Clinical Trials

Multiple completed Phase 1 and Phase 3 clinical trials sponsored by Takeda evaluated azilsartan (TAK-536) in healthy volunteers as well as general and pediatric hypertension populations. Phase 1 studies investigated single- and multiple-dose pharmacokinetics, food effects, and pediatric bioequivalence, while Phase 3 trials evaluated the drug's safety, efficacy, and long-term pediatric pharmacokinetics.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04668157 Completed
Hypertension
Takeda
 2021-05-17 Phase 3
NCT03434977 Completed
Healthy Volunteers
Takeda
 2018-02-14 Phase 1
NCT03042299 Completed
Japanese Healthy Adult Male Participants
Takeda
 2017-02-10 Phase 1
NCT02791438 Completed
Pediatric Hypertension
Takeda
 2016-08-18 Phase 3
NCT02541669 Completed
Healthy Volunteer
Takeda
 2015-11-20 Phase 1
NCT02451150 Completed
Pediatric Hypertension
Takeda
 2015-08 Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Azilsartan functions as a potent angiotensin II type 1 (AT1) receptor antagonist with an IC50 of 2.6 nM, effectively blocking angiotensin II from binding its target and suppressing downstream intracellular calcium signaling and vascular smooth muscle contraction. This targeted inhibition promotes vasodilation and lowers systemic vascular resistance, thereby establishing its clinical efficacy for blood pressure reduction in the treatment of pediatric and adult 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.