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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

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generalized anxiety disorder medical
Generalized anxiety disorder is a chronic mental health condition marked by persistent, excessive worry about everyday things that is hard to control and interferes with daily life. Think of it like a smoke alarm that stays on for weeks or months, making work, decision-making and productivity harder; for investors it matters because it drives demand for treatments, affects workforce performance and can influence regulatory scrutiny, clinical trial design and healthcare spending.
gad medical
Generalized Anxiety Disorder (GAD) is a chronic mental health condition marked by persistent, excessive worry and physical symptoms like restlessness, fatigue, trouble concentrating, and sleep problems. For investors, GAD signals a steady, large market for treatments, diagnostics and services — similar to a recurring customer base — so prevalence, treatment advances, and regulatory or reimbursement changes can directly affect revenue prospects and valuation for healthcare companies.
major depressive disorder medical
A clinical condition characterized by persistent, severe low mood, loss of interest in daily activities, and reduced ability to function at work or home, lasting weeks or longer. It matters to investors because it drives demand for treatments and mental health services, affects workforce productivity and absenteeism, influences health-care and insurance costs, and shapes risks and opportunities for companies developing drugs, therapies or workplace programs—like a long-lasting storm that lowers economic output.
mdd medical
Major depressive disorder (MDD) is a medical condition characterized by persistent low mood, loss of interest in daily activities, and impaired functioning similar to carrying a heavy backpack that makes ordinary tasks much harder. For investors, MDD matters because treatments and therapies for it are a large market regulated by health authorities; clinical trial outcomes, approvals, or safety concerns can strongly affect a drugmaker’s sales prospects, valuation, and risk profile.
comorbidity medical
Comorbidity is the presence of one or more additional medical conditions occurring alongside a primary illness, like carrying extra weights while trying to walk. For investors, comorbidities matter because they can change a treatment’s effectiveness, increase healthcare costs, complicate clinical trials and regulatory approval, and alter a drug or device’s market size and reimbursement prospects.
healthcare claims technical
Healthcare claims are requests for payment submitted by patients, doctors, hospitals, or other providers to an insurer or government health program after medical services, procedures, or products are delivered. For investors they act like business receipts and invoices, revealing how many services are being used, how much insurers or payers are being charged or reimbursing, and where costs or revenue pressures and financial risk may be rising or falling.
dsm-iv medical
A standardized manual that lists and defines mental health conditions used by clinicians and researchers to decide who has a particular psychiatric diagnosis. For investors, DSM-IV matters because clinical trials, regulatory filings and medical claims often rely on its definitions to determine which patients qualify for a treatment, how results are measured and how large a potential market is—think of it as the rulebook that shapes who counts as a customer.
longitudinal study technical
A longitudinal study follows the same people, companies, or data points over a period of time to see how they change, develop, or respond to events. For investors, these studies reveal trends, long-term effects and cause-and-effect patterns—like watching a garden throughout the seasons rather than judging it from one snapshot—helping judge whether a treatment, policy, product or business strategy produces lasting results or just short-term noise.
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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

NEW YORK--(BUSINESS WIRE)-- 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:

  1. Cascade E, Kalali AH, Kennedy SH. Real-world data on SSRI antidepressant side effects. Psychiatry (Edgemont). 2009;6(2):16-18.
  2. Bandelow B, Michaelis S, Wedekind D. Treatment of anxiety disorders. Dialogues Clin Neurosci. 2017;19(2):93-107.
  3. Jakubovski E, Johnson JA, Nasir M, Müller-Vahl K, Bloch MH. Systematic review and meta-analysis: Dose-response curve of SSRIs and SNRIs in anxiety disorders. Depress Anxiety. 2019;36(3):198-212.
  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
  6. Patriquin, M. A., & Mathew, S. J. (2017). The neurobiological mechanisms of generalized anxiety disorder and chronic stress. Chronic Stress, 1, 2470547017703993. https://doi.org/10.1177/2470547017703993
  7. Barrera, T. L., & Norton, P. J. (2009). Quality of life impairment in generalized anxiety disorder, social phobia, and panic disorder. Journal of Anxiety Disorders, 23, 1086–1090. https://doi.org/10.1016/j.janxdis.2009.07.011
  8. Armbrecht, E., Shah, R., Poorman, G. W., et al. (2021). Economic and humanistic burden associated with depression and anxiety among adults with non-communicable chronic diseases (NCCDs) in the United States. Journal of Multidisciplinary Healthcare, 14, 887–896. https://doi.org/10.2147/jmdh.s280200
  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

 

For further information, please contact:

Investors:
Gitanjali Jain
VP, Head of Investor Relations
ir@definiumtx.com

Media:
media@definiumtx.com

Source: Definium Therapeutics, Inc.