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Olmetec
Olmetec is a Small molecule drug developed by Daewoong Pharmaceutical Co. LTD.. It is currently in Phase 1 development for Hypertensive disorder. Also known as: the reference product.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 name | Olmetec |
|---|---|
| Also known as | the reference product |
| Sponsor | Daewoong Pharmaceutical Co. LTD. |
| Target | Type-1 angiotensin II receptor, Type-1 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 1 |
Approved indications
- Hypertensive disorder
Common side effects
Key clinical trials
- Clinical Trial to Compare Pharmacokinetics After Administration of ATB-101 or Co-administration of ATB-1011 and ATB-1012 (PHASE1)
- Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? (PHASE3)
- A Clinical Trial to Evaluate the Efficacy and Safety of Olmesartan/Amlodipine/Rosuvastatin Combination Treatment in Patients With Concomitant Hypertension and Hyperlipidemia (PHASE3)
- Clinical Trial to Evaluate Pharmacokinetic Interaction of ATB-1011 and ATB-1012 in Healthy Adult Volunteers (PHASE1)
- A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions (PHASE1)
- Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451 (PHASE3)
- The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions. (PHASE1)
- Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Combination Therapy in Patients With Hypertension Not Controlled With Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy (PHASE3)
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:
- Olmetec CI brief — competitive landscape report
- Olmetec updates RSS · CI watch RSS
- Daewoong Pharmaceutical Co. LTD. portfolio CI
Frequently asked questions about Olmetec
What is Olmetec?
What is Olmetec used for?
Who makes Olmetec?
Is Olmetec also known as anything else?
What development phase is Olmetec in?
What does Olmetec target?
Related
- Target: All drugs targeting Type-1 angiotensin II receptor, Type-1 angiotensin II receptor
- Manufacturer: Daewoong Pharmaceutical Co. LTD. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertensive disorder
- Also known as: the reference product
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing