JERSEY CITY, N.J., March 5, 2026 /PRNewswire/ -- Tanabe Pharma America, Inc. (TPA) today announced two poster presentations showcasing research in amyotrophic lateral sclerosis (ALS) at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, taking place March 8-11 in Orlando, Florida and online. Both presentations feature encore analyses that build on previously shared findings.
"We're encouraged by these important findings on RADICAVA ORS and insights from digital health-enabled monitoring TPA will be presenting at MDA this year," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, TPA. "Together, these studies highlight our ongoing efforts to deepen our medical knowledge on the potential prognostic biomarker for ALS and to study innovative approaches to improve outcomes for people living with the disease."
RADICAVA ORS Data:
A study will be presented evaluating the neutrophil-to-lymphocyte ratio (NLR) response to RADICAVA ORS in patients with ALS and the predictive value of baseline NLR versus propensity score-matched PRO-ACT placebo controls. These findings further explore the potential role of NLR as a novel prognostic biomarker in ALS.
- Exploratory Post Hoc Analysis of Neutrophil-to-Lymphocyte Ratio as a Novel Response Biomarker for Edaravone Oral Suspension-Treated Patients With Amyotrophic Lateral Sclerosis vs Untreated Propensity Score-Matched PRO-ACT Historical Placebo Controls (Manabu Hirai, M.S.; TPC)
Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, March 8
Digital Health Insights:
A study will be presented examining the potential clinical value of smartphone-based telespirometry as an at-home tool for ALS monitoring. In a prospective six-month study in edaravone-treated patients, ALS Functional Rating Scale-Revised (ALSFRS-R) decline differed in non-invasive ventilation (NIV) status. Additional analyses emphasized the importance of incorporating NIV use into clinical study designs when interpreting respiratory and functional outcomes.
- Smartphone Application–Mediated, Supervised, At-Home Telespirometry Identifies Statistically Significant Differences in Erect and Supine Slow Vital Capacity and ALSFRS-R Decline as a Function of Non-invasive Ventilation Treatment Status in Multicenter, Prospective, Longitudinal, Observational Clinical Study [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University)
Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, March 8
About RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1
Edaravone was discovered and developed for ALS by Tanabe Pharma and commercialized in the U.S. by Tanabe Pharma America, Inc. The Tanabe Pharma group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 22,000 people with ALS, with over 2.8-million days of therapy, and have been prescribed by over 2,800 HCPs.2-4
INDICATION
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
Sulfite Allergic Reactions
RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information, also available at www.RADICAVAORS.com.
About Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Tanabe Pharma America, Inc. (TPA) is a wholly-owned subsidiary of Tanabe Pharma Corporation. It was established by Tanabe Pharma Corporation to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit https://us.tanabe-pharma.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Tanabe Pharma Corporation
Tanabe Pharma Corporation is one of the oldest pharmaceutical companies in the world, founded in 1678. Tanabe Pharma is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. Tanabe Pharma sets the MISSION of "Creating hope for all facing illness." To that end, Tanabe Pharma is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. Tanabe Pharma is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.tanabe-pharma.com/en
Media inquiries:
Media_TPA.US@mb.tanabe-pharma.com
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Tanabe Pharma America, Inc.; 2025.
2 Data on file. Tanabe Pharma America, Inc.
3 Data on file. Tanabe Pharma America, Inc.
4 Data on file. Tanabe Pharma America, Inc.
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