Clinical Trials

Azilsartan medoxomil has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 development, focusing on essential hypertension, arterial hypertension, type 2 diabetes mellitus, stable chronic angina, obesity, and healthy volunteer pharmacokinetics. Sponsored by clinical research institutes and pharmaceutical entities including Takeda, Celltrion Pharm, and Hasten Biopharmaceutical, these studies are primarily completed, with remaining trials listed as terminated, unknown, or not yet recruiting. Phase 3 trials have specifically established the safety and antihypertensive efficacy of the compound both alone and in fixed-dose combinations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06990204 NOT_YET_RECRUITING
Hypertension
Gedeon Richter Plc.
 2025-06-06 PHASE1
NCT02235909 COMPLETED
Hypertension
Arbor Pharmaceuticals, Inc.
 2015-03-30 PHASE3
NCT02480764 COMPLETED
Essential Hypertension
Takeda
 2015-08-27 PHASE3
NCT02517866 COMPLETED
Essential Hypertension; Type 2 Diabetes Mellitus
Takeda
 2015-07-13 PHASE4
NCT02203916 COMPLETED
Hypertension
Takeda
 2014-07 PHASE3
NCT02541669 Completed
Healthy Volunteer
Takeda
 2015-11-20 Phase 1
NCT02235519 UNKNOWN
Hypertension; Obesity; Type 2 Diabetes Mellitus
Hospital General de México Dr. Eduardo Liceaga
 2014-01 PHASE2; PHASE3
NCT01078376 TERMINATED
Hypertension
Takeda
 2010-05 PHASE1
NCT01496430 TERMINATED
Hypertension; Diabetes
Takeda
 2012-01 PHASE3
NCT01456169 COMPLETED
Essential Hypertension
Takeda
 2011-10 PHASE3
NCT01309828 COMPLETED
Safety
Takeda
 2011-03 PHASE3
NCT00996281 COMPLETED
Essential Hypertension
Takeda
 2009-10 PHASE3
NCT01033071 COMPLETED
Essential Hypertension
Takeda
 2010-01 PHASE3
NCT00846365 COMPLETED
Essential Hypertension
Takeda
 2009-03 PHASE3
NCT00695955 COMPLETED
Hypertension
Takeda
 2007-06 PHASE3
NCT00847626 COMPLETED
Hypertension
Takeda
 2009-01 PHASE3
NCT00818883 COMPLETED
Essential Hypertension
Takeda
 2009-02 PHASE3
NCT00591578 COMPLETED
Hypertension
Takeda
 2007-12 PHASE3
NCT00696436 COMPLETED
Hypertension
Takeda
 2008-04 PHASE3
NCT00591253 COMPLETED
Hypertension
Takeda
 2007-10 PHASE3
NCT00760214 COMPLETED
Hypertension
Takeda
 2008-01 PHASE3
NCT00696384 COMPLETED
Hypertension
Takeda
 2007-06 PHASE3
NCT00591266 COMPLETED
Hypertension
Takeda
 2007-10 PHASE3
NCT00591773 COMPLETED
Hypertension
Takeda
 2007-09 PHASE3
NCT00696241 COMPLETED
Hypertension
Takeda
 2007-06 PHASE3
NCT00362115 COMPLETED
Hypertension
Takeda
 2006-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-05-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Azilsartan medoxomil functions as a potent and selective antagonist of the angiotensin II type 1 (AT1) receptor with an IC50 of 2.6 nM, thereby inhibiting renin-angiotensin-aldosterone system signaling. By blocking AT1 receptor activation, the compound suppresses angiotensin II-induced vasoconstriction and aldosterone secretion, promoting vascular relaxation and systemic blood pressure reduction in patient populations with essential hypertension and related cardiovascular conditions.

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.