Riluzole
- Generic Name
- Riluzole
- Brand Names
- Exservan, Rilutek, Tiglutik, Riluzole Zentiva
- Drug Type
- Small Molecule
- Chemical Formula
- C8H5F3N2OS
- CAS Number
- 1744-22-5
- Unique Ingredient Identifier
- 7LJ087RS6F
- Background
A glutamate antagonist (receptors, glutamate) used as an anticonvulsant (anticonvulsants) and to prolong the survival of patients with amyotrophic lateral sclerosis. Riluzole is marketed as Rilutek by Sanofi.
- Indication
For the treatment of amyotrophic lateral sclerosis (ALS, Lou Gehrig's Disease)
- Associated Conditions
- Amyotrophic Lateral Sclerosis (ALS)
IFB-088 Shows Promise in Phase 2 Trial for Bulbar-Onset ALS, Demonstrating Slower Disease Progression
• Phase 2 clinical trial demonstrates IFB-088 (icerguastat) meets primary safety endpoint and shows significant reduction in disease progression for bulbar-onset ALS patients.
• Treated patients in the per protocol population showed notably slower decline, losing 0.95 points monthly on ALSFRS-R compared to 1.42 points in the placebo group.
• Biomarker data confirms IFB-088's mechanism of action through integrated stress response activation and oxidative stress reduction, supporting further development.
Denali Therapeutics' DNL343 Fails to Meet Primary Endpoint in HEALEY ALS Platform Trial
• Denali Therapeutics' DNL343, an eIF2B agonist, did not meet the primary endpoint of slowing ALS disease progression in a Phase 2/3 trial.
• The HEALEY ALS Platform Trial's Regimen G assessed DNL343's impact on disease severity and survival over 24 weeks compared to placebo.
• While DNL343 was safe and well-tolerated, key secondary endpoints like muscle strength and respiratory function showed no significant difference.
• Further analyses, including biomarker assessments, are planned for 2025 to explore potential subgroup benefits and long-term effects.
NeuroSense Therapeutics to Discuss Phase 3 Trial of PrimeC for ALS with FDA
• NeuroSense Therapeutics will meet with the FDA to discuss the Phase 3 trial design for PrimeC, an experimental therapy for amyotrophic lateral sclerosis (ALS).
• PrimeC, a combination of ciprofloxacin and celecoxib, aims to modulate inflammation, RNA processing, and iron accumulation, all disrupted in ALS.
• Phase 2b trial data showed PrimeC slowed disease progression by 36% and improved survival rates by 43% compared to placebo after one year.
• NeuroSense is also seeking early marketing approval for PrimeC in Canada, based on the Phase 2b PARADIGM trial results.
EMA Confirms Negative Stance on Masitinib for Amyotrophic Lateral Sclerosis
• The EMA has upheld its negative opinion on granting conditional marketing authorization for masitinib as an add-on treatment for amyotrophic lateral sclerosis (ALS).
• The decision follows a re-examination request by AB Science after an initial rejection, with concerns raised about data analysis.
• AB Science will focus on a confirmatory Phase 3 program for masitinib in ALS to pursue full approval, while halting reconsideration in Canada.
Neuvivo Seeks FDA Approval for NP001, a Novel Immunotherapy for ALS
• Neuvivo has submitted a New Drug Application (NDA) to the FDA for NP001, an investigational treatment for amyotrophic lateral sclerosis (ALS).
• NP001 is designed to restore balance to the innate immune system, potentially modifying the course of ALS by addressing uncontrolled inflammation.
• Clinical data suggest NP001 may preserve lung function and extend overall survival, particularly in patients with specific biomarkers indicating inflammation.
• The FDA has granted NP001 Orphan Drug and Fast Track designations, potentially expediting the review and approval process.
NeuroSense's PrimeC Demonstrates Efficacy in ALS, Pursues Early Approval in Canada
• NeuroSense Therapeutics' PrimeC showed a 36% reduction in ALS disease progression and a 43% improvement in survival rates in clinical trials.
• The company is pursuing early commercialization approval in Canada based on Phase 2b trial results and Health Canada's Notice of Compliance with Conditions policy.
• PrimeC, a novel formulation of ciprofloxacin and celecoxib, has received a key U.S. patent extending its protection to 2042.
• Two abstracts featuring PrimeC data will be presented at the 2024 Annual NEALS Consortium Meeting, highlighting clinical outcomes and biomarker analysis.
RNS60 Shows Promise in Extending Survival for ALS Patients in Phase 2 Trial
• A post-hoc analysis of a Phase 2 trial reveals that RNS60, when added to standard ALS therapies, extends median survival by approximately six months compared to placebo.
• The study identifies that patients with slower decline in lung function and lower levels of NfL and MCP-1 biomarkers experienced greater survival benefits from RNS60.
• RNS60, an experimental therapy targeting inflammation and mitochondrial dysfunction, warrants further investigation in a Phase 3 clinical trial for ALS.
• Revalesio's RNS60 has received orphan drug and fast track status from the FDA, potentially accelerating its development and review for ALS treatment.
Drug Development Updates
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