Mezzion Pharma Co., Ltd.
KOSDAQ-listed pharma company developing new drugs for erectile dysfunction, prostatic hyperplasia, and single ventricle disease.
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Business overview
Source: DART corporate disclosureFounded in 2002 and listed on KOSDAQ in 2012, Mezzion Pharma is a new drug development company. It is pursuing global drug development across erectile dysfunction, benign prostatic hyperplasia, portal hypertension, pulmonary arterial hypertension, single ventricle disease, and autosomal dominant polycystic kidney disease. Its single ventricle disease treatment completed US clinical trials and an NDA was submitted to the FDA in March 2021, but the filing was withdrawn on FDA's recommendation in March 2022; following a Type-B meeting in May 2022, an additional clinical protocol was submitted in February 2023 and approved in March 2023, with additional trials now underway.
Regulatory approvals
1 Orphan Drug designations · 2016
- Orphan유데나필 87.5mg 필름코팅정2016-11-10Orphan Drug designation · in development20160264023
Clinical trials
data.go.kr2 MFDS clinical trial authorisations · 2016–2024 (Phase 3 2)
- Phase 3유데나필정2024-04-08
6 trial sites
- Phase 3유데나필정2016-12-26
2 trial sites
R&D and key agreements
Source: DART corporate disclosure발기부전치료제 · 발기부전
전립선비대증치료제 · 전립선비대증
간문맥고혈압치료제 · 간문맥고혈압
폐동맥고혈압치료제 · 폐동맥고혈압
단심실증치료제 · 단심실증 · NDA 재제출 준비(추가 임상 진행중) · NDA submitted Mar 2021, withdrawal advised Mar 2022, Type-B meeting May 2022, additional protocol submitted Feb 2023, approved Mar 2023
상염색체 우성 다낭신증치료제 · 상염색체 우성 다낭신증 · Developed as pipeline expansion
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Sources and updates
- Company basics
- Korea Exchange · DART
- Business content
- Compiled from disclosure filings
- AI visibility
- Measured 2026-08-13
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