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

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

2,166

Literatures (Medical) associated with Edaravone

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 ; Huang, Jeffrey K ; Hu, Chaur-Joug ; Huang, Jeffrey K. ; Ahsan, Asmar

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 Nov 2024·NEUROPHARMACOLOGY

Oral edaravone ameliorates behavioral deficits and pathologies in a valproic acid-induced rat model of autism spectrum disorder

Article

Author: Chen, Zhao-Rong ; Li, Yong-Tao ; Li, Fang ; Yao, Jia-Yu ; Zhou, Xin-Fu ; Zhang, Lin-Xuan ; Li, Meng-Qing ; Lu, Xiao-Yu ; Li, Chang-Qi ; Zeng, Ze-Hao ; Yu-Liu

Autism spectrum disorder (ASD) is neurodevelopmental disorder with a high incidence rate, characterized by social deficits and repetitive behaviors. There is currently no effective management available to treat the core symptoms of ASD; however, oxidative stress has been implicated in its pathogenesis. Edaravone (EDA), a free-radical scavenger, is used to treat amyotrophic lateral sclerosis (ALS) and acute ischemic stroke (AIS). Here, we hypothesized that an oral formula of EDA may have therapeutic efficacy in the treatment of core ASD symptoms. A rat model of autism was established by prenatal exposure to valproic acid (VPA), and the offsprings were orally treated with EDA at low (3 mg/kg), medium (10 mg/kg), and high (30 mg/kg) doses once daily for 28 days starting from postnatal day 25 (PND25). Oral EDA administration alleviated the core symptoms in VPA rats in a dose-dependent manner, including repetitive stereotypical behaviors and impaired social interaction. Furthermore, oral administration of EDA significantly reduced oxidative stress in a dose-dependent manner, as evidenced by a reduction in oxidative stress markers and an increase in antioxidants in the blood and brain. In addition, oral EDA significantly attenuated downstream pathologies, including synaptic and mitochondrial damage in the brain. Proteomic analysis further revealed that EDA corrected the imbalance in brain oxidative reduction and mitochondrial proteins induced by prenatal VPA administration. Overall, these findings demonstrate that oral EDA has therapeutic potential for ASD by targeting the oxidative stress pathway of disease pathogenesis and paves the way towards clinical studies.

01 Nov 2024·NEUROCHEMISTRY INTERNATIONAL

Therapeutic potential of oleanolic acid in modulation of PI3K/Akt/mTOR/STAT-3/GSK-3β signaling pathways and neuroprotection against methylmercury-induced neurodegeneration

Article

Author: Khan, Zuber ; Mehan, Sidharth ; Das Gupta, Ghanshyam ; Sharma, Ramaish ; Narula, Acharan S. ; Narula, Acharan S

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disorder that gradually deteriorates motor neurons, leading to demyelination, muscle weakness, and eventually respiratory failure. The disease involves several pathological processes, such as increased glutamate levels, mitochondrial dysfunction, and persistent neuroinflammation, often exacerbated by environmental toxins like mercury. This study explores the therapeutic potential of Olea europaea active phytoconstituents oleanolic acid (OLA) against ALS by targeting the overactivated PI3K/Akt/mTOR/STAT-3/GSK-3β signalling pathways. Methods involved in-silico studies, in vitro and in vivo experiments in which varying doses of methylmercury 5 mg/kg, p.o. and OLA (100 and 200 mg/kg, i.p.) were administered to rats for 42 days. Behavioural assessments, gross morphological, histopathological, and neurochemical parameters were measured in cerebrospinal fluid (CSF), blood plasma, and brain homogenates (cerebral cortex, hippocampus, striatum, midbrain, cerebellum) along with complete blood count (CBC) analysis. Results revealed OLA's significant neuroprotective properties. OLA effectively modulated targeted pathways, reducing pro-inflammatory cytokines, restoring normal levels of myelin basic protein (MBP) and neurofilament light chain (NEFL), and reducing histopathological changes. Gross pathological studies indicated less tissue damage, while CBC analysis showed improved hematology parameters. Additionally, the combination of OLA and edaravone (10 mg/kg, i.p.) demonstrated enhanced efficacy, improving motor functions and extending survival in ALS model rats. In conclusion, OLA exhibits significant therapeutic potential for ALS, acting as a potent modulator of key pathological signaling pathways. The findings suggest the feasibility of integrating OLA into existing treatment regimens, potentially improving clinical outcomes for ALS patients. However, further research must validate these findings in human clinical trials.

138

News (Medical) associated with Edaravone

30 Oct 2024

·www.prnewswire.com

World Stroke Congress | TASTE-2 significantly reduces stroke disability

NANJING, China, Oct. 30, 2024 /PRNewswire/ -- Oct 24th 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16th World Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Continue Reading Professor Yongjun Wang presented a late-breaking oral presentation at WCS Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+)-dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. 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

Clinical ResultDrug ApprovalClinical Study

25 Oct 2024

·www.prnewswire.com

TASTE-2 World Stroke Congress | Sanbexin ® combined with thrombectomy significantly reduces stroke disability

NANJING, China, Oct. 25, 2024 /PRNewswire/ -- On October 24, 2024, TASTE-2, a Chinese innovative stroke drug study led by Professor Wang Yongjun from Beijing Tiantan Hospital, was published in an oral report at the 16th World Stroke Conference (WSC): brain cell protection combined with edaravone dexborneol (Sanbexin ®) in patients with acute ischemic stroke before endovascular thrombectomy significantly improved the proportion of patients who recovered neurological independence at 90 days and reduced the proportion of patients with disability. Continue Reading Professor Wang Yongjun from Beijing Tiantan Hospital gave oral lectures on behalf of the research team at the 16th WSC Conference on Late Breaking and SRTThrombectomy plus Sanbexin ® for further stroke reduction Stroke is the leading cause of death and disability in adults in China, and acute ischemic stroke (AIS) accounts for about 70% of all strokes. Among them, about 40% of patients belong to the risk subtype of large vessel occlusion (LVO), with higher disability and mortality. After stroke, treatment with "reperfusion", which is represented by thrombolysis and thrombectomy, restores blood supply to the brain as soon as possible. Endovascular thrombectomy (EVT) is an important advance in reperfusion therapy in recent years, which can achieve recanalization in about 70% to 90% of patients with LVO stroke, but only nearly half of patients recover well. A significant proportion of patients with EVT remain disabled to varying degrees after 90 days of treatment. The oral report on 2024WSC showed that a multicenter, double-blind, randomized, placebo-controlled TASTE-2 study enrolled 1362 patients with moderate-severe stroke treated with EVT. Edaravone dexborneol, a brain cell protection was used before EVT, and the proportion of patients with functional score 2 below 90 days was 55.0% vs. 49.6% compared with placebo, which was statistically significant and safe. This suggests that brain cell protection prior to stroke thrombectomy may further improve treatment outcomes in patients with large vessel occlusive stroke and help them regain self-care ability. TASTE-2 Primary Efficacy Results: There was a significant difference between the treatment and placebo groups in the proportion of patients who were functionally independent (90-day mRS 0 to 2), OR = 1.24 (1.00 to 1.54), p = 0.047; RR = 1.11 (1.00 to 1.23), p = 0.047 Sanbexin ® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-target brain cell protection developed by Simcere Pharmaceutical Co., Ltd. The drug contains two active ingredients, edaravone and dexborneol, which efficiently penetrate the blood-brain barrier, reduce cascade damage caused by AIS through dual effects of anti-inflammation and free radical scavenging, and extend the existing treatment window from 24 hours to 48 hours. As the only innovative drug approved for marketing and sales in the field of stroke treatment worldwide since 2015, this drug has been developed for 12 years. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexin ® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke and also trigger lively on-site discussion in international academia. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for a long time. However, for the complex pathophysiological mechanism of stroke, single-target drugs have limited efficacy and are difficult to develop clinically. Corresponding to this, multi-target brain cytoprotectants continue to progress in clinical practice. Previously, the TASTE study led by Professor Yongjun Wang 's team from Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan from Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients without thrombectomy, respectively. The data were published in STROKE (Stroke) and JAMA Neurology (American Medical Association Journal of Neurology), in 2021 and 2024. In the future, Sanbexin ® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy and administered before reperfusion to further improve the effect of stroke treatment and reduce stroke disability. 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

Drug ApprovalClinical ResultClinical Study

21 Oct 2024

·www.prnewswire.com

Mitsubishi Tanabe Pharma America Presents New Results of RADICAVA ORS® (edaravone) from a Phase 3b Efficacy and Safety Extension Study and a Clinical Analysis of Multiple Studies at NEALS 2024

Phase 3b extension study reinforces current FDA-approved on/off regimen of RADICAVA ORS Analyses suggest improved survival in people with ALS on RADICAVA ORS compared to PRO-ACT placebo group JERSEY CITY, N.J., Oct. 21, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced new findings from two studies of RADICAVA ORS® (edaravone) presented at the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2024 Annual Meeting. The company presented results from the MT-1186-A04 Study, a Phase 3b extension of the previously reported MT-1186-A02 study which explored the superiority of investigational once daily dosing versus the FDA-approved on/off regimen of RADICAVA ORS in people living with ALS. MTPA also shared results from primary and post-hoc analyses of RADICAVA ORS compared with Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) historical placebo controls, with evidence suggesting treatment with RADICAVA ORS increased survival outcomes and decreased physical function decline versus controls. "We're pleased to share the findings of the Phase 3b extension study and an analysis of long-term function, which highlight additional data about the impact that RADICAVA ORS can have on function and survival for people living with ALS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These results reinforce our commitment to delivering valuable insights to the ALS and medical communities." Poster Presentation: Phase 3b Extension Study MT-1186-A04 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 The randomized, double-blind, multi-center extension study MT-1186-A04 followed patients for 48 weeks after completion of study MT-1186-A02, in which patients had been treated with either investigational once daily or on/off FDA-approved dosing of RADICAVA ORS. Daily dosing did not show superiority to the approved on/off dosing. No significant difference in ALS Functional Rating Scale-Revised (ALSFRS-R) score reductions between the two groups reinforces that the on/off regimen of RADICAVA ORS is the most appropriate regimen for patients with ALS. Poster Presentation: 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 Patients enrolled in the RADICAVA ORS Studies MT-1186-A02/A04 (prespecified analysis) and Studies MT-1186-A01/A02/A03/A04 (post hoc analysis) were propensity score-matched 1:1 on 10 baseline variables with historical, external, PRO-ACT controls (placebo-arm participants in their respective trials). These propensity score–matched cohort analyses provide evidence for a slowing of functional decline and improved survival outcomes with long-term RADICAVA ORS treatment versus PRO-ACT placebo group patients with ALS. 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. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". 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 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 . 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

Clinical ResultDrug ApprovalPhase 3Orphan Drug

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
Retinal Dystrophies	Preclinical	-	-	01 May 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04577404 (MT-1186-A03, CTgov)	Phase 3	Amyotrophic Lateral Sclerosis	124	MT-1186	ccvltczamd(rygwrrsrtc) = qivbeashem kwnuqrtcfm (kfpvpddvux, iajaczycek - erdgogdhgd) View more	-	28 Aug 2024
NCT04577404 (MT-1186-A03, Biospace) Manual	Phase 3	Amyotrophic Lateral Sclerosis	-	RADICAVA ORS	yavhaqzgkp(crqipamlar) = fall, muscular weakness, dyspnea, constipation, and dysphagia. yhrneqlhop (ymsbfkntvb )	Positive	17 Jun 2024
MDA2024	Not Applicable	Amyotrophic Lateral Sclerosis	-	Edaravone-naïve patients	qxlazsxgfd(yneycqmjvo) = hwtoavbhev xnqhmzmyei (jqdukawoys )	-	03 Mar 2024
				Edaravone-experienced patients	qxlazsxgfd(yneycqmjvo) = ztxdiqhsuy xnqhmzmyei (jqdukawoys )
NCT04176224 (CTgov)	Phase 1	Amyotrophic Lateral Sclerosis	9	MT-1186	pxokailsej(lvrqmjciwb) = rgznhvjibt rxgucbiipa (gindtubnxg, ffeujufhwo - bipvdbqaso) View more	-	24 Jan 2024
NCT04254913 (CTgov)	Phase 1	Amyotrophic Lateral Sclerosis	6	MT-1186	tbwkshzroe(yqhotvntph) = vxdihscdkm mlxlqydlsd (shiwvwqwgj, iorfdzmhjh - cnqsnlfgwb) View more	-	24 Jan 2024
NCT04493281 (CTgov)	Phase 1	-	42	Edaravone (Edaravone Oral Suspension)	vdgqwkqrpt(yrwowvmwjy) = ojyzusypfv ellevtrngt (efodqmtalj, stkaoxzsvn - yjaywkrjac) View more	-	18 Jan 2024
				Edaravone IV+Edaravone (Edaravone IV Formulation)	vdgqwkqrpt(yrwowvmwjy) = zybvwheoon ellevtrngt (efodqmtalj, omxmmactyi - qpfnkgjhse) View more
NCT05178810 \| EUCTR2022-003050-32-DE (ADOREXT, Corporate Publications) Manual	Phase 3	Amyotrophic Lateral Sclerosis	-	FAB122	qdfnxomtlu(czrhlcwboz) = 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. atliqxkmgp (opaflevyrz )	Negative	10 Jan 2024
				Placebo
NCT04776135 (CTgov)	Phase 1	-	36	MT-1186	naeplptbcg(htrdjitjnf) = mftjwaekac yftktvbfku (jylwrrnndp, ufcjtaoswm - xwnvurhkry) View more	-	08 Jan 2024
NCT01492686 (Study 19/MCI186-19, Pubmed)	Phase 3	Amyotrophic Lateral Sclerosis	-	IV edaravone	hywkqilxxf(uimnrhjjgm): P-Value = .02	-	01 Oct 2023
				Placebo

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