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Azilsartan Trimethylethanolamine

Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026 Quality 55/100

Azilsartan Trimethylethanolamine is a Angiotensin II Receptor Blocker (ARB) Small molecule drug developed by Jiangsu Hansoh Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.

Blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and aldosterone release to lower blood pressure.

Azilsartan Trimethylethanolamine is a small molecule that acts as a Type-1 angiotensin II receptor antagonist. It is used in a Phase I study to evaluate its single-dose pharmacokinetics in healthy volunteers.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameAzilsartan Trimethylethanolamine
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.
Drug classAngiotensin II Receptor Blocker (ARB)
ModalitySmall molecule
PhasePhase 1

Mechanism of action

Azilsartan selectively blocks the AT1 receptor, preventing angiotensin II from binding and causing vasoconstriction. This blockade reduces peripheral vascular resistance and decreases aldosterone secretion, leading to reduced blood pressure and improved cardiovascular outcomes.

Approved indications

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about Azilsartan Trimethylethanolamine

What is Azilsartan Trimethylethanolamine?

Azilsartan Trimethylethanolamine is a Angiotensin II Receptor Blocker (ARB) drug developed by Jiangsu Hansoh Pharmaceutical Co., Ltd..

How does Azilsartan Trimethylethanolamine work?

Blocks angiotensin II type 1 (AT1) receptors, preventing vasoconstriction and aldosterone release to lower blood pressure.

Who makes Azilsartan Trimethylethanolamine?

Azilsartan Trimethylethanolamine is developed by Jiangsu Hansoh Pharmaceutical Co., Ltd. (see full Jiangsu Hansoh Pharmaceutical Co., Ltd. pipeline at /company/jiangsu-hansoh-pharmaceutical-co-ltd).

What drug class is Azilsartan Trimethylethanolamine in?

Azilsartan Trimethylethanolamine belongs to the Angiotensin II Receptor Blocker (ARB) class. See all Angiotensin II Receptor Blocker (ARB) drugs at /class/angiotensin-ii-receptor-blocker-arb.

What development phase is Azilsartan Trimethylethanolamine in?

Azilsartan Trimethylethanolamine is in Phase 1.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing