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Biotech & Drug DiscoveryKOSDAQ 140410Orphan Drug1 approvals2 trials

Mezzion Pharma Co., Ltd.

KOSDAQ-listed pharma company developing new drugs for erectile dysfunction, prostatic hyperplasia, and single ventricle disease.

As of 2026-10-08, Mezzion Pharma Co., Ltd. has 3 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

Business overview

Source: DART corporate disclosure

Founded 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disease treatment completed US clinical trials and an NDA was submitted to the FDA in March 2021, but the filing was withdrawn on FDA's recommendation in March 2022; following a Type-B meeting in May 2022, an additional clinical protocol was submitted in February 2023 and approved in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 필름코팅정2016-11-10
    Orphan Drug designation · in development20160264023

Clinical trials

data.go.kr

2 MFDS clinical trial authorisations · 2016–2024 (Phase 3 2)

  • Phase 3유데나필정2024-04-08

    6 trial sites

  • Phase 3유데나필정2016-12-26

    2 trial sites

Global clinical trials

ClinicalTrials.gov · sponsor-matched

R&D and key agreements

Source: DART corporate disclosure

발기부전치료제 · 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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 22 more patents

AI reads

MAA server logs · IP-verified
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Times AI engines pulled Mezzion Pharma Co., Ltd.'s records

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Measured since Aug 27, 2026 · 5 AI engines · last read Oct 7, 2026

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Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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