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Neurim Pharmaceuticals

Full company profile

uuid00072fm

Namestring
Neurim Pharmaceuticals
Legal namestring
Neurim Pharmaceuticals (1991) Ltd.
Websiteurl
neurim.com
Company typeenum
Private
Founded yearint
1991
Descriptiontext

Neurim Pharmaceuticals (1991) Ltd. is a privately held, founder-led CNS-focused drug discovery and development company headquartered in Tel Aviv, Israel, with a Swiss subsidiary in Steinhausen. Founded in 1991 by neuroscientist Prof. Nava Zisapel and entrepreneur Yehuda Zisapel, the company has built a franchise around melatonin-receptor biology and proprietary prolonged-release melatonin formulations, supported by a portfolio of over 60 patents and 200+ peer-reviewed publications. Its two commercialized ethical drugs are Circadin® (2mg prolonged-release melatonin, EMA-approved in 2007 for primary insomnia in patients aged 55 and older) and Slenyto® (1mg/5mg prolonged-release melatonin mini-tablets, EMA-approved in 2018 for insomnia in children and adolescents with Autism Spectrum Disorder and/or neurogenetic disorders, and indicated in ADHD where sleep hygiene has been insufficient).

The business model is a partner-driven specialty pharma model: Neurim does not sell directly. It out-licenses Circadin and Slenyto to regional marketing and distribution partners (for example, an exclusive licensing and distribution agreement with KYE Pharmaceuticals for Canada following Health Canada approval of Slenyto in September 2025) and earns revenue through licensing fees, milestone payments, and royalties. Products are commercially available in more than 40 countries across 5 continents, and Neurim also runs a development pipeline (Piromelatine for REM Sleep Behavior Disorder/neurodegenerative disease, Neu-4752 for sleep apnea, Neu-6142 for ASD, Neu-601 for Parkinson's, Neu-14E for fibrosis) and pursues co-development partnerships. R&D leadership is concentrated in Prof. Nava Zisapel (CEO and principal inventor) and Dr. Tali Nir (VP Clinical and Regulatory since 1997), with commercial and finance functions strengthened since 2023–2024 by the additions of CFO Nitza Lifshitz and VP Commercial Operations Guy Manor.

Short descriptiontext

Neurim Pharmaceuticals is a privately held, Israel-based CNS drug discovery company marketing Circadin and Slenyto prolonged-release melatonin products in 40+ countries for insomnia in older adults and pediatric patients with neurodevelopmental disorders, and developing a six-asset neurology pipeline.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersTel Aviv-yafo, Israel
HQ citystring
Tel Aviv-yafo
HQ countrystring
Israel
HQ regionstring
Middle East
Markets served

Serves global market

Offices2 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
CNS pharmaceuticals, melatonin therapeutics, prolonged-release formulations, insomnia treatments, pediatric neurology drugs
Industry2 codes
1Neurology & Psychiatry (CNS) Pharmaceuticals
CodeHLAIAAAFPrimaryYes
2Neurology & CNS Specialty Pharmaceuticals
CodeHLAIACACPrimaryNo
NAICS code1 code
  • Pharmaceutical Preparation Manufacturing325412
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
CNS Pharmaceuticals
Social media profiles1 record
GTM motion2 records

Each record includes

Type, Description, Source

Revenue model3 records
1Pharmaceutical Product Sales
TypeOne Time License
Description

Revenue generated from sales of proprietary prescription pharmaceutical products including Circadin and Slenyto. Products are marketed through strategic alliances with marketing and distribution partners in over 40 countries.

neurim.com
2Licensing and Distribution Partnerships
TypeLicensing Royalties
Description

Revenue generated through licensing agreements with distribution partners such as KYE Pharmaceuticals for Canadian market. Partner handles regulatory, commercialization, and distribution activities while Neurim receives licensing fees and royalties.

neurim.com
3Co-development Partnerships
TypeLicensing Royalties
Description

Strategic collaborations for CNS drug co-development, sharing knowledge and resources with partners in pharmaceutical development and commercialization.

neurim.com
Marketing channels4 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels2 records

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Neurim Pharmaceuticals is a CNS-focused drug discovery and development company that discovers, develops, and commercializes proprietary prescription pharmaceutical products based on prolonged-release melatonin and related CNS compounds. Its two marketed products are Circadin (2mg prolonged-release melatonin for primary insomnia in adults aged 55+) and Slenyto (1mg/5mg prolonged-release melatonin mini-tablets for pediatric insomnia associated with Autism Spectrum Disorder and neurogenetic disorders), which are out-licensed and distributed through strategic marketing and distribution partners in more than 40 countries across five continents.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • Products are in use in more than 40 countries across 5 continents
+3 more records
Product overview1 text field

Neurim Pharmaceuticals is a CNS-focused pharmaceutical company with two marketed prescription drugs: Circadin (2mg prolonged-release melatonin for primary insomnia in adults 55+) and Slenyto (1mg/5mg prolonged-release melatonin for pediatric insomnia in ASD, neurogenetic disorders, and ADHD). Both are melatonin-based products marketed in over 40 countries. The company pipeline includes six investigational candidates targeting REM Sleep Behavioral Disorder (Piromelatine), metabolic disorders (Neu-4752), Autism Spectrum Disorder (Neu-6142), Parkinson's disease (Neu-601), and fibrosis (Neu-14E).

Product and service2 records
1Circadin
CategoryPrescription pharmaceutical
Description

Circadin is a 2mg prolonged-release melatonin tablet approved for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 years and older. It is an ethical prescription drug distributed in over 40 countries.

2Slenyto
CategoryPrescription pharmaceutical
Description

Slenyto is a 3mm diameter film-coated mini-tablet containing prolonged-release melatonin (1mg or 5mg). It is the first and only prescription extended-release melatonin specifically developed for treating insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder and/or neurogenetic disorders, and aged 6-17 with ADHD where sleep hygiene measures have been insufficient.

Scale indicator4 records

Each record includes

Type, Value, Description, Source

Partnership1 partner
Strategic tierCoreTypeChannel Partner/ Reseller/ DistributorAnnounced on2026-01-13
Description

Exclusive licensing and distribution agreement for Slenyto (extended-release melatonin) in Canada. KYE Pharmaceuticals handles all regulatory, commercialization, and distribution activities for Slenyto in Canada. Slenyto received Health Canada marketing authorization on September 8th, 2025. The partnership aligns with KYE's mission to bring differentiated therapies to patients with high unmet medical needs in Canada.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Specialty pharma built around a single sleep-disorder product (Lumryz for narcolepsy). Comparable as a small, sleep-focused company whose value is anchored by one differentiated therapeutic and a focused commercial strategy.

TypeBroad incumbent
Description

Global biopharma with a substantial CNS franchise (e.g., Keppra, Briviact in neurology and psychiatry). Comparable in CNS focus and branded specialty pharma orientation, though at much larger scale and broader therapeutic scope.

TypeDirect peer
Description

Swiss CNS-focused specialty pharma with a portfolio centered on sleep and neurology (e.g., Quviviq for insomnia). Comparable as a CNS/sleep-focused, mid-sized specialty pharma with a small but focused commercial organization.

TypeDirect peer
Description

European specialty pharmaceutical company exclusively focused on CNS disorders, with a portfolio spanning sleep, neurology, and psychiatry. Closely comparable business model: CNS-niche branded specialty pharma selling through partners and direct channels in Europe.

TypeBroad incumbent
Description

Established specialty pharma with a major sleep-medicine franchise (Xywav/Xyrem for narcolepsy, Sunosi for excessive daytime sleepiness) and broader CNS focus. Comparable as a CNS/sleep specialist with multiple approved products, though at meaningfully larger scale.

TypeBroad incumbent
Description

Global pharma with CNS products including Rozerem (ramelteon), a melatonin receptor agonist for insomnia. Comparable in the insomnia / melatonin-receptor therapeutic category, though as part of a much broader portfolio.

TypeEmerging player
Description

French independent specialty pharma active in CNS and rare diseases, and a known distribution partner for Circadin in certain markets. Comparable as an independent specialty CNS company, with overlap in pediatric and CNS therapeutic areas.

TypeBroad incumbent
Description

Major Japanese pharma with a strong CNS portfolio (e.g., Abilify in psychiatry, investigational CNS assets). Comparable in CNS development and commercialization, but at substantially greater scale and broader therapeutic footprint.

TypeDirect peer
Description

Small US specialty pharma focused on CNS and sleep disorders (e.g., Hetlioz for non-24 sleep-wake disorder). Directly comparable as a small, CNS-focused, sleep-medicine company with a small headcount and one or two core commercial assets.

TypeBroad incumbent
Description

Large European specialty pharma dedicated to CNS, including sleep and neurology. Comparable in therapeutic focus (CNS/neurology) but at significantly greater scale and broader portfolio than Neurim.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers1 record

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment3 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile3 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature5 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles4 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

Subsidiaries1 record

Each record includes

Name, Acquired on, Relationship type, Type, Business focus

No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Neurim Pharmaceuticals

CNS Pharmaceuticalsneurim.com

Neurim Pharmaceuticals is a privately held, Israel-based CNS drug discovery company marketing Circadin and Slenyto prolonged-release melatonin products in 40+ countries for insomnia in older adults and pediatric patients with neurodevelopmental disorders, and developing a six-asset neurology pipeline.

What Neurim Pharmaceuticals does

Neurim Pharmaceuticals (1991) Ltd. is a privately held, founder-led CNS-focused drug discovery and development company headquartered in Tel Aviv, Israel, with a Swiss subsidiary in Steinhausen. Founded in 1991 by neuroscientist Prof. Nava Zisapel and entrepreneur Yehuda Zisapel, the company has built a franchise around melatonin-receptor biology and proprietary prolonged-release melatonin formulations, supported by a portfolio of over 60 patents and 200+ peer-reviewed publications. Its two commercialized ethical drugs are Circadin® (2mg prolonged-release melatonin, EMA-approved in 2007 for primary insomnia in patients aged 55 and older) and Slenyto® (1mg/5mg prolonged-release melatonin mini-tablets, EMA-approved in 2018 for insomnia in children and adolescents with Autism Spectrum Disorder and/or neurogenetic disorders, and indicated in ADHD where sleep hygiene has been insufficient).

The business model is a partner-driven specialty pharma model: Neurim does not sell directly. It out-licenses Circadin and Slenyto to regional marketing and distribution partners (for example, an exclusive licensing and distribution agreement with KYE Pharmaceuticals for Canada following Health Canada approval of Slenyto in September 2025) and earns revenue through licensing fees, milestone payments, and royalties. Products are commercially available in more than 40 countries across 5 continents, and Neurim also runs a development pipeline (Piromelatine for REM Sleep Behavior Disorder/neurodegenerative disease, Neu-4752 for sleep apnea, Neu-6142 for ASD, Neu-601 for Parkinson's, Neu-14E for fibrosis) and pursues co-development partnerships. R&D leadership is concentrated in Prof. Nava Zisapel (CEO and principal inventor) and Dr. Tali Nir (VP Clinical and Regulatory since 1997), with commercial and finance functions strengthened since 2023–2024 by the additions of CFO Nitza Lifshitz and VP Commercial Operations Guy Manor.

Neurim Pharmaceuticals firmographics

Firmographics
Name
Neurim Pharmaceuticals
Legal name
Neurim Pharmaceuticals (1991) Ltd.
Website
https://neurim.com
Company type
Private
Founded year
1991
Operating status
Operating
Headcount range
11–50 employees
Short description
Neurim Pharmaceuticals is a privately held, Israel-based CNS drug discovery company marketing Circadin and Slenyto prolonged-release melatonin products in 40+ countries for insomnia in older adults and pediatric patients with neurodevelopmental disorders, and developing a six-asset neurology pipeline.
Ownership category
akta.pro rank

Neurim Pharmaceuticals industry classification

Industry
Product category
CNS Pharmaceuticals
NAICS
Pharmaceutical Preparation Manufacturing (325412)
SIC
Pharmaceutical Preparations (2834)
akta.pro primary industry
Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)
akta.pro secondary industry
Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

  • CNS pharmaceuticals
  • Melatonin therapeutics
  • Prolonged-release formulations
  • Insomnia treatments
  • Pediatric neurology drugs

Where Neurim Pharmaceuticals is headquartered

Location

Headquarters

HQ city
Tel Aviv-yafo
HQ country
Israel
HQ region
Middle East

Offices2 records

Markets served

Neurim Pharmaceuticals business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

  1. Pharmaceutical Product Sales: Revenue generated from sales of proprietary prescription pharmaceutical products including Circadin and Slenyto. Products are marketed through strategic alliances with marketing and distribution partners in over 40 countries.
  2. Licensing and Distribution Partnerships: Revenue generated through licensing agreements with distribution partners such as KYE Pharmaceuticals for Canadian market. Partner handles regulatory, commercialization, and distribution activities while Neurim receives licensing fees and royalties.
  3. Co-development Partnerships: Strategic collaborations for CNS drug co-development, sharing knowledge and resources with partners in pharmaceutical development and commercialization.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Neurim Pharmaceuticals product offering

Product offering

Core offering

Neurim Pharmaceuticals is a CNS-focused drug discovery and development company that discovers, develops, and commercializes proprietary prescription pharmaceutical products based on prolonged-release melatonin and related CNS compounds. Its two marketed products are Circadin (2mg prolonged-release melatonin for primary insomnia in adults aged 55+) and Slenyto (1mg/5mg prolonged-release melatonin mini-tablets for pediatric insomnia associated with Autism Spectrum Disorder and neurogenetic disorders), which are out-licensed and distributed through strategic marketing and distribution partners in more than 40 countries across five continents.

Product overview

Neurim Pharmaceuticals is a CNS-focused pharmaceutical company with two marketed prescription drugs: Circadin (2mg prolonged-release melatonin for primary insomnia in adults 55+) and Slenyto (1mg/5mg prolonged-release melatonin for pediatric insomnia in ASD, neurogenetic disorders, and ADHD). Both are melatonin-based products marketed in over 40 countries. The company pipeline includes six investigational candidates targeting REM Sleep Behavioral Disorder (Piromelatine), metabolic disorders (Neu-4752), Autism Spectrum Disorder (Neu-6142), Parkinson's disease (Neu-601), and fibrosis (Neu-14E).

Differentiator

Problem solved

Functional benefit

Products and services

  • Circadin Circadin is a 2mg prolonged-release melatonin tablet approved for the short-term treatment of primary insomnia characterized by poor quality of sleep in patients aged 55 years and older. It is an ethical prescription drug distributed in over 40 countries.
  • Slenyto Slenyto is a 3mm diameter film-coated mini-tablet containing prolonged-release melatonin (1mg or 5mg). It is the first and only prescription extended-release melatonin specifically developed for treating insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder and/or neurogenetic disorders, and aged 6-17 with ADHD where sleep hygiene measures have been insufficient.

Quantifiable outcome

  • Products are in use in more than 40 countries across 5 continents
  • +3 more outcomes

Companies that use Neurim Pharmaceuticals

Customer profile

Named customers1 record

Segments3 records

Ideal customer profiles3 records

Neurim Pharmaceuticals technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature5 records

Neurim Pharmaceuticals partnerships and signals

Strategic signal

Partnerships

One partnership is on record.

  • KYE Pharmaceuticals Inc.coreChannel Partner/ Reseller/ Distributor · 13 January 2026Exclusive licensing and distribution agreement for Slenyto (extended-release melatonin) in Canada. KYE Pharmaceuticals handles all regulatory, commercialization, and distribution activities for Slenyto in Canada. Slenyto received Health Canada marketing authorization on September 8th, 2025. The partnership aligns with KYE's mission to bring differentiated therapies to patients with high unmet medical needs in Canada.

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Neurim Pharmaceuticals competitors and assessment

Company assessment

Direct peers

  • Avadel Pharmaceuticals: Specialty pharma built around a single sleep-disorder product (Lumryz for narcolepsy). Comparable as a small, sleep-focused company whose value is anchored by one differentiated therapeutic and a focused commercial strategy.
  • Idorsia Pharmaceutical: Swiss CNS-focused specialty pharma with a portfolio centered on sleep and neurology (e.g., Quviviq for insomnia). Comparable as a CNS/sleep-focused, mid-sized specialty pharma with a small but focused commercial organization.
  • Neuraxpharm: European specialty pharmaceutical company exclusively focused on CNS disorders, with a portfolio spanning sleep, neurology, and psychiatry. Closely comparable business model: CNS-niche branded specialty pharma selling through partners and direct channels in Europe.
  • Vanda Pharmaceuticals: Small US specialty pharma focused on CNS and sleep disorders (e.g., Hetlioz for non-24 sleep-wake disorder). Directly comparable as a small, CNS-focused, sleep-medicine company with a small headcount and one or two core commercial assets.

Broad incumbents

  • UCB: Global biopharma with a substantial CNS franchise (e.g., Keppra, Briviact in neurology and psychiatry). Comparable in CNS focus and branded specialty pharma orientation, though at much larger scale and broader therapeutic scope.
  • Jazz Pharmaceuticals: Established specialty pharma with a major sleep-medicine franchise (Xywav/Xyrem for narcolepsy, Sunosi for excessive daytime sleepiness) and broader CNS focus. Comparable as a CNS/sleep specialist with multiple approved products, though at meaningfully larger scale.
  • Takeda Pharmaceutical: Global pharma with CNS products including Rozerem (ramelteon), a melatonin receptor agonist for insomnia. Comparable in the insomnia / melatonin-receptor therapeutic category, though as part of a much broader portfolio.
  • Otsuka Pharmaceutical: Major Japanese pharma with a strong CNS portfolio (e.g., Abilify in psychiatry, investigational CNS assets). Comparable in CNS development and commercialization, but at substantially greater scale and broader therapeutic footprint.
  • H. Lundbeck: Large European specialty pharma dedicated to CNS, including sleep and neurology. Comparable in therapeutic focus (CNS/neurology) but at significantly greater scale and broader portfolio than Neurim.

Emerging players

  • Biocodex: French independent specialty pharma active in CNS and rare diseases, and a known distribution partner for Circadin in certain markets. Comparable as an independent specialty CNS company, with overlap in pediatric and CNS therapeutic areas.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights7 records

Customer concentration

Neurim Pharmaceuticals social profiles

Digital presence

Neurim Pharmaceuticals financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Neurim Pharmaceuticals leadership team

Management profile

Number of profiles

Profiles4 records

Neurim Pharmaceuticals subsidiaries and ownership

Company hierarchy

Subsidiaries1 record

Neurim Pharmaceuticals funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Neurim Pharmaceuticals M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Neurim Pharmaceuticals

What does Neurim Pharmaceuticals do?

Neurim Pharmaceuticals is a CNS-focused drug discovery and development company that discovers, develops, and commercializes proprietary prescription pharmaceutical products based on prolonged-release melatonin and related CNS compounds. Its two marketed products are Circadin (2mg prolonged-release melatonin for primary insomnia in adults aged 55+) and Slenyto (1mg/5mg prolonged-release melatonin mini-tablets for pediatric insomnia associated with Autism Spectrum Disorder and neurogenetic disorders), which are out-licensed and distributed through strategic marketing and distribution partners in more than 40 countries across five continents.

Is Neurim Pharmaceuticals a public or private company?

Neurim Pharmaceuticals is a private company. It is classified as founder individual operated bootstrapped and is currently operating.

When was Neurim Pharmaceuticals founded?

Neurim Pharmaceuticals was founded in 1991. It employs 11 to 50 people.

Where is Neurim Pharmaceuticals based?

Neurim Pharmaceuticals is headquartered in Tel Aviv-yafo, Israel, in the Middle East region.

How does Neurim Pharmaceuticals make money?

Three revenue lines are on record. Pharmaceutical Product Sales are the primary driver. The others are licensing and Distribution Partnerships and co-development Partnerships.

Who are Neurim Pharmaceuticals's main competitors?

Direct peers on record are Avadel Pharmaceuticals, Idorsia Pharmaceutical, Neuraxpharm and Vanda Pharmaceuticals. Broad incumbents are UCB, Jazz Pharmaceuticals, Takeda Pharmaceutical, Otsuka Pharmaceutical and H. Lundbeck. Biocodex is listed as an emerging player.

Does Neurim Pharmaceuticals have an API?

No public API is recorded for Neurim Pharmaceuticals.

What industry is Neurim Pharmaceuticals in?

Neurim Pharmaceuticals's product category is CNS Pharmaceuticals. 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.

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Live signals
BioSpaceKye Pharmaceuticals Announces Licensing and Distribution Agreement with Neurim Pharmaceuticals for SLENYTO® in CanadaKye Pharmaceuticals announced a licensing and distribution agreement with Neurim Pharmaceuticals to commercialize SLENYTO® (extended-release melatonin) in Canada. SLENYTO® is the first and only prescription extended-release melatonin specifically developed for treating insomnia in children and adolescents with Autism Spectrum Disorder and/or Smith-Magenis Syndrome, and received Health Canada marketing authorization on September 8th, 2025. Under the agreement, Kye Pharmaceuticals will handle all regulatory, commercialization, and distribution activities for SLENYTO® in Canada.PR NewswireKye Pharmaceuticals Announces Licensing and Distribution Agreement with Neurim Pharmaceuticals for SLENYTO® in CanadaKye Pharmaceuticals announced a licensing and distribution agreement with Neurim Pharmaceuticals to commercialize SLENYTO® (extended-release melatonin) in Canada, with Kye handling regulatory, commercialization, and distribution activities. SLENYTO® is the first and only prescription extended-release melatonin developed specifically for treating insomnia in children with Autism Spectrum Disorder and/or Smith-Magenis Syndrome, and received Health Canada approval on September 8th, 2025. The partnership aligns with Kye's mission to bring differentiated therapies to patients with high unmet medical needs in Canada.PR NewswireHealth Canada Approves Slenyto® - Extended-Release Melatonin Formulation - as a Prescription Drug for Insomnia in Children with Autism Spectrum disorder and Smith Magenis SyndromeHealth Canada has granted marketing authorization to Neurim Pharmaceuticals for Slenyto®, an extended-release melatonin minitablet for treating insomnia in children and adolescents aged 2 to <18 years with Autism Spectrum Disorder and/or Smith-Magenis syndrome. Slenyto® is the first and only pharmacotherapy specifically developed and clinically tested for insomnia in this patient population, where sleep disorders affect up to 80% of individuals with ASD. The approval marks Neurim's entry into the North American market, with the product set to be available through pediatric specialists, sleep clinics, and pharmacies nationwide.PR NewswireNEURIM PHARMACEUTICALS RECEIVES EUROPEAN MARKETING AUTHORIZATION FOR PEDIATRIC PROLONGED-RELEASE MELATONIN (SLENYTO®) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISThe European Commission granted Neurim Pharmaceuticals marketing authorization to extend Slenyto® (prolonged-release melatonin) for treating insomnia in children and adolescents aged 6-17 with attention deficit hyperactivity disorder (ADHD). Slenyto® was previously approved in the EU in 2018 for insomnia in children with autism spectrum disorder and/or Smith-Magenis Syndrome, and the indication was expanded to neurogenetic disorders in 2024. The drug is the only authorized medication for insomnia in these neurodevelopmental populations, addressing a significant unmet medical need where up to 70% of children with ADHD experience sleep disturbances.PR NewswireNEURIM PHARMACEUTICALS ERHÄLT DIE EU-ZULASSUNG FÜR SLENYTO® (PÄDIATRISCHES MELATONIN MIT VERLÄNGERTER FREISETZUNG) ZUR BEHANDLUNG VON SCHLAFSTÖRUNGEN BEI KINDERN MIT AUFMERKSAMKEITSDEFIZIT-HYPERAKTIVIThe European Commission granted approval to expand Neurim Pharmaceuticals' Slenyto® indication to treat insomnia in children and adolescents (ages 6–17) with ADHD, following a positive recommendation from the EMA's CHMP in January 2025. Slenyto® is an extended-release melatonin formulation that was first approved in the EU in 2018 for sleep disorders in children with autism spectrum disorder and/or Smith-Magenis syndrome. This expansion addresses an unmet medical need, as up to 70% of children with ADHD experience sleep disturbances that can worsen core ADHD symptoms and impair quality of life.PR NewswireNEURIM PHARMACEUTICALS RECEIVES EUROPEAN MARKETING AUTHORIZATION FOR PEDIATRIC PROLONGED-RELEASE MELATONIN (SLENYTO®) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH ATTENTION DEFICIT HYPERACTIVITY DISNeurim Pharmaceuticals announced that the European Commission has approved an extension of the indication for Slenyto® to include the treatment of insomnia in children and adolescents aged 6-17 with attention deficit hyperactivity disorder (ADHD). The approval, which followed a recommendation by the Committee for Medicinal Products for Human Use (CHMP) in January 2025, makes Slenyto® the only authorized medication for insomnia across autism spectrum disorder, neurogenetic disorders, and ADHD in pediatric populations. Slenyto® is a child-appropriate prolonged-release melatonin formulation that delivers melatonin over the course of the night, designed to address both sleep initiation and maintenance difficulties.PR NewswireNEURIM PHARMACEUTICALS REÇOIT UN AVIS POSITIF DU CHMP SUR SLENYTO® (MÉLATONINE PÉDIATRIQUE À LIBÉRATION PROLONGÉE) POUR LE TRAITEMENT DE L'INSOMNIE CHEZ LES ENFANTS PRÉSENTANT DES MALADIES NEUROGÉNÉTINeurim Pharmaceuticals announced that the CHMP of the EMA adopted a positive opinion recommending an extension of the existing indication for Slenyto® to include treatment of insomnia in children and adolescents aged 2 to 18 years with neurogenetic diseases (NGD). Slenyto®, a prolonged-release melatonin formulation originally approved in the EU in 2018 for autism spectrum disorder (ASD) and/or Smith-Magenis syndrome, would become the only approved medication for sleep disorders in this specific pediatric population if approved by the European Commission. Professor Nava Zisapel, CEO of Neurim, stated that this opinion represents a significant milestone in addressing an unmet medical need for children with NGD who suffer from severe sleep disturbances.PR NewswireNEURIM PHARMACEUTICALS RECEIVES POSITIVE CHMP OPINION ON SLENYTO® (PEDIATRIC PROLONGED-RELEASE MELATONIN) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS (NGDs)Neurim Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending an extension of Slenyto®'s indication to include treatment of insomnia in children with Neurogenetic Disorders (NGDs). Slenyto®, a child-appropriate prolonged-release melatonin formulation previously approved in 2018 for insomnia in children with autism spectrum disorder and/or Smith-Magenis Syndrome, would become the first approved pharmacological treatment for this expanded indication covering children and adolescents aged 2-18. The extended indication specifically targets patients where sleep hygiene measures have proven insufficient.PR NewswireNEURIM PHARMACEUTICALS RICEVE IL PARERE POSITIVO DEL CHMP SU SLENYTO® (MELATONINA PEDIATRICA A RILASCIO PROLUNGATO) PER IL TRATTAMENTO DELL'INSONNIA NEI BAMBINI AFFETTI DA DISTURBI NEUROGENETICI (NGD)Neurim Pharmaceuticals announced that the CHMP of the EMA issued a positive opinion recommending an extension of Slenyto®'s existing indication to include treatment of insomnia in children and adolescents aged 2-18 with neurogenetic disorders (NGD). Slenyto® is a prolonged-release melatonin formulation that was first approved in the EU in 2018 for insomnia in children with autism spectrum disorder (ASD) and/or Smith-Magenis syndrome. Pending final approval, Slenyto® would become the first and only approved pharmacological treatment for sleep disorders in this pediatric population.PR NewswireNEURIM PHARMACEUTICALS RECEIVES POSITIVE CHMP OPINION ON SLENYTO® (PEDIATRIC PROLONGED-RELEASE MELATONIN) FOR THE TREATMENT OF INSOMNIA IN CHILDREN WITH NEUROGENETIC DISORDERS (NGDs)Neurim Pharmaceuticals announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending an extension of Slenyto®'s indication to treat insomnia in children and adolescents aged 2-18 with neurogenetic disorders (NGDs). Slenyto®, a child-appropriate prolonged-release melatonin formulation previously approved in the EU in 2018 for insomnia in autism spectrum disorder and/or Smith-Magenis Syndrome, would become the first authorized pharmacological treatment for sleep disorders in this pediatric population upon final approval. The extension addresses an unmet medical need, as up to 86% of children with NGDs experience disrupted sleep and current first-line behavioral interventions have only a 25% response rate.