23 completed, 4 terminated, 1 active not recruiting, 1 recruiting. 15 Phase 1, 12 Phase 3, 5 Phase 2, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 13, Recruiting 1, Terminated 1 |
| Phase 3 | 12 | Completed 9, Terminated 3 |
| Phase 2 | 5 | Completed 3, Terminated 2 |
| Phase 4 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| First-in-human Study to Assess the Safety, Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1/DSP-0546LP fH1 2 ug, fH1 8 ug, DSP-0546LP 2.5 ug - Influenza | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 144 | 2024-06-26 | 2026-04-17 |
| Transplantation of Human iPS Cell-derived Dopaminergic Progenitors (CT1-DAP001) for Parkinson's Disease (Phase I/II) Human induced pluripotent stem cell-derived dopaminergic progenitors (CT1-DAP001) - PD - Parkinson's Disease | Phase 1 | Recruiting | University of California, San Diego | 7 | 2024-06-01 | 2026-08-17 |
| A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease DSP-9632P 27.5 mg, DSP-9632P 82.5 mg, Placebo - Levodopa-induced Dyskinesia, Parkinson's Disease | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 7 | 2022-05-31 | 2023-08-09 |
| Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus Imeglimin, Metformin, Vildagliptin - Diabetes Mellitus, Type 2 | Phase 4 | Active not recruiting | National Center for Global Health and Medicine, Japan | 567 | 2022-05-26 | 2026-04-09 |
| A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan SEP-363856 - Schizophrenia | Phase 3 | Terminated | Sumitomo Pharma Co., Ltd. | 68 | 2022-05-16 | 2025-03-19 |
| A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase SEP-363856 50 mg, SEP-363856 75 mg, Placebo - Schizophrenia | Phase 2 / Phase 3 | Terminated | Sumitomo Pharma Co., Ltd. | 83 | 2021-03-29 | 2024-03-15 |
| Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia SEP-363856, Placebo - Schizophrenia | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 13 | 2020-03-31 | 2022-04-12 |
| A Study of DSP-2033 (Alvocidib) in Patients With Acute Myeloid Leukemia Alvocidib, Cytarabine, Mitoxantrone - Acute Myeloid Leukemia | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 10 | 2018-05-15 | 2022-04-12 |
| Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2). SEP-363856 - Schizophrenia | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 24 | 2017-11-29 | 2022-04-12 |
| Special Combination of BBI608 and Pembrolizumab Napabucasin, Pembrolizumab - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Terminated | Takayuki Yoshino | 55 | 2016-10-01 | 2021-09-05 |
| A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas DSP-7888 - Glioblastoma, Diffuse Intrinsic Pontine Glioma | Phase 1 / Phase 2 | Completed | Sumitomo Pharma Co., Ltd. | 18 | 2016-04-01 | 2022-04-12 |
| A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer BBI608, 5-FU, Irinotecan - Metastatic Colorectal Cancer | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 4 | 2015-12-01 | 2022-04-12 |
| Study of DSP-7888 in Patients With Myelodysplastic Syndrome DSP-7888 - Myelodysplastic Syndrome | Phase 1 / Phase 2 | Completed | Sumitomo Pharma Co., Ltd. | 48 | 2015-05-01 | 2022-04-12 |
| A Study of BBI503 in Advanced Solid Tumors, or BBI503/ Sorafenib in Advanced Hepatocellular Carcinoma BBI503, Sorafenib - Advanced Solid Tumors, Hepatocellular Carcinoma | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 60 | 2015-03-01 | 2022-04-12 |
| A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma BBI608, Pemetrexed, Cisplatin - Malignant Pleural Mesothelioma, Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Completed | Sumitomo Pharma Co., Ltd. | 28 | 2015-02-01 | 2022-04-12 |
| A Study of BBI608 Administrated With Sorafenib in Adult Patients With Advanced Hepatocellular Carcinoma BBI608, Sorafenib - Hepatocellular Carcinoma | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 12 | 2015-02-01 | 2022-04-12 |
| Confirmatory Study of DSP-5423P in Patients With Schizophrenia DSP-5423P Placebo, DSP-5423P 40mg, DSP-5423P 80mg - Schizophrenia | Phase 3 | Completed | Sumitomo Pharma Co., Ltd. | 580 | 2014-12-01 | 2022-04-12 |
| Long-term Study of DSP-5423P in Patients With Schizophrenia DSP-5423P - Schizophrenia | Phase 3 | Completed | Sumitomo Pharma Co., Ltd. | 200 | 2014-12-01 | 2022-04-12 |
| A Phase III Study of SM-13496 in Patients With Bipolar I Depression. Placebo, SM-13496 - Bipolar Depression | Phase 3 | Completed | Sumitomo Pharma Co., Ltd. | 525 | 2014-02-19 | 2022-04-12 |
| A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder. SM-13496 - Bipolar I Disorder | Phase 3 | Completed | Sumitomo Pharma Co., Ltd. | 495 | 2014-01-29 | 2022-04-12 |
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Schizophrenia (9) · Carcinoma, Hepatocellular (2) · Colorectal Neoplasms (2) · Leukemia, Myeloid, Acute (2) · Parkinson Disease (2) · Ataxia (1) · Bipolar Disorder (1) · Brain Diseases (1) · Carcinoma, Non-Small-Cell Lung (1) · Central Nervous System Diseases (1) · Diabetes Mellitus, Type 2 (1) · Diabetic Neuropathies (1) · Diffuse Intrinsic Pontine Glioma (1) · Dyskinesias (1) · Glioblastoma (1)
Lurasidone Hydrochloride (5) · SEP-363856 (4) · napabucasin (4) · Sorafenib (2) · Bevacizumab (1) · Cisplatin (1) · Cytarabine (1) · Daunorubicin (1) · Docetaxel (1) · Fluorouracil (1) · Irinotecan (1) · Leucovorin (1) · Metformin (1) · Mitoxantrone (1) · Pemetrexed (1)
Japan (25) · Taiwan (7) · Malaysia (5) · Philippines (4) · South Korea (4) · Russia (3) · Ukraine (3) · China (2) · Lithuania (2) · Slovakia (2) · United States (2) · Belgium (1) · Canada (1)
Drug Development Division (2) · Joseph Ciacci, MD (1) · Kohjiro Ueki, M.D., Ph.D. (1) · Takayuki Yoshino, Dr (1)
PMID 19366965, PMID 28426104, PMID 31883082, PMID 32827348, PMID 32902200, PMID 33321381, PMID 34342746, PMID 34785698, PMID 35689544, PMID 36369028, PMID 36632763, PMID 37188895, PMID 39098761, PMID 39428614, PMID 42176363
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