• Provide written informed consent before the initiation of any study specific procedures;

• Male or female patients ≥ 18 years of age;

• At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:

‣ HAM-A Total score of ≥ 22;

⁃ HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;

⁃ CGI-S score of ≥ 4;

• History of inadequate response (\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \[ATRQ\] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;

• Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least the minimum GAD-approved dose per package insert) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.

∙ NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.