Pipeline Progress in Clinical Development, Regulatory Approval and Commercialization
First written in FY2016-Q2. 47 of 48 entries say "Advanced", first in FY2016-Q3. Latest entry: 2026-10-23.
7 other companies' latest entry also says "Advanced".
- FY2026-H1AdvancedAnnual report
「EB-1020 centanafadine China attention-deficit/hyperactivity disorder March 2026, Phase II/III trial initiated TSND-201 — metylon United States post-traumatic stress disorder April 2026, Phase III trial initiated ASTX727 INQOVI/INAQOVI decitabine · cedazuridine United States acute myeloid leukemia May 2026, approval obtained Europe acute myeloid leukemia June 2026, approval obtained AB122 + TAS-120 — zimberelimab + futibatinib Japan biliary tract cancer June 2026, Phase III trial initiated AB521 — casdatifan Japan renal cell carcinoma June 2026, Phase III trial initiated ARC-02 — — United States non-Hodgkin lymphoma June 2026, Phase I trial initiated VIS649 VOYXACT sibeprenlimab China IgA nephropathy June 2026, approval obtained ISIS 721744 Dawnzera donidalorsen Europe hereditary angioedema January 2026, approval obtained」
The note covers specific development and regulatory progress, including the initiation of clinical trials for centanafadine, TSND-201, AB122 + TAS-120, AB521 and ARC-02, and approval of ASTX727, VIS649 and donidalorsen. - FY2025AdvancedAnnual report
「VIS649 VOYXACT sibeprenlimab United States IgA nephropathy November 2025, approval obtained」
In addition to US approval of VOYXACT, the note covers specific progress including the submission of approval applications, initiation of clinical trials and commencement of rolling submissions for multiple candidates. - FY2025-H1AdvancedAnnual report
「EB-1020 centanafadine Japan attention-deficit/hyperactivity disorder May 2025, Phase II/III initiated SEP-363856 — ulotaront Japan and United States schizophrenia March 2025, Phase III initiated VIS649 — sibeprenlimab United States IgA nephropathy March 2025, approval application submitted TAS6417 + SCC244 Hetayetan zipalertinib + gumarontinib Japan non-small cell lung cancer June 2025, Phase I initiated」
The note covers specific progress in the initiation of clinical trials and submission of approval applications for centanafadine, ulotaront, sibeprenlimab and the zipalertinib combination therapy, among others. - FY2024AdvancedAnnual report
「Sibeprenlimab met the primary endpoint in an interim analysis of the global Phase III trial for IgA nephropathy.」
The note reports that the primary endpoint was met in an interim analysis of the global Phase III trial of sibeprenlimab/VIS649. JNT-517 was also added to the pipeline through the acquisition of Junana. - FY2024-H1AdvancedAnnual report
「OPC-34712 Rexulti brexpiprazole United States post-traumatic stress disorder in adults April 2024, approval application submitted China schizophrenia June 2024, approval obtained AB122 + AB154 — zimberelimab + domvanalimab Japan non-small cell lung cancer January 2024, Phase III initiated TAS-120 Lytgobi futibatinib United States and Europe solid tumors (esophageal cancer, pancreatic cancer) February 2024, Phase II initiated ASTX030 — azacitidine · cedazuridine United States myelodysplastic syndromes, chronic myeloid leukemia, acute myeloid leukemia April 2024, Phase II/III initiated」
The note covers specific development and regulatory progress, including submission of a US approval application and approval in China for Rexulti, initiation of a Phase III trial in Japan for AB122 + AB154, initiation of Phase II trials in the United States and Europe for Lytgobi, and initiation of a Phase II/III trial for ASTX030. - FY2024-Q1AdvancedAnnual report
「2-month long-acting injectable aripiprazole Abilify Maintena aripiprazole Europe maintenance treatment of schizophrenia March 2024, approval obtained」
Approval was obtained in Europe for the 2-month long-acting injectable aripiprazole formulation. The note also covers the start of a Phase III trial in Japan for AB122 + AB154 and the start of Phase II trials in the United States and Europe for TAS-120. - FY2023AdvancedAnnual report
「Brexpiprazole was approved in the United States as the first antipsychotic indicated for agitation associated with Alzheimer’s disease. The ultrasound renal denervation system was approved in the United States as a renal denervation device, providing a new treatment option for hypertension and representing the first approval of its kind.」
In addition to the US approval of Rexulti for agitation and the US approval of the ultrasound renal denervation system, approvals progressed for the 2-month aripiprazole formulation and Lonsurf combination therapies, among others. - FY2023-Q3AdvancedAnnual report
「ASTX727 INAQOVI decitabine · cedazuridine Europe acute myeloid leukemia September 2023, approval obtained TAS-116 Jesel pimitespib Japan prostate cancer September 2023, Phase II initiated TAS-120 Lytgobi futibatinib Europe cholangiocarcinoma July 2023, approval obtained」
The note covers specific clinical development and regulatory progress, including European approval of ASTX727, initiation in Japan of a Phase II trial of TAS-116, and European approval of TAS-120. - FY2023-Q2AdvancedAnnual report
「United States agitation associated with Alzheimer’s disease May 2023, supplemental approval obtained 2-month long-acting injectable aripiprazole ABILIFY ASIMTUFII United States schizophrenia, bipolar I disorder April 2023, approval obtained TAS-120 Lytgobi futibatinib Japan unresectable biliary tract cancer with FGFR2 fusion-positive genes that has progressed after chemotherapy June 2023, approval obtained」
In addition to the supplemental US approval of Rexulti for agitation, the US approval of the 2-month aripiprazole formulation and the Japanese approval of Lytgobi, clinical trial initiation and approval applications progressed for multiple candidates. - FY2023-Q1AdvancedAnnual report
「<Psychiatry and neurology> OPC-34712 Rexulti brexpiprazole Japan major depressive disorder January 2023, approval application submitted United States agitation associated with Alzheimer’s disease January 2023, approval application submitted <Oncology and cancer supportive care> ASTX660 + ASTX727 United States T-cell lymphoma February 2023, Phase I initiated AP24534 Iclusig China chronic myeloid leukemia, acute lymphoblastic leukemia March 2023, approval application submitted」
The note covers specific development and regulatory progress, including approval applications for Rexulti in Japan and the United States, initiation of a Phase I trial for ASTX660 + ASTX727, and submission in China of an approval application for Iclusig. - FY2022AdvancedAnnual report
「In a clinical trial of an ultrasound renal denervation system being developed for uncontrolled hypertension, the primary endpoint was met and the US FDA accepted the approval application.」
The ultrasound renal denervation system met its primary endpoint, and the US FDA accepted the approval application. There was also progress in approval applications and trials for the 2-month aripiprazole formulation, Rexulti and Lonsurf, among others. - FY2022-Q3AdvancedAnnual report
「<United States> • A Phase II trial was initiated in September 2022 for major depressive disorder. <United States> • Approved in September 2022 for intrahepatic cholangiocarcinoma. <Europe> • Approved in September 2022 for active lupus nephritis.」
Clinical trial initiation and approvals progressed for centanafadine, LYTGOBI and Lupkynis, among others. The note also covers a once-weekly oral formulation trial of Rexulti and the submission in the United States of an approval application for a 2-month aripiprazole formulation. - FY2022-Q2AdvancedAnnual report
「<United States> • A Phase II/III trial was initiated in February 2022 for binge-eating disorder. <Europe> • An approval application was submitted in June 2022 for schizophrenia. <United States and Europe> • Approval applications were submitted in the United States (March 2022) and Europe for cholangiocarcinoma. <Japan> • Approved in March 2022 for chemotherapy-induced nausea and vomiting. <Japan> • Approved in June 2022 for gastrointestinal stromal tumors.」
Specific clinical development and regulatory progress included the start of a Phase II/III trial of centanafadine, submission in Europe of an approval application for a 2-month long-acting injectable formulation of aripiprazole, submission of approval applications for futibatinib in the United States and Europe, and approval in Japan of Arokaris and Jesel, among others. - FY2022-Q1AdvancedAnnual report
「<United States> • A Phase II/III trial was initiated in February 2022 for binge-eating disorder.」
Specific clinical development and regulatory progress included the start of a Phase II/III trial of centanafadine for binge-eating disorder, submission of a US approval application for futibatinib, initiation of a trial for solid tumors, and approval of Arokaris and Samtasu. The note also reports discontinuation of development of Rexulti for borderline personality disorder and the decision to terminate the licensing agreement for vadadustat. - FY2021AdvancedAnnual report
「<Japan> • A Phase III trial was initiated in November 2021 for bipolar I depression.」
Specific development and regulatory progress included the submission in China of an approval application for a long-acting injectable formulation of aripiprazole, approval of Ajovy in Japan, the initiation of Phase II and III trials for multiple candidates, and the submission of approval applications for Lonsurf-related products, among others. Development was also discontinued for TBI-1401 and TBI-1501. - FY2021-Q3AdvancedAnnual report
「“Moizerto” (difamilast) <Japan> • Approved in September 2021 for the treatment of atopic dermatitis.」
The note covers specific development and regulatory progress, including the approval of Moizerto in Japan, the start of a Phase II smoking-cessation trial for EB-1020, the submission of an approval application for TAS-116, and the start of multiple Phase I–III trials and submission of approval applications. It continues to report the discontinuation of development of VIS410. - FY2021-Q2AdvancedAnnual report
「“Ajovy” (fremanezumab (genetically recombinant)) TEV-48125 <Japan> • Approved in June 2021 for the prevention of migraine attacks.」
The note states that Ajovy was approved in Japan in June 2021 for the prevention of migraine attacks. It also covers the initiation of clinical trials for ASTX727, TAS-117, TAS-120 and TAS0953, among others, as well as the submission and acceptance of approval applications for multiple products. - FY2021-Q1AdvancedAnnual report
「<China> Filed for approval in January 2021 for the schizophrenia indication.」
In addition to the Chinese filing for the long-acting injectable formulation of aripiprazole, progress was made in the initiation of clinical trials, regulatory filings, and marketing applications for ASTX727, TAS-120, TAS0953, TAS1553, Pro-NETU, OPC-61815 and vadadustat. Development of VIS410 for influenza A infection was discontinued. - FY2020AdvancedAnnual report
「Long-acting injectable aqueous suspension of Abilify <Japan> An additional indication, prevention of recurrence and relapse of mood episodes in bipolar I disorder, was added in September 2020.」
Specific development and regulatory progress was reported, including the addition of an indication for the long-acting formulation of Abilify in Japan, U.S. approval of ASTX727, and the initiation of clinical trials and regulatory filings for several candidates. Development was discontinued for several products. - FY2020-Q3AdvancedAnnual report
「<U.S.> Approved in July 2020 as a treatment for myelodysplastic syndromes and chronic myelomonocytic leukemia.」
Specific development and regulatory progress was reported, including U.S. approval of ASTX727, a combination trial of ASTX727 and ASTX660, the initiation of clinical trials for TAS-115, TAS-120, TAS1440, VIS649 and other products, regulatory filings for TEV-48125 and OPA-15406, and approval of Enflurane infusion. - FY2020-Q2AdvancedAnnual report
「<Japan> Initiated a Phase 2 trial for major depressive disorder in April 2020. <Japan> An additional approved indication, improvement of hyponatremia associated with syndrome of inappropriate antidiuretic hormone secretion, was added in June 2020.」
Specific development, regulatory and out-licensing progress was reported, including the initiation of a Phase 2 trial for OPC-64005, the addition of an approved indication for Samsca, the initiation of clinical trials for ASTX727, TAS-120 and TAS1440, and the out-licensing of TAS-119. - FY2020-Q1AdvancedAnnual report
「<U.S.> Initiated a Phase 1 trial for epilepsy in February 2020. <Europe> Initiated a Phase 3 trial for acute myeloid leukemia in January 2020. <Japan> An additional indication, preconditioning for autologous hematopoietic stem cell transplantation in malignant lymphoma, was approved in March 2020 based on a public knowledge application.」
Specific development and regulatory progress was reported, including the initiation of clinical trials for OPC-214870 and ASTX727 and the addition of an indication for Busulfex. - FY2019AdvancedAnnual report
「<U.S.> Initiated a Phase 3 trial for post-traumatic stress disorder in October 2019. Initiated a Phase 2 trial for borderline personality disorder in October 2019. <Japan, U.S. and Europe> Received approval for an additional gastric cancer indication in the U.S. in February 2019, Japan in August 2019, and Europe in September 2019.」
Specific development and regulatory progress was reported, including the initiation of a new clinical trial for Rexulti in the U.S., approval of an additional gastric cancer indication for Lonsurf, and a U.S. filing for ASTX727. Development was discontinued and applications were withdrawn for several candidates. - FY2019-Q3AdvancedAnnual report
「<Japan> Filed for approval in September 2019 for the bipolar disorder indication. <Japan, U.S. and Europe> Received approval for an additional gastric cancer indication in the U.S. in February 2019, Japan in August 2019, and Europe in September 2019. <China> Approved in August 2019 as a treatment for colorectal cancer.」
Specific regulatory progress was reported, including the Japanese filing for the long-acting formulation of Abilify, approval of the additional gastric cancer indication for Lonsurf in the U.S., Japan and Europe, and approval of Lonsurf in China. Development of Lu AF20513 was discontinued and the application for TBI-1401 was withdrawn. - FY2019-Q2AdvancedAnnual report
「<China> Initiated a Phase 3 trial for schizophrenia in May 2019.」
Initiated a Phase 3 trial for Rexulti in China in May 2019 for schizophrenia. - FY2019-Q1AdvancedAnnual report
「<U.S.> Initiated a Phase 2/3 trial for negative symptoms of schizophrenia in March 2019.」
Clinical trials were initiated for AVP-786, EB-1020, ASTX727, TAS0313, Pro-NETU, OPC-61815 and other products, while approvals and regulatory filings progressed for Selincro, Lonsurf and diagnostic products. - FY2018AdvancedAnnual report
「<Japan> Approved in January 2018 for the schizophrenia indication. Initiated a Phase 3 trial for adjunctive treatment of major depressive disorder in August 2018. Initiated a Phase 3 trial for agitation associated with Alzheimer's dementia in September 2018.」
Specific development, regulatory and commercialization progress was reported, including Japanese and European approval of Rexulti, the initiation of several Phase 3 trials, a regulatory filing for Lonsurf for gastric cancer, U.S. approval of JINARC, and approval of the live-cell TSH receptor antibody assay. - FY2018-Q3AdvancedAnnual report
「<Japan> Initiated a Phase 3 trial for adjunctive treatment of major depressive disorder in August 2018. Initiated a Phase 3 trial for agitation associated with Alzheimer's dementia in September 2018. <Europe> Approved in July 2018 for the schizophrenia indication.」
Specific development and regulatory progress was reported, including European approval of Rexulti, the initiation of several Phase 3 trials, a regulatory filing for Lonsurf, and the initiation of clinical trials for TAS0313, TAS0728 and other products. Development was discontinued and applications were withdrawn for several candidates. - FY2018-Q2AdvancedAnnual report
「<U.S.> Approved in April 2018 for autosomal dominant polycystic kidney disease (ADPKD).」
Specific development and regulatory progress was reported, including U.S. approval of JINARC for ADPKD, the initiation of clinical trials for TAS-120, TAS0313, TAS0728, ASTX029 and other products, and approval of the live-cell TSH receptor antibody assay, Otsuka. - FY2018-Q1AdvancedAnnual report
「<Japan> Approved in January 2018 for the schizophrenia indication. <U.S.> Initiated a Phase 2 trial for intermittent explosive disorder in February 2018. <U.S.> Initiated a Phase 3 trial for myelodysplastic syndromes in February 2018. <Asia> Approved in Taiwan in March 2018 for autosomal dominant polycystic kidney disease (ADPKD).」
Specific development and regulatory progress was reported, including Japanese approval of Rexulti, the initiation of a Phase 2 trial of AVP-786 for another indication, the initiation of a Phase 3 trial of ASTX727, and approval of Samsca/JINARC in Taiwan. - FY2017AdvancedAnnual report
「<U.S.> Received approval in July 2017 for an additional indication in bipolar disorder.」
Specific development, regulatory and commercialization progress was reported, including U.S. approval of an additional indication for the long-acting formulation of Abilify, a U.S. filing for Samsca in ADPKD, the initiation of trials for Rexulti and other products, and multiple regulatory filings and additional-indication approvals. Development was discontinued for several candidates. - FY2017-Q3AdvancedAnnual report
「<U.S.> Initiated a Phase 2 trial for solid tumors and lymphoma in September 2017.」
Specific development and regulatory progress was reported, including the initiation of new clinical trials, additional-indication approvals, and regulatory filings for ASTX660, HF10, TAS-302 and other products. Development was discontinued for several candidates. - FY2017-Q2AdvancedAnnual report
「<Japan, U.S., Europe and Asia> Initiated a Phase 3 trial for myelodysplastic syndromes in February 2017. <Asia> Filed for approval in May 2017 for the colorectal cancer indication. <Japan> Initiated a Phase 3 trial for syndrome of inappropriate antidiuretic hormone secretion in June 2017.」
Specific development, regulatory and commercialization progress was reported, including the initiation of trials and regulatory filings for SGI-110, Lonsurf and Samsca, additional-indication approvals for Zosyn and other products, and the start of REXULTI commercialization in Canada. Development was discontinued for several candidates. - FY2017-Q1AdvancedAnnual report
「<Japan> Filed for approval in January 2017 for the schizophrenia indication. <Europe> Filed for approval in March 2017 for the schizophrenia indication. <U.S.> Initiated a Phase 1 trial of a long-acting injectable for schizophrenia in February 2017.」
Specific development progress was reported, including regulatory filings for REXULTI in Japan and Europe, the initiation of a Phase 1 trial of a long-acting injectable, the initiation of a Phase 3 trial of SGI-110, and the initiation of trials for TAS-115 and TAS4464. - FY2016AdvancedAnnual report
「Iclusig (ponatinib) <Japan> Approved in September 2016 for chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Commercialization began in November of the same year.」
Numerous specific full-year development and launch milestones were reported, including regulatory approvals and commercialization, additional indications, and the initiation of clinical trials. - FY2016-Q3AdvancedAnnual report
「<Europe> Approved in April 2016 for the colorectal cancer indication.」
Numerous specific developments in clinical development, regulatory approvals and commercialization were reported, including approvals for Lonsurf, Iclusig and VILANOVA, the initiation and continuation of Phase trials for several candidates, and the start of commercialization in Europe. - FY2016-Q2First statedAnnual report
「<U.S.> Approved in January 2016 for the acute migraine indication. Commercialization began in May of the same year.」
Progress in R&D included the approval and commercialization of new products and the initiation of Phase trials for several candidates.