RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Inclusion Criteria: * Has Generalized Anxiety Disorder as defined by DSM-5-TR * Is on stable use of antidepressants (i.e., SSRIs or SNRIs) or psychotherapy, or is willing to delay the use until the end of study * If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant. * Is willing and able to comply with the conditions and requirements of the study Exclusion Criteria: * Has a significant risk of suicide * Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder * Has other concurrent psychiatric disorders that is the primary disorder. * Has other medically significant conditions rendering unsuitability for the study * Has used or will need to use prohibited medications or therapies * Has a known sensitivity or intolerance to study intervention or potential rescue medications