Drugs / clofutriben
clofutriben
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT07227922 | Nov 2025 → Apr 2026 overdue | — | Sparrow Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07226635 | Oct → Dec 2025 | — | Sparrow Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT06281236 | Feb 2022 → Mar 2025 | polymyalgia rheumatica | Sparrow Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT05409027 | Jul 2021 → Mar 2022 | obesity disorder, type 2 diabetes mellitus | Sparrow Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02194491 | Apr 2014 → May 2016 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07296484 | Nov 2025 → Dec 2027 expected | Cushing syndrome, type 2 diabetes mellitus | Sparrow Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT05436639 | Jul 2023 → Dec 2024 | ACTH-independent adrenal Cushing syndrome, somatic | Sparrow Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT05307328 | Sep 2022 → Aug 2025 | ACTH-dependent Cushing syndrome, ectopic ACTH secretion syndrome | Sparrow Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT05436652 | Jul 2022 → Apr 2025 | polymyalgia rheumatica | Sparrow Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02372578 | May 2015 → May 2016 | diabetic polyneuropathy | Astellas Pharma Global Development, Inc. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Announces Phase 2a Data Showing Cardiometabolic Benefits of Clofutriben in Adults with Type 2 Diabetes sparrowpharma.com ↗
Clofutriben improved HbA1c and other cardiometabolic parameters in patients with Type 2 diabetes in a 6-week, placebo-controlled, randomized Phase 2 trial |
| 2024-10-28 | Sparrow Pharmaceuticals | Regulatory Sparrow Pharmaceuticals Announces Completion of Phase 2 Trial and FDA Orphan Drug Designation of Clofutriben for Endogenous Cushing’s Syndrome sparrowpharma.com ↗
In addition, Sparrow announced that clofutriben has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of endogenous Cushing’s syndrome. |
| 2024-06-04 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents Novel Data on Clofutriben (SPI-62) Reducing Glucocorticoid Toxicities with a Low Risk of Adrenal Insufficiency at the 2024 Annual Endocrine Society Conference sparrowpharma.com ↗
To date, the HSD-1 inhibitor clofutriben (SPI-62) has normalized urine free cortisol (UFC) in >60% of patients with endogenous Cushing’s syndrome (EnCS) without suppressing serum cortisol to levels considered to indicate risk for adrenal insufficiency (AI). |
| 2022-11-14 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents Pharmacology Data on SPI-62 at American College of Rheumatology Convergence 2022 sparrowpharma.com ↗
The study data presented at ACR demonstrate that SPI-62 can prevent cardiometabolic, muscular, and dermal adverse side effects of CORT in mouse. |
| 2022-06-14 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents Clinical Trial Data Analyses on HSD-1 Inhibitor SPI-62 at the Endocrine Society (ENDO) 2022 Annual Meeting sparrowpharma.com ↗
Large changes of the amount of cortisol that can bind intracellular receptors, and thus cause cortisol-related morbidity, can occur independently of urinary free cortisol levels. |
| 2022-06-04 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents New Pharmacological Data on HSD-1 Inhibitor SPI-62 at the 2022 Annual European Congress of Rheumatology sparrowpharma.com ↗
The results of the study suggest that SPI-62 has the potential to mitigate adverse effects of glucocorticoids. |
| 2022-05-25 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents New Clinical Trial Data Analyses on HSD-1 Inhibitor SPI-62 at the 24th European Congress of Endocrinology sparrowpharma.com ↗
ACTH increase compensates for the effect of HSD-1 inhibition on systemic cortisol levels. |
| 2021-12-13 | Sparrow Pharmaceuticals | Regulatory Sparrow Pharmaceuticals Announces FDA Clearance of IND for SPI-62 for the Treatment of Cushing’s Syndrome sparrowpharma.com ↗
Having received clearance for the IND, Sparrow plans to begin enrolling patients in early 2022. |
| 2021-05-22 | Sparrow Pharmaceuticals | Results Sparrow Pharmaceuticals Presents Data on SPI-62 at the European Congress of Endocrinology sparrowpharma.com ↗
In subjects with diabetic peripheral neuropathy, SPI-62 showed clinically meaningful separation from placebo on HbA1c, glucose, cholesterol, and triglycerides. |
All press releases naming this drug 15 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | clofutriben | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07227922 ↗ |
| Known as | AS-2473662 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314513 ↗ |
| Known as | ASP3662 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02194491 ↗ |
| Known as | Clofutribene | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314513 ↗ |
| Known as | HDD-1697 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314513 ↗ |
| Known as | SPI-62 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05436639 ↗ |
| Action | Inhibit | “11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor” NCT05307328 ↗ |
| Modality | Small molecule | — CHEMBL5314513 ↗ |
| Route | Oral | “single oral dose administration of ASP3662” NCT02194491 ↗ |