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AGSCT101 12.5mg
AGSCT101 12.5mg is a Small molecule drug developed by Ahn-Gook Pharmaceuticals Co.,Ltd. It is currently in Phase 3 development.
AGSCT101 12.5mg is being studied in a Phase III clinical trial to evaluate its antihypertensive effect in patients with essential hypertension. This trial is comparing the efficacy of AGSCT101 12.5mg to carvedilol 25mg.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | AGSCT101 12.5mg |
|---|---|
| Sponsor | Ahn-Gook Pharmaceuticals Co.,Ltd |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Clinical Trial to Evaluate the Antihypertensive Effect of AGSCT101 in Patient With Hypertension (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:
- AGSCT101 12.5mg CI brief — competitive landscape report
- AGSCT101 12.5mg updates RSS · CI watch RSS
- Ahn-Gook Pharmaceuticals Co.,Ltd portfolio CI
Frequently asked questions about AGSCT101 12.5mg
What is AGSCT101 12.5mg?
Who makes AGSCT101 12.5mg?
What development phase is AGSCT101 12.5mg in?
Related
- Manufacturer: Ahn-Gook Pharmaceuticals Co.,Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing