Radicava ORS (edaravone oral) / Mitsubishi Tanabe 
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  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Evolution of the treatment landscape for patients diagnosed with ALS in the United States (Poster Hall at the Palais de Congres Montreal; 517b/c) -  Nov 7, 2024 - Abstract #ALSMND2024ALS_MND_624;    
    Mitsubishi Tanabe Pharma America (MTPA) IV edaravone was introduced in 2017 and saw a consistent increase from 1 to 4.8% between 2017 and 2021. However, with the introduction of oral edaravone in 2022, the use of IV edaravone decreased to 1%, while the use of oral edaravone increased to 8.9%.
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Health care resource utilization of oral edaravone () -  Apr 9, 2024 - Abstract #AMCP2024AMCP_109;    
    BACKGROUND: Intravenous (IV) edaravone (Radicava) was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of amyotrophic lateral sclerosis (ALS) and was shown in clinical trials to slow the rate of physical functional decline. These real-world data may help clinicians and payers better understand the demographics, clini- cal characteristics, and HCRU of oral edaravone
  • ||||||||||  edaravone oral (TTYP01) / Auzone Biological
    Trial completion, Trial completion date:  Bioequivalence of TTYP01 Tablets in Healthy Adult Subjects (clinicaltrials.gov) -  Mar 25, 2024   
    P1,  N=29, Completed, 
    These real-world data may help clinicians and payers better understand the demographics, clini- cal characteristics, and HCRU of oral edaravone Recruiting --> Completed | Trial completion date: May 2024 --> Dec 2023
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe
    Interim Analysis of the Radicava/ Edaravone Findings in Biomarkers from ALS (REFINE-ALS) Study (Event Halle, Messe Basel, Ground Floor) -  Nov 7, 2023 - Abstract #ALSMND2023ALS_MND_457;    
    Biomarker and clinical data from this interim analysis will be presented. Results from this ongoing study may help to identify prognostic and disease monitoring markers of ALS and predictive and pharmacodynamic biomarkers of edaravone effect.
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Trial termination:  Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Oct 30, 2023   
    P3b,  N=384, Terminated, 
    Group 1 and Group 2 were predominantly male (59.3 and 58.7%), White (72.9 and 77.3%), from the southern US (39.0 and 40.1%), and covered by Medicare (69.5% and 59.3%), with a mean Active, not recruiting --> Terminated; Futility was met.
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Oct 30, 2023   
    P3b,  N=202, Terminated, 
    Active, not recruiting --> Terminated; Futility was met. N=300 --> 202 | Trial completion date: Jun 2024 --> Sep 2023 | Recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Sep 2023; Futility Analysis of parent study MT-1186-A02 was met.
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Trial completion:  Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Oct 27, 2023   
    P3,  N=124, Completed, 
    N=300 --> 202 | Trial completion date: Jun 2024 --> Sep 2023 | Recruiting --> Terminated | Trial primary completion date: Jun 2024 --> Sep 2023; Futility Analysis of parent study MT-1186-A02 was met. Active, not recruiting --> Completed
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe
    Biomarker, Enrollment closed, Trial completion date, Trial primary completion date:  Radicava (clinicaltrials.gov) -  Aug 24, 2023   
    P=N/A,  N=300, Active, not recruiting, 
    Recruiting --> Completed | N=30 --> 15 Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2023 --> Mar 2024
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Enrollment closed:  Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Feb 15, 2023   
    P3b,  N=380, Active, not recruiting, 
    Background An intravenous (IV) formulation of edaravone (Radicava Recruiting --> Active, not recruiting
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe
    PK/PD data, Journal:  Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants. (Pubmed Central) -  Nov 17, 2022   
    P1
    Oral administration of edaravone with a meal decreased the plasma concentration of edaravone. Oral administration of edaravone 8 hours after a high-fat meal, 4 hours after a low-fat meal, 2 hours after a light meal, and 1 hour before a high-fat meal showed no effect of food on the PK profile of unchanged edaravone compared with that observed under a fasted condition.
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Enrollment open:  Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS (clinicaltrials.gov) -  Nov 16, 2022   
    P3,  N=30, Enrolling by invitation, 
    Oral administration of edaravone 8 hours after a high-fat meal, 4 hours after a low-fat meal, 2 hours after a light meal, and 1 hour before a high-fat meal showed no effect of food on the PK profile of unchanged edaravone compared with that observed under a fasted condition. Not yet recruiting --> Enrolling by invitation
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Journal:  In brief: Edaravone oral suspension (Radicava ORS) for ALS. (Pubmed Central) -  Sep 20, 2022   
    These results suggest that oral edaravone suspension can be administered directly to the stomach without dose adjustment via feeding tubes; both oral and NGT administration are well tolerated. No abstract available
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe, Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Journal:  New Oral Form for ALS Drug. (Pubmed Central) -  Sep 2, 2022   
    The Food and Drug Administration has approved an oral suspension form of edaravone (Radicava ORS) for the treatment of amyotrophic lateral sclerosis.Edaravone should be taken on an empty stomach in the morning either by mouth or through a feeding tube. Feeding tubes should be flushed before and after drug administration.
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe
    Clinical, PK/PD data, Journal:  Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults. (Pubmed Central) -  Feb 23, 2022   
    Study 2 was conducted in 2 cohorts (n = 84); the first assessed DDIs with multiple-dose edaravone 120 mg/day given over 5 or 8 days (coadministered with single-dose rosuvastatin, sildenafil, or furosemide), and the second evaluated PK and racial (Japanese/White) differences in PK parameters with doses of 100-mg edaravone...The oral edaravone formulations were safe and tolerable under the assessed conditions. Mathematical modeling determined that equivalent exposures in plasma with the approved dose of the IV edaravone formulation, as reported previously, could be achieved when the oral edaravone formulation was administered at a dose of  ≈100 mg, with an absolute bioavailability of ≈60%.
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Trial completion date, Trial primary completion date:  Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Feb 21, 2022   
    P3b,  N=380, Recruiting, 
    Mathematical modeling determined that equivalent exposures in plasma with the approved dose of the IV edaravone formulation, as reported previously, could be achieved when the oral edaravone formulation was administered at a dose of  ≈100 mg, with an absolute bioavailability of ≈60%. Trial completion date: Mar 2022 --> Jul 2023 | Trial primary completion date: Mar 2022 --> Jul 2023
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Enrollment open:  Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Feb 9, 2022   
    P3b,  N=300, Recruiting, 
    Trial completion date: Mar 2022 --> Jul 2023 | Trial primary completion date: Mar 2022 --> Jul 2023 Not yet recruiting --> Recruiting
  • ||||||||||  Radicava (edaravone) / Mitsubishi Tanabe
    Biomarker, Trial completion date, Trial primary completion date:  Radicava (clinicaltrials.gov) -  Dec 21, 2021   
    P=N/A,  N=300, Recruiting, 
    Not yet recruiting --> Recruiting Trial completion date: Feb 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Mar 2023
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Trial completion:  Safety Study of Oral Edaravone Administered in Subjects With ALS (clinicaltrials.gov) -  Nov 8, 2021   
    P3,  N=185, Completed, 
    Trial completion date: Feb 2022 --> Mar 2023 | Trial primary completion date: Feb 2022 --> Mar 2023 Active, not recruiting --> Completed
  • ||||||||||  Radicava ORS (edaravone oral) / Mitsubishi Tanabe
    Trial completion:  Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube (clinicaltrials.gov) -  May 12, 2021   
    P1,  N=36, Completed, 
    The first phase 3 trial of oral edaravone will provide important information on the long-term safety and tolerability of this new formulation of edaravone in patients with ALS. Active, not recruiting --> Completed
  • ||||||||||  edaravone (MT-1186) / Mitsubishi Tanabe
    Journal:  Oxidative stress evaluation of skeletal muscle in ischemia-reperfusion injury using enhanced magnetic resonance imaging. (Pubmed Central) -  Dec 18, 2020   
    Furthermore, the effect of edaravone (radical scavenger) was evaluated in the 4-h ischemia-24-h reperfusion injury rat model...The signal intensity of the ischemia-reperfusion limb was stronger than that of the intact limb, presumably reflecting the oxidative stress in the former. 3-CP MRI examination shows promise for effective assessment of oxidative stress and may facilitate early diagnosis of ischemia-reperfusion injury.
  • ||||||||||  ebselen (SPI-3005) / Sound Pharma, edaravone (MT-1186) / Mitsubishi Tanabe
    Journal:  Reaction targets of antioxidants in azo-initiator or lipid hydroperoxide induced lipid peroxidation. (Pubmed Central) -  Dec 16, 2020   
    In contrast, ebselen and ferrostatin-1 showed strong antioxidative activity in the HpODE/hemin-induced peroxidation...In conclusion, we found that each antioxidant had different antioxidative activities that prevented the progression of LPO. We expect that these findings will contribute to the design of novel therapeutic strategies using an appropriate antioxidant targeted to each step of the development of oxidative stress diseases.