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Details:
PH94B (fasedienol) is a first-in-class, rapid-onset investigational pherine nasal spray. It is being evaluated for the acute treatment of social anxiety disorder.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2024
Details:
Vistagen intends to use the proceeds for research and development associated with development of its product candidates, including its Phase 3 program for fasedienol, an investigational neuroactive pherine nasal spray, for anxiety in adults with social anxiety disorder.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BVF Partners
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 02, 2023
Details:
PH94B (fasedienol) is a pherine nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic ANS, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons in the brain.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2023
Details:
PH94B (fasedienol) is a pherine nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic ANS, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons in the brain.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 07, 2023
Details:
PH94B (fasedienol) is a pherine nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic ANS, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons in the brain.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 30, 2023
Details:
PH94B (fasedienol) is a pherine nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic ANS, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons in the brain.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2023
Details:
Through the acquisition, Vistagen owns all intellectual property rights to PH94B (aloradine), in Phase 3 development for SAD and Phase 2 development for AjDA, and PH10, in clinical development for MDD, as well as three additional candidates in earlier stages of development.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: VistaGen Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition February 02, 2023
Details:
PH94B (aloradine) is a rapid-onset investigational pherine nasal spray that regulates olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic ANS, without systemic distribution, potentiation of GABA-A or direct activity on CNS neurons.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2023
Details:
PH94B (aloradine) is a first-in-class synthetic investigational neurosteroid developed from proprietary compounds called pherines. PH94B is a nasal spray administered at microgram-level doses and designed to achieve rapid-onset anti-anxiety, or anxiolytic, effects.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2022
Details:
PH94B (aloradine) is a first-in-class synthetic investigational neurosteroid developed from proprietary compounds called pherines. With its novel MOA, PH94B is a nasal spray designed to achieve rapid-onset anti-anxiety, or anxiolytic, effects.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: VistaGen Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 21, 2022
Details:
In the presented study, Vistagen compared the effect of intranasal administration of PH94B (aloradine) and steroidal hormones on the electrical activity (the electrogram) of the nasal chemosensory mucosa and on biomarkers of autonomic nervous system activity.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
PH94B (aloradine) is an innovative, fast-acting, odorless pherine administered intranasally at microgram doses,demonstrated tolerability in PALISADE-1 that was consistent with reported results from previous clinical trials.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2022
Details:
Although trial did not meet its primary endpoint, tolerability profile of PH94B (aloradine) in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials. No severe or serious adverse events were reported in prior clinical trials.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2022
Details:
PH94B (aloradine) is first-in-class, odorless, tasteless, rapid-onset (approximately 15 minutes) investigational pherine nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of sympathetic autonomic nervous system.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Aloradine (PH94B) is a first-in-class, odorless, tasteless rapid-onset investigational pherine nasal spray with MOA that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: Aloradine
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
The FDA also agreed that additional nonclinical studies are not necessary to evaluate the abuse potential of PH94B (aloradine) and, at this time, based on studies completed to date, a human abuse potential (HAP) study with PH94B is not required.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Preclinical data demonstrate that intranasal radiolabelled-PH94B is largely confined to nasal passages where it stimulates chemosensory neurons located in nasal epithelium.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2022
Details:
PH94B is an investigational pherine nasal spray with a unique potential mechanism of action designed to achieve rapid-onset anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects and safety concerns.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2021
Details:
Preclinical tissue distribution study in laboratory rats demonstrating that a single intranasal administration of radiolabeled carbon-14 PH94B ([14C]PH94B) was largely confined to the nasal passages and minimal or undetectable in most other tissues, including the CNS.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2021
Details:
PH94B is designed with potential to provide rapid-onset acute treatment of anxiety for millions of individuals suffering from social anxiety disorder (SAD) without directly activating gamma-amino butyric acid (GABA-A) receptors.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
PH94B is an innovative odorless synthetic neuroactive steroid nasal spray with therapeutic potential in a wide range of mental health disorders involving anxiety or phobia. New electrophysiological data demonstrate that PH94B does not directly modulate GABA receptors.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
EverInsight brings with it a strong team and portfolio in neurological and psychiatric disorders, including its neurosteroid nasal spray, PH94B, which is moving into Phase 3 development for social anxiety disorder with licensing rights from VistaGen Therapeutics.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: EverInsight Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger October 14, 2020
Details:
VistaGen currently intends to use the net proceeds from the offering for the continued development of its CNS pipeline programs, general research and development, working capital and general corporate purposes.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maxim Group LLC
Deal Size: $12.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering August 05, 2020
Details:
EverInsight is responsible for clinical development, regulatory submissions and commercialization of PH94B, VistaGen's rapid-onset neuroactive nasal spray, for acute treatment of anxiety in adults with social anxiety disorder, in Greater China South Korea and Southeast Asia.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: EverInsight Therapeutics
Deal Size: Undisclosed Upfront Cash: $5.0 million
Deal Type: Licensing Agreement August 04, 2020
Details:
VistaGen currently intends to use the net proceeds from the offering to fund continued development of its CNS pipeline programs, and for general research and development, working capital and general corporate purposes.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maxim Group LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Public Offering July 31, 2020
Details:
VistaGen and the FDA reached consensus on key aspects of a unique initial pivotal Phase 3 clinical trial of PH94B involving a single-event, laboratory-simulated public speaking challenge in adult patients with SAD.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 23, 2020
Details:
Collaboration intended to support Phase 3 development and commercialization of PH94B in key Asian markets
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: PH94B
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: EverInsight Therapeutics
Deal Size: $177.0 million Upfront Cash: $5.0 million
Deal Type: Collaboration June 25, 2020
Details:
The proposed Phase 2A study of PH94B will an open-label basis and involve approximately 30 patients suffering from adjustment disorder with anxiety from stressors related to the pandemic.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
VistaGen plans to submit its proposed protocol for a Phase 2 study of PH94B for treatment of adjustment disorder to the U.S. FDA through the FDA's new Coronavirus Treatment Acceleration Program.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2020
Details:
VistaGen plans to use proceeds for general corporate purposes, including ongoing preparation for Phase 3 clinical development of PH94B neuroactive nasal spray.
Lead Product(s): Fasedienol
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lincoln Park Capital Fund
Deal Size: $10.2 million Upfront Cash: Undisclosed
Deal Type: Agreement March 25, 2020
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