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Amosartan
Amosartan is a Small molecule drug developed by Huons Co., Ltd.. It is currently in Phase 2 development. Also known as: amosartan, P.O.
Amosartan is a medication that has been studied in combination with amlodipine and hydrochlorothiazide for the treatment of hypertension. The exact mechanism of action of Amosartan is not specified in the provided facts, but it is often combined with other medications to treat hypertension.
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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).
| 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 |
|---|---|
| Also known as | amosartan, P.O |
| Sponsor | Huons Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Effect on Improvement of LVH by the Control of BP in Hypertension Patients With AV Disease (PHASE4)
- An Observational Study to Evaluate Effectiveness and Safety of Amosartan Plus Tablet
- An Observational Study to Evaluate Effectiveness and Safety of Amosartan Q Tablet
- Open Label RCT for Chronic Severe AR : Entresto vs. CCB/ARB (PHASE2)
- Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure
- Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients (PHASE4)
- Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension (PHASE3)
- Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject (PHASE1)
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 CI brief — competitive landscape report
- Amosartan updates RSS · CI watch RSS
- Huons Co., Ltd. portfolio CI
Frequently asked questions about Amosartan
What is Amosartan?
Who makes Amosartan?
Is Amosartan also known as anything else?
What development phase is Amosartan in?
Related
- Manufacturer: Huons Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: amosartan, P.O
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing