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GIVING PEOPLE THE CONFIDENCE TO DEFINE THEIR NEU NORMAL

At Neurelis, we know what empowerment can mean for people. That’s why we are dedicated to innovation that enables people to gain greater control over their journeys, so they can define their neu normal.

NEURELIS PIPELINE

Neurelis’ mission is to build a leading neuroscience company that advances the care of people suffering from neurological conditions. To do so, Neurelis is developing multiple wholly-owned product candidates for underserved acute neurological conditions. Product candidates include NRL-1004 (acute agitation), which utilizes our proprietary Intravail®  drug delivery technology. 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 that employ Intravail®  technology, including TOSYMRA® (acute migraine), NEFFY™ (anaphylaxis), OPVEE®  (opioid overdose), and OPNT002 (alcohol use disorder).

pipeline graphic
polygon PRE-CLIN
 
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OTHER

Phase 1 PHASE
1
 
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NRL-1049

NRL-1004

Phase 2 PHASE
2
 
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OPNT002

Phase 3 PHASE
3
 
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VALTOCO®
(diazepam nasal spray)
Ages 2 through 5

NDA NDA
 
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NEFFY™

FDA FDA
APPROVED
 
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VALTOCO®
(diazepam nasal spray)*
Ages 6 and older

TOSYMRA®
(sumatriptan nasal spray)

OPVEE®
(nalmefene 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
Details
LEARN MORE ABOUT VALTOCO® >
 

Click here for full prescribing and important safety information.

 
dividing line
 
Diazepam Nasal Spray
Ages 2 through 5
Episodes of Frequent Seizures
polygonPhase 3
 
NRL-1004
Noninvasive proprietary formulation
Acute Agitation Episodes
PolygonPhase 1
Details
LEARN MORE ABOUT NRL-1004 >
NRL-1049
Proprietary oral formulation
Cerebral Cavernous
Malformations
PolygonPhase 1
Details
LEARN MORE ABOUT NRL-1049 >
OTHER
Noninvasive proprietary formulation
Epilepsy/Central Nervous System Disorders
polygonPre-Clin

No details at this time

*VALTOCO® is licensed outside the US in China, Hong Kong, Taiwan, Singapore, and Macau by China Medical System, and in Australia, Brunei, Cambodia, Myanmar, New Zealand, the Philippines, Thailand, and Vietnam by AculysPharma.

NEURELIS CLINICAL TRIALS

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 Tonix Pharmaceuticals for the acute treatment of migraine with or without aura in adults. Tosymra offers an alternative to oral therapies, as well as to Imitrex® (sumatriptan nasal spray). Tosymra has demonstrated faster tmax as well as increased bioavailability when compared to subcutaneous sumatriptan.

Acute Migraine
polygonFDA Approved
  • Tonix Pharmaceuticals
  • FDA Approved: January 2019
OPVEE®
(nalmefene nasal spray)

An FDA-approved nalmefene nasal spray utilizing Intravail® technology being commercialized by Indivior for the treatment of opioid overdose.OPVEE® nasal spray was shown to provide fast onset and long duration reversal of opioid-induced respiratory depression.

Opioid Overdose
polygonFDA Approved
  • Indivior
  • FDA Approved: May 2023
NEFFY™
(epinephrine nasal spray)

An intranasal formulation of low-dose epinephrine utilizing Intravail® technology, licensed to ARS Pharmaceuticals, Inc. For the emergency treatment of severe type I allergic reactions in children and adults who weigh 30 kilograms (66 pounds) or more.

Anaphylaxis
PolygonNDA
  • ARS Pharma
OPNT002

A naltrexone nasal spray product candidate being developed by Indivior for the treatment of alcohol use disorder (AUD).

Alcohol Use Disorder
polygonPhase 2
  • Indivior

LEARN MORE ABOUT OUR INNOVATIVE PRODUCT AND PIPELINE PROGRAMS

VALTOCO®
NRL-1004
NRL-1049

THE NEURELIS TEAM HAS A ROBUST HISTORY OF CNS INDUSTRY EXPERIENCE

SEE OUR TECHNOLOGIES
SEE OUR PARTNERS