Clinical Research Directory

Inclusion Criteria: * Written informed consent provided prior to conducting any study-specific assessment. * Male and female adults, 18 through 65 years of age, inclusive. * Current diagnosis of SAD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, and confirmed by the Mini-International Neuropsychiatric Interview (MINI). * Clinician-rated Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening (Visit 1). * Clinician-rated Hamilton Depression Rating Scale (HAM-D) (17-items) total score \<16. * Female subjects of childbearing potential must be able to commit to the consistent and correct use of an effective method of birth control throughout the study * Subjects must have normal olfactory function Exclusion Criteria: * Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism spectrum disorder, or obsessive-compulsive disorder. * Any other current principal or personality disorder (previously known as Axis I or Axis II disorders), except for specific phobias or generalized anxiety disorder, provided that these are not the primary diagnosis. * Subjects who meet criteria for moderate or severe alcohol use disorder within the 1 year prior to study entry, or any use of illicit substances or tetrahydrocannabinol ("THC") within 2 months prior to study entry. * In the opinion of the investigator, the subject has a significant risk for suicidal behavior during the course of their participation in the study, or the subject is considered to be an imminent danger to themself or others. * Clinically significant nasal pathology or history of significant nasal trauma, nasal surgery, total anosmia, or nasal septum perforation that may have damaged the nasal chemosensory epithelium. * Two or more documented failed adequate treatment trials with a registered medication approved for SAD. * Currently receiving cognitive-behavioral therapy (CBT), exposure therapy, or acceptance and commitment therapy. * Subjects taking psychotropic medications within 30 days before Visit 2. * Use of any over-the-counter product, prescription product, off-label treatment, cannabidiol ("CBD"), or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before Visit 2. * Prior participation in a clinical trial involving fasedienol. * Participation in any other clinical trial within the last 30 days or during the course of the current trial. * Subjects with a positive urine drug screen. * Women who have a positive urine pregnancy test. * Women who are currently breastfeeding are not eligible unless they are willing to stop breastfeeding for the duration of the study. * Subjects who have tested positive and/or have exhibited symptoms consistent with SARS-CoV-2 infection during the 4 weeks prior to Screening (Visit 1). * Any clinically significant medical history or findings as determined by the Investigator that could interfere with the objectives of the study or put the participant at risk.