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Also known as L-4-chlorokynurenine, L-4-Cl-KYN
AV-101 · 2 trials · 2 indications
Depression questionnaire
To evaluate pharmacokinetics of three dose levels of orally-administered AV-101 given once a day for 14 days in healthy volunteers by measuring Cmax, half-life, Tmax, and AUC.
To evaluate the safety of three dose levels of orally-administered AV-101 given once a day for 14 days in healthy volunteers by evaluating the number of subjects with treatment-emergent adverse events and changes from baseline to end of study in vital signs, hematology, hepatic profile, renal profile, urinalysis, and clinical laboratory parameters.
| Arm | Type | Description |
|---|---|---|
| AV-101 | EXPERIMENTAL | L-4-chlorokynurenine 1440 mg daily for 14 days |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| microcrystalline cellulose | PLACEBO_COMPARATOR | Subjects will be randomized into one of three cohorts (360, 1,080, and 1,440 mg) to receive a daily oral dose for 14 consecutive days. Each cohort will have 12 subjects on active drug and 4 subjects on placebo. |
| Name | Type | Description |
|---|---|---|
| AV-101 | DRUG | Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| Placebo | DRUG | Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
Inclusion Criteria: * Diagnosed with MDD, single or recurrent, and currently experiencing a MDE of at least 8 weeks in duration. * Has a history of inadequate response to at least 1 approved antidepressant including at least 1 and no more than 3 during the current depressive episode. * Meet the thr...
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AV-101 is an investigational small molecule being developed by Vistagen Therapeutics, Inc. (ticker VTGN) for Major Depressive Disorder and Neuropathic Pain. It is in Phase 2 clinical development and is designed as an antagonist targeting the NMDA receptor subunits GRIN1, GRIN2A, GRIN2B, GRIN2C, GRIN2D, and GRIN3B.
AV-101 is being studied as an adjunct antidepressant therapy in patients with Major Depressive Disorder. A completed Phase 2 trial, NCT03078322, evaluated AV-101 as adjunct antidepressant therapy in 180 patients with major depression in the United States. The drug is also being explored for Neuropathic Pain.
AV-101 targets the NMDA receptor, specifically the GRIN1, GRIN2A, GRIN2B, GRIN2C, GRIN2D, and GRIN3B subunits. It acts as an antagonist at these targets. This mechanism is being investigated for its potential role in Major Depressive Disorder and Neuropathic Pain.
AV-101 is being developed by Vistagen Therapeutics, Inc., which trades under the ticker VTGN. The company is responsible for the clinical development of AV-101 in psychiatry, including its Phase 2 program in Major Depressive Disorder and Neuropathic Pain.
AV-101 is in Phase 2 clinical development. It has completed a Phase 2 trial in Major Depressive Disorder and a Phase 1 trial in healthy volunteers for Neuropathic Pain. AV-101 is investigational and has not been approved by the FDA for any indication.
AV-101 has been studied in two completed trials. NCT03078322 was a Phase 2, randomized, double-blind, placebo-controlled trial of AV-101 as adjunct antidepressant therapy in 180 patients with Major Depressive Disorder. NCT01483846 was a Phase 1 trial evaluating safety, tolerability, and pharmacokinetics of multiple doses in 50 healthy volunteers for Neuropathic Pain.