ALS can progress rapidly.22 Beginning treatment with RADICAVA ORS® can be meaningful in slowing the loss of physical function.18,23
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MEDICAL PRACTICE
REVIEW THE PIVOTAL STUDY DATA FOR RADICAVA® AND THE RESULTS FROM AN OBSERVATIONAL ANALYSIS FOR RADICAVA ORS® REVIEW NOW
RADICAVA ORS®
RADICAVA ORS® (edaravone) gives patients an ORAL option that can fit their life's routines.1RADICAVA ORS®—the difference is experience
RADICAVA ORS® was recognized as a major contribution to patient care2
17,300+ people have been treated with RADICAVA ORS® since 2022 for
1.9 million+ days of therapy3,a,b (see footnote)
RADICAVA ORS® has been prescribed by 1600+ physicians3,a
RADICAVA ORS® is equivalent to the IV formulation of edaravone1,4
RADICAVA® (edaravone) has been evaluated in over 2 decades of clinical research, including 4 phase 3 trials1,4-12
RADICAVA formulations have had 8+ years on the market since initial FDA approval in 20171
aBased on RADICAVA ORS® prescriptions submitted in the US as of May 2026. Not independently verified.
RADICAVA ORS®—built on years of clinical research and development
2024
RADICAVA ORS® recognized as a major contribution to patient care2
- Offering an oral route of administration provides a less burdensome option vs intravenous administration
2022
RADICAVA ORS® approved for ALS13
2021
RADICAVA ORS® submitted for FDA approval3
2019-2021
Pharmacokinetic studies
- A phase 1 bioequivalence and safety study conducted in healthy subjects1,4
- 3 phase 1 trials evaluated the pharmacokinetics of RADICAVA ORS®8-10
Safety study
- A 6-month, phase 3, open-label clinical trial evaluated the safety and tolerability of RADICAVA ORS® in 185 patients with ALS1,6
Alternate administration studies
- A phase 1 clinical trial evaluated the pharmacokinetics and safety of RADICAVA ORS® administered via PEG tube in patients with ALS11
- A phase 1, open-label study investigated the safety, tolerability, pharmacokinetics, and bioavailability of RADICAVA ORS® administered orally and via NG tube in healthy subjects12
2017
RADICAVA® approved for ALS
- The only FDA-approved treatment for ALS that met its primary endpoint in a pivotal phase 3 clinical trial13-15
2016
RADICAVA® submitted for FDA approval3
2015
RADICAVA® granted orphan drug status16
2001-2016
Edaravone clinical trials in ALS commence
- A phase 2 study evaluating the efficacy and safety of 2 different concentrations of edaravone11
- 3 phase 3 studies evaluating the efficacy and safety of edaravone in patients with ALS12
Since 1995, RADICAVA is the only FDA-approved treatment for ALS that met its primary endpoint in a phase 3 clinical study.13-15,c (see footnote)
In ALS, every point matters17
Losing or keeping a single point on the ALSFRS-R can have a significant impact on those living with ALS.17 That’s why the pivotal phase 3 clinical trial of RADICAVA® was specifically designed to measure change in physical function assessed by the ALSFRS-R.17-19
For your appropriate patients, initiate treatment with RADICAVA ORS® upon diagnosis20
On average, patients on RADICAVA® lost 2.49 fewer points on the ALSFRS-R vs placebo1,18
RADICAVA was generally well tolerated1
The most common adverse reactions (≥10%) reported in RADICAVA-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.1
In the pivotal phase 3 study, the P value was calculated based on the results
It’s important to note a treatment difference of 2.49-point change from baseline in ALSFRS-R (0.99, 3.98) with P=0.0013 is considered statistically significant.18
To put the results in context, consider what P values suggest and how probable the results are due to chance.21
Very strong statistical differenceP<0.001
That means that there is less than 1 in 1000 probability that the results are due to random chance
Statistical differenceP≤0.05
That means that there is less than 5% probability that the results were due to random chance
No statistical differenceP>0.05
No statistical difference
between groups
Request a rep visit to:
- Learn more about the efficacy and safety of RADICAVA ORS®
- Get answers to your questions about RADICAVA ORS®
bDays of therapy based on number of Starter Kit and Maintenance Kit cartons sold for RADICAVA ORS® as of May 2026. Each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy. Return to content
cBased on a systematic review of phase II, II/III, and III trials in ALS conducted between 2008 and 2019. Return to content
ALSFRS-R=ALS Functional Rating Scale–Revised; BL=baseline; FDA=Food and Drug Administration; IV=intravenous; LS=least squares; NG=nasogastric; PEG=percutaneous endoscopic gastrostomy; SE=standard error.
References: 1. RADICAVA and RADICAVA ORS [package insert]. Florham Park, NJ: Shionogi Inc. 2. US Food and Drug Administration. Clinical superiority findings. Accessed June 12, 2026. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings 3. Data on file. Shionogi Inc. 4. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 5. Yoshino H, Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (phase II study). Amyotroph Lateral Scler. 2006;7(4):247-251. 6. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04165824 7. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 8. ClinicalTrials.gov. Study of oral edaravone in healthy adult males. Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04481750 9. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04176224 10. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04481789 11. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04254913 12. ClinicalTrials.gov. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. Accessed May 4, 2026. https://clinicaltrials.gov/study/NCT04776135 13. US Food and Drug Administration. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). Accessed May 4, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als 14. Tzeplaeff L, Wilfling S, Requardt M, et al. Current state and future directions in the therapy of ALS. Cells. 2023;12(11):1523. 15. ALS Association. Medications for treating ALS. Accessed May 4, 2026. https://www.als.org/navigating-als/living-with-als/medications 16. US Food and Drug Administration. Orphan drug designations and approvals. Accessed May 4, 2026. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=478215 17. Cedarbaum JM, Stambler N, Malta E, et al; BDNF ALS Study Group (Phase III). The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci. 1999;169(1-2):13-21. 18. Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512. 19. Takei K, Tsuda K, Takahashi F, et al. Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):64-70. 20. Leigh PN, Swash M, Iwasaki Y, et al. Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(2):84-98. 21. Singh P. P value, statistical significance and clinical significance. J Clin Prev Cardiol. 2013;2(4):202-204. 22. Sawada H. Considerations for pharmacotherapy use in patients with amyotrophic lateral sclerosis: the earlier it starts, the better the results. Expert Opin Pharmacother. 2019;20(14):1671-1674. 23. Samadhiya S, Sardana V, Bhushan B, et al. Assessment of therapeutic response of edaravone and riluzole combination therapy in amyotrophic lateral sclerosis patients. Ann Indian Acad Neurol. 2022;25(4):692-697.
