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Mezzion Pharma

Ownership: Public · 140410
Employees: ~50
Development stage: Phase 3

Overview

The company’s lead asset, udenafil (JURVIGO®), has completed pivotal Phase 3 studies in the Fontan population. Topline data from the FUEL study were presented at AHA Scientific Sessions in 2019 and recognized as a major advancement for congenital heart disease. The FDA requested an additional confirmatory trial (FUEL‑2), which was funded by a $40 million investment secured in 2023. NDA resubmissions are ongoing.

Therapeutic areas: GastroenterologyCardiovascular
Modalities: Small molecules
Industry: Biotech

Drug pipeline

1 asset

udenafil

Phase 3

Indications: Single ventricle congenital heart disease

Partnerships

CRO selected for clinical trials; no major pharma partnerships publicly disclosed as of latest updates

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