RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (United States)

Structure/Sequence

Molecular FormulaC10H10N2O

InChIKeyQELUYTUMUWHWMC-UHFFFAOYSA-N

CAS Registry89-25-8

Clinical Trials associated with Edaravone

ChiCTR2500101472

/ SuspendedNot ApplicableIIT

Early Application of Edaravone Dexrazoxane In The Treatment of Acute Non-Large Vessel Occlusive Ischemic Stroke

Start Date01 May 2025

Sponsor / Collaborator-

ChiCTR2500099139

/ SuspendedPhase 4IIT

Effects of concentrated Edaravone and Dexborneol Concentrated Solution for Injection on inflammatory factors in patients with amyotrophic lateral sclerosis

Start Date11 Apr 2025

Sponsor / Collaborator

Yichang Central People's Hospital

NCT06757504

/ RecruitingPhase 2

A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-controlled Phase II Trial of TTYP01 Tablets in Adolescents and Children With Autism Spectrum Disorders

This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.

Start Date13 Jan 2025

Sponsor / Collaborator

Shanghai Auzone Biological Technology Co., Ltd.

100 Clinical Results associated with Edaravone

100 Translational Medicine associated with Edaravone

100 Patents (Medical) associated with Edaravone

6,167

Literatures (Medical) associated with Edaravone

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Edaravone reduces brain injury in hepatic encephalopathy by upregulation of Nrf2/HO-1 and inhibition of NF-κB, iNOS/NO and inflammatory cytokines

Article

Author: Amirshahrokhi, Keyvan ; Imani, Mahsa

BACKGROUND:

Brain damage is the most important complication in patients with hepatic encephalopathy (HE). Oxidative stress and inflammation are essential factors in the progression of brain injury caused by HE. The aim of this study was to investigate the potential therapeutic effect of edaravone and its underlying mechanisms against brain injury associated with HE in mice.

METHODS AND RESULTS:

HE was induced by the injection of thioacetamide (200 mg/kg) for 2 days and then mice treated with edaravone (10 or 20 mg/kg/day, ip) for four consecutive days. The brain tissues were dissected for histopathological, biochemical, ELISA, RT-qPCR and immunofluorescence analysis. The results showed that edaravone improved the locomotor function and ameliorated brain histopathological changes in mice with HE. Edaravone inhibited oxidative stress markers by increasing the levels of glutathione, catalase, superoxide dismutase, glutathione reductase and the upregulation of nuclear erythroid 2-related factor (Nrf2)/HO-1 pathway in the brain tissue. Administration of edaravone significantly decreased the expression of p-NF-κB and iNOS. Edaravone treatment reduced the levels of NO, MPO and MMP-9 in the brain of mice. Additionally, the brain levels and expressions of inflammatory cytokines IL-1β, IL-6, TNF-α and IFN-γ were downregulated in mice treated with edaravone.

CONCLUSIONS:

These results suggest that edaravone exerts significant neuroprotection by modulating of inflammatory and oxidative responses in HE and may serve as a promising agent for the treatment of brain injury associated with HE.

01 Nov 2025·Neural Regeneration Research

Biochemical dissection of STAT3 signaling in amyotrophic lateral sclerosis

Article

Author: Apolloni, Savina ; D’Ambrosi, Nadia

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the loss of upper and lower motor neurons, clin. marked by muscle atrophy and weakness.Although the clin. course is highly variable, the average time from the onset of symptoms to the need for respiratory support or death is 3-5 years.ALS is the most prevalent motor neuron disease in adults, occurring at a rate of 2 per 100,000 individuals and affecting 5.4 per 100,000 individuals overall.

01 Aug 2025·Neural Regeneration Research

Carboplatin restores neuronal toxicity in FUS-linked amyotrophic lateral sclerosis

Article

Author: Kim, Kiyoung

Amyotrophic lateral sclerosis (ALS), also known as Lou Geh rig′s disease, is a progressive neurodegenerative disorder that affects motor neurons in the brain and spinal cord.This leads to muscle weakness, paralysis, and ultimately, respiratory failure (Cha and Kim, 2022).There is currently no cure for ALS.Riluzole, a primary treatment for ALS, has been shown to extend survival by an average of three months.Another drug, Edaravone, has been approved for ALS treatment in some countries; however, its efficacy remains controversial (Cha and Kim, 2022).These drugs target various mechanisms that contribute to neuronal degeneration in ALS, including glutamate excitotoxicity and oxidative stress.Although several studies have attempted to elucidate the underlying mechanisms, there remains an unmet need for more effective therapies to halt or reverse disease progression.Therefore, novel therapeutic strategies are urgently needed.

198

News (Medical) associated with Edaravone

03 Apr 2025

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Highlight Latest Advances in Neurodegenerative Research at the American Academy of Neurology 2025 Annual Meeting

Presentations will highlight findings from studies evaluating investigational ND0612 in Parkinson's disease and RADICAVA® (edaravone) formulations in ALS JERSEY CITY, N.J., April 3, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced 11 presentations will be shared at the American Academy of Neurology (AAN) 2025 Annual Meeting, taking place April 5-9 in San Diego, CA, and online. The presentations will discuss two posters in Parkinson's disease (PD) and nine in amyotrophic lateral sclerosis (ALS). "We are honored to join the scientific community at this year's AAN meeting, where we will discuss key insights from our clinical and real-world studies across PD and ALS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "Our presence at the meeting, and the data presented, underscore our dedication to advancing impactful research and deepening our understanding of these progressive neurodegenerative diseases." PD data to be presented at the meeting include: Investigational ND0612: Presentations will highlight findings from the pivotal Phase 3 BouNDless trial (NCT04006210), including an oral presentation detailing the impact of 24-hour treatment with ND0612 on PD motor state transitions throughout the day, as well as an analysis of quality of life outcomes in people with PD experiencing motor fluctuations. Impact of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Function: Efficacy Outcomes from the Phase 3 BouNDless Study (Rajesh Pahwa, M.D.; University of Kansas Medical Center) Scientific Platform Session S37 (#001): 1:00 p.m. – 1:12 p.m. PDT, April 9 Quality of Life With 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): QoL Results from a Phase 3, Randomized, Active-Controlled Study (Harini Sarva, M.D., FAAN; New York Presbyterian Hospital) Poster Session P11 (#5-007): 8:00 a.m. – 9:00 a.m. PDT, April 9 ALS data to be presented at the meeting include: RADICAVA ORS Studies: A presentation will share final results from the MT-1186-A03 extension study, which evaluated the safety and tolerability of RADICAVA ORS® (edaravone) over 96 weeks in ALS patients who had previously participated in MT-1186-A01. Additionally, findings from the MT-1186-A04 extension study will be presented, assessing the continued efficacy and safety of RADICAVA ORS over an additional 48 weeks, comparing investigational daily dosing with the U.S. Food and Drug Administration (FDA)-approved on/off regimen. Lastly, an analysis will examine the impact of RADICAVA ORS on survival and function in ALS patients, leveraging data from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database and propensity score matching to compare RADICAVA ORS-treated patients with participants from studies MT-1186-A01 through A04. Phase 3, Open-Label, Safety Extension Study of Oral Edaravone (Radicava ORS®) Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Scientific Platform Session S27 (#007): 2:12 p.m. – 2:24 p.m. PDT, April 8 Extension Study MT-1186-A04 Evaluating Oral Edaravone (Radicava ORS®) Continued Efficacy and Safety up to an Additional 48 Weeks in Patients With ALS (Stephen Apple, M.D.; MTPA) Poster Session P9 (#2-007): 11:45 a.m. – 12:45 p.m. PDT, April 8 Long-term Function and Survival of Radicava ORS® (Oral Edaravone)-Treated Patients With ALS vs Propensity Score–Matched PRO-ACT Historical Controls (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session P8 (#2-003): 8:00 a.m. – 9:00 a.m. PDT, April 8 Real-World Data: Multiple posters highlighting real-world data will be presented, including two studies evaluating at-home telespirometry in ALS. One examines changes in erect and supine slow vital capacity based on non-invasive ventilation (NIV) status, while the other assesses point-of-care quality classifications for slow and forced vital capacity measurements. Additionally, an analysis of real-world data will examine trends in ALS treatment utilization in the U.S. from 2016 to 2022, highlighting shifts in prescribing patterns, adoption of FDA-approved therapies and the decreasing proportion of untreated patients. Other presentations include an analysis of referral patterns and healthcare utilization among people with ALS enrolled in the OPTUM claims database, a secondary analysis describing demographics and healthcare resource utilization across specialty vs. non-specialty treatment centers, and the application of a clinical algorithm to electronic medical records to reduce the delay in time to diagnosis and treatment for patients with ALS. Smartphone─Mediated At-Home Telespirometry Erect and Supine Slow Vital Capacity Decline Differences Based On NIV Status in Subjects With ALS (Stephen Apple, M.D.; MTPA) Poster Session P8 (#2-004): 8:00 a.m. – 9:00 a.m. PDT, April 8 Smartphone─Mediated, At-Home Telespirometry Vital Capacity (VC) Measurements in ALS: Point-of-Care Quality Assessment for Slow VC and Forced VC (Stephen Apple, M.D.; MTPA) Poster Session P8 (#2-006): 8:00 a.m. – 9:00 a.m. PDT, April 8 Evolution of the Treatment Landscape for Patients Diagnosed with Amyotrophic Lateral Sclerosis in the United States (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session P9 (#2-006): 11:45 a.m. – 12:45 a.m. PDT, April 8 Referral Patterns for Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session P8 (#2-009): 8:00 a.m. – 9:00 a.m. PDT, April 8 Treatment of Amyotrophic Lateral Sclerosis in General and Specialist US Healthcare Settings: Results From a Real-World Survey (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session P8 (#2-012): 8:00 a.m. – 9:00 a.m. PDT, April 8 Application of a Clinical Algorithm on Real-World Electronic Medical Record Data to Assist With Earlier Detection of Amyotrophic Lateral Sclerosis (Amanda E. Fiander, M.D., FRCPC, CSCN (EMG); Maritime Neurology) Poster Session P8 (#2-010): 8:00 a.m. – 9:00 a.m. PDT, April 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 Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC 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) 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 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 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 Mitsubishi 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 . Please see the full Prescribing Information, also available at . About ND0612 ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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 . About NeuroDerm, Ltd. NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at  or follow the Company on LinkedIn.  Media inquiries: [email protected] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Orphan Drug

25 Mar 2025

·www.prnewswire.com

Mitsubishi Tanabe Pharma America Announces Publication of Preclinical Research on the Role of Edaravone in Mitigating TDP-43 Mislocalization in ALS

Results from this analysis were published in Free Radical Biology and Medicine JERSEY CITY, N.J., March 25, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of new preclinical research in Free Radical Biology and Medicine, highlighting the role of edaravone in mitigating TDP-43 mislocalization, a hallmark feature observed in more than 97% of sporadic amyotrophic lateral sclerosis (ALS) cases. The study, conducted using induced pluripotent stem cell (iPSC)-derived motor neurons from a single patient with ALS, demonstrated that edaravone significantly reduced the abnormal cytoplasmic accumulation of TDP-43, restoring its nuclear localization. This mislocalization is a key driver of neuronal dysfunction and degeneration in ALS, and suggests that edaravone may offer a varied therapeutic approach for ALS by targeting oxidative stress and TDP-43 mislocalization through distinct molecular pathways. "These findings help build upon our understanding of edaravone's potential effects in ALS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "By modulating TDP-43 pathology and engaging molecular pathways linked to neurodegeneration, edaravone may play a broader role in ALS management than previously understood and should continue to be studied." "This study provides preclinical evidence that edaravone's MOA in ALS extends beyond its known antioxidant properties," said Satsuki Mikuriya, Research Scientist at MTPA and lead author of the study. Key findings from the study include: In ALS patient-derived neurons from a patient with ALS harboring a TDP-43 mutation, edaravone significantly reduced the cytoplasmic accumulation of TDP-43, restoring its nuclear localization. Unlike vitamin C, edaravone preserved neurite structures and reduced neurotoxicity, supporting a unique mechanism of action. Edaravone treatment induced significant changes in gene expression as early as six hours post-treatment, with key pathways related to protein degradation and neuroprotection. Edaravone's effects were associated with modulation of the SIRT1-XBP1 pathway, a key regulator of cellular stress responses, suggesting a broader role in ALS neuroprotection. This preclinical study was conducted using iPSC-derived motor neurons from a single ALS patient with a specific TDP-43 mutation (A382T) in an in vitro setting. Additional research in animal models and clinical settings (including those with other ALS-related mutations and patients with sporadic ALS) is needed to confirm these findings. Additionally, recent research has highlighted not only the toxic gain of function caused by TDP-43 aggregation but also the pathological sequences of TDP-43 loss of function due to its nuclear depletion. Further studies are required to explore how edaravone influences the loss of TDP-43 function. While the study provides important new insights into edaravone's potential role in ALS treatment, further research is needed to confirm its effects in larger, more diverse ALS models and to explore its long-term impact on disease progression. This analysis was funded and conducted by MTPA. Additional results can be found in the publication, titled, "Edaravone mitigates TDP-43 mislocalization in human amyotrophic lateral sclerosis neurons with potential implication of the SIRT1-XBP1 pathway." About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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 Media inquiries: [email protected] SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

12 Mar 2025

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Showcase New Research Findings in ALS at 2025 MDA Clinical and Scientific Conference

JERSEY CITY, N.J., March 12, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of eleven abstracts covering research in amyotrophic lateral sclerosis (ALS) at the 2025 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference being held in Dallas, Texas, March 16-19. "We are looking forward to presenting our latest ALS research, including an innovative study exploring how clinical algorithms may aid in the diagnosis of ALS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "We remain dedicated to advancing ALS research and fostering scientific dialogue at medical meetings and congresses on our mission to provide meaningful treatment options and help improve the lives of those affected by this disease." RADICAVA ORS® (edaravone) Studies: Final efficacy and safety results from two multi-center, Phase 3b, double-blind, parallel group studies will be presented, including a comparison of daily dosing of RADICAVA ORS® (edaravone) with the FDA-approved on/off regimen, assessed at 48 weeks (MT-1186-A02) and its extension study (MT-1186-A04). Safety data from a Phase 3 open-label safety extension study for up to 96 weeks (MT-1196-A03) will also be shared. An additional presentation will examine the long-term function and survival of patients treated with RADICAVA ORS using data from propensity score-matched patients in the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with ALS (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Stephen Apple, M.D.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Phase 3b Study MT-1186-A04 Extension Study to Evaluate the Continued Efficacy and Safety of Radicava ORS® (Oral Edaravone) for up to an Additional 48-Weeks in Patients With Amyotrophic Lateral Sclerosis (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Analysis of Long-term Function and Survival of Radicava ORS® (Oral Edaravone)-Treated Patients With Amyotrophic Lateral Sclerosis vs Propensity Score–Matched PRO-ACT Historical Controls (Stephen Apple, M.D.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Real World Data: Presentations will highlight a clinical algorithm designed to analyze electronic medical record (EMR) data of neurologists, which aims to reduce delays in ALS diagnosis and treatment. Findings from the ALS/Motor Neuron Disease National History Consortium database will provide insights into the survival, treatment patterns and clinical outcomes of patients treated for ALS. In addition, studies examining referral patterns for ALS diagnosis, as well as demographics and healthcare resource utilization (HCRU) trends across specialty and non-specialty treatment centers, will be shared. Further, two studies will explore point-of-care quality classifications and at-home telespirometry assessments, evaluating forced vital capacity as well as erect and supine slow vital capacity in individuals with ALS. Smartphone Application-Mediated Supervised At-Home Telespirometry Erect and Supine Slow Vital Capacity (eSVC/sSVC) Measurements in Subjects With Amyotrophic Lateral Sclerosis Identify Statistically Significant Differences in eSVC/sSVC Decline as Function of Non-Invasive Ventilation Treatment Status [NCT05106569] (Stephen Apple, M.D.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Smartphone Application–Mediated, Supervised, At-Home Telespirometry Vital Capacity Measurements in Amyotrophic Lateral Sclerosis: Comparison of American Thoracic Society/European Respiratory Society Point-of-Care Quality Assessment Algorithms Implemented for Slow Vital Capacity and Forced Vital Capacity [NCT05106569] (Stephen Apple, M.D.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Referral Patterns for Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Investigating Application of a Clinical Algorithm on Real-World Electronic Medical Record Data for Earlier Detection of Amyotrophic Lateral Sclerosis (Dung Pham, Ph.D.; MTP-CA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Treatment of Amyotrophic Lateral Sclerosis in General and Specialist US Healthcare Settings: Results From a Real-World Survey (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Survival Benefits and Treatment Patterns of Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 Preclinical Data: Data from a preclinical study examining the effects of edaravone on spinal motor neurons derived from an ALS patient carrying the A382T mutation in TDP-43, as analyzed through a comprehensive transcriptomic approach, will be presented. Transcriptomic Signature Induced by Edaravone in Motor Neurons From an ALS Patient With a TDP-43 Mutation (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session: 6:00 p.m. – 8:00 p.m. CT, March 16 – March 18, 2025 About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. 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. 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 Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC 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) 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 and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA (edaravone) and RADICAVA ORS (edaravone) are 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 with RADICAVA. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA and 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-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi 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 . INDICATION RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). For more information, including full Prescribing Information, please visit . About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is 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 Media inquiries: [email protected] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalOrphan Drug

100 Deals associated with Edaravone

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KEGG	Wiki	ATC	Drug Bank
D01552	Edaravone	N07XX14	DB12243

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Amyotrophic Lateral Sclerosis	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jun 2015
Brain Infarction	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jun 2015
Acute Ischemic Stroke	China	Nanjing Simcere Dongyuan Pharmaceutical Co. Ltd.	31 Dec 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Androgen-Insensitivity Syndrome	Phase 3	China	Shanghai Auzone Biological Technology Co., Ltd.	25 Apr 2023
Amyotrophic Lateral Sclerosis 2, Juvenile	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	01 Dec 2011
Alzheimer Disease	Phase 3	Netherlands	Treeway BV	-
Autism Spectrum Disorder	Phase 2	China	Shanghai Auzone Biological Technology Co., Ltd.	24 Dec 2024
Autistic Disorder	Phase 2	China	Shanghai Auzone Biological Technology Co., Ltd.	-
Liver Injury	Phase 1	Japan	Mitsubishi Tanabe Pharma Corp.	16 Nov 2016
Chronic Kidney Diseases	Phase 1	Japan	Mitsubishi Tanabe Pharma Corp.	27 Oct 2016
Retinal Dystrophies	Preclinical	-	-	01 May 2004

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05151471 (CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	202	Edaravone (Edaravone 105 mg (Once Daily))	iqctvlhsni(kadjsvxrdq) = fzrfszkrfq ymzrusmgqk (zgwuiqeofl, jfdvqncyvf - mkuppaoikm) View more	-	27 Mar 2025
				Edaravone (Edaravone 105 mg (on/Off))	iqctvlhsni(kadjsvxrdq) = wfbfiscfib ymzrusmgqk (zgwuiqeofl, razbsbpwgp - dxtrfdullh) View more
NCT04569084 (CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	384	Edaravone (Edaravone 105 mg (Once Daily))	ndoxhittaa(qqdlhhkghx) = vzixoyaezn qjmndqmkfj (oejwxwhxqn, pknsqzltqo - clydjythsw) View more	-	27 Mar 2025
				Edaravone (Edaravone 105mg (2 Weeks On/Off ))	ndoxhittaa(qqdlhhkghx) = kbtgfkcoiu qjmndqmkfj (oejwxwhxqn, kyfeezowzc - siyafhwaln) View more
NCT05178810 (ADOREXT \| ADORE, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	313	FAB122 (FAB122)	rpnpswlyzz(bhcultgktd) = povvopmjfh wmfzorniwx (qydfjiocai, 7.9) View more	-	18 Mar 2025
				Placebo (Placebo)	rpnpswlyzz(bhcultgktd) = fxrboiezph wmfzorniwx (qydfjiocai, 8.4) View more
NCT05866926 (ADOREXT, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	201	FAB122 (FAB122)	dxpninxlzo = lcctplheze zghsmcqjll (lxkhyzosac, nabljbukcf - iycqmkikdq) View more	-	04 Mar 2025
				FAB122 (Placebo)	dxpninxlzo = vwvlwpfddc zghsmcqjll (lxkhyzosac, pqwcmhcbcb - hufkhxjwbg) View more
NCT05568615 (CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	15	MT-1186	ztbhoxorep = mevyzpuerw ujdmraobfj (ksxmytixxq, yrdknjxphz - xdtdntlyjf) View more	-	03 Feb 2025
NCT03346538 (CTgov)	Phase 2	Acute Ischemic Stroke	17	Approved dosing regimen placebo+Continuous infusion high-dose MCI-186 (Continuous Infusion High-dose Group (Group H))	zworwytaxh = irejtcsgyq gtymhphxbt (pmeymbddow, uxyhnilyli - caefpzrvhg) View more	-	09 Jan 2025
				Approved dosing regimen placebo+Continuous infusion low-dose MCI-186 (Continuous Infusion Low-dose Group (Group L))	zworwytaxh = vlkrsbqloz gtymhphxbt (pmeymbddow, oolzhqdpib - ewvrtjsyip) View more
NCT04577404 (MT-1186-A03, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	124	MT-1186	ptpgbbvypx = whubpqbelk sdxuudvwze (ovsuoviwpe, kcupknsnts - rmgxnopekv) View more	-	28 Aug 2024
NCT04577404 (MT-1186-A03, Biospace) Manual	Phase 3	Amyotrophic Lateral Sclerosis	-	RADICAVA ORS	dqyuilfysw(ldegkpsxoy) = fall, muscular weakness, dyspnea, constipation, and dysphagia. bvkbiynwed (jrmpnghles )	Positive	17 Jun 2024
AAN2024	Not Applicable	Amyotrophic Lateral Sclerosis	231	IV edaravone to oral edaravone	ngtxywoouq(ecwywgwpeh) = lwxkebiezn xqcvldjcvq (mxxwsbopmu ) View more	Positive	09 Apr 2024
				Oral edaravone-naïve	ngtxywoouq(ecwywgwpeh) = nxaqbznnfg xqcvldjcvq (mxxwsbopmu ) View more
AAN2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-naive patients	mcuklbtldj(cpyxvbaefq) = nsfqthynws ynsgzerybv (tqknqfoabw )	-	09 Apr 2024
				Edaravone-experienced patients	mcuklbtldj(cpyxvbaefq) = ohbcltzcwb ynsgzerybv (tqknqfoabw )

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