Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Study of NTX-1472 in Social Anxiety Disorder (NCT07323784) is a Phase 2 interventional studying Social Anxiety Disorder (SAD), sponsored by Newleos Therapeutics, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Social Anxiety Disorder (SAD) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Social Anxiety Disorder (SAD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Inclusion Criteria - Has provided written willing to sign a consent form 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. Key Exclusion Criteria - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria * 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. Key Exclusion Criteria * 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.

Treatments Being Tested

DRUG

NTX-1472

Daily (QD) x 8 weeks.

DRUG

Placebo

Daily (QD) x 8 weeks.

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SOAR Clinical Study Site
Pheonix, Arizona, United States
SOAR Clinical Study Site
Encino, California, United States
SOAR Clinical Study Site
Los Angeles, California, United States
SOAR Clinical Study Site
Oceanside, California, United States
SOAR Clinical Study Site
San Jose, California, United States
SOAR Clinical Study Site
Jacksonville, Florida, United States
SOAR Clinical Study Site
Tampa, Florida, United States
SOAR Clinical Study Site
Boston, Massachusetts, United States
SOAR Clinical Study Site
Brooklyn, New York, United States
SOAR Clinical Study Site
Memphis, Tennessee, United States
SOAR Clinical Study Site
Austin, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07323784), the sponsor (Newleos Therapeutics, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07323784 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07323784?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07323784?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07323784. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07323784. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.