About Intepirdine (RVT-101)
Intepirdine (RVT-101) is an investigational drug candidate that has the potential to be a best-in-class, once-daily, orally-administered neurotransmitter-targeted therapy to improve cognition and daily functioning in people living with dementia. Intepirdine has a number of favorable properties as a product candidate for dementia.
Favorable safety and tolerability profile observed with more than 1,300 human subjects exposed to intepirdine
Immediate and sustained efficacy observed for at least 48 weeks over placebo in the Phase 2b clinical trial for intepirdine
If approved, intepirdine will offer patients oral, once-daily dosing, without the need for PET imaging, MRI monitoring or IV infusions
Intepirdine (RVT-101) Clinical Trials
Intepirdine (RVT-101) is currently undergoing a Phase 3 international, multi-center, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of intepirdine in patients with mild-to-moderate Alzheimer’s disease called the MINDSET study. If this study is successful, it could lead to the approval of intepirdine in the US and the EU for patients with mild-to-moderate Alzheimer’s disease.
Intepirdine is also currently undergoing a Phase 2b multi-center, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of intepirdine in patients with dementia with Lewy bodies called the HEADWAY-DLB study.
Intepirdine is also currently undergoing a Phase 2, multi-center, double-blind, placebo-controlled crossover study evaluating its effect on gait and balance in patients with dementia. In this study, Axovant intends to further investigate the observation of a reduced rate of falls seen in patients treated with intepirdine in the prior 684-patient study of intepirdine on a background of stable donepezil therapy
Intepirdine (RVT-101) is an investigational new drug candidate and is not approved for any indication in any markets.