are underway to respond to the review toward obtaining approval. We also entered into an agreement with Rigel Pharmaceuticals (US) to acquire exclusive development and marketing rights in Japan, China, South Korea and Taiwan for R788, a small-molecule tyrosine kinase inhibitor (development code; generic name: fostamatinib), and are preparing to start a domestic Phase III clinical trial.」
JR-131 has progressed to the regulatory review-response stage, while R788 has progressed to the stage of preparing to start a domestic Phase III clinical trial. - FY2019AdvancedAnnual report
「For the additional formulation of the diabetes treatment Gurbece Combination Tablets, an orally disintegrating tablet, we obtained marketing approval in February this year and plan to launch it after its inclusion in the National Health Insurance drug price list.」
The additional Gurbece formulation progressed through additional trials and a new application to receipt of marketing approval. - FY2019-Q3RestatedAnnual report
「In September last year, JCR Pharmaceuticals Co., Ltd., our co-development partner, filed a marketing application for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code). For the additional formulation of the diabetes treatment Gurbece Combination Tablets, an orally disintegrating tablet, for which the application was withdrawn for the time being in June the year before last, we filed a new application after completing additional trials.」
We are reaffirming the status in which a marketing application has been filed for JR-131 and a new application has been filed for the additional Gurbece formulation. - FY2019-Q2AdvancedAnnual report
「In September this year, JCR Pharmaceuticals Co., Ltd., our co-development partner, filed a marketing application for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code). For the additional formulation of the diabetes treatment Gurbece Combination Tablets, an orally disintegrating tablet, for which the application was withdrawn for the time being in June last year, we filed a new application after completing additional trials.」
JR-131 progressed to the marketing-application stage following completion of its Phase III trial, and a new application was filed for the additional Gurbece formulation after completion of additional trials. - FY2019-Q1AdvancedAnnual report
「The Phase III clinical trial for JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), which we are co-developing with JCR Pharmaceuticals Co., Ltd., has been completed, and we are preparing to file a marketing application. We are also continuing research and development across our programs and seeking to advance them through the development stages.」
JR-131 progressed from completion of its Phase III clinical trial to the stage of preparing a marketing application, representing concrete progress toward approval of the late-stage development product. - FY2018AdvancedAnnual report
「For AJM300, a treatment for ulcerative colitis that we are co-developing with EA Pharma Co., Ltd., we began an additional Phase III clinical trial.」
The additional Phase III clinical trial for AJM300 began. For JR-131, we are verifying equivalence to the reference product, representing progress in clinical development. - FY2018-Q3AdvancedAnnual report
「In addition, we launched in December last year the ulcerative colitis treatment Rectable 2 mg rectal foam, 14 doses, which was co-developed with EA Pharma Co., Ltd.」
The co-developed product progressed from approval to launch, representing concrete progress in introducing the late-stage development product to the market. - FY2018-Q2AdvancedAnnual report
「As we obtained marketing approval in September this year for AJG511 (development code; generic name: budesonide), a treatment for ulcerative colitis for which our co-development partner EA Pharma Co., Ltd. filed an application last October, we are preparing to launch it under the product name RECTABUL 2mg rectal foam, 14 doses, after its inclusion in the National Health Insurance drug price list.」
AJG511 received marketing approval and progressed to the stage of preparing for launch after inclusion in the National Health Insurance drug price list. - FY2018-Q1SoftenedAnnual report
「Regarding the additional formulation of Glubes, an orally disintegrating tablet for which an application for approval was filed last July, we temporarily withdrew the application in June this year in connection with the conduct of additional studies.」
For the additional formulation of Gurbece, the application for early approval was withdrawn for the time being, making additional trials necessary. - FY2017RestatedAnnual report
「We will promote market penetration for the new product group by obtaining marketing approvals for late-stage development products early and steadily, while conducting promotion based on detailed market analysis.」
We are reaffirming our policy of pursuing early and reliable approval of late-stage development products and market introduction based on market analysis. - FY2017-Q3RestatedAnnual report
「The Company has commenced Phase III clinical trials of JR-131, a biosimilar of the long-acting erythropoiesis-stimulating agent darbepoetin alfa (generic name; development code), and additional Phase III clinical trials of KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: lovotirelin).」
The Phase III clinical trials for JR-131 and KPS-0373 remain ongoing. - FY2017-Q2AdvancedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: troriluzole), we began an additional Phase III clinical trial during the current consolidated cumulative period.」
KPS-0373 progressed from the decision stage to conduct an additional Phase III clinical trial to the trial-start stage. - FY2017-Q1AdvancedAnnual report
「For KPS-0373, a treatment for spinocerebellar degeneration (development code; generic name: troriluzole), we decided during the current consolidated cumulative period to conduct an additional Phase III clinical trial.」
The decision to conduct an additional Phase III clinical trial for KPS-0373 represents concrete progress in clinical development. - FY2016First statedAnnual report
「We will strengthen our development management structure to secure early and reliable marketing approvals for development programs, optimally allocate management resources, and promote efficient development operations.」
We aim to accelerate and ensure the acquisition of marketing approvals by strengthening the development management structure and optimally allocating management resources.