Prilenia

What Prilenia does

Prilenia is a clinical-stage biotech company that develops novel treatments for neurodegenerative and neurodevelopmental disorders. Its lead asset is Pridopidine, a n oral drug candidate with an established safety profile and potential in multiple movement disorders and neurodegenerative diseases affecting adults and children. The company was founded in 2018 and is based in Israel, the Netherlands, and Boston.

Name

Prilenia

Legal name

Prilenia Therapeutics B.V.

Website

https://www.prilenia.com

Company type

Private

Founded year

2018

Operating status

Operating

Headcount range

11–50 employees

Short description

Prilenia is a clinical-stage biotech company that develops novel treatments for neurodegenerative and neurodevelopmental disorders.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Rare Neurology & Neurodegenerative Disorder Therapies (HLAIAIAD)

akta.pro secondary industries

Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN), Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)

Keywords

• Neurodegenerative disease therapeutics
• Sigma-1 receptor agonist
• Huntington's disease treatment
• ALS drug development
• Clinical stage biotechnology

Headquarters

HQ city

Herzliya

HQ country

Israel

HQ region

Middle East

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pharmaceutical Product Revenue: Prilenia is a clinical-stage biotechnology company focused on developing pridopidine for Huntington's disease and ALS. The company is not yet generating revenue as the drug is still in clinical development and has not been approved by regulatory agencies.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Prilenia develops pridopidine, an oral investigational drug (45 mg twice daily) and first-in-class selective sigma-1 receptor (S1R) agonist being advanced through Phase 3 clinical trials for Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS). The compound activates the S1R to stimulate multiple cellular protective pathways including autophagy, axonal transport, mitochondrial energy production, and calcium homeostasis, with a safety profile established across more than 1,700 studied patients and up to 7 years of long-term safety data. The company also operates expanded access programs such as the ACT for ALS protocol to provide pridopidine to patients not eligible for clinical trials.

Product overview

Prilenia is a clinical-stage biotechnology company developing pridopidine, a first-in-class oral sigma-1 receptor (S1R) agonist, as a disease-modifying treatment for Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS). The company's product portfolio centers on pridopidine (45 mg twice daily), which is advancing through Phase 3 clinical trials including PREVAiLS for ALS and a planned confirmatory trial for HD following the PROOF-HD study. Prilenia operates alongside strategic partnerships including a collaboration with Ferrer for European commercialization, expanded access programs (ACT for ALS), and data-sharing initiatives with CHDI Foundation. The company is incorporated in the Netherlands with operations across the U.S., Canada, Europe, and Israel.

Differentiator

Problem solved

Functional benefit

Brands

• Nurzigma: Brand name for pridopidine submitted for European marketing authorization (withdrawn in November 2025)

Products and services

• Pridopidine Pridopidine is an oral investigational drug (45 mg twice daily) and a highly selective, potent sigma-1 receptor (S1R) agonist in Phase 3 development for Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS). It activates the S1R to stimulate cellular protective pathways including autophagy, axonal transport, mitochondrial energy production, and calcium homeostasis. It has been studied in more than 1,700 people with long-term safety data available up to 7 years.
• ACT for ALS Expanded Access Program The ACT for ALS Expanded Access Program is an NIH NINDS-sponsored expanded access protocol for pridopidine, led by Massachusetts General Hospital's Sean M. Healey & AMG Center for ALS. It makes pridopidine available at treating sites across the U.S. for up to 200 ALS individuals not eligible for other clinical trials, with treatment duration of up to two years.

Quantifiable outcome

• Phase 2 HEALEY trial showed 32% slowing of overall disease progression, 62% slowing of respiratory function decline, 93% reduction in speech deterioration, and 57% improvement in survival benefit in rapidly progressive ALS subgroup
• +2 more outcomes

Segments3 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Five partnerships are on record, tiered core.

• CHDI FoundationcoreStrategic or Co-development Partner · 1 May 2026Prilenia entered into a Data Use Agreement with CHDI Foundation to provide clinical data from the placebo arms of its PRIDE and PROOF studies for Huntington's disease research. CHDI receives a worldwide, non-exclusive license to use individual patient-level data and can share it with qualified third-party research institutions. The collaboration aims to improve clinical trial design and support the development of more effective treatments for Huntington's disease.
• Healey ALS Center / NEALS ConsortiumcoreStrategic or Co-development Partner · 1 April 2026Collaboration with Mass General Brigham Healey ALS Center and NEALS (Northeast ALS Consortium) for the PREVAiLS Phase 3 trial. The first participant was enrolled at Mass General Brigham. The trial will include up to 60 treatment centers in 13 countries.
• FerrercoreStrategic or Co-development Partner · 1 April 2025In April 2025, Prilenia and Ferrer entered into a collaboration and license agreement for the co-development and commercialization of pridopidine in Europe and other select international markets. The collaboration is valued at approximately $500 million. Prilenia retains full commercialization and development rights to pridopidine in North America, Japan and Asia Pacific. The partnership aims to bring pridopidine to HD and ALS patients as quickly as possible.
• Huntington Study Group (HSG)coreStrategic or Co-development PartnerThe Huntington Study Group (HSG) is a world leader in clinical research for Huntington's disease and a valued collaborator for Prilenia. HSG conducted the PROOF-HD clinical trial. The group includes leading HD researchers and clinicians including Dr. Ralf Reilmann (European Lead PI) and Dr. Andrew Feigin (North American Lead PI).
• Mass General Hospital / Sean M. Healey & AMG Center for ALScoreStrategic or Co-development PartnerPrilenia collaborated with Massachusetts General Hospital's Healey ALS Center for the HEALEY ALS Platform Trial. The trial was conducted at 54 NEALS consortium sites. Dr. Merit Cudkowicz serves as principal investigator and sponsor of the HEALEY ALS Platform Trial.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• Wave Life Sciences: Clinical-stage oligonucleotide therapeutics company developing treatments for Huntington's disease and ALS, including WVE-003 and ALS-targeted programs. Directly competes with Prilenia for the same patient populations and KOL relationships in HD/ALS.
• Amylyx Pharmaceuticals: Commercial-stage biotech focused on ALS with AMX0035 (Relyvrio) approved in the US and now pursuing additional neurodegenerative indications. Directly comparable in ALS positioning, disease-modifying mechanism narrative, and late-stage development profile.
• uniQure: Gene therapy company developing AMT-130 for Huntington's disease, in Phase 1/2 trials. Targets the same HD patient population with a different (gene-silencing) modality; both are private/clinical-stage HD-focused biotechs.
• Voyager Therapeutics: Clinical-stage gene therapy company with CNS-focused pipeline including programs for Huntington's disease and ALS. Competes for similar patient populations and partnership dollars with novel CNS-delivery platforms.

Broad incumbents

• Ionis Pharmaceuticals: Established antisense oligonucleotide leader with tominersen (co-developed with Roche) for HD and several ALS programs. Larger and broader platform, but directly competes in the same antisense/RNA-targeted HD space and adjacent ALS space.
• Biogen: Large CNS-focused biopharmaceutical company with tofersen (Qalsody) approved for SOD1 ALS and multiple HD-adjacent programs. Represents the broad incumbent in neurodegenerative disease with established commercial infrastructure overlapping Prilenia's targets.
• Sage Therapeutics: CNS-focused biotech with approved neurology products and a neurodegenerative pipeline including potential HD/ALS-adjacent indications. Comparable in CNS development focus, regulatory pathway experience, and rare neurology commercial strategy.
• PTC Therapeutics: Mid-sized rare disease biopharmaceutical company with SMA, Duchenne, and Huntington's disease programs (including PTC518, an oral splicing modulator for HD). Direct overlap in rare neurological indications and oral small-molecule HD strategy.

Emerging players

• Annexon Biosciences: Clinical-stage biotech developing complement-targeted therapies for neurodegenerative and autoimmune diseases including Huntington's disease. Similar stage and modality (anti-inflammatory/neuroprotective), competing for the same prescribers and investors.

Regional players

• PegBio: China-based clinical-stage biopharmaceutical company developing treatments for neurodegenerative and metabolic diseases, including ALS and rare neurological indications. Operates in a different geography but pursues comparable disease-modifying CNS mechanisms.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks1 record

Key highlights7 records

Customer concentration

• Xx.com/PrileniaTx
• LinkedInlinkedin.com/company/prilenia

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds2 records

Investors8 records

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

M&A

Investments

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

Frequently asked questions about Prilenia