Mezzion Pharma

What Mezzion Pharma does

Mezzion Pharma Co., Ltd. is a South Korea-headquartered, KOSDAQ-listed (ticker A140410) pharmaceutical company founded in September 2002 that develops udenafil, a highly selective long-acting phosphodiesterase-5 (PDE5) inhibitor with up to 24-hour duration of effect. The company's lead program is JURVIGO (udenafil), an investigational oral therapy in global Phase 3 development (FUEL-2 trial, 436 patients) for single ventricle heart disease patients with Fontan circulation — a rare congenital condition affecting roughly 5 per 100,000 newborns with no FDA-approved treatment and a market projected at approximately $3 billion. Mezzion also markets Zydena, an udenafil-based erectile dysfunction treatment approved in Korea since 2005 and licensed to Valenta in Russia, and is developing udenafil for autosomal dominant polycystic kidney disease (ADPKD) following favorable FDA pre-IND feedback. The asset carries Rare Pediatric Disease Designation (FDA, 2017) and Orphan Drug Designation in the US (2015), EU (2016), and Korea (2016), supported by a granted patent portfolio covering adult and adolescent Fontan treatment, myocardial performance index enhancement, and benign prostatic hyperplasia.

Name

Mezzion Pharma

Legal name

Mezzion Pharma Co., Ltd. (주식회사 메지온)

Website

https://mezzion.co.kr

Company type

Public

Founded year

2002

Operating status

Operating

Headcount range

11–50 employees

Short description

Mezzion Pharma is a South Korean, KOSDAQ-listed pharmaceutical company developing JURVIGO (udenafil), a long-acting PDE5 inhibitor targeting single ventricle heart disease Fontan patients with no approved therapies. It also markets Zydena for erectile dysfunction and is expanding udenafil into ADPKD.

Ownership category

akta.pro rank

Product category

Specialty Rare Disease Pharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Rare Cardiovascular & Vascular Disorder Therapies (HLAIAIAH)

akta.pro secondary industry

Cardiology & Vascular Specialty Pharmaceuticals (HLAIACAG)

Keywords

• Orphan drug development
• PDE5 inhibitor therapy
• Rare pediatric disease
• Single ventricle heart disease
• Specialty pharmaceuticals

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Operations, Marketing or Sales, Personnel, Infrastructure

Revenue model

1. JURVIGO (udenafil) US Sales: Upon FDA approval, Mezzion Pharmaceuticals, Inc. (US subsidiary) will commercialize JURVIGO directly in the US market for single ventricle heart disease with Fontan circulation. US sales rights were transferred from the parent company to the US subsidiary.
2. Licensing Royalties (International): International licensing-out arrangements for udenafil across various indications in territories outside US. The company has established license-out partner pools for various regions and has prior licensing experience from Zydena sales in Russia.
3. ADPKD Pipeline Revenue: Upon successful development and approval, udenafil for ADPKD is expected to generate revenue through commercial sales, with potential market size estimated at $3 billion. The company plans Phase 2b clinical trials.
4. Priority Review Voucher (PRV): Following the Give Kids a Chance Act restoring the Rare Pediatric Disease Priority Review Voucher program, Mezzion may monetize PRVs upon FDA approval of JURVIGO, providing additional revenue stream.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Mezzion Pharma develops and commercializes udenafil, a long-acting PDE5 inhibitor. Its lead investigational product JURVIGO (udenafil) targets single ventricle heart disease with Fontan circulation in adolescents and young adults and is in a global Phase 3 FUEL-2 trial. The company also markets Zydena (udenafil) for erectile dysfunction in Korea and Russia and is developing udenafil for ADPKD and benign prostatic hyperplasia.

Product overview

Mezzion Pharma is a pharmaceutical company with a dual product strategy: (1) JURVIGO (udenafil) is an investigational drug in late-stage clinical development for single ventricle heart disease with Fontan circulation, a rare congenital heart condition with no approved therapies; (2) Zydena (자이데나) is the company's marketed erectile dysfunction product approved in Korea since 2005 and sold in Russia. The company is also expanding its pipeline to include ADPKD (autosomal dominant polycystic kidney disease) as a second indication for udenafil.

Differentiator

Problem solved

Functional benefit

Brands

• JURVIGO (udenafil): Brand name for udenafil being developed for single ventricle heart disease with Fontan circulation. JURVIGO is an investigational drug — not yet FDA approved.
• Zydena (자이데나)
• FUEL
• FUEL-2
• FUEL OLE
• FUEL FALD

Products and services

• JURVIGO (udenafil) Investigational oral drug (PDE5 inhibitor) being developed for single ventricle heart disease with Fontan circulation in adolescents and young adults. Currently in global Phase 3 FUEL-2 clinical trials with Rare Pediatric Disease Designation from the U.S. FDA. Targeted for the orphan/rare pediatric cardiology market in the U.S. via Mezzion Pharmaceuticals, Inc. and internationally via licensing.
• Zydena (자이데나) Erectile dysfunction treatment containing udenafil as the active ingredient, approved by Korea MFDS in December 2005 and marketed in Korea. Also sold in Russia under the same brand name (Zydena/Зидена) through licensing partner Valenta.

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Eight partnerships are on record, tiered major, core and minor.

• IQVIAmajorImplementation/ SI/ Consulting Partner · 1 November 2022Selected as CRO (Contract Research Organization) for FUEL-2 Phase 3 trial in November 2022 to manage global clinical trial operations.
• Mezzion Pharmaceuticals, Inc.coreStrategic or Co-development Partner · 1 January 2016US subsidiary established in January 2016 (originally Mezzion International LLC, later renamed Mezzion Pharmaceuticals, Inc.) to conduct US clinical trials and commercialize JURVIGO (udenafil) in the US market. US sales rights transferred from parent company Mezzion Pharma Co., Ltd.
• National Heart, Lung, and Blood Institute (NHLBI)coreStrategic or Co-development Partner · 1 January 2016NHLBI, part of the NIH, co-develops and co-funds the FUEL clinical trial program for udenafil in Fontan patients. The FUEL trial was developed using clinical protocols from the Pediatric Heart Network (PHN). NHLBI recognizes FUEL as the most significant contributing research in congenital heart disease.
• Pol PharmacoreTechnology or IntegrationPolish API (active pharmaceutical ingredient) manufacturer contracted to produce udenafil following issues with previous CMO Dr. Reddy's. Pol Pharma's manufacturing process and quality standards were confirmed by FDA to meet requirements during CMC pre-NDA meeting.
• Halo PharmacoreTechnology or IntegrationCanadian formulation manufacturer contracted for udenafil drug product manufacturing (dosage form synthesis) as part of the post-Dr. Reddy's manufacturing restructuring.
• Valenta (Russia)minorChannel Partner/ Reseller/ DistributorRussian licensing-out partner for Zydena (udenafil) for erectile dysfunction since 2007, with expansion to benign prostatic hyperplasia indication and contract extension through patent expiry (2026). Contract value $4 million; future revenue potential ~75 billion KRW over 15 years.
• Actavis / Forest LaboratoriesminorChannel Partner/ Reseller/ DistributorNorth American licensing partner for udenafil erectile dysfunction indication. Actavis acquired Forest Laboratories for $25 billion, expanding distribution channels to include internal medicine and psychiatry beyond urology.
• Takeda (formerly Nycomed)minorChannel Partner/ Reseller/ DistributorMexican licensing partner for udenafil in erectile dysfunction and BPH indications (through Nycomed's acquisition by Takeda). Takeda generates ~$19 billion in annual revenue, ranked among top 10 global pharma companies.

Scale indicators8 records

Recent moves10 records

Expansion highlights6 records

Market position

Competitive moat5 records

Key highlights6 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Mezzion Pharma