Trial Profile

A Phase 2 dose finding proof of concept study to assess the progression of coronary atherosclerosis in patients

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 24 Feb 2025

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At a glance

24 Feb 2025 New trial record
13 Feb 2025 According to a Veru Healthcare media release, the company had a pre-IND meeting with the FDA Division of Cardiology and Nephrology Center for Drug Evaluation and Research on December 26, 2024. The FDA agreed with the general design of the small Phase 2 study using coronary CT angiography imaging as primary endpoint and requested to conduct animal toxicology studies to support the chronic use. The IND submission is expected in first half of 2026.
13 Feb 2025 According to a Veru Healthcare media release, the company plans to partner with the Colorado Prevention Center, Aurora, Colorado and Lundquist Institute, Torrence, California for this trial.

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