A Phase 2 interventional study of SRX246 and Placebo in Aggressive Behavior in Fragile X Syndome, sponsored by Azevan Pharmaceuticals. Not yet recruiting at 3 sites in United States. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Azevan Pharmaceuticals · Phase 2, Interventional, and Treatment
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:
Participants will:
114 studies on the registry are indexed under Fragile X Syndrome; 24 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 91 interventional studies indexed under Fragile X Syndrome.
Browse Fragile X Syndrome studies →Azevan Pharmaceuticals is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SRX246 will be provided as 120mg capsule to be taken orally, twice per day, once in the morning and once in the evening.
Drug: SRX246
Placebo will be provided as a matching capsule to be taken orally, twice per day, once in the morning and once in the evening.
Drug: Placebo
SRX246 120mg capsules for oral administration
Placebo capsules for oral administration
Aberrant Behavior Checklist
The Aberrant Behavior Checklist-Community Edition (ABC-C) Irritability subscale - Caregiver rated and then scored using the using the FXS-specific factoring system (ABCFX). Responses will be rated using a scale ranging from 0=not a problem to 3=severe problem.
Time frame: Over an 8 month period
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 15 phase 2 interventional studies under Fragile X Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 12 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: start Mar 2026 → Dec 2026, primary completion Mar 2027 → Dec 2027 and completion Mar 2028 → Dec 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SRX246
Azevan Pharmaceuticals