Recruiting
Phase 2

NTX-1472

Sponsor:

Newleos Therapeutics, Inc.

Code:

NCT07323784

Conditions

Social Anxiety Disorder (SAD)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

NTX-1472

Placebo

Study Details

Brief 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)

Study ID

NCT07323784

Start date

Dec 9, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NTX-1472

placebo comparator: Placebo

Interventions

NTX-1472

Daily (QD) x 8 weeks.

Placebo

Daily (QD) x 8 weeks.

Primary outcome measure

  • Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to Week 8 ]

Central Contacts and Locations

Central contacts

Newleos Therapeutics Clinical Trial Team

978-780-5937clinicaltrials@newleos.com

Locations

SOAR Clinical Study Site

Recruiting

Encino, California, United States, 91316

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Los Angeles, California, United States, 90025

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Oceanside, California, United States, 92056

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

San Jose, California, United States, 95124

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Tampa, Florida, United States, 33615

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Brooklyn, New York, United States, 11229

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Memphis, Tennessee, United States, 38119

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

SOAR Clinical Study Site

Recruiting

Austin, Texas, United States, 78737

Contacts

SOAR Clinical Study Site

978-780-5937clinicaltrials@newleos.com

More Information

Sponsor

Newleos Therapeutics, Inc.

Last update posted

Jul 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Newleos Therapeutics, Inc. on 2026-07-09.