New Definium Therapeutics Study Published in the Journal of Mood and Anxiety Disorders Reveals Increasing Prevalence and Burden of Generalized Anxiety Disorder in the United States

The annual prevalence of newly diagnosed generalized anxiety disorder (GAD) increased from 5.4% in 2020 to 6.6% in 2023

The 3-year total prevalence of GAD reached 10.3%, representing more than 1 in 10 U.S. adults

Definium Therapeutics, Inc. ("Definium" or the "Company"), announced results from a retrospective, longitudinal study published in the Journal of Mood and Anxiety Disorders examining the real-world prevalence, incidence, and burden of GAD in the United States healthcare system from 2020 to 2023. These findings show a steadily increasing diagnosed prevalence of GAD and highlight a substantial and growing burden affecting more than 1 in 10 adults in the U.S. Together, these results underscore the need for improved access to care, including identification, diagnosis, and treatment options for patients living with GAD.

This study, based on a large U.S. healthcare claims database, found that the diagnosed prevalence of GAD increased from 5.4% in 2020 to 6.6% in 2023, while the three-year cumulative prevalence reached 10.3%. Annual incidence rates remained consistently high, ranging from 2.1% to 2.3%, indicating a steady influx of newly diagnosed patients. Results also show that GAD disproportionately affects women (67%) and is highly associated with major depressive disorder (MDD). These findings meet or exceed previously reported prevalence estimates, which range from approximately 5% to 8%.

"This rise likely reflects a convergence of greater awareness, shifting screening, and increasing societal stressors, which have occurred against a backdrop of persistent unmet need. Taken together, these data make clear the urgency of developing more effective treatments for individuals living with GAD," said Jeffrey Strawn, M.D., co-author and Professor of Psychiatry & Behavioral Neuroscience at the University of Cincinnati College of Medicine.

"Importantly, these data emphasize the urgency of advancing more effective and accessible treatment options for patients living with GAD," said Erin Ferries, Ph.D., lead author and Senior Director, Healthcare Economics Outcomes Research (HEOR) at Definium Therapeutics. "The high rate of comorbidity of GAD and MDD, both among the most prevalent mental health disorders, highlights the complex overlapping burden between these conditions and reinforces the need for more integrated approaches that address them concurrently."

GAD remains one of the most common psychiatric disorders, characterized by excessive and persistent worry that can significantly impair daily functioning and quality of life. There has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007. Even with available treatment options, many patients do not achieve adequate or sustained symptom relief, and many experience adverse effects such as weight gain and sexual dysfunction, contributing to ongoing clinical and societal burden.^1-3

Despite its significant clinical and societal impact, the prevalence of GAD in the U.S. has been difficult to quantify accurately. Many existing estimates are outdated, rely on DSM-IV diagnostic criteria, or are derived from survey methodologies with inherent limitations. As a result, there is a clear need for updated real-world data, particularly among individuals actively engaged with the healthcare system. This analysis provides a current and comprehensive view of the prevalence of GAD, its persistence over time, and its relationship to comorbid conditions.

The authors also note that real-world prevalence estimates derived from healthcare claims may more accurately reflect diagnosed and treated populations than historical survey-based estimates and suggest that the true burden of GAD may be even higher due to underdiagnosis and misdiagnosis.

About the Study

This retrospective, longitudinal study analyzed de-identified Health Insurance Portability and Accountability Act (HIPAA)-compliant patient-level data from the Komodo Healthcare Map^™ claims database between January 1, 2020, and December 31, 2023, the most recent, complete years available. This large dataset is broadly representative of the U.S. population and includes adjudicated, payer-complete, closed medical pharmacy claims. Patients with GAD were identified using the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic code F41.1. Payer-complete, closed claims data were used to estimate annual and multi-year prevalence and annual incidence trends.

About Generalized Anxiety Disorder (GAD)

GAD is one of the most common psychiatric disorders, affecting approximately 26 million U.S. adults.^4,5 People with GAD experience constant, overwhelming worry that is hard to control. Common symptoms include fatigue, muscle tension, trouble concentrating, and difficulty sleeping.⁶ GAD often occurs alongside other health problems like chronic physical symptoms, depression, other anxiety disorders, and trauma-related conditions. Together, these issues can seriously impact a person's daily life, including substantial functional, economic, and quality-of-life burdens, and are associated with increased healthcare utilization and costs.^7-9

While several GAD pharmacotherapies are approved, many patients do not experience sustained relief, and approximately 50% inadequately respond to first-line treatments.¹⁰ Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.¹¹

About Definium Therapeutics

The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today's mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

For more information, visit www.definiumtx.com and follow Definium Therapeutics on Instagram, LinkedIn , and X.

References:

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4. Ringeisen, H., et al. (2023). Mental and substance use disorders prevalence study (MDPS): Findings report. RTI International and current U.S. Census data and internal company estimates.
5. Ferries, E., et al. The Prevalence and Burden of Generalized Anxiety Disorder in the United States Healthcare System: Real-World Prevalence and Incidence from 2020-2023. Journal of Mood and Anxiety Disorders. 2026;13. https://doi.org/10.1016/j.xjmad.2026.100172
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9. Newman, M. G., Llera, S. J., Erickson, T. M., Przeworski, A., & Castonguay, L. G. (2013). Worry and generalized anxiety disorder: A review and theoretical synthesis of evidence on nature, etiology, mechanisms, and treatment. Annual Review of Clinical Psychology, 9, 275–297. https://doi.org/10.1146/annurev-clinpsy-050212-185544
10. Ansara, E. D. (2020). Management of treatment-resistant generalized anxiety disorder. Mental Health Clinician, 10(6), 326–334. https://doi.org/10.9740/mhc.2020.11.326
11. U.S. Food and Drug Administration. (2007, August 9). FDA approves Cymbalta for treatment of generalized anxiety disorder [Press release]. https://investor.lilly.com/static-files/499f0aa3-281f-49f4-9655-049aae179593

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