Numerous clinical trials spanning Phase 1 through Phase 4 have evaluated ipragliflozin for type 1 and type 2 diabetes mellitus, as well as pharmacokinetic assessments in healthy volunteers. Sponsored by pharmaceutical companies such as Astellas Pharma and academic medical centers including Yonsei University, these studies evaluated Phase 2 and Phase 3 regimens, including combination therapies with metformin. Most registered trials have reached completed status, with a small fraction terminated, establishing a solid clinical data profile for the drug.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03076112 | COMPLETED | Type 2 Diabetes Mellitus |
Seoul National University Bundang Hospital |
2017-04-25 | PHASE3 |
| NCT03118713 | TERMINATED | Type 2 Diabetes Mellitus |
Astellas Pharma Korea, Inc. |
2017-04-25 | PHASE4 |
| NCT02847091 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2016-07-29 | PHASE4 |
| NCT02897219 | COMPLETED | Type 1 Diabetes Mellitus |
Astellas Pharma Inc |
2016-08-29 | PHASE3 |
| NCT02875821 | COMPLETED | Type 2 Diabetes With Non-alcoholic Fatty Liver (NAFLD) |
Yonsei University |
2016-04-26 | PHASE4 |
| NCT02564211 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2015-10-26 | PHASE3 |
| NCT02794792 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Europe B.V. |
2016-05-11 | PHASE3 |
| NCT02791035 | COMPLETED | Type 2 Diabetes Mellitus |
Asan Medical Center |
2016-06 | PHASE4 |
| NCT02452632 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Korea, Inc. |
2015-06-22 | PHASE3 |
| NCT02577003 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2015-11-09 | PHASE3 |
| NCT02577016 | COMPLETED | Type 2 Diabetes Mellitus |
Merck Sharp & Dohme LLC |
2015-11-05 | PHASE3 |
| NCT02291874 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2014-10-08 | PHASE4 |
| NCT02794792 | Completed | Type 2 Diabetes Mellitus |
Astellas Pharma Europe B.V.|Astellas Pharma Inc |
2016-05-11 | Phase 3 |
| NCT02529449 | COMPLETED | Type 1 Diabetes Mellitus |
Astellas Pharma Inc |
2015-09-01 | PHASE2 |
| NCT02529449 | Completed | Type 1 Diabetes Mellitus |
Astellas Pharma Inc |
2015-09-01 | Phase 2 |
| NCT02175784 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2014-03-31 | PHASE4 |
| NCT01972880 | COMPLETED | Healthy; Plasma Concentration of ASP1941 |
Astellas Pharma Inc |
2013-09 | PHASE1 |
| NCT01972880 | Completed | Healthy|Plasma Concentration of ASP1941 |
Astellas Pharma Inc |
2013-09 | Phase 1 |
| NCT01672762 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2012-05-25 | PHASE3 |
| NCT01505426 | COMPLETED | Type II Diabetes Mellitus |
Astellas Pharma Inc |
2011-11-28 | PHASE3 |
| NCT01316094 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2011-01-18 | PHASE3 |
| NCT01316107 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2011-01-15 | PHASE3 |
| NCT01514838 | TERMINATED | Type II Diabetes Mellitus |
Astellas Pharma Inc |
2012-04-23 | PHASE3 |
| NCT01242228 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-10-21 | PHASE3 |
| NCT01242202 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-10-21 | PHASE3 |
| NCT01225081 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-09-15 | PHASE3 |
| NCT01242215 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-09-17 | PHASE3 |
| NCT01611363 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Europe B.V. |
2011-10-27 | PHASE1 |
| NCT01135433 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-05-15 | PHASE3 |
| NCT01611363 | Completed | Type 2 Diabetes Mellitus |
Astellas Pharma Europe B.V.|Astellas Pharma Inc |
2011-10-27 | Phase 1 |
| NCT01611415 | COMPLETED | Healthy Subjects; Pharmacokinetics of Ipragliflozin |
Astellas Pharma Europe B.V. |
2011-07 | PHASE1 |
| NCT01403818 | COMPLETED | Healthy; Pharmacokinetics of ASP1941; Pharmacokinetics of Mitiglinide |
Astellas Pharma Inc |
2011-06 | PHASE1 |
| NCT01054092 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-01-14 | PHASE3 |
| NCT01611415 | Completed | Healthy Subjects|Pharmacokinetics of Ipragliflozin |
Astellas Pharma Europe B.V.|Astellas Pharma Inc |
2011-07 | Phase 1 |
| NCT01611428 | COMPLETED | Bioavailability of Ipragliflozin; Healthy Subjects |
Astellas Pharma Europe B.V. |
2011-06 | PHASE1 |
| NCT01611428 | Completed | Bioavailability of Ipragliflozin|Healthy Subjects |
Astellas Pharma Europe B.V.|Astellas Pharma Inc |
2011-06 | Phase 1 |
| NCT01071850 | COMPLETED | Diabetes Mellitus, Type 2 |
Astellas Pharma Inc |
2010-03-03 | PHASE2 |
| NCT01117584 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-04-06 | PHASE2 |
| NCT01373060 | COMPLETED | Healthy; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2011-02 | PHASE1 |
| NCT01232413 | COMPLETED | Healthy Subjects; Cardiac Repolarization |
Astellas Pharma Inc |
2010-09 | PHASE1 |
| NCT01674777 | COMPLETED | Healthy; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2010-10 | PHASE1 |
| NCT01057628 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-01-13 | PHASE3 |
| NCT01187186 | COMPLETED | Liver Disease |
Astellas Pharma Inc |
2010-05 | PHASE1 |
| NCT01302028 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-01-22 | PHASE1 |
| NCT01097681 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2010-02-16 | PHASE1 |
| NCT01099839 | COMPLETED | Healthy Volunteers; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2010-02 | PHASE1 |
| NCT01302158 | COMPLETED | Healthy Subjects |
Astellas Pharma Inc |
2009-12 | PHASE1 |
| NCT01023945 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2009-11-07 | PHASE1 |
| NCT01104532 | COMPLETED | Healthy; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2010-02 | PHASE1 |
| NCT01302145 | COMPLETED | Type 2 Diabetes Mellitus |
Astellas Pharma Inc |
2009-02-25 | PHASE1 |
| NCT01088919 | COMPLETED | Healthy; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2009-11 | PHASE1 |
| NCT00621868 | COMPLETED | Diabetes Mellitus |
Astellas Pharma Inc |
2008-03-26 | PHASE2 |
| NCT00790660 | COMPLETED | Diabetes Mellitus, Type 2 |
Astellas Pharma Inc |
2008-10-23 | PHASE2 |
| NCT01302132 | COMPLETED | Healthy Subjects |
Astellas Pharma Inc |
2008-05 | PHASE1 |
| NCT01288898 | COMPLETED | Healthy |
Astellas Pharma Inc |
2007-05 | PHASE1 |
| NCT01678287 | COMPLETED | Healthy Volunteers; Pharmacokinetics of ASP1941 |
Astellas Pharma Global Development, Inc. |
2007-11 | PHASE1 |
| NCT01121198 | COMPLETED | Healthy Volunteer; Pharmacokinetics of ASP1941 |
Astellas Pharma Inc |
2006-12 | PHASE1 |
| NCT01288885 | COMPLETED | Healthy |
Astellas Pharma Inc |
2006-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2022-10-04)
Check the
Ipragliflozin (ASP1941)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Ipragliflozin (ASP1941) Solubility in DMSO
- Ipragliflozin (ASP1941) Stock Solution
- Ipragliflozin (ASP1941) Storage
- Ipragliflozin (ASP1941) Stability
- Ipragliflozin (ASP1941) Molecular Weight
- Ipragliflozin (ASP1941) SMILES
- Ipragliflozin (ASP1941) CAS Number
- Ipragliflozin (ASP1941) Chemical Structure (2D and 3D)
- Ipragliflozin (ASP1941) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.