NCT07323784

A Study of NTX-1472 in Social Anxiety Disorder

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of NTX-1472, a V1a Receptor Antagonist, in Adults With Social Anxiety Disorder

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Newleos Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are: * Is NTX-1472 safe and well tolerated in adults with SAD? * How effectively does NTX-1472 treat adults with SAD? Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug). Participants will: * Take NTX-1472 or matching placebo every day for 8 weeks * Visit the clinic 6 times over the course of 14 weeks for checkups and tests

Conditions

• Social Anxiety Disorder (SAD)

Interventions

Type	Name	Description
DRUG	NTX-1472	Daily (QD) x 8 weeks.
DRUG	Placebo	Daily (QD) x 8 weeks.

Timeline

• Start date: 2025-12-09
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-01-07
• Last updated: 2026-01-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study