Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AV-101 · 3 trials · 3 indications
Depression questionnaire
Mean power (in microVolt squared; uV\^2) of 40-Hz Auditory Steady State Response (ASSR; an auditory task using 40Hz click trains) calculated across 38-42Hz. Mean +/- SE across pre-treatment baseline and 4 post-treatment measures one every hour controlled for time, with outcomes the mean per treatment arm obtained from Linear Mixed Model analysis.
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 |
| Placebo, then AV-101 720mg, then AV-101 1440mg | PLACEBO_COMPARATOR | Participants first received oral placebo. After at least 3 days wash-out participants get oral AV-101 720mg (matching placebo capsules). After at least 3 days wash-out participants get oral AV-101 1440mg (matching placebo capsules). |
| AV-101 720mg, then AV-101 1440mg, then placebo | EXPERIMENTAL | Participants first received oral AV-101 720mg (matching placebo capsules). After at least 3 days wash-out participants get oral AV-101 1440mg (matching placebo capsules). After at least 3 days wash-out participants get oral placebo. |
| AV-101 1440mg, then placebo, then AV-101 720mg | EXPERIMENTAL | Participants first received oral AV-101 1440mg (matching placebo capsules). After at least 3 days wash-out participants get oral placebo. After at least 3 days wash-out participants get oral AV-101 720mg (matching placebo capsules). |
| 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) |
| AV-101 720 mg | DRUG | Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules |
| AV-101 1440 mg | DRUG | Single dose of 4 360 mg AV-101 oral capsules |
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. It has been studied in healthy volunteers, major depressive disorder, and neuropathic pain. AV-101 is also known as AV-101 720 mg. It remains in clinical development and is not an approved therapy.
AV-101 has been studied for major depressive disorder and neuropathic pain, and in healthy volunteers for biomarker and pharmacokinetic research. Its development programs have included an adjunct antidepressant therapy study in major depression and a safety, tolerability, and pharmacokinetics study in neuropathic pain.
AV-101 is developed by Vistagen Therapeutics, Inc., which trades under the ticker VTGN. The company has sponsored the clinical trials evaluating AV-101 in healthy volunteers, major depressive disorder, and neuropathic pain.
AV-101 is in Phase 1 development. Its clinical program includes Phase 1 studies in healthy volunteers and a Phase 2 study in major depressive disorder, all of which are completed. AV-101 is investigational and has not been approved for any indication.
AV-101 has been evaluated in completed trials including NCT03583554, an electrophysiological biomarkers study in healthy volunteers; NCT03078322, a Phase 2 adjunct antidepressant therapy trial in major depressive disorder; and NCT01483846, a Phase 1 safety, tolerability, and pharmacokinetics study in healthy volunteers.