NCT07328529

Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome

Safety, Tolerability, and Efficacy of SRX246, a Vasopressin 1a Receptor Antagonist, in Aggressive Participants With Fragile X Syndrome

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Azevan Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug SRX246 works to treat irritability, agitation, aggression and self-injury (IAAS) behaviors in adult males with Fragile X Syndrome (FXS). It will also learn about the safety of drug SRX246. The main questions it aims to answer are: * Does drug SRX246 lower the number of times participants experience IAAS behaviors? * What medical problems do participants have when taking drug SRX246? Researchers will compare drug SRX246 to a placebo (a look-alike substance that contains no drug) to see if drug SRX246 works to treat IAAS behaviors. Participants will: * Take drug SRX246 or a placebo every day for up to 8 months * Have weekly checkups by phone or video to answer study questions * Have periodically scheduled home visits by nurses to conduct medical check-ups and tests * Keep a diary of their symptoms

Conditions

• Aggressive Behavior in Fragile X Syndome

Interventions

Type	Name	Description
DRUG	SRX246	SRX246 120mg capsules for oral administration
DRUG	Placebo	Placebo capsules for oral administration

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-03-01
• Completion: 2028-03-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study