Drugs / AV-101
AV-101
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05280054 | Dec 2021 → Sep 2022 | — | VistaGen Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT01483846 | Dec 2011 → Sep 2012 | neuropathy, painful | VistaGen Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03583554 | Sep 2018 → Oct 2019 | — | Marijn Lijffijt, PhD | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT04147949 | Aug 2022 → Dec 2023 | Parkinson disease, drug-induced dyskinesia | VistaGen Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT03078322 | Mar 2018 → Oct 2019 | major depressive disorder | VistaGen Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02484456 | Oct 2015 → Feb 2019 | major depressive disorder | National Institute of Mental Health (NIMH) | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT05557942 | Nov 2022 → Aug 2024 | pulmonary arterial hypertension | Aerovate Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2022-11-17 | VistaGen Therapeutics, Inc. | Results Vistagen Announces Publication in Cells Demonstrating AV-101’s Potential for Treating Levodopa-Induced Dyskinesia in Patients with Parkinson's Disease vistagen.com ↗
In the preclinical study, AV-101 reduced L-Dopa-induced dyskinesias (LID) by about 25% while maintaining the antiparkinsonian response to L-Dopa. |
| 2020-09-03 | VistaGen Therapeutics, Inc. | Results VistaGen Reports Positive New Data from Second Preclinical Study of AV-101 in Combination with Probenecid vistagen.com ↗
"These new positive results amplify our message that AV-101, when administered in combination with probenecid, has exciting therapeutic potential across a wide range of CNS indications," said Shawn Singh, Chief Executive Officer of VistaGen . |
| 2020-02-11 | VistaGen Therapeutics, Inc. | Results VistaGen Therapeutics Announces Positive Preclinical Data of AV-101 Combined with Probenecid Suggesting Substantially Increased Brain Concentration Effects vistagen.com ↗
The remarkable preclinical data announced today demonstrate a 7-fold concentration increase in the brain of AV-101 prodrug, and, more importantly, a 35-fold increase of 7-Cl-KYNA, AV-101's active metabolite, when AV-101 is administered adjunctively with probenecid. |
| 2020-01-30 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Therapeutics Receives FDA Clearance of IND for Phase 2 Clinical Study of AV-101 as a Potential Treatment of Dyskinesia in Parkinson's Disease Patients vistagen.com ↗
The FDA's IND clearance permits VistaGen to proceed with Phase 2 clinical development of AV-101 in this indication. |
| 2019-12-19 | VistaGen Therapeutics, Inc. | Results VistaGen and Baylor College of Medicine Announce Successful Results of First-Step Target Engagement Study with VistaGen's AV-101 Focused on Treating Suicidal Ideation in Veterans vistagen.com ↗
We interpret the findings of this biomarker study to mean that the high dose of AV-101 was sufficient to reduce NMDA function. |
| 2019-11-14 | VistaGen Therapeutics, Inc. | Results VistaGen Reports Topline Phase 2 Results for AV-101 as an Adjunctive Treatment of Major Depressive Disorder vistagen.com ↗
In this study, the AV-101 treatment arm did not differentiate from placebo on the primary endpoint (change in the Montgomery-Åsberg Depression Rating Scale (MADRS-10) total score compared to baseline). |
| 2019-06-20 | VistaGen Therapeutics, Inc. | Results VistaGen Announces Positive Preclinical Data Supporting AV-101's Potential For Treating Levodopa-Induced Dyskinesia In Patients With Parkinson's Disease, Without The Psychological Side Effects And Safety Concerns Of Amantadine vistagen.com ↗
This study demonstrated that AV-101 significantly (p = 0.01) reduced LID without affecting the timing, extent, or duration of the therapeutic benefits of levodopa. |
| 2019-05-30 | VistaGen Therapeutics, Inc. | Results VistaGen Announces Positive Preclinical Data Supporting AV-101's Potential for Treating Neuropathic Pain Comparable to Pregabalin (Lyrica(R)), without its Side Effects vistagen.com ↗ |
| 2019-05-02 | VistaGen Therapeutics, Inc. | Results VistaGen Reports Top Line Results from NIMH's Exploratory Study of AV-101 Monotherapy for Treatment-Resistant Depression vistagen.com ↗
In the 19-patient study sponsored and conducted by the U.S National Institute of Mental Health (NIMH), AV-101 did not demonstrate significant separation from placebo on the primary outcome measure, the change from baseline in the Hamilton Depression Rating Scale (HDRS) total score compared to placebo. |
| 2019-01-31 | VistaGen Therapeutics, Inc. | Results AV-101 Stimulates the Formation of New Brain Cells in Nonclinical Studies vistagen.com ↗
Robert Schwarcz, Ph.D., Professor of Psychiatry, University of Maryland, Baltimore, and Gloria Hoffman, Ph.D., Professor of Biology, Morgan State University, Baltimore, conducted the rodent studies, which showed increased neurogenesis in the hippocampus following oral daily dosing of AV-101 for 14 -16 days. |
| 2018-10-03 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Therapeutics Receives FDA Fast Track Designation for Development of AV-101 as a Non-Opioid Treatment for Neuropathic Pain vistagen.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for development of AV-101 as a non-opioid, non-sedating treatment for neuropathic pain. |
| 2018-01-03 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Therapeutics Receives FDA Fast Track Designation for AV-101 for the Treatment of Major Depressive Disorder vistagen.com ↗
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AV-101 for development as a potential adjunctive treatment for Major Depressive Disorder (MDD). |
| 2017-10-26 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Announces FDA Authorization to Initiate Phase 2 Study of AV-101 for Major Depressive Disorder vistagen.com ↗ |
| 2017-06-22 | VistaGen Therapeutics, Inc. | Results VistaGen Announces Peer-Reviewed Publication in the Scandinavian Journal of Pain Highlighting Orally-Available AV-101's Excellent Safety Profile and Potential as a Non-Opioid Treatment for Neuropathic Pain vistagen.com ↗
Safety data from both the single and multi-dose Phase 1 studies indicated that oral AV-101 was extremely safe and well tolerated, with no meaningful difference in adverse events (AEs) at any dose between AV-101 and placebo. |
| 2017-04-27 | VistaGen Therapeutics, Inc. | Results VistaGen Therapeutics Announces Peer-Reviewed Publication in The Journal of Pain Highlighting AV-101's Potential for Treating Neuropathic Pain vistagen.com ↗ |
| 2015-09-16 | VistaGen Therapeutics, Inc. | Results Favorable Data on VistaGen Therapeutics' AV-101 for Major Depressive Disorder Published in Peer-reviewed Journal of Pharmacology and Experimental Therapeutics vistagen.com ↗
Data from the published study, which utilized four, widely accepted animal models for evaluating antidepressive drugs, showed rapid, dose-dependent and persistent ketamine-like antidepressant effects following a single treatment. |
| 2015-07-01 | VistaGen Therapeutics, Inc. | Regulatory VistaGen Receives FDA and NIH Clearance to Initiate NIH-Funded Phase 2 Study of Orally Active AV-101 in Major Depressive Disorder vistagen.com ↗ |
| 2013-01-23 | VistaGen Therapeutics, Inc. | Results Vistagen Therapeutics Successfully Completes Final Phase 1 Safety Study of AV-101 vistagen.com ↗
The study results indicate that AV-101 is safe and well tolerated, with favorable bioavailability and pharmacokinetics. |
All press releases naming this drug 47 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AV-101 | “Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder” NCT02484456 ↗ |
| Known as | 4-Chlorokynurenine | “4-Chlorokynurenine (4-Cl-KYN, AV-101) is a prodrug of a NMDA receptor antagonist and is in clinical development for potential CNS indications.” PMID 38261609 ↗ Jan 20242“Antidepressant Effects of the Glycine Receptor Antagonist AV-101 (4-chlorokynurenine) in Major Depressive Disorder” NCT02484456 ↗ “AV-101 (4-chlorokynurenine, 4-Cl-KYN), an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA)” PMID 33318635 ↗ Dec 2020 |
| Known as | 4-Cl-KYN | “4-Chlorokynurenine (4-Cl-KYN, AV-101) is a prodrug of a NMDA receptor antagonist and is in clinical development for potential CNS indications.” PMID 38261609 ↗ Jan 20241“AV-101 (4-chlorokynurenine, 4-Cl-KYN), an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA)” PMID 33318635 ↗ Dec 2020 |
| Known as | imatinib | “AV-101 (imatinib) administered via dry powder inhalation” NCT05557942 ↗ |
| Known as | l-4 chlorokynurenine | “the antidepressant effects of AV 101 (L-4-chlorokynurenine or 4-Cl- KYN) in MDD; this is a synthetic compound which is enzymatically converted into the selective glycine/NMDAR...” NCT02484456 ↗1“A novel oral prodrug, AV-101 (l-4 chlorokynurenine), which, in the brain, is converted into one of the most potent and selective GlyB site antagonists of the NMDAR” PMID 29229209 ↗ Jun 2017 |
| Action | Inhibit | “glycine receptor antagonist AV-101” NCT02484456 ↗ |
| Modality | Small molecule | “this is a synthetic compound” NCT02484456 ↗ |
| Route | Oral | “AV-101 or placebo were administered orally daily for 14 consecutive days” PMID 29229209 ↗ Jun 2017 |