Risk of Development Candidate Discontinuation and Partnership Termination
First written in FY2016-Q2. 35 of 36 entries say "Materialised", first in FY2016-Q3. Latest entry: 2026-07-31.
Otsuka Holdings moved to the "Worse" side of this theme in 2016, 4 years before the typical company in this theme (2020).
The whole theme swung hardest in 2022: 20 of 40 companies on the "Worse" side.
22 other companies' latest entry also says "Materialised".
- 2026-07-31MaterialisedEarnings
「Development discontinued for strategic reasons」
The company stated that development of OPC-214870, ulotaront, and TAS1553 had been discontinued for strategic reasons. - FY2026-H1MaterialisedAnnual report
「OPC-214870 ― ― United States Epilepsy Development discontinued for strategic reasons SEP-363856 ― Ulotaront United States Major depressive disorder Development discontinued for strategic reasons TAS1553 ― ― United States Acute myeloid leukemia Development discontinued for strategic reasons」
The discontinuation of development of OPC-214870, ulotaront and TAS1553 for strategic reasons has newly been documented, and the discontinuation of candidates continues to occur. - FY2025MaterialisedAnnual report
「EB-1020 Centanafadine United States Major depressive disorder Development discontinued for strategic reasons／SEP-363856 ― Ulotaront Japan and China Schizophrenia Ongoing Phase 2/3 trial discontinued for strategic reasons」
The discontinuation of development of centanafadine, ulotaront and OPC-131461, among others, has newly occurred, and the discontinuation risk for candidates remains evident. - FY2025-H1MaterialisedAnnual report
「EB-1020 Centanafadine United States Major depressive disorder Phase 2 trial discontinued for strategic reasons SEP-363856 ― Ulotaront Japan and China Schizophrenia Ongoing Phase 2/3 trial discontinued for strategic reasons OPC-131461 ― ― Japan Cardiac edema Phase 2 trial discontinued for strategic reasons」
The discontinuation of development of centanafadine, ulotaront and OPC-131461 has newly been documented, and the discontinuation risk for development candidates remains evident. - FY2024MaterialisedAnnual report
「After conducting a detailed analysis and comprehensive review of the results of the Phase 3 trial (Trial 305) for AVP-786, which ended in February 2024, we decided to discontinue development of the drug.」
Following the completion of the Phase 3 trial for AVP-786, development was discontinued and the carrying amount of in-process research and development was reduced to zero. - FY2024-H1MaterialisedAnnual report
「AVP-786 ― Dextromethorphan hydrobromide and quinidine United States and Europe Agitation associated with Alzheimer’s disease Development discontinued for strategic reasons」
Following a comprehensive review of the results of the Phase 3 trial for AVP-786, which ended in February 2024, development was discontinued, newly highlighting the discontinuation risk for the development candidate. - FY2023MaterialisedAnnual report
「AVP-786 ― Dextromethorphan hydrobromide and quinidine United States Negative symptoms of schizophrenia Development discontinued for strategic reasons SEP-4199 ― ― Japan and United States Bipolar I disorder depression Trial discontinued due to substantial delays in recruitment progress ASTX660 ― tolinapant United States Solid tumors, lymphoma Development discontinued for strategic reasons」
The discontinuation of development or trials has newly been confirmed for AVP-786, SEP-4199, ASTX660, TAS3681 and OPB-171775, among others, making the discontinuation risk for development candidates evident. - FY2023-Q3MaterialisedAnnual report
「SEP-4199 ― ― Japan and United States Bipolar I disorder depression Trial discontinued due to substantial delays in recruitment progress ASTX660 ― tolinapant United States Solid tumors, lymphoma Development discontinued for strategic reasons TAS3681 ― ― United States and Europe Prostate cancer Development discontinued for strategic reasons」
Discontinuation of development candidates has newly occurred, including the discontinuation of the SEP-4199 trial and the discontinuation of development of ASTX660 and TAS3681. - FY2023-Q2MaterialisedAnnual report
「Rexulti Brexpiprazole Europe Major depressive disorder Development discontinued for business strategy reasons Agitation associated with Alzheimer’s disease Development discontinued for business strategy reasons」
In addition to the discontinuation of development of Rexulti for major depressive disorder and agitation associated with Alzheimer’s disease in Europe, the discontinuation of development of AVP-786 and OPB-171775 has also been documented. - FY2023-Q1MaterialisedAnnual report
「AVP-786 ― Dextromethorphan hydrobromide and quinidine United States Negative symptoms of schizophrenia Development discontinued for strategic reasons OPB-171775 ― ― Japan Solid tumors Development discontinued for strategic reasons」
The discontinuation of development for AVP-786 in negative symptoms of schizophrenia and OPB-171775 in solid tumors has been newly documented, and the discontinuation risk for development candidates remains evident. - FY2022MaterialisedAnnual report
「<United States> • For strategic reasons, development for intermittent explosive disorder and traumatic brain injury was discontinued.」
Development was discontinued for Rexulti, AVP-786, centanafadine, OPC-64005 and TAS-114, among others, and the TBI-1301 project was returned to the partner. - FY2022-Q3MaterialisedAnnual report
「• For strategic reasons, development for smoking cessation was discontinued. <United States> • For strategic reasons, development for intermittent explosive disorder and traumatic brain injury was discontinued. <Japan> • For strategic reasons, development for major depressive disorder was discontinued. On 13 May 2022, a decision was made to terminate the global licensing agreement with Akebia Therapeutics, Inc.」
In addition to the discontinuation of development of centanafadine, AVP-786 and OPC-64005, among others, the note reports the decision to terminate the global licensing agreement for vadadustat. - FY2022-Q2MaterialisedAnnual report
「<United States> • For strategic reasons, development for intermittent explosive disorder was discontinued.」
The note reports the new discontinuation of development of AVP-786 for intermittent explosive disorder. It also reports the decision to terminate the global licensing agreement for vadadustat with Akebia Therapeutics. - FY2022-Q1MaterialisedAnnual report
「“Rexulti” (brexpiprazole) OPC-34712 <United States> • For strategic reasons, development for borderline personality disorder was discontinued.」
The actual discontinuation of development of Rexulti for borderline personality disorder occurred. The note also states that a decision was made to terminate the global licensing agreement for vadadustat with Akebia Therapeutics. - FY2021MaterialisedAnnual report
「<Japan> • Development for pancreatic cancer was discontinued following termination of the agreement.」
The actual discontinuation of development of TBI-1401 and TBI-1501 occurred following termination of the agreement. The discontinuation of VIS410 development continues to be reported. - FY2021-Q1MaterialisedAnnual report
「VIS410 <United States> • For strategic reasons, development for influenza A infection was discontinued.」
The note reports the new discontinuation of development of VIS410 for strategic reasons. - FY2020MaterialisedAnnual report
「<Japan, United States and Europe> • Following a comprehensive assessment of the Phase III trial results for acute myeloid leukemia and myelodysplastic syndromes, development was discontinued for all target diseases.」
In addition to the discontinuation of guadecitabine development for all target diseases, development was discontinued for Rexulti, OPC-64005, TAS-118, OPS-2071 and C13-CAC, among others. - FY2020-Q3MaterialisedAnnual report
「<Japan, United States and Europe> • Following a comprehensive assessment of the Phase III trial results for acute myeloid leukemia and myelodysplastic syndromes, development was discontinued for all target diseases.」
Development of guadecitabine was discontinued for all target diseases. The note also reports the discontinuation of certain indications and development candidates for Rexulti, OPC-64005, TAS-118, OPS-2071 and C13-CAC, among others. - FY2020-Q2MaterialisedAnnual report
「<Japan> • For strategic reasons, development for gastric cancer was discontinued.」
The actual discontinuation of development occurred for certain Rexulti indications, OPC-64005 for attention-deficit/hyperactivity disorder, TAS-118, OPS-2071 and C13-CAC, among others. - FY2020-Q1MaterialisedAnnual report
「<United States and Europe> • For strategic reasons, development for bipolar I disorder was discontinued. <China> • For strategic reasons, development for major depressive disorder was discontinued.」
The note reports the actual discontinuation of development of Rexulti for bipolar I disorder in the United States and Europe and for major depressive disorder in China. - FY2019MaterialisedAnnual report
「<Europe> • Development by the company was discontinued for strategic reasons. <Japan> • Takara Bio withdrew its approval application for melanoma in September 2019. <Japan, United States and Europe> • Development was discontinued for strategic reasons.」
The note reports the actual discontinuation of development or withdrawal of approval applications for Lu AF20513, TBI-1401 and TAS4464, among others. - FY2019-Q3MaterialisedAnnual report
「<Europe> • Development by the company was discontinued as part of its development strategy. <Japan> • Takara Bio withdrew its approval application for melanoma in September 2019.」
The note reports the actual discontinuation of development of Lu AF20513 and the withdrawal of the approval application for TBI-1401. - FY2019-Q1MaterialisedAnnual report
「<Europe> • Development by the company was discontinued as part of its development strategy.」
The actual discontinuation of development of Lu AF20513 occurred for strategic reasons. - FY2018MaterialisedAnnual report
「<Japan> • Following discussions with the regulatory authorities, the approval application for adjunctive treatment of major depressive disorder was withdrawn. <United States> • As part of its development strategy, development for dyskinesia associated with Parkinson’s disease was discontinued.」
The note reports the withdrawal of the approval application for ASC-01 and the actual discontinuation of development for AVP-923, AVP-786, TAS-121, OCV-C02 and OCV-501, among others. - FY2018-Q3MaterialisedAnnual report
「<Japan> • Following discussions with the regulatory authorities, the approval application for adjunctive treatment of major depressive disorder was withdrawn. <United States> • As part of its development strategy, development for dyskinesia associated with Parkinson’s disease was discontinued.」
The withdrawal of the approval application for ASC-01 and the actual discontinuation of development for ASC-01, AVP-923, TAS-121, OCV-C02 and OCV-501, among others, occurred. - FY2018-Q2MaterialisedAnnual report
「<Japan> • Development was discontinued as part of the development strategy.」
The note reports the actual discontinuation of development for TAS-121 and OCV-C02. - FY2018-Q1MaterialisedAnnual report
「<United States> • As part of its development strategy, development for disinhibition associated with neurodegenerative disease was discontinued.」
The note reports the actual discontinuation of development of AVP-786 for disinhibition associated with neurodegenerative disease. Meanwhile, a Phase II trial has been initiated for intermittent explosive disorder. - FY2017MaterialisedAnnual report
「After a comprehensive assessment of the Phase III trial results, development for Alzheimer’s disease was discontinued.」
The actual discontinuation of development for Abilify, Abilify long-acting formulations, Lu AE58054, SGI-110, TAS-118 and SATIVEX, among others, has occurred based on trial results and development strategy. - FY2017-Q3MaterialisedAnnual report
「<United States and Europe> • After a comprehensive assessment of the Phase II trial results, development for hepatocellular carcinoma was discontinued.」
The note reports the actual discontinuation of development for SGI-110, TAS-118, SATIVEX, AT13387, AT7519, OPB-111001 and OPC-12759, among others, based on trial results and development strategy. - FY2017-Q2MaterialisedAnnual report
「After a comprehensive assessment of the Phase III trial results, development for Alzheimer’s disease was discontinued.」
The note reports the actual discontinuation of development for Lu AE58054, Abilify-related programs, SGI-110, TAS-118 and SATIVEX, among others, based on trial results and development strategy. - FY2017-Q1MaterialisedAnnual report
「“Abilify” • As part of its development strategy, development for agitation associated with Alzheimer’s disease was discontinued.」
The note reports the actual discontinuation of development for Abilify, Abilify long-acting intramuscular injection, Lu AE58054, SGI-110 and SATIVEX, among others. - FY2016MaterialisedAnnual report
「Because the primary endpoint was not met in the Phase III trial of the development code Lu AE58054 (generic name: idalopirdine), which Otsuka Pharmaceutical Co., Ltd. was co-developing with H. Lundbeck A/S, its carrying amount of ¥14,305 million was written down to a recoverable amount of zero.」
In addition to the discontinuation of development and termination of partnerships for multiple candidates, the Phase III trial of Lu AE58054 failed, resulting in the recognition of a related impairment loss. - FY2016-Q3MaterialisedAnnual report
「Development was discontinued because sufficient efficacy to continue development could not be confirmed from the Phase II trial results in major depressive disorder.」
The note reports the discontinuation of development of AVP-786, S-1, OPC-108459, OPC-6535 and OPA-6566, as well as the termination of the co-development and commercialization agreement for ACU-4429. - FY2016-Q2First statedAnnual report
「Development was discontinued because the Phase I trial results did not provide sufficient scientific evidence to support moving into Phase II.」
The note reports the discontinuation of development of OPC-108459 and ACU-4429 and the termination of the co-development and commercialization agreement for OPC-6535.