Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 have evaluated bexagliflozin under industry and academic sponsorship, including Theracos and Yale University. Ranging in status from completed and recruiting to withdrawn, these studies primarily assess glycemic efficacy in Type 2 diabetes mellitus while also examining essential hypertension and sleep apnea. Late-stage Phase 3 trials focused on glycemic control in diabetic cohorts, whereas active Phase 4 initiatives investigate physiological outcomes in sleep apnea.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05612594 RECRUITING
Sleep Apnea
Yale University
 2024-03-27 PHASE4
NCT02769481 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2016-08-15 PHASE3
NCT03259789 COMPLETED
Type2 Diabetes Mellitus
Theracos
 2017-11-28 PHASE3
NCT03557658 COMPLETED
Type2 Diabetes Mellitus
Theracos
 2018-07-26 PHASE1
NCT03514641 COMPLETED
Essential Hypertension
Theracos
 2017-10-18 PHASE2; PHASE3
NCT03115112 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2017-10-12 PHASE3
NCT03417076 WITHDRAWN
Type 2 Diabetes Mellitus
Theracos
 2018-08-01 PHASE1
NCT02558296 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2015-10 PHASE3
NCT03417076 Withdrawn
Type 2 Diabetes Mellitus
Theracos
 2018-08-01 Phase 1
NCT02836873 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2016-09-23 PHASE3
NCT03296800 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2017-09-27 PHASE1
NCT03197324 COMPLETED
Type2 Diabetes Mellitus
Theracos
 2017-07-24 PHASE1
NCT03167411 COMPLETED
Type2 Diabetes Mellitus
Theracos
 2017-05-24 PHASE1
NCT02715258 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2016-03 PHASE3
NCT02956044 COMPLETED
Type2 Diabetes Mellitus
Theracos
 2016-11 PHASE1
NCT02820298 COMPLETED
Type 2 Diabetes Mellitus
Theracos
 2016-06-20 PHASE1
NCT02390050 COMPLETED
Diabetes Mellitus, Type 2
Theracos
 2015-05-12 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the Bexagliflozin (EGT1442) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bexagliflozin selectively binds to sodium-glucose cotransporter 2 (SGLT2) with an IC50 of 2 nM, effectively blocking renal glucose reabsorption in the proximal convoluted tubules. This inhibition increases urinary glucose excretion and promotes osmotic diuresis, thereby lowering plasma glucose levels and contributing to therapeutic blood pressure reduction in clinical conditions such as Type 2 diabetes mellitus and hypertension.

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>).

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Note: Technical data last updated: Sep 1, 2026.