A Study of NTX-1472 in Social Anxiety Disorder

This study is testing a new medication called NTX-1472 for adults with Social Anxiety Disorder (SAD). Researchers want to see if NTX-1472 is safe, well-tolerated, and effective in treating SAD. You would either receive NTX-1472 or a placebo (a pill with no medicine) daily for 8 weeks. The main goal is to track any side effects you might experience. This study is looking for about 100 participants, aged 18 to 65, who speak English and have a current diagnosis of SAD. The current recruitment status is unclear.

Study design: This is a Phase 2 interventional study comparing NTX-1472 to a placebo in approximately 100 participants.
What's involved: You would take NTX-1472 or a placebo daily for 8 weeks and visit the clinic 6 times over 14 weeks for checkups and tests.
Compensation: Not stated in the trial record.
Follow-up: Side effects will be measured from the start of the study until Week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of NTX-1472 in Social Anxiety Disorder

Recruiting

PHASE2Ages 18–65InterventionalTreatment

Newleos Therapeutics, Inc.

~100 participants

Updated 2026-07-09 on ClinicalTrials.gov

What's tested:NTX-1472Placebo

At a glance

Recruiting sites

10 of 11 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence and severity of treatment-emergent adverse events (TEAEs)

Measured over Baseline to Week 8

Conditions

Social Anxiety Disorder (SAD)

NCT07323784

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

SOAR Clinical Study Site
Encino, Californiastudy coordinator listed
Recruiting
SOAR Clinical Study Site
Los Angeles, Californiastudy coordinator listed
Recruiting
SOAR Clinical Study Site
Oceanside, Californiastudy coordinator listed
Recruiting
SOAR Clinical Study Site
San Jose, Californiastudy coordinator listed
Recruiting
SOAR Clinical Study Site
Jacksonville, Floridastudy coordinator listed
Recruiting
SOAR Clinical Study Site
Tampa, Floridastudy coordinator listed
Recruiting
SOAR Clinical Study Site
Boston, Massachusettsstudy coordinator listed
Recruiting
SOAR Clinical Study Site
Brooklyn, New Yorkstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Newleos Therapeutics Clinical Trial Team

[email protected]

978-780-5937

Email the study team

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Eligibility criteria

Inclusion

Has provided written informed consent for the study and is willing to comply with all requirements of the protocol

English speaker

Male or female, ≥18 and ≤65 years of age

Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT).

Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening

Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score \<16 at Screening

If participant is of childbearing potential, must commit to practicing effective methods of birth control during the study and at least 14 days after the last dose.

Exclusion

Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT.

Current diagnosis of any of the following psychiatric condition(s) as defined by the DSM-5 (participants with current generalized anxiety disorder may be included): Attention-deficit/hyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder.

Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder (in adulthood), Obsessive-compulsive disorder, Schizophrenia spectrum or other psychotic disorder, Substance use disorder (within 12 months of Screening).

Receiving daily psychotropics within 4 weeks of Screening

Is at risk for suicidal ideation as per C-SSRS

Has moderate or severe hepatic impairment

Has severe renal impairment

Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.

What this trial measures

Incidence and severity of treatment-emergent adverse events (TEAEs)Baseline to Week 8

Trialytics