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Vistagen (VTGN) has initiated a repeat dose study for fasedienol, its investigational nasal spray for treating Social Anxiety Disorder (SAD). The exploratory Phase 2 trial will evaluate the efficacy, safety, and tolerability of repeat doses in adults with SAD during public speaking challenges.
The multi-center, randomized, double-blind, placebo-controlled study includes three arms: fasedienol followed by fasedienol (6.4 micrograms total), fasedienol followed by placebo (3.2 micrograms total), and placebo followed by placebo. The second dose will be administered ten minutes after the initial dose. The study design mirrors the ongoing PALISADE Phase 3 studies, including an open-label extension.
Vistagen (VTGN) ha avviato uno studio a dosi ripetute per fasedienol, il suo spray nasale in fase di studio per il trattamento del Disturbo d'Ansia Sociale (SAD). La sperimentazione esplorativa di Fase 2 valuterà l'efficacia, la sicurezza e la tollerabilità delle dosi ripetute in adulti con SAD durante sfide di parlare in pubblico.
Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo include tre braccia: fasedienol seguito da fasedienol (6,4 microgrammi totali), fasedienol seguito da placebo (3,2 microgrammi totali) e placebo seguito da placebo. La seconda dose sarà somministrata dieci minuti dopo la dose iniziale. Il design dello studio rispecchia gli ongoing studi di Fase 3 PALISADE, inclusa un'estensione in aperto.
Vistagen (VTGN) ha iniciado un estudio de dosis repetidas para fasedienol, su aerosol nasal en investigación para el tratamiento del Trastorno de Ansiedad Social (SAD). El ensayo exploratorio de Fase 2 evaluará la eficacia, seguridad y tolerabilidad de las dosis repetidas en adultos con SAD durante desafíos de hablar en público.
El estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo incluye tres grupos: fasedienol seguido de fasedienol (6.4 microgramos totales), fasedienol seguido de placebo (3.2 microgramos totales) y placebo seguido de placebo. La segunda dosis se administrará diez minutos después de la dosis inicial. El diseño del estudio refleja los estudios en curso de Fase 3 PALISADE, incluida una extensión abierta.
비스타겐 (VTGN)은 사회 불안 장애 (SAD) 치료를 위한 실험적인 비강 스프레이인 파세디에놀에 대한 반복 투여 연구를 시작했습니다. 탐색적 2상 시험은 공개 연설 과제 중 SAD를 앓고 있는 성인에서 반복 투여의 효과, 안전성 및 내약성을 평가할 것입니다.
다기관, 무작위 배정, 이중 맹검, 위약 대조 연구는 세 가지 그룹으로 구성됩니다: 파세디에놀 뒤에 파세디에놀 (총 6.4 마이크로그램), 파세디에놀 뒤에 위약 (총 3.2 마이크로그램), 그리고 위약 뒤에 위약. 두 번째 용량은 초기 용량 후 10분에 투여됩니다. 연구 설계는 PALISADE 3상 연구의 진행 중인 부분을 반영하며, 개방형 확장이 포함됩니다.
Vistagen (VTGN) a lancé une étude de doses répétées pour fasedienol, son spray nasal expérimental pour le traitement du trouble d'anxiété sociale (SAD). L'essai exploratoire de phase 2 évaluera l'efficacité, la sécurité et la tolérance des doses répétées chez des adultes souffrant de SAD lors de défis de prise de parole en public.
L'étude multicentrique, randomisée, en double aveugle et contrôlée par placebo comprend trois bras : fasedienol suivi de fasedienol (total de 6,4 microgrammes), fasedienol suivi de placebo (total de 3,2 microgrammes) et placebo suivi de placebo. La deuxième dose sera administrée dix minutes après la dose initiale. La conception de l'étude reflète les études en cours PALISADE de phase 3, y compris une extension en ouvert.
Vistagen (VTGN) hat eine Studie zur Wiederholungsdosis für Fasedienol initiiert, sein investigatives Nasenspray zur Behandlung der Sozialen Angststörung (SAD). Die explorative Phase-2-Studie wird die Wirksamkeit, Sicherheit und Verträglichkeit von Wiederholungsdosen bei Erwachsenen mit SAD während öffentlicher Redeschallenges bewerten.
Die multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie umfasst drei Gruppen: Fasedienol gefolgt von Fasedienol (insgesamt 6,4 Mikrogramm), Fasedienol gefolgt von Placebo (insgesamt 3,2 Mikrogramm) und Placebo gefolgt von Placebo. Die zweite Dosis wird zehn Minuten nach der ersten Dosis verabreicht. Das Studiendesign spiegelt die laufenden PALISADE-Studien der Phase 3 wider, einschließlich einer offenen Erweiterung.
Positive
All planned clinical studies in fasedienol Phase 3 program are now underway
Study expands potential therapeutic applications by testing repeat dosing
Negative
None.
Insights
This Phase 2 repeat dose study represents a strategic expansion of Vistagen's clinical development program for fasedienol. The trial design incorporating multiple dose arms (3.2 micrograms and 6.4 micrograms) will provide important data on dose-response relationships and potential additive benefits of repeat administration. The double-blind, placebo-controlled methodology adds scientific rigor.
The public speaking challenge model is particularly relevant for SAD evaluation, as it simulates real-world anxiety-provoking situations. The inclusion of an open-label extension phase will generate valuable long-term safety data. Most notably, this study could help optimize the dosing protocol for the ongoing Phase 3 PALISADE trials.
For context, social anxiety disorder affects approximately 15 million adults in the U.S., with current treatments to chronic SSRIs or benzodiazepines. An FDA-approved acute treatment would be groundbreaking for this underserved market. Think of it like having an EpiPen for anxiety attacks - an as-needed rescue medication that could transform how SAD is managed.
The nose-to-brain delivery mechanism of fasedienol is particularly innovative. This pherine nasal spray leverages the direct neural pathways between nasal passages and emotional processing centers in the brain, potentially enabling rapid onset of action - critical for acute anxiety treatment. The 10-minute interval between doses in this study is specifically designed to align with these neural kinetics.
The inclusion of both single and double dose arms (3.2μg vs 6.4μg total) will help establish the optimal therapeutic window while managing safety considerations. Like adjusting the volume on a speaker, finding the right "signal strength" is important - too little won't help, too much might cause side effects.
All planned clinical studies in fasedienol U.S. registration-directed Phase 3 program for the acute treatment of social anxiety disorder are underway
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in a repeat dose study of fasedienol, its investigational neuroactive pherine nasal spray in Phase 3 development for the acute treatment of social anxiety disorder (SAD).
The repeat dose study is a small exploratory U.S. Phase 2 multi-center, randomized, double-blind, placebo-controlled, three-arm clinical trial designed to assess the efficacy, safety, and tolerability of a repeat dose of fasedienol (3.2 micrograms) in adults with SAD during a public speaking challenge conducted in a clinical setting. The three dosing arms will be fasedienol followed by fasedienol (total 6.4 micrograms), fasedienol followed by placebo (total 3.2 micrograms), and placebo followed by placebo, with the second dose in each arm administered ten minutes after the initial dose. Other than the repeat dose and the additional study arm, the study is similar in design to the ongoing PALISADE Phase 3 studies for the acute treatment of adults with SAD, including an open-label extension.
"The initiation of this fasedienol repeat dose study marks another significant milestone in our U.S. Phase 3 program for the acute treatment of social anxiety disorder,” said Shawn Singh, President and Chief Executive Officer of Vistagen. “With the increasing prevalence of social anxiety disorder over decades, millions of individuals in the U.S. live with debilitating acute fear and anxiety in everyday social situations without any U.S. FDA-approved acute treatment option. Our mission and PALISADE Phase 3 program for fasedienol are focused on changing that."
About Vistagen’s U.S. Registration-directed PALISADE Phase 3 Program for Fasedienol for the Acute Treatment of Social Anxiety Disorder
Complementing its statistically significant PALISADE-2 U.S. Phase 3 trial of fasedienol for the acute treatment of adults with SAD reported in 2023, Vistagen's U.S. registration-directed PALISADE Phase 3 program for fasedienol for the acute treatment of SAD includes its ongoing PALISADE-3 and PALISADE-4 U.S. Phase 3 trials and a small U.S. Phase 2 repeat dose study. PALISADE-3 and PALISADE-4 are each a multi-center randomized, double-blind, placebo-controlled Phase 3 trial designed similarly to PALISADE-2 to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in subjects with SAD induced by a public speaking challenge conducted in a clinical setting. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD.
About Fasedienol Nasal Spray for the Acute Treatment of Social Anxiety Disorder
Fasedienol is a potential first-in-class, investigational neurocircuitry-focused pherine nasal spray designed to have rapid onset with a novel mechanism of action (MOA) that is differentiated from all currently approved anxiety medications. Fasedienol is designed to regulate the olfactory-amygdala neural circuits of fear and anxiety and attenuate the tone of the sympathetic autonomic nervous system without systemic absorption, potentiation of GABA-A receptors, or binding to neurons in the brain. Vistagen’s U.S. registration-directed PALISADE Phase 3 program for fasedienol is focused on the acute treatment of SAD. There is no U.S. FDA-approved acute treatment for SAD, and the U.S. FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of SAD.
About Vistagen
Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of a new class of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate brain neurocircuitry through the olfactory system to achieve desired therapeutic benefits. Pherines do not require systemic absorption or binding to neurons in the brain, which may contribute to a favorable safety profile. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, 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 disorders, 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 U.S. 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 timelines, 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 any of Vistagen’s product candidates will successfully complete ongoing or future clinical trials within the timeframe estimated by Vistagen or at all, receive regulatory approval or be commercially successful, or that Vistagen will be able to successfully replicate the result of past studies of its product candidate fasedienol or its other product candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including trials that are a part of Vistagen’s PALISADE Phase 3 development program for fasedienol; Vistagen’s submission of a NDA to the U.S. FDA for any product candidate, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the U.S. FDA to support a NDA; the availability as well as the scope and enforceability of Vistagen’s patents in the U.S. and elsewhere, including patents related to Vistagen’s pherine product candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct Vistagen’s ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen’s product candidates. These risks are more fully discussed in the section entitled “Risk Factors” in Vistagen’s most recent 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 September 30, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen’s SEC filings are available on the SEC’s website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.
What is the purpose of Vistagen's (VTGN) new fasedienol repeat dose study?
The study aims to assess the efficacy, safety, and tolerability of repeat doses of fasedienol nasal spray in adults with Social Anxiety Disorder during public speaking challenges.
What are the dosing arms in VTGN's new fasedienol study?
The study has three arms: fasedienol+fasedienol (6.4 micrograms), fasedienol+placebo (3.2 micrograms), and placebo+placebo, with second doses given 10 minutes after initial doses.
How does the new VTGN fasedienol study relate to the PALISADE Phase 3 trials?
The repeat dose study follows a similar design to the ongoing PALISADE Phase 3 studies, including an open-label extension, but adds the repeat dosing component and an additional study arm.
What is the current development stage of VTGN's fasedienol for Social Anxiety Disorder?
Fasedienol is in Phase 3 development for acute treatment of Social Anxiety Disorder, with all planned clinical studies in the U.S. registration-directed program now underway.
