55 completed, 4 recruiting, 3 terminated, 2 active not recruiting. 30 Phase 2, 29 Phase 3, 4 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 30 | Completed 29, Recruiting 1 |
| Phase 3 | 29 | Completed 23, Terminated 3, Active not recruiting 2, Withdrawn 1 |
| Phase 1 | 4 | Completed 4 |
| Phase 4 | 2 | Completed 1, 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 |
|---|---|---|---|---|---|---|
| A Clinical Trial of Olutasidenib in Patients With Acute Myeloid Leukemia Olutasidenib - Relapsed or Refractory IDH1 Mutation-Positive Acute Myeloid Leukemia | Phase 2 | Recruiting | Kissei Pharmaceutical Co., Ltd. | 3 | 2026-06-01 | 2026-05-27 |
| Confirmatory Study 3 of KPS-0373 in Patients With Spinocerebellar Degeneration KPS-0373, Placebo - Spinocerebellar Degeneration | Phase 3 | Active not recruiting | Kissei Pharmaceutical Co., Ltd. | 142 | 2025-08-15 | 2026-09-04 |
| A Clinical Study of KLH-2109 in Patients With Endometriosis KLH-2109, Leuprorelin acetate - Endometriosis | Phase 3 | Active not recruiting | Kissei Pharmaceutical Co., Ltd. | 288 | 2025-06-09 | 2026-03-02 |
| A Late Phase II Clinical Trial of KDT-3594 in Patients With Parkinson's Disease KDT-3594, Placebo - Parkinson Disease | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 178 | 2024-12-16 | 2026-09-10 |
| Avacopan vs Reduced-dose Glucocorticoids in ANCA-associated Vasculitis Avacopan, prednisolone and rituximab, Prednisolone and rituximab - ANCA Associated Vasculitis (AAV) | Phase 4 | Recruiting | Chiba University | 160 | 2024-11-15 | 2025-05-04 |
| Special Drug Use-results Survey for Long-term Use (Fostamatinib) fostamatinib - Chronic Idiopathic Thrombocytopenic Purpura | Recruiting | Kissei Pharmaceutical Co., Ltd. | 149 | 2023-05-29 | 2025-01-03 | |
| An Early Phase 2 Clinical Study of KSP-0243 KSP-0243, Placebo - Colitis, Ulcerative | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 108 | 2023-04-27 | 2025-03-17 |
| A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain KLH-2109, Placebo - Uterine Fibroids (MeSH Heading: Leiomyoma) | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 89 | 2022-10-11 | 2025-11-25 |
| A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia KLH-2109, Leuprorelin - Uterine Fibroids (MeSH Heading: Leiomyoma) | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 287 | 2022-10-11 | 2025-03-14 |
| Special Drug Use-results Survey for Long-term Use（Avacopan） Avacopan - Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA) | Recruiting | Kissei Pharmaceutical Co., Ltd. | 250 | 2022-07-29 | 2025-01-17 | |
| A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease KDT-3594 - Parkinson Disease | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 7 | 2021-05-15 | 2022-05-11 |
| A Phase III Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. MR13A9, Placebo - Uremic Pruritus | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 178 | 2021-01-16 | 2025-09-10 |
| Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Terminated | Kissei Pharmaceutical Co., Ltd. | 30 | 2020-03-23 | 2025-04-02 |
| Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6) 75 mg linzagolix tablet, 200 mg linzagolix tablet, Placebo tablet to match 75 mg linzagolix tablet - Endometriosis | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 356 | 2020-03-05 | 2025-04-02 |
| A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788 R788, Placebo - Idiopathic Thrombocytopenic Purpura | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 34 | 2019-12-24 | 2025-08-11 |
| Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain. 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Completed | Kissei Pharmaceutical Co., Ltd. | 486 | 2019-06-13 | 2025-04-02 |
| A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain 75 mg linzagolix tablet, 200 mg linzagolix tablet, Add-back capsule (E2 1 mg / NETA 0.5 mg) - Endometriosis | Phase 3 | Terminated | Kissei Pharmaceutical Co., Ltd. | 85 | 2019-05-23 | 2025-04-02 |
| A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease. KDT-3594, Pramipexole - Parkinson Disease | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 74 | 2019-02-26 | 2021-02-17 |
| A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus. MR13A9, Placebo - Uremic Pruritus | Phase 2 | Completed | Kissei Pharmaceutical Co., Ltd. | 247 | 2019-02-01 | 2025-12-05 |
| A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis AJM300, Placebo - Colitis, Ulcerative | Phase 3 | Completed | EA Pharma Co., Ltd. | 198 | 2018-06-06 | 2023-07-21 |
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Endometriosis (9) · Spinocerebellar Degenerations (9) · Conjunctival Diseases (8) · Corneal Diseases (8) · Dry Eye Syndromes (8) · Constipation (7) · Hyperphosphatemia (5) · Dysmenorrhea (4) · Dyspareunia (4) · Parkinson Disease (4) · Spinocerebellar Ataxias (4) · Gastrointestinal Diseases (3) · Urinary Bladder, Overactive (3) · Urinary Incontinence, Urge (3) · Anemia (2)
linzagolix (11) · Leuprolide (3) · mitiglinide (3) · ritobegron ethyl (3) · avacopan (2) · fostamatinib (2) · silodosin (2) · AJM300 (1) · Darbepoetin alfa (1) · Dexrazoxane (1) · Insulin (1) · Pramipexole (1) · Prednisolone (1) · Rituximab (1) · Sevelamer (1)
Japan (59) · United States (4) · Austria (2) · Bulgaria (2) · Canada (2) · Czechia (2) · France (2) · Poland (2) · Puerto Rico (2) · Romania (2) · Spain (2) · Ukraine (2) · Hungary (1) · United Kingdom (1)
Yoshitaka Shimizu (8) · Tatsuro Takei (7) · Yasuhiro Omori (6) · Katsumi Hontani (5) · Naomi Koshihara (2) · Nobuo Kanai (2) · Masayoshi Harigai, MD, PhD (1) · Xin Gao, Professor (1) · Yumi Ikezaki (1)
PMID 30056028, PMID 31937586, PMID 40576086, PMID 19054820, PMID 23045170, PMID 33596356, PMID 34061144, PMID 35110332, PMID 35110333, PMID 35366419, PMID 35511180, PMID 36791280, PMID 36927642, PMID 38320524, PMID 38648863, PMID 42077502, PMID 42406777, PMID 9041949