Neurelis was founded to license, develop, and commercialize product candidates for epilepsy, psychiatry, and the broader central nervous system (CNS) market with an emphasis on rescue therapies that empower patients, caregivers, and healthcare providers. Our extensive expertise in the development and commercialization of CNS compounds, combined with our strong relationships with leading researchers and clinicians in these markets, allows us to advance the development of unique product candidates that address significant unmet medical needs.
1996
Diazepam rectal gel approved for use outside medical setting.
Clear unmet need for additional seizure rescue options with different routes of delivery.
Clear unmet need for additional seizure rescue options with different routes of delivery.
Late 1990s - Early 2000s
Various formulation approaches explored for intranasal benzodiazepines.
Multiple challenges encountered with nasal administration.
Multiple challenges encountered with nasal administration.
2007
Neurelis is founded in San Diego, CA.
2009
Neurelis develops a proprietary combination of technologies to address challenges.
Diazepam formulated with technology platform to create NRL-1.
Diazepam formulated with technology platform to create NRL-1.
2010
Angel funding secured.
Pre-clinical trial initiated for NRL-1.
Pre-clinical trial initiated for NRL-1.
2011
Proof-of-concept clinical trials initiated for NRL-1.
Pre-IND meeting with FDA
for NRL-1.
Pre-IND meeting with FDA
for NRL-1.
2012-2014
Additional pre-clinical trials initiated.
Manufacturing facility transfer in preparation for clinical & commercial supply.
Manufacturing facility transfer in preparation for clinical & commercial supply.
2015
Series A financing secured.
Orphan Drug designation granted by FDA.
Orphan Drug designation granted by FDA.
2016
Initiation of
phase 3 clinical program for NRL-1.
Series B financing secured.
NRL-1 granted Fast Track designation by FDA.
phase 3 clinical program for NRL-1.
Series B financing secured.
NRL-1 granted Fast Track designation by FDA.
2017
NRL-1 phase 3 clinical program nears completion.
Preparation for NDA filing
for NRL-1.
Preparation for NDA filing
for NRL-1.