SEOUL, South Korea, May 7, 2026 /PRNewswire/ — Mezzion Pharma Co., Ltd. today announced written feedback from the U.S. Food and Drug Administration (FDA) following a pre-IND Type C Guidance meeting interaction for the development of udenafil in autosomal dominant polycystic kidney disease (ADPKD).

Based on its review, the FDA indicated that Mezzion’s nonclinical data package together with its prior clinical and safety experience with udenafil may provide a reasonable foundation to support development in clinical studies.

To date, udenafil has been studied in multiple clinical programs in other therapeutic areas with multi-year exposure. Now, Mezzion plans to add to this dataset with the goal of advancing the program toward potential Phase 2 clinical and subsequent Phase 3 development in ADPKD.

“We are encouraged by the FDA’s feedback, which we feel supports our scientific rationale and stated development approach for udenafil in ADPKD,” said Dean Park, Chairman and CEO of Mezzion. “We hope that our existing clinical dataset may enable a more efficient path into potential clinical studies.”

ADPKD is a serious, progressive genetic kidney disease with significant unmet medical need and limited treatment options. Mezzion believes udenafil’s mechanism and prior clinical experience in other therapeutic areas may support evaluation as a potential investigational therapy in ADPKD.

Mezzion views this pre-IND interaction as an additional step in advancing the potential development of udenafil for ADPKD and expanding potential treatment options for patients living with this progressive disease.

About Mezzion Pharma Co., Ltd.
Mezzion Pharma Co., Ltd., based in South Korea and listed on the KOSDAQ (140410), is a clinical-stage biopharmaceutical company focused on developing therapies for rare and underserved diseases. The Company is developing udenafil across multiple potential indications, including potential indications in Fontan physiology and autosomal dominant polycystic kidney disease (ADPKD). Udenafil is an investigational product and has not been approved by any regulatory authority.

Media Contacts:
John Presser, EVP, CBO: john.presser@mezzion.com
Mr. Sung-Il Noh, CFO: seongil.roh@mezzion.com

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SOURCE Mezzion Pharma Co., Ltd.