Clinical Trials

Mizagliflozin is currently being evaluated across several Phase 2 clinical trials sponsored by Vogenx Inc. to regulate postprandial glucose dynamics in postbariatric hypoglycemia. Completed investigations include single ascending dose and repeat-dose crossover studies, while a double-blind, placebo-controlled Phase 2B parallel-group trial assessing repeat dosing is planned and not yet recruiting. Together, these studies represent the active clinical development landscape for mizagliflozin in metabolic disease management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07760961 NOT_YET_RECRUITING
Postbariatric Hypoglycemia
Vogenx, Inc.
 2026-10 PHASE2
NCT05721729 COMPLETED
Postbariatric Hypoglycemia
Vogenx, Inc.
 2023-06-23 PHASE2
NCT05541939 COMPLETED
Postbariatric Hypoglycemia
Vogenx, Inc.
 2022-09-13 PHASE2
NCT05541939 Completed
Postbariatric Hypoglycemia
Vogenx Inc.
 2022-09-13 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-12)

Check the Mizagliflozin (KWA 0711, DSP-3235 free base) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mizagliflozin functions as a potent, selective inhibitor of human sodium-glucose cotransporter 1 with a Ki of 27 nM, thereby blocking intestinal luminal glucose uptake and attenuating rapid glucose absorption into the systemic circulation. By suppressing postprandial glucose spikes and modulating gastrointestinal nutrient transport, this mechanism provides a targeted therapeutic strategy for addressing postbariatric hypoglycemia and chronic constipation.

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.