5 completed, 2 recruiting, 1 terminated. 4 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 2, Recruiting 1, Terminated 1 |
| Phase 2 | 4 | Completed 3, 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 |
|---|---|---|---|---|---|---|
| Clofutriben Pharmacokinetics in Patients With Impaired Renal Function 12mg clofutriben - Moderate Renal Impairment | Phase 1 | Recruiting | Sparrow Pharmaceuticals | 16 | 2025-11-30 | 2025-12-23 |
| Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D) clofutriben, Placebo - Type 2 Diabetes, Cortisol Excess | Phase 2 | Recruiting | Sparrow Pharmaceuticals | 1500 | 2025-11-29 | 2026-10-06 |
| Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone midazolam, clofutriben once daily for 16 days, 2 single oral doses of prednisolone - Healthy Participants | Phase 1 | Completed | Sparrow Pharmaceuticals | 16 | 2025-10-03 | 2026-07-08 |
| SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor SPI-62 dose - Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome | Phase 2 | Completed | Sparrow Pharmaceuticals | 30 | 2023-07-01 | 2026-02-13 |
| SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing's Syndrome SPI-62, Placebo - Cushing's Syndrome I, Cushing Disease Due to Increased ACTH Secretion | Phase 2 | Completed | Sparrow Pharmaceuticals | 26 | 2022-09-01 | 2025-10-08 |
| A Trial of Prednisolone in Combination With SPI-62 or Placebo in Subjects With Polymyalgia Rheumatica (PMR) SPI-62, SPI-62 matched placebo, Prednisolone 10mg - Polymyalgia Rheumatica | Phase 2 | Completed | Sparrow Pharmaceuticals | 66 | 2022-07-22 | 2025-05-11 |
| A Trial of Prednisolone in Combination With SPI-62 in Participants With Polymyalgia Rheumatica (PMR) Prednisolone, SPI-62 - Polymyalgia Rheumatica | Phase 1 | Terminated | Sparrow Pharmaceuticals | 1 | 2022-02-22 | 2025-05-16 |
| A Study to Assess 11 Beta-hydroxysteroid Dehydrogenase Type 1 Inhibition in Adipose Tissue by SPI-62 SPI-62, Cortisone-d8 - Type 2 Diabetes Mellitus in Obese, Obesity | Phase 1 | Completed | Sparrow Pharmaceuticals | 12 | 2021-07-23 | 2024-04-22 |
ACTH Syndrome, Ectopic (2) · Cushing Syndrome (2) · Polymyalgia Rheumatica (2) · Acth-Independent Macronodular Adrenal Hyperplasia (1) · Diabetes Mellitus, Type 2 (1) · Obesity (1) · Pituitary ACTH Hypersecretion (1)
Prednisolone (2) · ASP3662 (1) · Anti-Inflammatory Agents (1) · Glucocorticoids (1) · Midazolam (1)
United States (6) · Germany (2) · Romania (2) · Bulgaria (1) · Poland (1) · United Kingdom (1)
David Katz (2) · Frank Czerwiec, MD (2) · David Katz, PhD (1)