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AV-101

DRUG6 trials

Sponsors

VistaGen Therapeutics, Inc., Aerovate Therapeutics

Conditions

Drug Drug InteractionDyskinesia, Medication-InducedL-Dopa Causing Adverse Effects in Therapeutic UseMajor Depressive DisorderNeuropathic PainParkinson DiseasePulmonary Arterial Hypertension

Phase 1

Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
CompletedNCT01483846
VistaGen Therapeutics, Inc.Neuropathic Pain
Start: 2011-12-31End: 2012-09-30Updated: 2012-12-20
AV-101 Alone and in Combination With Probenecid in Healthy Subjects
NCT05280054
VistaGen Therapeutics, Inc.Drug Drug Interaction
Start: 2021-12-23End: 2022-11-01Target: 24Updated: 2022-03-15

Phase 2

AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
CompletedNCT03078322
VistaGen Therapeutics, Inc.Major Depressive Disorder
Start: 2018-03-05End: 2019-10-01Updated: 2019-10-09
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
NCT04147949
VistaGen Therapeutics, Inc.Dyskinesia, Medication-Induced, L-Dopa Causing Adverse Effects in Therapeutic Use, Parkinson Disease
Start: 2022-08-31End: 2024-04-30Target: 20Updated: 2021-05-26
A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)
TerminatedNCT05036135
Aerovate TherapeuticsPulmonary Arterial Hypertension
Start: 2021-12-02End: 2024-08-09Updated: 2024-08-23

Phase 3

Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)
TerminatedNCT05557942
Aerovate TherapeuticsPulmonary Arterial Hypertension
Start: 2022-11-02End: 2024-08-08Updated: 2024-10-10

Related Papers

Phase 2b trial of inhaled imatinib for treatment of pulmonary arterial hypertension
American Journal of Respiratory and Critical Care Medicine2026-01-05
IMPAHCT: A randomized phase 2b/3 study of inhaled imatinib for pulmonary arterial hypertension
Pulmonary Circulation2024-01-0110 citations
AV-101, a novel inhaled dry-powder formulation of imatinib, in healthy adult participants: a phase 1 single and multiple ascending dose study
ERJ Open Research2022-11-1024 citations
Randomized, double-blind, placebo-controlled, dose-escalation study: Investigation of the safety, pharmacokinetics, and antihyperalgesic activity of l-4-chlorokynurenine in healthy volunteers.
2017-06-1529 citations