Neurelis was founded to license, develop, and commercialize product candidates for the broader central nervous system (CNS), including epilepsy and psychiatry. Our emphasis is on highly differentiated therapies that empower patients, care partners, and healthcare providers. The benefits of our unique platform technology allow us to form strategic partnerships to address significant unmet needs in other therapeutic areas as well.
Late 1990s - Early 2000s
Diazepam rectal gel FDA-approved for use outside medical setting.
Intranasal administration of benzodiazepines explored extensively.
Multiple challenges encountered with nasal administration.
Intranasal administration of benzodiazepines explored extensively.
Multiple challenges encountered with nasal administration.
2007
Neurelis is founded in San Diego, CA.
2009
Neurelis develops a proprietary combination of technologies to address drug delivery challenges.
Diazepam formulated with technology platform to create VALTOCOTM (diazepam nasal spray).
Diazepam formulated with technology platform to create VALTOCOTM (diazepam nasal spray).
2010
Angel funding secured.
Pre-clinical trial initiated for VALTOCO nasal spray.
Pre-clinical trial initiated for VALTOCO nasal spray.
2011
Proof-of-concept clinical trials initiated for VALTOCO nasal spray.
Pre-IND meeting with FDA
for VALTOCO nasal spray.
Pre-IND meeting with FDA
for VALTOCO nasal spray.
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 VALTOCO nasal spray.
Series B financing secured.
VALTOCO nasal spray granted Fast Track designation by FDA.
Series B financing secured.
VALTOCO nasal spray granted Fast Track designation by FDA.
2017
VALTOCO nasal spray phase 3 clinical program nears completion.
Preparation for NDA filing
for VALTOCO nasal spray.
Preparation for NDA filing
for VALTOCO nasal spray.
2018
New Drug Application (NDA) for VALTOCO nasal spray filed with the FDA.
Neurelis acquires Aegis Therapeutics.
Neurelis acquires Aegis Therapeutics.