In-Licensing Promising New Drug Candidate Compounds and Accelerating Clinical Trials
First written in FY2016. 38 of 39 entries say "Advanced", first in FY2017-Q1. Latest entry: 2026-07-31.
1 other company's latest entry also says "Advanced".
- 2026-07-31AdvancedEarnings
「In July 2026, we began a domestic Phase II study of DCC-3014, which is being developed for tenosynovial giant cell tumor.」
The domestic clinical development of DCC-3014 advanced to Phase II. - FY2026AdvancedAnnual report
「In February this year, we began an international Phase III trial in polycythemia vera for the TMPRSS6 gene-expression inhibitor ONO-0530/sapablursen.」
For Sapablursen, which was in-licensed from Ionis Pharmaceuticals, an international Phase III trial has begun, advancing the clinical development of the in-licensed candidate to a late stage. - FY2026-H1AdvancedAnnual report
「In August this year, we began a Phase III trial in the United States in relapsed or refractory primary central nervous system lymphoma for the BTK inhibitor Belexibr (ONO-4059). In August this year, we began a Phase I trial in the United States in renal cell carcinoma, urothelial cancer and castration-resistant prostate cancer for the GCN2 activator DCC-2812.」
We began a Phase III trial in the United States for Belexibr and a Phase I trial in the United States for DCC-2812, marking concrete progress in efforts to advance the clinical development of candidate compounds. - FY2025AdvancedAnnual report
「In March this year, we entered into a license agreement with Ionis Pharmaceuticals for Sapablursen, which is currently in a Phase II trial as a treatment for polycythemia vera, and acquired exclusive worldwide rights to develop and commercialize it.」
We acquired exclusive worldwide development and commercialization rights from Ionis Pharmaceuticals for Phase II-stage Sapablursen, advancing the in-licensing of external candidates and the acceleration of clinical development. - FY2025-H1AdvancedAnnual report
「In September this year, we began a Phase I trial in healthy adults in Japan for the PD-1/CD19 bispecific antibody ONO-4915. In July this year, the marketing authorization application for the CSF-1R inhibitor DCC-3014/Vimseltinib in tenosynovial giant cell tumor was accepted in Europe. In August this year, the marketing authorization application for DCC-3014/Vimseltinib in tenosynovial giant cell tumor was accepted for priority review in the United States.」
In addition to beginning a domestic Phase I trial for ONO-4915, marketing authorization applications for DCC-3014/Vimseltinib, originally developed by Deciphera, were accepted in Europe and the United States, marking progress in clinical development and regulatory filings. - FY2024AdvancedAnnual report
「• In March this year, we began a domestic Phase I/II trial in solid tumors for the anti-CCR8 antibody ONO-7427.」
A domestic Phase I/II trial has begun for ONO-7427, expanding the indications and modality covered by clinical development. - FY2024-Q3AdvancedAnnual report
「As of 24 January 2024 ※2: We started a Phase I study in Japan of the subcutaneous formulation ONO-4538HSC (a combination product of nivolumab and berahyaluronidase alfa) of ONO-4538 in patients with “solid tumors.” ※3: We started a Phase I study in the United States of the iPS cell-derived HER2 CAR-T cell therapy “ONO-8250” in patients with “HER2-positive solid tumors.”」
Phase I trials have begun in Japan and overseas for ONO-4538HSC and ONO-8250, broadening the indications and modalities covered by clinical development. - FY2024-Q2AdvancedAnnual report
「For combination therapy with ONO-4578 and Opdivo, we began Phase II trials in gastric cancer in Japan in August this year and in South Korea and Taiwan in October this year. In August this year, we began a domestic Phase I trial in pancreatic cancer for combination therapy with the Axl/Mer inhibitor ONO-7475 and Opdivo. In June this year, we began a domestic Phase II trial in chemotherapy-induced peripheral neuropathy for the Schwann cell differentiation-promoting agent ONO-2910. In July this year, we began a Phase II trial in the United States in multiple system atrophy for the S1P5 receptor agonist ONO-2808.」
Phase I–II trials have begun in Japan and overseas for multiple candidate compounds and combination therapies, expanding the diseases and regions covered by clinical development. - FY2024-Q1AdvancedAnnual report
「Note 4: We began a domestic Phase II trial in chemotherapy-induced peripheral neuropathy for the Schwann cell differentiation-promoting agent ONO-2910. Note 5: We began a Phase II trial in the United States in multiple system atrophy for the S1P5 receptor agonist ONO-2808.」
New Phase II trials have begun for ONO-2910 in Japan and ONO-2808 in the United States, expanding the indications and regions covered by clinical development. - FY2023-Q3AdvancedAnnual report
「Note 1: The FXIa inhibitor ONO-7684 began a Phase I trial in healthy adults in Japan. Note 2: The endocannabinoid modulator ONO-1110 began a Phase I trial in healthy adults in Japan.」
Phase I trials have begun in Japan in healthy adults for 2 new candidate compounds, marking concrete progress in their clinical development. - FY2023-Q2AdvancedAnnual report
「In August this year, we began a Phase I trial in non-Hodgkin lymphoma and chronic lymphocytic leukemia in the United States for the MALT1 inhibitor ONO-7018. In April this year, we began a domestic Phase III trial in pemphigus for Belexibr tablets.」
We began a Phase I trial in the United States for ONO-7018 and a domestic Phase III trial for Belexibr tablets, marking concrete progress in the clinical development of the candidate compounds. - FY2023-Q1AdvancedAnnual report
「※2: We started a Phase I study in the United States of the epigenetic regulator “ONO-2020” in patients with “neurodegenerative diseases.”」
A Phase I trial has begun for ONO-2020 in the United States, marking concrete progress in efforts to advance the clinical development of the candidate compound. - FY2022AdvancedAnnual report
「In February this year, we had been conducting a Phase III trial in bladder cancer in Japan, South Korea and Taiwan for combination therapy with Opdivo and the IDO1 inhibitor ONO-7701, but discontinued development for strategic reasons. In April this year, we had been conducting a domestic Phase I trial in solid tumors for combination therapy with Opdivo and the PEGylated IL-2 ONO-7911, but discontinued development for strategic reasons.」
While the regions and stages covered by clinical development are expanding, development has also been discontinued for multiple combination therapies, indicating ongoing candidate selection. - FY2022-Q3AdvancedAnnual report
「Note 8: We began a Phase III trial for ONO-2017, a voltage-gated sodium current inhibitor/GABAA ion-channel function enhancer, in generalized tonic-clonic seizures. / Note 9: We are conducting a Phase III trial for ONO-2017 in focal seizures.」
ONO-2017, an in-licensed product, has advanced to the start and conduct of Phase III trials in 2 epilepsy indications, marking concrete progress in the clinical development of the candidate compound. - FY2022-Q2AdvancedAnnual report
「In April this year, we began a domestic Phase I trial in pancreatic cancer and colorectal cancer for combination therapy with Opdivo and ONO-7913. In April this year, we began a domestic Phase I trial in myelodysplastic syndromes for ONO-7913. In August this year, we began a domestic Phase I trial in solid tumors for combination therapy with Opdivo and ONO-7119. In July this year, we began a domestic Phase I trial in hormone receptor-positive, HER2-negative breast cancer for ONO-4578.」
Phase I trials have begun for ONO-7913, ONO-7119, ONO-4578 and other compounds across multiple indications and combination therapies, expanding the scope of clinical development. - FY2022-Q1AdvancedAnnual report
「Note 4: We began a Phase I trial in Japan in pancreatic cancer and colorectal cancer for combination therapy with Opdivo and ONO-7913. / Note 5: We began a Phase II trial in the United States in primary central nervous system lymphoma for ONO-4059. / Note 6: We began a Phase I trial in Japan in non-small cell lung cancer for ONO-7475. / Note 7: We began a Phase I trial in Japan in myelodysplastic syndromes for ONO-7913.」
New clinical trials have begun for the Opdivo combination therapy, ONO-4059, ONO-7475 and ONO-7913, marking concrete progress in efforts to advance the clinical development of candidate compounds. - FY2021AdvancedAnnual report
「In November last year, we began a domestic Phase III trial in COVID-19 for Foipan tablets. In April this year, we began a domestic Phase II trial in diabetic peripheral neuropathy for ONO-2910. In March this year, we submitted a marketing authorization application in Japan for an indication covering adjuvant therapy after surgery for urothelial cancer.」
Multiple candidate compounds have advanced through the clinical trial stages, and marketing authorization applications have been submitted for new indications, including for Opdivo, marking concrete progress in clinical development. - FY2021-Q3AdvancedAnnual report
「Note 4: We began Phase II trials in biliary tract cancer in Japan, South Korea and Taiwan for Opdivo. / Note 5: We began separate domestic Phase I trials in colorectal cancer, pancreatic cancer and non-small cell lung cancer for the prostaglandin receptor (EP4) antagonist ONO-4578. / Note 6: We began a domestic Phase II trial in thyroid cancer for combination therapy with the BRAF inhibitor Braftovi capsules and the MEK inhibitor Mektovi tablets.」
Clinical trials have begun for new indications and combination therapies involving Opdivo, ONO-4578, and Braftovi/Mektovi. - FY2021-Q2AdvancedAnnual report
「In June this year, we began a domestic Phase I trial in pancreatic cancer for the cancer metabolism inhibitor ONO-7912 (CPI-613)/Devimistat. In June this year, we began a domestic Phase I trial in healthy adult men for the Schwann cell differentiation-promoting agent ONO-2910. In June this year, we began a domestic Phase I trial related to COVID-19 for the protease inhibitor Foipan tablets.」
New Phase I trials have begun for ONO-7912, ONO-2910 and Foipan tablets, marking progress in the clinical development of multiple candidate compounds. - FY2021-Q1AdvancedAnnual report
「Note 2: We began Phase III trials in prostate cancer in Japan, South Korea and Taiwan for Opdivo. / Note 3: We began a domestic Phase I trial in pancreatic cancer for the cancer metabolism inhibitor ONO-7912. / Note 6: We began a Phase I trial in healthy adult men for the Schwann cell differentiation-promoting agent ONO-2910.」
The document reports the start of Phase I or Phase III clinical trials for multiple candidate compounds and indications, indicating concrete progress in efforts to advance the clinical development of candidate compounds. - FY2020AdvancedAnnual report
「In March this year, we began a domestic Phase I trial in solid tumors for the anti-CD47 antibody ONO-7913. In February this year, we began a domestic Phase III trial in microsatellite instability-high (MSI-H) colorectal cancer for combination therapy with Yervoy.」
Clinical trials have begun for multiple candidate compounds and combination therapies, marking concrete progress in efforts to accelerate the in-licensing and development of candidate compounds. - FY2020-Q3AdvancedAnnual report
「We began a Phase II trial in biliary tract cancer for Opdivo. / The S1P5 receptor agonist ONO-2808 has entered a Phase I trial in healthy adults. / In South Korea, we began a Phase III trial in pancreatic cancer and acute myeloid leukemia for the cancer metabolism inhibitor ONO-7912 (CPI-613)/Devimistat.」
The document reports the start of clinical trials for multiple candidate compounds in new indications and regions, indicating concrete progress in efforts to in-license and clinically develop candidate compounds. - FY2020-Q2AdvancedAnnual report
「• In September this year, we began a Phase III trial in hepatocellular carcinoma in Japan, South Korea and Taiwan for combination therapy with Yervoy. • In June this year, we began a domestic Phase I/II trial in solid tumors for combination therapy with a liposomal formulation of Halaven, together with Eisai Co.,Ltd.」
We began a Phase III trial in hepatocellular carcinoma for an Opdivo combination therapy and a Phase I/II trial in solid tumors for combination therapy with a liposomal formulation of Halaven, marking progress in clinical development. - FY2020-Q1AdvancedAnnual report
「The PD-1×CD3 bispecific antibody ONO-4685 has entered a Phase I trial in autoimmune diseases.」
A Phase I trial in autoimmune diseases has begun for the PD-1×CD3 bispecific antibody ONO-4685, marking concrete progress in the clinical development of the candidate compound. - FY2019AdvancedAnnual report
「In January this year, we began a domestic Phase III trial in bladder cancer for combination therapy with the IDO1 inhibitor ONO-7701. In August last year, we began a domestic Phase I trial in advanced or metastatic solid tumors for combination therapy with the Axl/Mer inhibitor ONO-7475. In October last year, we began a domestic Phase I trial in solid tumors for combination therapy with the PEGylated interleukin-2 ONO-7911.」
The document reports the start of Phase I to Phase III clinical trials for multiple Opdivo combination therapies and candidate compounds, indicating an expansion in the scope and stages of clinical development. - FY2019-Q3AdvancedAnnual report
「Note 4: We began a Phase III trial in bladder cancer for combination therapy with the IDO1 inhibitor ONO-7701 and Opdivo.」
The document reports concrete clinical development progress: a Phase III trial has begun in bladder cancer for combination therapy with ONO-7701 and Opdivo. - FY2019-Q2AdvancedAnnual report
「In June of this year, the XPO1 inhibitor ONO-7705 began a Phase I trial in multiple myeloma and non-Hodgkin lymphoma. In July, Opdivo and the anti-CSF-1R antibody ONO-4687 (BMS-986227)/cabiralizumab began a Phase II trial in pancreatic cancer. In August, development of the combination of Opdivo and the anti-CCR4 antibody mogamulizumab in solid tumors was discontinued because it failed to demonstrate the expected efficacy, although a Phase I trial had been conducted. In October, the combination of Opdivo and the PEGylated interleukin-2 product NKTR-214 (BMS-986321) began a Phase I trial in solid tumors.」
Phase I to II trials were initiated for the XPO1 inhibitor and Opdivo combination therapies, among others, advancing the clinical development of multiple candidate compounds and combination therapies. - FY2019-Q1AdvancedAnnual report
「Changes from the results announcement for the fiscal year ended March 2018 Note 2: Opdivo and the anti-CSF-1R antibody ONO-4687 (BMS-986227)/cabiralizumab began a Phase II trial in pancreatic cancer. Note 3: The XPO1 inhibitor ONO-7705 began a Phase I trial in multiple myeloma and non-Hodgkin lymphoma.」
The initiation of development of new combinations and indications for Opdivo and other products, together with the start of clinical trials for ONO-7705, is giving concrete shape to efforts to advance clinical development of candidate compounds. - FY2018AdvancedAnnual report
「In March of this year, Opdivo began a Phase II/III trial in colorectal cancer. Overseas, Bristol Myers Squibb obtained U.S. approval for the combination of Opdivo and Yervoy and obtained approvals for multiple additional indications in Taiwan and Korea.」
The initiation of a new clinical trial for Opdivo and approvals for combination therapies and multiple indications in Japan and overseas mark continued progress toward clinical development and commercialization. - FY2018-Q3AdvancedAnnual report
「Note 4: The IDO1 inhibitor ONO－7701 began a Phase III trial in malignant melanoma in combination with Opdivo. / Note 5: The anti-LAG-3 antibody ONO－4482 began a Phase I/II trial in malignant melanoma in combination with Opdivo. / Note 8: Onoact intravenous infusion began a Phase II/III trial for tachyarrhythmia associated with sepsis. / Note 9: The BTK inhibitor ONO-4059 began a Phase I trial in healthy adults.」
Multiple new clinical trial initiations for combination therapies and indications have been reported, representing tangible progress in the initiative to advance clinical development of candidate compounds. - FY2018-Q2AdvancedAnnual report
「In May of this year, Opdivo began a Phase I/II trial in sepsis. In June, Opdivo began a Phase II trial in multiple myeloma. In October, Opdivo began a Phase Ib trial in combination with Lenvima in hepatocellular carcinoma together with Eisai Co.,Ltd.」
Clinical development of the candidate compounds is advancing across multiple areas, including the initiation of trials for Opdivo in sepsis, multiple myeloma and hepatocellular carcinoma. - FY2018-Q1AdvancedAnnual report
「Opdivo began a Phase II trial in multiple myeloma. Opdivo began a Phase I/II trial in sepsis. Orencia subcutaneous injection began a Phase III trial in polymyositis and dermatomyositis.」
The initiation of clinical trials in multiple myeloma and sepsis for Opdivo and in polymyositis and dermatomyositis for subcutaneous Orencia represents tangible progress. - FY2017AdvancedAnnual report
「In January of this year, the prostaglandin receptor (EP4) antagonist ONO-4578 began a Phase I trial in solid tumors. In January, Opdivo began a Phase III trial in ovarian cancer. In March, Opdivo began a Phase III trial in combination with standard chemotherapy in non-small cell lung cancer.」
Additional clinical trial initiations for Opdivo in ovarian cancer and in combination therapy for non-small cell lung cancer, as well as for ONO-4578, indicate progress in clinical development within the pipeline. - FY2017-Q3AdvancedAnnual report
「Opdivo intravenous infusion began a Phase III trial in ovarian cancer. Opdivo intravenous infusion began a Phase I trial in sepsis. The prostaglandin receptor (EP4) antagonist ONO-4578 began a Phase I trial in solid tumors.」
The initiation of clinical trials in ovarian cancer and sepsis for Opdivo and in solid tumors for ONO-4578 indicates progress in the clinical stage of the development pipeline. - FY2017-Q2AdvancedAnnual report
「In August of this year, Opdivo began a Phase III trial in gastroesophageal junction cancer and esophageal cancer. In September, Opdivo began a Phase III trial in combination with Yervoy in head and neck cancer. In October, the ghrelin-receptor agonist ONO-7643/anamorelin began a Phase III trial in cancer cachexia.」
The initiation of Phase III trials for multiple Opdivo indications and anamorelin represents tangible progress in clinical development. - FY2017-Q1AdvancedAnnual report
「Opdivo intravenous infusion began a Phase III trial in multiple myeloma. Opdivo intravenous infusion began a Phase III trial in gastroesophageal junction cancer and esophageal cancer.」
The initiation of Phase III trials in multiple myeloma and gastroesophageal junction cancer and esophageal cancer represents a clinical development milestone for Opdivo. - FY2016First statedAnnual report
「We will continue to focus on acquiring new drug candidates with high strategic value or targeting diseases with significant unmet medical needs, thereby pursuing continued new drug launches. We are also working to accelerate clinical trials.」
In addition to internally discovering candidates, the company is using in-licensing and the acceleration of clinical trials to support continued product launches.