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.
2007-08
Neurelis formed in San Diego to address unmet needs for central nervous system disorders
Licensed Intravail® absorption enhancement technology from Aegis Therapeutics
Licensed Intravail® absorption enhancement technology from Aegis Therapeutics
2009-10
Exploration of various formulations to address solubility and bioavailability challenges with nasal delivery
Active ingredient formulated with vitamin E and Intravail® technology to create lead investigational product candidate
Active ingredient formulated with vitamin E and Intravail® technology to create lead investigational product candidate
2011-12
Proof-of-concept clinical trials initiated for lead investigational product candidate
Pre-investigational New Drug (IND) meeting with FDA for lead investigational product candidate
Pre-investigational New Drug (IND) meeting with FDA for lead investigational product candidate
2013-15
Orphan drug designation granted for lead investigational product candidate
Aligned with the FDA to initiate studies for pre-clinical and clinical safety programs for lead investigational product candidate
Aligned with the FDA to initiate studies for pre-clinical and clinical safety programs for lead investigational product candidate
2016-17
Initiated FDA-requested studies in patients for lead investigational product candidate
Lead investigational product candidate granted fast track designation by FDA
Lead investigational product candidate granted fast track designation by FDA
2018-19
New Drug Application (NDA) for lead investigational product candidate filed
Neurelis acquires Aegis Therapeutics
Initiated pre-clinical activities for second and third investigational product candidates
Neurelis acquires Aegis Therapeutics
- Intravail®
- Protek®
- Hydrogel®
Initiated pre-clinical activities for second and third investigational product candidates
2020
FDA Approves first Neurelis product