Luka, college student living with epilepsy
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 people with neurological conditions, 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, LLC
Licensed Intravail® absorption enhancement technology from Aegis Therapeutics, LLC
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
2013-15
Orphan drug designation granted 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
Filed New Drug Application (NDA) for lead investigational product candidate
Neurelis acquires Aegis Therapeutics, LLC
Advanced proprietary pipeline
Neurelis acquires Aegis Therapeutics, LLC
- Intravail®
- ProTek®
- Hydrogel™
Advanced proprietary pipeline
2020
FDA approves first Neurelis product and grants Orphan Drug Exclusivity
Early availability of first Neurelis product through specialty pharmacy
Completed commercial build-out & launch of first Neurelis product
Achieved coverage of >175M insured U.S. lives in 3 months for first Neurelis product
Extended expiration of first Neurelis product to 24 months
Expanded access to first Neurelis product through retail pharmacies
Early availability of first Neurelis product through specialty pharmacy
Completed commercial build-out & launch of first Neurelis product
Achieved coverage of >175M insured U.S. lives in 3 months for first Neurelis product
Extended expiration of first Neurelis product to 24 months
Expanded access to first Neurelis product through retail pharmacies
2021
94% (>285M) of insured lives in U.S. covered for first Neurelis product
Surpassed 50k cartons prescribed within one year of launch for first Neurelis product
Initiated label expansion program for first Neurelis product
Surpassed 50k cartons prescribed within one year of launch for first Neurelis product
Initiated label expansion program for first Neurelis product