Drugs / Miglitol
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GLYSET | — | 1999-08-16 | fda.gov ↗ |
| Approved | US (FDA) | GLYSET | — | 1996-12-18 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01099839 | Feb → Apr 2010 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT00334399 | — | type 2 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00334503 | — | type 2 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00213070 | — | type 2 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00213109 | — | type 1 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00380822 | — | type 2 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00213122 | — | type 2 diabetes mellitus | Sanwa Kagaku Kenkyusho Co., Ltd. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT01242202 Background | Oct 2010 → May 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Miglitol | “Chemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors” NCT06449235 ↗ |
| Known as | BAY M 1099 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1561 ↗ |
| Known as | Diastabol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1561 ↗ |
| Known as | Glyset | ChEMBL registry synonym — accepted as the source's own label CHEMBL1561 ↗ |
| Known as | NSC-758702 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1561 ↗ |
| Action | Inhibit | “Inhibits alpha-glucosidase enzymes in the small intestine.” NCT06449235 ↗ |
| Modality | Small molecule | — CHEMBL1561 ↗ |
| Route | Oral | “Administration: Administered orally, typically taken with the first bite of each main meal.” NCT06449235 ↗ |
| Target | GAA | “Lysosomal alpha-glucosidase inhibitor” CHEMBL1561 ↗ |
| Target | MGAM | “Maltase-glucoamylase inhibitor” CHEMBL1561 ↗ |