RegulationPriority Review (US), Fast Track (US), Orphan Drug (EU), Priority Review (CN), Orphan Drug (JP), Orphan Drug (AU), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (US)

Structure

Molecular FormulaC10H10N2O

InChIKeyQELUYTUMUWHWMC-UHFFFAOYSA-N

CAS Registry89-25-8

Clinical Trials associated with Edaravone

IRCT20240224061102N1 / SuspendedPhase 3IIT

Evaluation of the effect of edaravone on the patients with ischemic stroke

Start Date30 May 2024

Sponsor / Collaborator-

ChiCTR2400082879 / SuspendedPhase 4IIT

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

Start Date01 May 2024

Sponsor / Collaborator

Yichang Central People's Hospital

CTR20241131 / CompletedNot Applicable

评估TTYP01片(规格:30mg)在健康成年参与者不同饮食状态下生物利用度的单中心、开放、随机、单剂量、三周期、六序列、交叉食物影响实验

[Translation] A single-center, open, randomized, single-dose, three-period, six-sequence, crossover food effect study to evaluate the bioavailability of TTYP01 tablets (specification: 30 mg) in healthy adult participants under different dietary conditions

主要试验目的：研究不同饮食状态下单次口服TTYP01片（规格：30 mg，苏州澳宗生物科技有限公司委托无锡合全药业有限公司生产）在健康参与者体内的药代动力学特征，评价食物对TTYP01片生物利用度的影响。次要试验目的：研究TTYP01片在健康参与者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of TTYP01 tablets (specification: 30 mg, produced by Wuxi Hequan Pharmaceutical Co., Ltd. commissioned by Suzhou Aozong Biotechnology Co., Ltd.) in healthy participants under different dietary conditions, and to evaluate the effect of food on the bioavailability of TTYP01 tablets. Secondary purpose of the study: to study the safety of TTYP01 tablets in healthy participants.

Start Date31 Mar 2024

Sponsor / Collaborator

Suzhou Auzone Biological Technology Co., Ltd.

100 Clinical Results associated with Edaravone

100 Translational Medicine associated with Edaravone

100 Patents (Medical) associated with Edaravone

2,156

Literatures (Medical) associated with Edaravone

01 Mar 2025·BIOMATERIALS

Metal-organic framework-edaravone nanoparticles for radiotherapy-induced brain injury treatment

Article

Author: Ding, Zhongxiang ; Li, Xuejiao ; Hua, Shiyuan ; Zhou, Min ; Zhong, Danni

Cranial radiotherapy may cause damage to normal brain tissues and induce cognitive dysfunction, so developing an effective strategy to prevent radiotherapy-induced brain injury is essential. Metal-organic frameworks (MOFs) can be used as vectors for the delivery of neuroprotective drugs due to their high drug loading capacity and low toxicity. In this study, we synthesized MIL-53(Cr) nanoparticles, which were used to deliver edaravone, and modified the surface of the nanoparticles with polyethylene glycol and Angiopep-2 (EDA@MIL-53(Cr)-P/A) to improve their oral bioavailability and ability to cross the blood-brain barrier (BBB). We confirmed that MIL-53(Cr)-P/A nanoparticles could achieve the sustained release of edaravone and enhance its ability to cross the BBB. The results of in vitro experiments showed that EDA@MIL-53(Cr)-P/A could exert radioprotective effects on HT22 and BV2 cells. We also demonstrated that EDA@MIL-53(Cr)-P/A could alleviate brain injury and cognitive dysfunction in mice receiving whole-brain irradiation. Mechanistically, EDA@MIL-53(Cr)-P/A alleviated irradiation-induced brain damage by inhibiting oxidative stress, DNA damage, apoptosis and inflammatory reactions. This study provides a new strategy for the protection against radiotherapy-induced brain injury.

01 Jan 2025·EXPERIMENTAL NEUROLOGY

Potential role of solid lipid curcumin particle (SLCP) as estrogen replacement therapy in mitigating TDP-43-related neuropathy in the mouse model of ALS disease

Article

Author: Lee, Yi-Chao ; Ashan, Asmar ; Hsieh, Yi-Chen ; Majumder, Pritha ; Huang, Chi-Chen ; Hsu, Tsung-I ; Hu, Chaur-Joug ; Huang, Jeffrey K ; Ahsan, Asmar ; Huang, Jeffrey K.

BACKGROUND:

Amyotrophic lateral sclerosis (ALS) was first identified in 1869, but it wasn't until the 2014 Ice Bucket Challenge that widespread attention was drawn to the disease. Since then, substantial research has been dedicated to developing treatments for ALS. Despite this, only three drugs - riluzole, edaravone and AMX0035, have been approved for clinical use, and they can only temporarily alleviate mild symptoms without significant disease modification or cure. Therefore, there remains a critical unmet need to identify disease modifying or curative therapies for ALS. The higher incidence and more severe progression of ALS and FTLD (frontotemporal lobar degeneration) observed in men and postmenopausal woman compared to young women suggests that sex hormones may significantly influence disease onset and progression. In both animal models and human clinical studies, 17β estradiol (E2) has been shown to delay and improve the outcomes of many neurodegenerative diseases. Here, we examined the role of TDP-43 in the regulation of estrogen-related enzymes, CYP19A1 and CYP3A4. In addition, we examined the impact of curcumin on the regulation of estrogen E2 levels and TDP-43-associated neuropathy as a potential therapeutic strategy for the treatment of FTLD and ALS.

METHODS:

Prp-TDP-43^A315T mice was used as a model of ALS/FTLD to examine the expression patterns of E2 and its biosynthesis and degradation enzymes, CYP19A1 and CYP3A4. Moreover, the molecular mechanisms and the potency of solid lipid curcumin particles (SLCP) as an E2 replacement therapy for TDP-43 associated neuropathy was analyzed. We further examined the survival rates and the pathological TDP43 patterns in female and male Prp-TDP-43^A315T mice administrated with or without SLCP. In addition, the changed expression levels of enzymes corresponding to E2 biosynthesis and degradation in the spinal cord of female and male Prp-TDP-43^A315T mice with or without SLCP were determined.

RESULTS:

We found that in addition to E2, the expression patterns of CYP19A1 and CYP3A4 proteins differed between Prp-TDP-43^A315T mice compared to wild-type control, suggesting that toxic phosphorylated TDP43 oligomers may disrupt the balance between CYP19A1 and CYP3A4 expression, leading to reduced estrogen biosynthesis and accelerated degradation. In addition, we found that oral administration of SLCP prolonged the survival rates in female Prp-TDP-43^A315T mice and significantly reduced the pathological insoluble phosphorylated TDP-43 species. Furthermore, SLCP attenuated disease progression associated with TDP-43-related neuropathies through modulating estrogen biosynthesis and the activity of CYP450 enzymes.

CONCLUSIONS:

Our results showed that Prp-TDP-43^A315T mice exhibit altered estradiol levels. Moreover, we demonstrated the efficacy of SLCP as an estrogen replacement therapy in mitigating TDP-43-associated disease progression and pathogenesis. These findings suggest that SLCP could be a promising strategy to induce E2 expression for the treatment of ALS and FTLD.

01 Jan 2025·BRAIN RESEARCH

A coloaded liposome in situ gel as a novel therapeutic strategy to treat cerebral ischemia reperfusion injury

Article

Author: Xia, Zhangyong ; Li, Jin ; Lv, Rongbin ; Wang, Yanfen ; Tian, Qiang ; Sun, Baoliang ; Zhou, Guangan ; Liu, Xinyun

BACKGROUND:

Ischemic stroke has become one of the leading causes of death and disability worldwide in individuals aged 60 and above. However, currently available drugs show limited efficacy. Therefore, research to find more effective and safer therapeutic strategies is an urgent requirement for the treatment of cerebral ischemia reperfusion injury (CIRI).

METHODS:

First, the free radical scavenger Edaravone and a Ginseng active ingredient were coloaded into liposomes (aER@Lip), followed by optimization and characterization. Pluronic F127 and F68 at different concentrations were mixed and stored at 4 °C for more than 24 h to obtain gel solutions. Then, aER@Lip was added to the gel solutions to prepare the drug-loaded in situ gel, termed aER@Lip-TSG.

RESULTS:

In vitro experiments showed that aER@Lip-TSG was taken up by cells and had a good protective effect on oxygen-glucose deprivation/reoxygenation in pheochromocytoma 12 cells. In a rat CIRI model, aER@Lip-TSG delivered by intranasal administration not only decreased the apoptosis in brain tissue induced by CIRI, but also decreased the resultant inflammatory response. Moreover, the results suggested that aER@Lip-TSG had good biosafety.

CONCLUSION:

This delivery system provides a promising multi-factor combination, synergistic effects, sustained-release capabilities, and is a non-invasive treatment strategy for CIRI. It thus meets the urgent need for effective treatments of central nervous system diseases.

142

News (Medical) associated with Edaravone

04 Dec 2024

·www.prnewswire.com

China NMPA approves Simcere's Sanbexin® sublingual tablets for the treatment of Acute Ischemic Stroke

NANJING, China, Dec. 4, 2024 /PRNewswire/ -- On November 2, 2024, Simcere Pharmaceutical announced that Sanbexin® sublingual tablets (generic name: edaravone and dexborneol sublingual tablets), an innovative drug for stroke, has been approved for marketing by the National Medical Products Administration. This product is indicated for the improvement of neurological symptoms, daily activities, and functional impairment due to acute ischemic stroke. Continue Reading Packaging of Sanbexin® sublingual tablets Sanbexin® sublingual tablets is a dual-target brain cytoprotective agent composed of edaravone and dexborneol. These two active ingredients exert synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell damage caused by acute ischemic stroke. The sublingual tablets are designed for quick disintegration once in contact with saliva under the tongue. This facilitates the active ingredients' rapid absorption into the blood and brain through the sublingual venous plexus. Compared to conventional oral formulations, sublingual tablets bypass the first-pass hepatic metabolism, which is conducive to higher drug bioavailability and faster onset of action. Previously, Sanbexin® injection was approved for marketing in China in 2020. As the world's only innovative drug approved for stroke since 2015, it has helped over 3 million patients in the past 4 years. The phase III clinical trial led by Professor Fan Dongsheng of Peking University Third Hospital showed that the patients in the Sanbexin® sublingual tablets group after 14 consecutive days of drug administration, obtained a significantly higher proportion of functional independence outcome at 90 days post-treatment than those in the placebo group (64.4% vs. 54.7%,). The latest data was published in JAMA Neurology on February 19, 2024. Professor Fan Dongsheng, Principal Investigator of TASTE-SL and Professor at Peking University Third Hospital mentioned:"Sanbexin® sublingual tablets has shown significant effects and good safety in improving recovery of cerebral cells and independent living ability during the acute phase in patients with acute ischemic stroke. The more convenient administration allows for sequential therapy with Sanbexin® injection, facilitating stroke patients to receive a complete course of brain cytoprotection in and outside of the hospital during the acute phase of stroke." Professor Wang Yongjun, Director of Beijing Tiantan Hospital, Capital Medical University "The average length of hospital stay for stroke patients in China is about one week, while clinical studies suggest that brain cytoprotective drugs need to be used for 14 consecutive days. Sanbexin® sublingual tablets is easy to take, allowing patients to receive treatment at home. This can better reduce disability among patients and is also expected to lower medical costs." In August 2024, Sanbexin® sublingual tablets was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for AIS, making it the world's first innovative drug in the field of stroke treatment to have received such acknowledgment. Currently, a global multi-centered clinical trial of Sanbexin® sublingual tablets is under preparation. "The approval of Sanbexin® sublingual tablets in China is believed to significantly reduce the number of stroke-related disabilities in China." Professor Gregory W. Albers, Director of the Stroke Center and the Medical Center at Stanford University commented, " We are planning to conduct a large-scale Phase III clinical trial of Sanbexin® sublingual tablets in the United States, hoping to replicate the success of the trial in China and help reduce the global burden of stroke-related disabilities." Dr. Marc Fisher, former President of the World Stroke Organization and Professor at Harvard Medical School, commented on this new approval:"Sanbexin® has gradually gained popularity in China and is now available in a sublingual tablets formulation, with clinical data confirming its safety and efficacy. We are hoping to see trials of Sanbexin® sublingual tablets conducted outside China. If the trial results are positive and it receives approval in other countries, such as the U.S., it will have a huge impact globally on the treatment of acute ischemic stroke." The Sanbexin® sublingual tablets, with its convenient delivery method, will make stroke prevention and treatment more comprehensive and accessible. Its therapeutic area is expected to be expanded to pre-hospital emergency treatment for the acute phase of stroke, as well as to the treatment for the sub-acute and chronic phases of cerebrovascular diseases, to further promote the recovery of neurological functions and to improve the functional prognosis of stroke patients. SOURCE Simcere Pharmaceutical Group Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalBreakthrough TherapyClinical Result

04 Dec 2024

·www.biopharmadive.com

Dewpoint, Mitsubishi partner on ALS drug in deal worth up to $480M

Dewpoint Therapeutics, a young biotechnology company, could receive nearly half a billion dollars if all goes to plan in a new partnership focused on its experimental medicine for ALS.Through a deal announced Wednesday, Dewpoint has given Mitsubishi Tanabe Pharma the exclusive right to license the medicine once it hits certain near-term research and development goals. Should Mitsubishi Tanabe choose to license the program, the Japan-based company would then be responsible for its clinical development and commercialization.In exchange, Dewpoint has received an undisclosed upfront sum of money and could take home more through milestone and tiered royalty payments. The total value of the deal could reach as high as $480 million.Mitsubishi Tanabe a distant corporate cousin of the car manufacturer already sells Radicava, one of the few drugs approved in the U.S. to treat amyotrophic lateral sclerosis. Radicava is available as an infusion or, since 2022, a mixture taken orally. Doctors have said the drug offers only modest effects and its administration, at least with the infused version, can be so cumbersome that patients often dont find it worthwhile.With limited treatment options, people with ALS currently live an average of two to five years after they are diagnosed. Roughly 90% of cases are classified as sporadic, meaning experts dont know the root cause.ALS remains a critical area of unmet medical needs and [Mitsubishi Tanabe] is committed to addressing it, said Masao Nawano, head of the companys research division, in a statement. Together with Dewpoint, we have the potential to deliver meaningful innovations to patients and families affected by this devastating condition.Launched in 2019, Dewpoint believes that mysterious clusters of molecules may be a path to new drugs for cancer, heart conditions and nerve-destroying disorders like ALS. Studies have suggested these clusters, known as biomolecular condensates, are important in cell regulation and may causes diseases if they malfunction.The idea has intrigued venture capitalists, giving rise to a few startups that debuted shortly after Dewpoint. Nereid Therapeutics launched in the middle of November 2020 with $50 million in funding from Apple Tree Partners. Two weeks later, Transition Bio unveiled itself and announced the closing of a seed funding round led by Lifeforce Capital.Faze Medicines also emerged in late 2020, backed by powerful investment firms like Third Rock Ventures and Alexandria Venture Investments as well as large pharmaceutical companies like Novartis, AbbVie and Eli Lilly. Yet less than two years later, Faze abruptly shut down. The companys science did not progress sufficiently to meet our bar for further investment, a Third Rock spokesperson said at the time.Dewpoint, meanwhile, has continued to draw in money since its launch. The company inked collaborations with Bayer, Merck & Co., Pfizer and Novo Nordisk that collectively could be worth well over $1 billion.Some of that money hasn't materialized, though. The company reportedly lost its alliances with Merck and Pfizer, and laid off staff earlier this year.Ameet Nathwani, Dewpoints CEO and a former Sanofi executive, said in a statement that Mitsubishi Tanabe is the ideal partner for the ALS program, given the companys knowledge of the disease and its global clinical capability and expansive patient network.Dewpoints drug is meant to treat ALS by breaking up abnormal accumulations of a protein called TDP-43. This protein is essential for processing RNA, and some scientists believe that when it stops functioning correctly, or when there isnt enough of it in the core of nerve cells, diseases like ALS can develop. '

License out/in

03 Dec 2024

·www.prnewswire.com

Mitsubishi Tanabe Pharma America to Present New ALS Research at MNDA's 35th International Symposium on ALS/MND

JERSEY CITY, N.J., Dec. 3, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced 10 presentations covering advances in amyotrophic lateral sclerosis (ALS) research at the Motor Neurone Disease Association (MNDA) 35th International Symposium on ALS/MND, being held in Montreal, Canada, from December 6-8. "We are honored to participate in this year's MNDA symposium, where we will share insights from our preclinical, clinical and real-world studies on RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) and discuss the evolving ALS treatment landscape," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "Our commitment to advancing ALS research is underscored by over eight years of continuous contributions at this symposium. This dedication guides us in leveraging both clinical and real-world evidence to help support the ALS community." RADICAVA ORS Results: Final 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 over 48 weeks (MT-1186-A02) and up to 96 weeks (MT-1186-A04). Additionally, safety data from a Phase 3 open-label safety extension study (MT-1196-A03) will be shared. 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 B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 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 (Stephen Apple, M.D.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Real World Data: Presentations will highlight the evolving ALS treatment landscape with insights from the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) registry covering treatment patterns, clinical outcomes and survival rates in RADICAVA-treated individuals. Additional presentations include a preliminary analysis of the OPTUM claims database, evaluating treatment combinations in people with ALS. Further highlights include studies on point-of-care quality assessment and at-home telespirometry, evaluating erect and supine slow vital capacity measurements in people with ALS. Evolution of the Treatment Landscape for Patients Diagnosed With ALS in the United States (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Treatment Patterns and Survival Benefit of Edaravone–Treated People With Amyotrophic Lateral Sclerosis in the ALS/MND Natural History Consortium (Malgorzata Ciepielewska, M.S.; MTPA) Oral Session 2B – Improving Clinical Management: 10:30 a.m. – 12:30 p.m. ET, Friday, December 6 Preliminary Analysis of Treatment Combinations in Patients With Amyotrophic Lateral Sclerosis Enrolled in an US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 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] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 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] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 Preclinical Data: Two preclinical studies will be presented, showcasing key mechanisms in ALS pathology. The first study demonstrates edaravone's role in modulating glutamate-mediated hyperexcitability in spinal motor neurons, using an ALS animal model. The second study explores how LRSAM1 contributes to TDP-43 clearance, a critical process in ALS, using induced pluripotent stem cells (iPSCs) derived from ALS patients. Edaravone Reduces the Enhanced Glutamatergic Transmission Onto Motor Neurons in the Spinal Cord of a Mouse Model of Amyotrophic Lateral Sclerosis (Yun Kyung Park, Ph.D.; MTPC) Poster Session B: 5:30 p.m. – 7:00 p.m. ET, Saturday, December 7 LRSAM1 Protects Neurons in Amyotrophic Lateral Sclerosis by Regulating the TDP-43 Proteostasis (Takayuki Shirakawa, Ph.D.; MTPA) Oral Session 6A – Proteostasis and Proteotoxicity: 10:30 a.m. – 12:30 p.m. ET, Saturday, December 7 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 Approval

100 Deals associated with Edaravone

External Link

KEGG	Wiki	ATC	Drug Bank
D01552	Edaravone	N07XX14	DB12243

R&D Status

Approved

10 top approved records.

to view more data

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

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Amyotrophic Lateral Sclerosis 2, Juvenile	Phase 3	JP	Mitsubishi Tanabe Pharma Corp.	01 Dec 2011
Alzheimer Disease	Phase 3	NL	Treeway BV	-
Autistic Disorder	Phase 2	CN	Suzhou Auzone Biological Technology Co., Ltd.	-
liver function failure	Phase 1	JP	Mitsubishi Tanabe Pharma Corp.	16 Nov 2016
Liver Injury	Phase 1	JP	Mitsubishi Tanabe Pharma Corp.	16 Nov 2016
Renal Insufficiency	Phase 1	JP	Mitsubishi Tanabe Pharma Corp.	27 Oct 2016
Autism Spectrum Disorder	IND Approval	CN	Suzhou Auzone Biological Technology Co., Ltd.	10 Dec 2024
Retinal Dystrophies	Preclinical	-	-	01 May 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04577404 (MT-1186-A03, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	124	MT-1186	ljulcoptrf(bjsijkbwrm) = rhzrakxmlw nrrnrvpdpc (edujhbaxtf, uwdhbuxttq - fkpnqvkzzv) View more	-	28 Aug 2024
NCT04577404 (MT-1186-A03, Biospace) Manual	Phase 3	Amyotrophic Lateral Sclerosis	-	RADICAVA ORS	fsbcvvvxlq(izqzbdgrhj) = fall, muscular weakness, dyspnea, constipation, and dysphagia. wunuiivwql (epyshwvlgw )	Positive	17 Jun 2024
AAN2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-naive patients	apppmnvwmh(jmqvexzgoz) = yzrtqkxxaz diifpspwhe (waqmmvystf )	-	09 Apr 2024
AAN2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-experienced patients	apppmnvwmh(jmqvexzgoz) = iiivtflyxe diifpspwhe (waqmmvystf )	-	09 Apr 2024
MDA2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-naïve patients	hvtpfbejuw(anbwvmrrac) = hjonwqmlek rqkazvszeh (eivunhtrsc )	-	03 Mar 2024
MDA2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-experienced patients	hvtpfbejuw(anbwvmrrac) = zfvxzhasat rqkazvszeh (eivunhtrsc )	-	03 Mar 2024
NCT04254913 (CTgov)	Phase 1	Amyotrophic Lateral Sclerosis	6	MT-1186	eoqgmdqwjr(oxdmbdhqmd) = khdlptzsno klrthyyled (dnhjslnxnt, cxvturuiek - lurgcwvjmf) View more	-	24 Jan 2024
NCT04176224 (CTgov)	Phase 1	Amyotrophic Lateral Sclerosis	9	MT-1186	gmcuilllvb(nlshxuqqag) = hkhcdhsrok ynnstllpag (ydexpsgjku, pjhmguhaam - mffukdcjme) View more	-	24 Jan 2024
NCT04493281 (CTgov)	Phase 1	-	42	Edaravone (Edaravone Oral Suspension)	hlbgfoibwn(bxudgswjhm) = jvdbfndqco shwkvzuimu (rsruffsggn, auhinwbuqq - hxgvmueqeo) View more	-	18 Jan 2024
NCT04493281 (CTgov)	Phase 1	-	42	Edaravone IV+Edaravone (Edaravone IV Formulation)	hlbgfoibwn(bxudgswjhm) = hwhimtdsrd shwkvzuimu (rsruffsggn, zfjxodvoov - acvazppezu) View more	-	18 Jan 2024
NCT05178810 \| EUCTR2022-003050-32-DE (ADOREXT, Corporate Publications) Manual	Phase 3	Amyotrophic Lateral Sclerosis	-	FAB122	xzijwnfhic(xrhhabrbph) = Data from ADORE indicates that product did not show significant benefit over placebo in patients with ALS in slowing the disease progression as measured by change from baseline in the ALSFRS-R score after 48 weeks of daily dosing with the oral edaravone formulation. ybvjyhculf (jofaxkjeik )	Negative	10 Jan 2024
	Phase 3	Amyotrophic Lateral Sclerosis	-	Placebo		Negative	10 Jan 2024
NCT04776135 (CTgov)	Phase 1	-	36	MT-1186	hksqomreds(irpqfmeqnp) = zvewsfcimj qzmsriofij (cncmqwxywe, qpdcqfvntb - rdjttnuafp) View more	-	08 Jan 2024

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