A New Generation Oral Antidepressant

AV-101(4-CI-KYN)
H1 2016 H2 2016 H1 2017 H2 2017 H1 2018
Phase 2 Monotherapy Treatment
Major Depressive Disorder
H1 2016 NIMH Phase 2 monotherapy study completion expected early 2018 H2 2016 H1 2017 H2 2017 H1 2018
H2 2017 H1 2018 H2 2018 H1 2019
Phase 2 Adjunctive Treatment
Major Depressive Disorder
H2 2017 Clinical Site Preparation & FDA Approval to Launch H1 2018 Launch and completion anticipated in 2018 H2 2018 H1 2019 Topline results
2H 2017
FDA green light for AV-101 Phase 2 MDD adjunctive treatment study
1H 2018
FDA Fast Track designation for AV-101 for MDD
1H 2018
LAUNCH AV-101 PHASE 2 MDD ADJUNCTIVE TREATMENT STUDY
1H 2018
Completion of NIMH AV-101 Phase 2 MDD monotherapy study
2H 2018
Completion of AV-101 Phase 2 MDD adjunctive treatment study
1H 2019
AV-101 Phase 2 MDD adjunctive treatment study topline results

Potential to expand av-101 into multiple cns indications, each representing a blockbuster opportunity

Neuropsychiatric Disorders

  • Depression
  • Bipolar Disorder

Neurological Disorders

  • Chronic Neuropathic Pain
  • Epilepsy

Neurodegenerative Disorders

  • Huntington's Disease
  • Parkinson's Disease