Neurelis
Neurelis is a San Diego-based specialty pharmaceutical company that develops and commercializes intranasal therapies for neurological conditions, led by VALTOCO (diazepam nasal spray) for acute seizure clusters in patients aged two and older, and supported by proprietary Intravail®, ProTek®, and Hydrogel™ drug delivery platforms licensed to multiple partners.
- Company typePrivate
- Founded2007
- HeadquartersSan Diego, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What Neurelis does
Neurelis is a San Diego-based, privately held specialty pharmaceutical company founded in 2007 that develops and commercializes non-invasive intranasal therapies for neurological conditions. Its flagship product, VALTOCO (diazepam nasal spray), is the first FDA-approved nasal spray for the acute treatment of seizure clusters in patients aged two years and older, having received FDA approval and Orphan Drug Exclusivity in 2020 and a pediatric label expansion to ages 2-5 in April 2025. VALTOCO achieved 94% coverage of US insured lives (285+ million) within its first year on the market, with over 50,000 cartons prescribed and 12,000+ pediatric patients treated post-expansion.
The company's underlying value rests on three proprietary drug delivery technology platforms — Intravail® (transmucosal absorption enhancement), ProTek® (protein stabilization reducing immunogenicity), and Hydrogel™ (thixotropic delivery vehicle) — acquired through the 2019 purchase of Aegis Therapeutics, LLC. Beyond the direct VALTOCO franchise, these platforms are licensed to third parties and have produced FDA-approved products including TOSYMRA (Tonix Pharmaceuticals/Dr. Reddy's, acute migraine), OPVEE (Indivior, opioid overdose reversal), and neffy (ARS Pharmaceuticals, severe allergic reactions). Neurelis is also advancing two Phase 1 pipeline assets: NRL-1004 (intranasal olanzapine for acute agitation in schizophrenia/bipolar) and NRL-1049 (a Rho kinase inhibitor for cerebral cavernous malformations licensed from BioAxone).
Neurelis generates revenue primarily through VALTOCO product sales distributed via specialty pharmacy and retail pharmacy channels, supplemented by myNEURELIS — a patient support program offering nurse educators, insurance navigation, and savings programs. International revenue is captured through licensing partnerships with Aculys Pharma (nine Asia-Pacific markets) and China Medical System (Greater China). The company reported 2025 net revenue of $295-300M (more than doubling 2024) with EBITDA margins exceeding 30%, supported by a $175M+ cash position and no bank debt. The business model combines direct US commercial sales with a technology royalty stream, an emerging ex-US licensing footprint, and a CNS-focused pipeline leveraging the Intravail platform.
Neurelis firmographics
Firmographics- Name
- Neurelis
- Legal name
- Neurelis, Inc.
- Website
- https://neurelis.com
- Company type
- Private
- Founded year
- 2007
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Neurelis is a San Diego-based specialty pharmaceutical company that develops and commercializes intranasal therapies for neurological conditions, led by VALTOCO (diazepam nasal spray) for acute seizure clusters in patients aged two and older, and supported by proprietary Intravail®, ProTek®, and Hydrogel™ drug delivery platforms licensed to multiple partners.
- Ownership category
- akta.pro rank
Neurelis industry classification
Industry- Product category
- Specialty Pharmaceuticals — Neurology / Epilepsy
- NAICS
- Pharmaceutical Preparation Manufacturing (325412), Medical Equipment and Supplies Manufacturing (3391)
- SIC
- Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)
- akta.pro secondary industries
- Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Nasal Drug Delivery Devices (Sprays/Powder Devices) (HLAHAIAK)
Keywords
Where Neurelis is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Neurelis business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Operations
Revenue model
- VALTOCO Product Sales: Primary revenue stream from direct sales of VALTOCO (intranasal diazepam) for acute seizure clusters, distributed through specialty pharmacy channels
- Intravail® Technology Licensing Royalties: Royalty income from licensing proprietary drug delivery technology to pharmaceutical partners for their products (TOSYMRA, OPVEE, neffy)
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Patient assistance and support program |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels3 records
Neurelis product offering
Product offeringCore offering
Neurelis develops and commercializes specialty neurology therapeutics, with its flagship product VALTOCO (diazepam nasal spray) approved by the FDA for the acute treatment of seizure clusters in patients aged 2 and older. The company also monetizes its proprietary non-invasive drug delivery technology platforms (Intravail®, ProTek®, Hydrogel™) through licensing partnerships with pharmaceutical companies whose products (TOSYMRA, OPVEE, NEFFY) use these technologies.
Product overview
Neurelis is a neuroscience company with a diversified portfolio centered on its proprietary drug delivery technologies (Intravail, ProTek, Hydrogel) and a growing pipeline of CNS therapeutics. The commercial flagship is VALTOCO (diazepam nasal spray), FDA-approved for seizure clusters in patients 2+, while the proprietary pipeline includes NRL-1004 (Phase 1 acute agitation) and NRL-1049 (Phase 1 cerebral cavernous malformations). Technology licensing to partners has generated approved products including TOSYMRA, OPVEE, and NEFFY. The company also operates myNEURELIS, a patient support program for VALTOCO users.
Differentiator
Problem solved
Functional benefit
Brands
- VALTOCO: FDA-approved diazepam nasal spray for acute treatment of seizure clusters in patients 2 years and older
- myNEURELIS
- Intravail
- ProTek
- Hydrogel
Products and services
- VALTOCO (diazepam nasal spray) FDA-approved diazepam nasal spray for the acute treatment of seizure clusters (episodes of frequent seizure activity) in patients 2 years of age and older. Uses proprietary Intravail® technology for non-invasive intranasal delivery.
- myNEURELIS patient support program Patient and care partner support program providing access to nurse educators, instructional information, assistance with pharmacy connections, and patient savings programs for VALTOCO users.
- Intravail® drug delivery technology (licensing program) Proprietary non-invasive drug delivery technology enabling transmucosal delivery of proteins, peptides, and small molecule drugs, licensed to pharmaceutical partners for use in their commercial products.
- ProTek® protein stabilization technology (licensing program)
Quantifiable outcome
- Achieved 94% US insured life coverage (285+ million lives) within first year of VALTOCO launch
- +2 more outcomes
Companies that use Neurelis
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
Neurelis technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Neurelis partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core and minor.
- China Medical SystemcoreLicensed VALTOCO for commercialization in China, Hong Kong, Taiwan, and Macau regions. Enables regional access for epilepsy patients with seizure clusters.
- Aculys PharmacoreLicensed VALTOCO for commercialization in Australia, Brunei, Cambodia, Myanmar, New Zealand, Philippines, Singapore, Thailand, and Vietnam. Expands Asia-Pacific market access.
- Aegis Therapeutics, LLCcoreWholly-owned subsidiary providing proprietary drug delivery technology platforms (Intravail®, ProTek®, Hydrogel™) for non-invasive pharmaceutical delivery.
- Tonix PharmaceuticalsminorCommercializes TOSYMRA using Intravail® drug delivery technology for acute migraine treatment.
- IndiviorminorCommercializes OPVEE using Intravail® drug delivery technology for opioid overdose reversal.
- ARS PharmaceuticalsminorLicensed neffy (epinephrine nasal spray) using Intravail® technology for severe allergic reaction treatment.
- BioAxoneminorLicensed BA-1049 (now NRL-1049) for cerebral cavernous malformations treatment. Strategic partnership for rare disease pipeline development.
- Dr. Reddy's LaboratoriesminorAssociated with Tosymra commercialization, providing additional distribution and market access for migraine treatment product.
Scale indicators7 records
Recent moves8 records
Expansion highlights6 records
Neurelis competitors and assessment
Company assessmentDirect peers
- Impel Pharmaceuticals: Develops intranasal drug delivery therapies for CNS and acute conditions (e.g., Trudhesa for migraine), directly paralleling Neurelis's intranasal VALTOCO approach and nasal-delivery platform strategy.
- Indivior: Commercializes OPVEE (intranasal nalmefene) for opioid overdose using Neurelis's Intravail platform; an adjacent player in the acute-rescue CNS category sharing Neurelis's nasal delivery platform and commercial channels.
- ARS Pharmaceuticals: Markets neffy, the first FDA-approved intranasal epinephrine spray built on Neurelis's licensed Intravail technology; competes with Neurelis's commercial team in CNS-adjacent acute-care rescue markets and validates the same platform.
- Supernus Pharmaceuticals: Neurology-focused specialty pharma with epilepsy and CNS products; competes in the same physician channels and patient populations as Neurelis's VALTOCO and shares the specialty pharma commercial model targeting neurologists and epileptologists.
- Aquestive Therapeutics: Specialty pharma developing oral and transmucosal drug delivery formulations for CNS indications, including a diazepam buccal film (Libervant) directly competing with Neurelis's VALTOCO in the seizure-cluster rescue market.
- Tonix Pharmaceuticals: Licenses Neurelis's Intravail technology to commercialize TOSYMRA for acute migraine and develops CNS therapeutics; a platform partner whose commercial fate is partially tied to Neurelis's technology performance.
Broad incumbents
- Lundbeck: Pure-play CNS specialty pharma with established epilepsy and neurology portfolios; competes for the same specialist prescribers that drive VALTOCO demand and represents a potential strategic acquirer.
- UCB: Global CNS specialty pharma with leading epilepsy franchises (Briviact, Keppra, Vimpat) that compete head-to-head with VALTOCO for neurologist share-of-voice and formulary positioning.
- Jazz Pharmaceuticals: Diversified CNS/neurology specialty pharma (Xywav, Epidiolex, Sunosi) with the commercial infrastructure, payer relationships, and M&A track record that make it a natural strategic acquirer of a profitable CNS asset like Neurelis.
Regional players
- Upsher-Smith Laboratories: US-focused neurology specialty pharma with epilepsy and seizure-cluster generics/biosimilar exposure (Vigadrone, Qudexy); competes in the same neurology patient pool and could enter diazepam nasal spray on a generic basis.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Neurelis social profiles
Digital presenceNeurelis compliance and trust
Trust signalCompliance1 record
Neurelis financial estimates
Financial estimateRevenue estimate
Valuation estimate
Neurelis leadership team
Management profileNumber of profiles
Profiles12 records
Neurelis subsidiaries and ownership
Company hierarchySubsidiaries1 record
Neurelis funding detail
Funding detailFunding overview
Funding rounds9 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Neurelis M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Neurelis
What does Neurelis do?
Neurelis develops and commercializes specialty neurology therapeutics, with its flagship product VALTOCO (diazepam nasal spray) approved by the FDA for the acute treatment of seizure clusters in patients aged 2 and older. The company also monetizes its proprietary non-invasive drug delivery technology platforms (Intravail®, ProTek®, Hydrogel™) through licensing partnerships with pharmaceutical companies whose products (TOSYMRA, OPVEE, NEFFY) use these technologies.
Is Neurelis a public or private company?
Neurelis is a private company. It is classified as venture growth investor backed and is currently operating.
When was Neurelis founded?
Neurelis was founded in 2007. It employs 51 to 100 people.
Where is Neurelis based?
Neurelis is headquartered in San Diego, United States, in the North America region.
How does Neurelis make money?
Two revenue lines are on record. VALTOCO Product Sales are the primary driver. The others are intravail® Technology Licensing Royalties.
Who are Neurelis's main competitors?
Direct peers on record are Impel Pharmaceuticals, Indivior, ARS Pharmaceuticals, Supernus Pharmaceuticals, Aquestive Therapeutics and Tonix Pharmaceuticals. Broad incumbents are Lundbeck, UCB and Jazz Pharmaceuticals. Upsher-Smith Laboratories is listed as a regional player.
Does Neurelis have an API?
No public API is recorded for Neurelis.
What industry is Neurelis in?
Neurelis's product category is Specialty Pharmaceuticals — Neurology / Epilepsy. Its primary akta.pro industry code is HLAIAAAF, Neurology & Psychiatry (CNS) Pharmaceuticals, with a secondary code of HLAIACAC, Neurology & CNS Specialty Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.