Vistagen Presents New Research on the Impact of Social Anxiety Disorder at The Anxiety and Depression Association 2025 Conference
Vistagen (VTGN) presented new research on Social Anxiety Disorder (SAD) at the 2025 ADAA Conference, building on findings from the 2024 NEI Congress. The research reveals that SAD affects nearly 31 million U.S. adults, with increasing prevalence especially among young adults aged 18-22.
Key findings show that while SAD prevalence has increased, diagnosis rates remain stagnant and treatment rates have decreased. Over 20% of adults with SAD reported suicidal ideation, and 75% experienced mild to severe depression. In the 18-22 age group, 48.1% reported suicidal ideation, showing higher depression rates and worse mental health outcomes than those without SAD.
Data from Vistagen's fasedienol PALISADE Phase 3 studies revealed that 30% of participants had SAD onset at age 10 or younger, with an average 27-year delay before first treatment. The research emphasizes the urgent need for improved diagnosis, treatment options, and social support mechanisms.
Vistagen (VTGN) ha presentato nuove ricerche sul Disturbo d'Ansia Sociale (SAD) alla Conferenza ADAA 2025, ampliando i risultati emersi al Congresso NEI 2024. Lo studio evidenzia che il SAD colpisce quasi 31 milioni di adulti negli Stati Uniti, con una prevalenza in aumento soprattutto tra i giovani adulti di età compresa tra 18 e 22 anni.
I risultati principali mostrano che, sebbene la prevalenza del SAD sia cresciuta, i tassi di diagnosi sono rimasti stabili mentre quelli di trattamento sono diminuiti. Oltre il 20% degli adulti con SAD ha riportato ideazione suicidaria, e il 75% ha sperimentato una depressione da lieve a grave. Nel gruppo di età 18-22 anni, il 48,1% ha riferito ideazione suicidaria, evidenziando tassi di depressione più elevati e peggiori esiti di salute mentale rispetto a chi non soffre di SAD.
I dati degli studi di fase 3 PALISADE sul fasedienol di Vistagen hanno rivelato che il 30% dei partecipanti ha avuto l’insorgenza del SAD a 10 anni o meno, con una media di 27 anni di ritardo prima del primo trattamento. La ricerca sottolinea l’urgenza di migliorare la diagnosi, le opzioni terapeutiche e i meccanismi di supporto sociale.
Vistagen (VTGN) presentó nuevas investigaciones sobre el Trastorno de Ansiedad Social (SAD) en la Conferencia ADAA 2025, ampliando los hallazgos del Congreso NEI 2024. La investigación revela que el SAD afecta a casi 31 millones de adultos en EE. UU., con una prevalencia creciente especialmente entre jóvenes adultos de 18 a 22 años.
Los hallazgos clave muestran que, aunque la prevalencia del SAD ha aumentado, las tasas de diagnóstico se mantienen estables y las de tratamiento han disminuido. Más del 20% de los adultos con SAD reportaron ideación suicida, y el 75% experimentó depresión de leve a severa. En el grupo de 18 a 22 años, el 48,1% reportó ideación suicida, mostrando tasas más altas de depresión y peores resultados de salud mental que quienes no tienen SAD.
Los datos de los estudios de fase 3 PALISADE con fasedienol de Vistagen revelaron que el 30% de los participantes tuvo inicio del SAD a los 10 años o menos, con un retraso promedio de 27 años antes del primer tratamiento. La investigación enfatiza la necesidad urgente de mejorar el diagnóstico, las opciones de tratamiento y los mecanismos de apoyo social.
Vistagen (VTGN)은 2025년 ADAA 컨퍼런스에서 사회불안장애(SAD)에 관한 새로운 연구 결과를 발표했으며, 이는 2024년 NEI 학회에서 발표된 내용을 기반으로 합니다. 연구에 따르면 SAD는 미국 성인 약 3,100만 명에게 영향을 미치며, 특히 18세에서 22세 사이의 젊은 성인들 사이에서 유병률이 증가하고 있습니다.
주요 결과는 SAD 유병률이 증가했음에도 불구하고 진단률은 정체되어 있고 치료율은 감소했다는 점을 보여줍니다. SAD를 가진 성인의 20% 이상이 자살 생각을 보고했으며, 75%는 경증에서 중증 우울증을 경험했습니다. 18-22세 그룹에서는 48.1%가 자살 생각을 보고했으며, 이는 SAD가 없는 사람들보다 더 높은 우울증 비율과 더 나쁜 정신 건강 결과를 나타냅니다.
Vistagen의 fasedienol PALISADE 3상 연구 데이터에 따르면 참가자의 30%가 10세 이하에 SAD가 발병했으며, 첫 치료까지 평균 27년의 지연이 있었습니다. 이 연구는 진단, 치료 옵션 및 사회적 지원 체계 개선의 긴급한 필요성을 강조합니다.
Vistagen (VTGN) a présenté de nouvelles recherches sur le trouble d'anxiété sociale (SAD) lors de la conférence ADAA 2025, s'appuyant sur les résultats du congrès NEI 2024. Les recherches révèlent que le SAD touche près de 31 millions d'adultes aux États-Unis, avec une prévalence en augmentation, notamment chez les jeunes adultes âgés de 18 à 22 ans.
Les principales conclusions montrent que, bien que la prévalence du SAD ait augmenté, les taux de diagnostic restent stables et les taux de traitement ont diminué. Plus de 20 % des adultes atteints de SAD ont rapporté des idées suicidaires, et 75 % ont souffert de dépression légère à sévère. Dans le groupe des 18-22 ans, 48,1 % ont signalé des idées suicidaires, avec des taux de dépression plus élevés et des résultats en santé mentale plus défavorables que ceux sans SAD.
Les données des études de phase 3 PALISADE sur le fasedienol de Vistagen ont révélé que 30 % des participants avaient une apparition du SAD à 10 ans ou moins, avec un retard moyen de 27 ans avant le premier traitement. La recherche souligne l'urgence d'améliorer le diagnostic, les options de traitement et les mécanismes de soutien social.
Vistagen (VTGN) stellte neue Forschungsergebnisse zur Sozialen Angststörung (SAD) auf der ADAA-Konferenz 2025 vor, basierend auf Erkenntnissen vom NEI-Kongress 2024. Die Forschung zeigt, dass SAD fast 31 Millionen erwachsene US-Bürger betrifft, mit einer zunehmenden Prävalenz insbesondere bei jungen Erwachsenen im Alter von 18 bis 22 Jahren.
Wesentliche Ergebnisse zeigen, dass die Prävalenz von SAD zwar gestiegen ist, die Diagnoseraten jedoch stagnieren und die Behandlungsraten zurückgegangen sind. Über 20 % der Erwachsenen mit SAD berichteten von suizidalen Gedanken, und 75 % litten unter leichter bis schwerer Depression. In der Altersgruppe 18-22 Jahre berichteten 48,1 % von suizidalen Gedanken, was höhere Depressionsraten und schlechtere psychische Gesundheitsergebnisse im Vergleich zu Personen ohne SAD zeigt.
Daten aus den Phase-3-Studien PALISADE mit fasedienol von Vistagen zeigten, dass bei 30 % der Teilnehmer der SAD-Beginn im Alter von 10 Jahren oder jünger lag, mit einer durchschnittlichen Verzögerung von 27 Jahren bis zur ersten Behandlung. Die Forschung unterstreicht den dringenden Bedarf an verbesserter Diagnostik, Behandlungsmöglichkeiten und sozialen Unterstützungsmechanismen.
- Company advancing research in significant market with 31 million affected U.S. adults
- Phase 3 clinical program (PALISADE) for fasedienol nasal spray ongoing
- Company identifying important unmet medical needs in SAD treatment
- No efficacy data or treatment outcomes presented from Phase 3 trials
- Research shows decreasing treatment rates despite increasing SAD prevalence
- Long delay between SAD onset and treatment indicates potential challenges in market penetration
New Data Build on Recent Epidemiology Findings Presented by the Company at the 2024 Neuroscience Education Institute Congress
The Need for Improved Diagnosis and Treatment Options Underscored by Data Presented in Posters
“This new research provides a clearer and more comprehensive picture of social anxiety disorder — shining light on its rising prevalence and significant impact on young adults,” said Ross Baker, Ph.D., MBA, Vice President, Medical Strategy at Vistagen and a co-author of the research. “Existing therapies remain limited, and these findings reinforce the urgent need for new treatment options. The new research also highlights the critical role of timely diagnosis to improve patient outcomes.”
The key findings from the poster presentations by Vistagen at the ADAA and NEI conferences reveal important insights into SAD, including:
Overall prevalence:
-
SAD affects nearly 31 million adults in the
U.S. -
The prevalence of SAD overall among adults in the
U.S. has increased over time, with the largest increase being among adults in the youngest age group (18–22 years). -
Although the rate of
U.S. adults who experienced SAD has increased over time, the rate of SAD diagnosis has not increased, and treatment rates have decreased. -
More than one in five
U.S. adults surveyed who experienced SAD reported suicidal ideation on more than half the days in the past two weeks and worse mental health quality of life than the generalU.S. adult population. - Over three-quarters of those experiencing SAD reported mild to severe depression.
Subgroup aged 18-22:
-
The prevalence of SAD experienced among
U.S. young adults has increased over time, while the proportion of those treated for SAD has decreased. -
Close to half (
48.1% ) ofU.S. young adults surveyed who reported experiencing SAD also reported suicidal ideation on at least several days in the past 2 weeks, markedly higher than those without SAD (31.6% ). - Those with SAD also had higher rates of depression and worse mental health quality of life than those without SAD.
-
Among those experiencing SAD, economic factors were generally worse than those not experiencing SAD: lower rates of full-time employment; significantly higher rates of household incomes lower than
$50,000 - These findings collectively elucidate the importance of diagnosing/treating SAD and providing social support, as well as various alternative mechanisms to cope with SAD.
Age of onset of SAD in participants in Vistagen’s fasedienol Phase 3 studies completed to date:
-
Approximately
30% of participants in Vistagen’s PALISADE Phase 3 Program studies of fasedienol nasal spray completed to date had a self-reported early onset of SAD in childhood, at 10 years of age or younger. - Remarkably, the time to first treatment for SAD was, on average, 27 years from time of onset for the early-onset group and, on average, 18 years from onset for the adolescent/adult-onset group, underscoring a high unmet need for diagnosis and treatment of SAD, especially among children and adolescents.
- Baseline severity of SAD and psychiatric and treatment histories were similar between early onset and adolescent/adult-onset subjects.
- History of alcohol/drug use was higher in the early-onset group than the adolescent/adult-onset group.
Key Takeaways from this Research:
- Promoting timely diagnosis and treatment of SAD is needed to improve various patient-reported outcomes, including physical and mental health and work productivity.
- Approved treatments for SAD are limited, and new treatments are needed.
- In conjunction with treatments, providing young adults with social support and various alternative mechanisms to cope with SAD is imperative.
- Consumer education on the severity of SAD may also help drive discussions with healthcare providers.
The posters presented by Vistagen at the ADAA and NEI conferences are available on the Publications page of the Company’s website.
About Vistagen
Headquartered in
Pherines specifically and selectively bind as agonists to peripheral receptors in human nasal chemosensory neurons, rapidly activating olfactory bulb-to-brain neurocircuits which regulate brain areas involved in behavior and autonomic nervous system activity. They achieve therapeutic benefits without requiring absorption into blood, or uptake into the brain, giving them a differentiated safety profile vs. other pharmacological options. Vistagen’s neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or developments may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that fasedienol or any of Vistagen’s other product candidates will successfully complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. These risks and others are more fully discussed in the section entitled “Risk Factors” in Vistagen’s Annual Report on Form 10-K for the fiscal year ended March 31, 2024, and Quarterly Report on Form 10-Q for the period ended December 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the
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Investor Inquiries:
Mark A. McPartland
markmcp@vistagen.com
Media Inquiries:
Michelle P.
mwellington@vistagen.com
Source: Vistagen
FAQ
What is the current prevalence of Social Anxiety Disorder (SAD) according to Vistagen's VTGN research?
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What are the economic impacts of SAD on young adults according to Vistagen's research?
