AV-101 is under clinical development by VistaGen Therapeutics and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect AV-101’s likelihood of approval (LoA) and phase transition for Drug-Induced Dyskinesia took place on 22 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 22 Mar 2022 increased AV-101’s Phase Transition Success Rate (PTSR) for Neuropathic Pain (Neuralgia).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their AV-101 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

AV-101 overview

AV-101 is under development for the treatment of neuropathic pain, dyskinesia associated with levodopa therapy for Parkinson’s disease, major depressive disorder and suicidal ideation, epilepsy. The drug candidate is administered orally as a capsule. AV-101 is a pro-drug that is converted in the brain into an active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA). It acts by targeting NMDA receptors and AMPA receptors. It was under development for treatment resistant depression and Huntington's disease.

VistaGen Therapeutics overview

VistaGen Therapeutics (VistaGen) is a clinical stage biopharmaceutical company that develops new generation medicines for depression and neuropsychiatric disorders. The company’s pipeline product, AV-101, currently under Phase 2 clinical development, is an oral N-methyl-D-aspartate receptor glycine B intended to treat the major depressive disorder. Its other pipeline products comprise of PH94B treats social anxiety disorder and PH10 nasal spray treats for major depressive disorder. The company offers its products in the form of sprays and oral. It partners with other healthcare industries for researching and assessing drug effects on cardiac risk. VistaGen is headquartered in South San Francisco, California, the US.

Quick View AV-101 LOA Data

Report Segments
  • Innovator
Drug Name
  • AV-101
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
Key Developers
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.