NeuroSense Therapeutics

What NeuroSense Therapeutics does

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company founded in 2017 and headquartered in Herzliya, Israel, with a U.S. office in Cambridge, Massachusetts. The company is publicly traded on NASDAQ under the ticker NRSN and develops combination drug therapies targeting neurodegenerative diseases, with a particular focus on amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and Parkinson's disease. Its lead product candidate, PrimeC, is a proprietary fixed-dose combination of ciprofloxacin (an antibiotic with RNA dysregulation effects) and celecoxib (a COX-2 inhibitor targeting neuroinflammation and iron accumulation), formulated as a synchronized extended-release tablet for twice-daily oral administration. PrimeC is designed as a multi-target disease-modifying therapy addressing the complex multifactorial pathology of ALS where single-agent therapies have historically failed. The pipeline also includes CogniC for Alzheimer's disease and StabiliC for Parkinson's disease indications.

The company's business model is structured around three potential revenue streams: (1) future direct drug sales of PrimeC upon regulatory approval, with a projected peak market opportunity of $100-150 million in Canada alone via Health Canada's Notice of Compliance with Conditions pathway; (2) licensing and royalty revenue from a binding term sheet with a leading global pharmaceutical company covering certain key territories, including upfront payment, Phase 3 study funding, milestone payments, and double-digit royalties on annual net sales; and (3) retained rights for independent commercialization in other territories. NeuroSense has accumulated a strong global intellectual property position with patents granted in the U.S., Europe, Japan, Australia, Brazil, South Korea, and Israel extending through 2042-2043, complemented by FDA and EMA orphan drug designations providing 7-10 years of market exclusivity upon approval.

The company has completed Phase 2b PARADIGM clinical trials demonstrating a 65% statistically significant reduction in the risk of death (hazard ratio 0.35, p=0.0037) with over 14 months median survival benefit in ALS patients, published in JAMA Neurology, and has received FDA clearance to initiate the pivotal Phase 3 PARAGON trial enrolling 300 patients across U.S. and EU sites. NeuroSense has built relationships with leading academic institutions including Harvard/Mass General, Loma Linda University, Trinity College Dublin, and the NEALS Consortium, and leverages AI partnerships with PhaseV and NeuroKaire for clinical trial optimization and patient stratification. As a clinical-stage company with no current revenue, the company is funded through equity financings and is pursuing accelerated regulatory pathways including FDA 505(b)(2), EMA approval, and Health Canada NOC/c.

Name

NeuroSense Therapeutics

Legal name

NeuroSense Therapeutics Ltd.

Website

https://neurosense-tx.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company developing PrimeC, a fixed-dose combination drug targeting multiple neurodegenerative pathways for ALS, Alzheimer's, and Parkinson's disease, with FDA clearance for a pivotal Phase 3 ALS trial.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417)

SIC

Medicinal Chemicals & Botanical Products (2833), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Rare Neurology & Neurodegenerative Disorder Therapies (HLAIAIAD)

Keywords

• ALS drug development
• Neurodegenerative disease therapeutics
• Fixed-dose combination drugs
• Clinical-stage biopharmaceuticals
• Orphan drug development

Headquarters

HQ city

Herzliya

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Future Drug Sales: NeuroSense is a clinical-stage company without current revenue. Future revenue will come from commercial sales of PrimeC, pending regulatory approval. Projected peak market opportunity estimated at $100-150 million in Canada alone. The company is preparing for potential Canadian market launch via Health Canada's NOC/c pathway while pursuing global approvals.
2. Licensing and Royalty Revenue: Partnership with leading global pharmaceutical company includes upfront payment, funding for Phase 3 study, milestone payments, and double-digit royalties on annual net sales in certain territories. NeuroSense retains full rights to PrimeC in other key territories, allowing for independent commercialization or additional partnership arrangements.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company developing PrimeC, a novel fixed-dose extended-release oral combination of ciprofloxacin and celecoxib, as a disease-modifying treatment for ALS and other neurodegenerative diseases. The company's pipeline also includes CogniC for Alzheimer's disease and StabiliC for Parkinson's disease. PrimeC completed Phase 2b PARADIGM trials with statistically significant survival benefits and has received FDA clearance for a pivotal Phase 3 PARAGON study.

Product overview

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of combination drug therapies for neurodegenerative diseases. The company's lead product is PrimeC, a novel fixed-dose combination of ciprofloxacin and celecoxib targeting ALS, which completed Phase 2b trials and has received FDA clearance for a pivotal Phase 3 study. The pipeline also includes CogniC and StabiliC as trademarked product candidates.

Differentiator

Problem solved

Functional benefit

Brands

• PrimeC: Lead drug candidate - novel formulation of ciprofloxacin and celecoxib for ALS treatment
• CogniC
• StabiliC

Products and services

• PrimeC PrimeC is a novel fixed-dose extended-release combination drug comprising ciprofloxacin (an antibiotic with RNA dysregulation effects) and celecoxib (a COX-2 inhibitor targeting neuroinflammation and iron accumulation). Developed as a disease-modifying treatment for amyotrophic lateral sclerosis (ALS), administered twice-daily as an oral tablet. Targets multiple neurodegenerative pathways including RNA dysregulation, neuroinflammation, and iron accumulation. Demonstrated 65% reduction in risk of death and over 14 months median survival benefit in Phase 2b PARADIGM trials.
• CogniC CogniC is a pipeline drug candidate under development by NeuroSense Therapeutics for the treatment of cognitive impairment and Alzheimer's disease. The product is being evaluated in the Phase 2 RoAD proof-of-concept study with biomarker findings. Based on the PrimeC combination platform targeting multiple neurodegenerative disease pathways.
• StabiliC StabiliC is a pipeline drug candidate under development by NeuroSense Therapeutics for Parkinson's disease treatment. Based on shared pathological pathways among neurodegenerative diseases that PrimeC addresses. No active clinical programs currently disclosed for this indication.

Quantifiable outcome

• 65% reduction in risk of death (hazard ratio: 0.35; p=0.0037) in Phase 2b PARADIGM trial
• +6 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Twelve partnerships are on record, tiered core and flagship.

• EverythingALScoreGTM or Marketing Partner · 24 June 2026EverythingALS hosted a virtual community event on June 24, 2026 to discuss emerging clinical data on PrimeC with Prof. Jeffrey Rosenfeld and NeuroSense CEO Alon Ben-Noon. Event focused on ALS patients, families, caregivers, and clinicians.
• Leading Global Pharmaceutical CompanyflagshipStrategic or Co-development Partner · 24 December 2024Binding term sheet with leading global pharmaceutical company for development and commercialization of PrimeC in certain key territories. Deal structure includes substantial upfront payment, funding for Phase 3 study, milestone payments, and double-digit royalties on annual net sales. NeuroSense retains full rights to PrimeC in other key territories. Transaction subject to finalization of definitive agreement anticipated in Q1 2025.
• PhaseVcoreTechnology or Integration · 14 May 2024NeuroSense partnered with PhaseV to optimize the upcoming ALS Phase 3 trial using advanced causal machine learning. PhaseV provides deeper insights into PARADIGM Phase 2b data to identify the optimal ALS patient profile that would benefit most from PrimeC in preparation for the pivotal Phase 3 PARAGON study. This collaboration helps optimize trial design and patient stratification.
• NeuroKairecoreStrategic or Co-development PartnerCollaboration with NeuroKaire for Alzheimer's drug development using AI to predict treatment responses. NeuroKaire uses peripheral blood mononuclear cells (PBMCs) to create induced pluripotent stem cells (iPSCs) differentiated into cortical neurons. AI-based predictive models project each patient's disease progression based on experimental results with PrimeC treatment, enabling patient stratification.
• Global CDMOcoreImplementation/ SI/ Consulting PartnerPartnership with global Contract Development and Manufacturing Organization (CDMO) for commercial-scale PrimeC production. The CDMO supports both clinical trial supply and future commercial manufacturing. Validated analytical methods confirmed with 36-month shelf life at room temperature. Supply chain includes qualified U.S. and Canadian DMF and CEP holders for both active ingredients.
• Mass General HospitalcoreStrategic or Co-development PartnerCollaboration with Mass General Hospital (Harvard Medical School) for clinical research. Dr. Steven E. Arnold serves as Professor of Neurology at Harvard Medical School and Managing Director of the Interdisciplinary Brain Center at Mass General. The hospital leads Alzheimer's Clinical and Translational Research Unit conducting early phase clinical trial and biomarker research.
• University of Southern CaliforniacoreStrategic or Co-development PartnerAcademic collaboration with University of Southern California for clinical research and development programs. Part of NeuroSense's network of world-leading academic labs and research institutions.
• Tel-Aviv UniversitycoreStrategic or Co-development PartnerAcademic collaboration with Tel-Aviv University for neuroscience research and development. Part of NeuroSense's research network leveraging Israeli academic expertise.
• Harvard UniversitycoreStrategic or Co-development PartnerAcademic collaboration with Harvard University through Mass General Hospital affiliations. Dr. Niva Russek-Blum holds PhD from Weizmann Institute. Research collaborations span neuroscience and drug development.
• Loma Linda UniversitycoreStrategic or Co-development PartnerCollaboration with Prof. Jeffrey Rosenfeld at Loma Linda University School of Medicine, Director of the Neuromuscular ALS/MND Program. Prof. Rosenfeld serves on NeuroSense's Scientific Advisory Board and leads discussion on PrimeC data at community events.
• Trinity College Dublin / Beaumont HospitalcoreStrategic or Co-development PartnerCollaboration with Prof. Orla Hardiman, Head of Academic Unit of Neurology at Trinity College Dublin and Director of National ALS service at Beaumont Hospital. Prof. Hardiman serves on NeuroSense's Scientific Advisory Board and is Co-Chair of European Network for Cure of ALS (ENCALS).
• NEALS ConsortiumcoreStrategic or Co-development PartnerCollaboration with Northeast ALS (NEALS) Consortium, a network of over 134 clinical sites performing collaborative clinical trials and research in ALS. Multiple NeuroSense team members and advisors have connections to NEALS. Abstract presentations accepted at 2024 NEALS Annual Meeting.

Scale indicators7 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Cytokinetics: Cytokinetics is a late-stage biopharmaceutical company developing muscle-directed therapeutics, with reldesemtiv in Phase 3 for ALS. It is directly comparable to NeuroSense as a small-cap ALS-focused clinical-stage biotech pursuing regulatory approval in the same indication.
• Clene Nanomedicine: Clene Nanomedicine is developing CNM-Au8, a gold nanocatalyst for ALS and other neurodegenerative diseases, with FDA orphan drug designation and ongoing Phase 3 program. It is a direct comparable as a clinical-stage company focused on disease-modifying ALS therapy in a similar regulatory and commercial pathway.
• Ionis Pharmaceuticals: Ionis co-developed Tofersen with Biogen for SOD1-ALS, which received FDA accelerated approval in 2023. Ionis is comparable as a leading antisense oligonucleotide developer with a meaningful ALS franchise and rare-neurodegenerative disease focus.
• MediciNova: MediciNova is a clinical-stage biopharmaceutical company developing MN-166 (ibudilast) for ALS and other neurodegenerative conditions. It is directly comparable as a small-cap biotech pursuing ALS regulatory approval with a repositioned small-molecule asset.
• AB Science: AB Science is developing masitinib for ALS and other neurodegenerative diseases. It is a direct comparable as a small-cap European-listed clinical-stage company targeting ALS with a small-molecule kinase inhibitor approach.
• Alector: Alector is a clinical-stage biotechnology company focused on developing immuno-neurology treatments for neurodegenerative diseases, including programs in frontotemporal dementia and Alzheimer's. It is comparable to NeuroSense as a small-cap CNS biotech developing disease-modifying therapies in adjacent neurodegenerative indications.
• Annexon: Annexon is a clinical-stage biopharmaceutical company developing complement pathway inhibitors for neurodegenerative and autoimmune diseases. It is comparable to NeuroSense as a small-cap rare-neurology biotech with late-stage clinical assets targeting CNS indications with high unmet need.

Broad incumbents

• Biogen: Biogen is a global neuroscience-focused biopharmaceutical company that commercializes Tofersen/QALSODY for SOD1-ALS and previously led Riluzole commercialization. It is a broad incumbent in the ALS therapeutic category where NeuroSense is competing, with substantially greater resources and commercial reach.

Emerging players

• Denali Therapeutics: Denali Therapeutics is a clinical-stage biotech developing therapeutics for neurodegenerative diseases, including DNL343 for ALS. It is an emerging player in the ALS space with a broader neurodegeneration pipeline and a focus on CNS drug delivery, comparable to NeuroSense in clinical maturity and disease focus.

Others

• Wave Life Sciences: Wave Life Sciences is a clinical-stage genetic medicines company developing stereopure oligonucleotides for CNS indications including ALS and Huntington's disease. It is adjacent to NeuroSense in the rare-neurodegeneration CNS space but differentiated by its oligonucleotide platform rather than small-molecule combination therapy.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/neurosenset
• Facebookfacebook.com/neurosensetx

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Funding overview

Funding rounds7 records

Investors1 record

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M&A

Investments

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Frequently asked questions about NeuroSense Therapeutics