Last reviewed 2026-06-03 · How we verify

Amosartan Q tablet

Hanmi Pharmaceutical Company Limited · Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 10/100

Amosartan Q tablet is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited. It is currently in Phase 2 development. Also known as: amosartan Q.

Amosartan Q tablet is a small molecule used to treat hypertension and dyslipidemia. It is being studied in a prospective, observational study to evaluate its effectiveness and safety in managing blood pressure and blood lipids.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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 name	Amosartan Q tablet
Also known as	amosartan Q
Sponsor	Hanmi Pharmaceutical Company Limited
Modality	Small molecule
Phase	Phase 2

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

Amosartan Q tablet CI brief — competitive landscape report
Amosartan Q tablet updates RSS · CI watch RSS
Hanmi Pharmaceutical Company Limited portfolio CI

Frequently asked questions about Amosartan Q tablet

What is Amosartan Q tablet?

Amosartan Q tablet is a Small molecule drug developed by Hanmi Pharmaceutical Company Limited.

Who makes Amosartan Q tablet?

Amosartan Q tablet is developed by Hanmi Pharmaceutical Company Limited (see full Hanmi Pharmaceutical Company Limited pipeline at /company/hanmi-pharmaceutical-company-limited).

Is Amosartan Q tablet also known as anything else?

Amosartan Q tablet is also known as amosartan Q.

What development phase is Amosartan Q tablet in?

Amosartan Q tablet is in Phase 2.

Manufacturer: Hanmi Pharmaceutical Company Limited — full pipeline
Also known as: amosartan Q

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