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 Completion currently anticipated year end 2017 H2 2016 H1 2017 H2 2017 H1 2018 NIMH topline results
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 Fast Track designation for AV-101 for MDD
2H 2017
FDA green light for AV-101 Phase 2 MDD adjunctive treatment study
2H 2017
Launch AV-101 Phase 2 MDD adjunctive treatment study
2H 2017
NIMH completion of AV-101 Phase 2 MDD monotherapy study
2H 2018
Launch AV-101 Phase 2 studies in neuropathic pain and LID Parkinson’s
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