Clinical Trials

Multiple clinical trials led by academic sponsors, including the University of Colorado, Denver, the University of British Columbia, and the University of Waterloo, evaluate methazolamide across Phase I through Phase IV. Research targets conditions such as high-altitude effects, hypoxia, open-angle glaucoma, pulmonary hypertension, essential tremor, and cervical cancer. Although Phase IV studies evaluating hypoxic exercise performance and intraocular pressure control are active or completed, several clinical trials in Phase II and Phase III have been withdrawn or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02390284 TERMINATED
Glaucoma
University of Miami
 2015-09 PHASE3
NCT05575180 COMPLETED
High Altitude Effects
University of Waterloo
 2023-08-11 PHASE4
NCT05498103 ACTIVE_NOT_RECRUITING
Glaucoma, Open-Angle
University of Colorado, Denver
 2023-02-17 PHASE4
NCT02758470 COMPLETED
Hypoxia
University of British Columbia
 2016-11 PHASE4
NCT06312800 WITHDRAWN
Essential Tremor
Henry Ford Health System
 2016-03 PHASE2
NCT02463357 COMPLETED
Mountain Sickness
University of Colorado, Denver
 2015-08 PHASE4
NCT02760121 COMPLETED
Altitude Sickness; Hypertension, Pulmonary
University of British Columbia
 2016-05 PHASE4
NCT01702025 COMPLETED
Physiological Function in Low Oxygen Environment
Colorado State University
 2012-06 PHASE1; PHASE2
NCT01587027 COMPLETED
Mountain Sickness
Poudre Valley Health System
 2011-12 PHASE1
NCT00257829 WITHDRAWN
Cervical Cancer
University of California, Irvine
 2004-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-08-26)

Check the Methazolamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Methazolamide potently binds to human carbonic anhydrase isoforms I and II (hCA I, hCA II) and bovine isoform IV (bCA IV) with Ki values of 50 nM, 14 nM, and 36 nM, respectively, inhibiting the reversible hydration of carbon dioxide. This enzymatic inhibition diminishes bicarbonate production and fluid secretion, providing the clinical rationale for lowering intraocular pressure in glaucoma and attenuating physiological strain under high-altitude hypoxia.

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.