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OUR PASSION FOR PROGRESS™ BEGINS WITH OUR PIPELINE

For more than a decade, Neurelis has been working diligently to develop a pipeline of products and technologies to address significant unmet needs for patients.

NEURELIS PIPELINE

Neurelis’ mission is to build a leading neuroscience company that advances the care of patients suffering from neurological conditions. To do so, Neurelis is developing multiple wholly-owned product candidates utilizing Intravail®, for underserved acute neurological conditions. Product candidates include NRL-4 (acute agitation), NRL-2 (acute panic attacks), and NRL-3 (status epilepticus). In addition, Neurelis is developing NRL-1049, a new chemical entity for the treatment of cerebral cavernous malformations. If approved, NRL-1049 could be the first FDA-approved treatment for patients with this condition. Neurelis has also partnered with select program product candidates, including TOSYMRA® (acute migraine), NEFFY™ (anaphylaxis), OPNT003 (opioid overdose), and OPNT002 (alcohol use disorder).

pipeline graphic
polygonPRE-CLIN
 
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NRL-2

NRL-3

NRL-1049

Phase 1PHASE
1
 
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NRL-4

Phase 2PHASE
2
 
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VALTOCO®
(diazepam nasal spray)
Ages 2 through 5*

OPNT002

Phase 3PHASE
3
 
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NEFFY™

OPNT003

NDANDA
 
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FDAFDA
APPROVED
 
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VALTOCO®
(diazepam nasal spray)
Ages 6 and older

TOSYMRA®
(sumatriptan nasal spray)

NEURELIS PROGRAMS

NEURELIS PROGRAMS
DESCRIPTION
DISEASE STATE
STATUS
DETAILS
VALTOCO®
(diazepam nasal spray)

Diazepam Nasal Spray
Ages 6 and older

Episodes of Frequent Seizures
polygonFDA Approved
 

Click here for full prescribing and important safety information.

 
dividing line
 
Diazepam Nasal Spray
Ages 2 through 5*
Episodes of Frequent Seizures
polygonPhase 2
 
NRL-2
Intranasal formulation with Intravail®
Acute Panic Attacks
polygonPre-Clin
NRL-3
Intranasal formulation with Intravail®
Status Epilepticus
polygonPre-Clin
NRL-4
Intranasal formulation with Intravail®
Acute Agitation Episodes
polygonPhase 1
NRL-1049
Oral formulation Rho Kinase
Cerebral Cavernous
Malformations
polygonPre-Clin

*Phase 1/2a

Select Partner Programs

Select PARTNER PROGRAMS
DESCRIPTION
DISEASE STATE
STATUS
DETAILS
TOSYMRA®
(sumatriptan nasal spray)

An FDA-approved sumatriptan nasal spray utilizing Intravail® technology commercialized by Upsher-Smith Laboratories for the acute treatment of migraine with or without aura in adults. Tosmyra offers an alternative to oral therapies, as well as to Imitrex® (sumatriptan nasal spray). Tosmyra has demonstrated faster tmax as well as increased bioavailability when compared to subcutaneous sumatriptan.

Acute Migraine
polygonFDA Approved
  • Upsher-Smith
  • FDA Approved: January 2019
NEFFY™
(epinephrine nasal spray)

An intranasal formulation of low-dose epinephrine utilizing Intravail® technology, licensed to ARS Pharmaceuticals, Inc. Neffy is in Phase 3 in the US and under regulatory review in Europe. ARS Pharma plans to submit a marketing application for the emergency treatment of severe allergic reactions (Type I), including anaphylaxis.

Anaphylaxis
polygonPhase 3
  • ARS Pharma
OPNT003

A nalmefene nasal spray product candidate being developed by Opiant Pharmaceuticals for the treatment of opioid overdose. The formulation includes Intravail®. Opiant reported positive topline results from a multidose pharmacokinetic study and plans to submit a marketing application for approval in the US in 2022.

Opioid Overdose
polygonPhase 3
  • Opiant Pharmaceuticals
OPNT002

A naltrexone nasal spray product candidate being developed by Opiant for the treatment of alcohol use disorder (AUD). It also contains Intravail®. Results from a double-blind, placebo-controlled Phase 2 study in patients diagnosed with AUD are anticipated in 2023.

Alcohol Use Disorder
polygonPhase 2
  • Opiant Pharmaceuticals

LEARN MORE ABOUT OUR INNOVATIVE PRODUCT AND PIPELINE PROGRAMS

VALTOCO®
NRL-2
NRL-3
NRL-4
NRL-1049

THE NEURELIS TEAM HAS A ROBUST HISTORY OF CNS INDUSTRY EXPERIENCE

SEE OUR TECHNOLOGIES
SEE OUR PARTNERS