REVIEW THE PIVOTAL STUDY DATA FOR RADICAVA® AND THE RESULTS FROM AN OBSERVATIONAL ANALYSIS FOR RADICAVA ORS® REVIEW NOW
Get answers to some of the most common questions about RADICAVA ORS® (edaravone). For appropriate patients, initiate treatment with RADICAVA ORS® upon diagnosis1
You can also download the RADICAVA ORS® FAQs brochure for HCPs.DOWNLOAD 
Scroll to see all the FAQs, or jump to a section with these links:
Q: How was the efficacy of RADICAVA ORS® (edaravone) determined?
The efficacy of RADICAVA ORS® was based on the pivotal clinical trial for RADICAVA® (edaravone) and the phase 1 pharmacokinetic study for RADICAVA ORS®.2
Q: What studies were evaluated in the approval of RADICAVA ORS®?
Seven clinical studies specific to RADICAVA ORS® were conducted, in addition to the original set of clinical studies for RADICAVA®.2-10
RADICAVA ORS® efficacy is supported by data from a pivotal clinical trial for RADICAVA®2,11
Q: Can RADICAVA ORS® be taken with riluzole?
Consider RADICAVA ORS® in addition to riluzole upon diagnosis.1,11
Have more questions or want to learn more?
Request a visit by a representative
Q: What is RADICAVA ORS®?
RADICAVA ORS® is an FDA-approved prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Learn more about RADICAVA ORS®.
Q: What is the mechanism of action?
The exact mechanism of action of edaravone to treat ALS is unknown. It is believed, based on preclinical studies, to reduce oxidative stress.1,2
Q: Can patients take RADICAVA ORS® if they are pregnant or breastfeeding?
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with RADICAVA ORS®, or if they intend to breastfeed or are breastfeeding.1
There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production1
Q: Does RADICAVA ORS® have any drug interactions?
There are no known Drug-Drug Interactions (DDIs) associated with RADICAVA ORS®.1
The pharmacokinetics of edaravone are not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters1
Q: Does RADICAVA ORS® have any contraindications?
RADICAVA ORS® is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions and anaphylactic reactions have occurred.1
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.1
Q: Can RADICAVA ORS® be taken with riluzole?
Consider RADICAVA ORS® in addition to riluzole upon diagnosis.3,5
Q: What are the ingredients in RADICAVA ORS®?
The active ingredient in RADICAVA ORS® is edaravone.1
Inactive ingredients include L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.1
Q: How is RADICAVA ORS® stored?
Patients should store RADICAVA ORS® upright at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light. Discard 15 days after opening the bottle or, if unopened, 30 days from date of shipment indicated on the carton pharmacy label.1
Pharmacies should store RADICAVA ORS® refrigerated between 2°C to 8°C (36°F to 46°F) and protect from light. Do not freeze. Store upright.1
Q: How is RADICAVA ORS® supplied?
RADICAVA ORS® is supplied in a white-to-off-white oral suspension in a multidose, child-resistant 60 mL amber glass bottle. It is supplied as 2 configurations1:
RADICAVA ORS® Maintenance Kit (10-day treatment cycle) includes 1 bottle of 1050 mg/50 mL (105 mg/5 mL dose) with 2 oral dosing syringes and 1 bottle adapter
Q: What can my patients expect with their RADICAVA ORS® shipments?
Q: How can I determine if RADICAVA ORS® is covered by insurance?
RADICAVA ORS® has formulary coverage among major health insurance carriers including ESI, CVS, Express Scripts, Optum, Prime Therapeutics, and Veterans Affairs (VA).
Once you have prescribed RADICAVA ORS® and submitted a BIF to check how your patient’s health insurance covers RADICAVA ORS®, an Insurance & Access Specialist will reach out to the patient to help them understand the insurance process.
An Insurance & Access Specialist will:
Q: Is RADICAVA ORS® covered by insurance?
With RADICAVA ORS®, patients get access they can count on.4,6 There is strong coverage for RADICAVA ORS® across most insurance types.4,6,a (see footnote)
A JourneyMate Support Program™ Insurance and Access Specialist can help your patients navigate their coverage for RADICAVA ORS®. To learn more, call 1-844-772-4548.
This information is provided for educational purposes only. Shionogi Inc. does not guarantee coverage or reimbursement. Formulary status subject to change.
Q: Is there patient support available?
The JourneyMate Support Program™ helps to give patients and their care partners understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address their educational needs and provide them with personalized answers and resources for living with ALS.
Learn more about the JourneyMate Support Program™.
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed a Shionogi Inc. product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Shionogi Inc. product. An ALS Clinical Educator is provided by Shionogi Inc. and Momentum Life Sciences and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient's doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient’s doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.
Q: What clinical and real-world experience supports oral RADICAVA ORS® treatment?
RADICAVA ORS® is equivalent to the IV formulation of edaravone, which was FDA-approved in 2017 but is no longer available to prescribe.1,7 RADICAVA® (edaravone) has been evaluated in over two decades of clinical research, including four phase 3 trials.1,2,8-15
As of May 2026, RADICAVA ORS® has been prescribed by 1600+ physicians, and 17,900+ people have been treated with RADICAVA ORS® for 2 million+ days of therapy.4,d,e
dBased on RADICAVA ORS® prescriptions submitted in the US as of May 2026. Not independently verified.
eDays 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.
Q: What is the safety profile of RADICAVA ORS®?
RADICAVA ORS® has a demonstrated safety and tolerability profile which was shown in a 6-month, phase 3, open-label clinical trial in 185 patients with ALS, and offers a similar safety profile as the intravenous formulation.2
RADICAVA® and RADICAVA ORS® have the same Contraindications and Warnings and Precautions. (See Important Safety Information)2
Q: Does RADICAVA ORS® have any drug interactions?
There are no known DDIs associated with RADICAVA ORS®.2
The pharmacokinetics of edaravone are not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters2
Q: Does RADICAVA ORS® have any contraindications?
RADICAVA ORS® is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred.2
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 resolves2
Q: Can patients take RADICAVA ORS® if they are pregnant or breastfeeding?
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with RADICAVA ORS®, or if they intend to breastfeed or are breastfeeding.2
There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production2
Q: What was the discontinuation rate in the safety study of RADICAVA ORS®?
There was a low rate of discontinuations due to adverse events.12
Have more questions or want to learn more?
Request a visit by a representative
Q: How is RADICAVA ORS® administered?
RADICAVA ORS® was designed with ALS patients in mind2:
These are not the full instructions for administration. See Section 2.3 “Preparation and Administration Information for RADICAVA ORS® Oral Suspension” of the Prescribing Information to learn more.
Q: What is the dosing schedule for RADICAVA ORS®?
For subsequent treatment cycles, RADICAVA ORS® is taken for 10 out of 14 treatment days followed by 14 consecutive drug-free days.1
Q: Are there fasting requirements with RADICAVA ORS®?
RADICAVA ORS® should be taken on an empty stomach in the morning after overnight fasting. Patients should not consume any food or drink (except water) for 1 hour after administration.2
Food can affect the absorption of the medication. Patients should wait 8 hours after having high-fat meals (800-1000 calories, 50% fat), or 4 hours after low-fat meals (400-500 calories, 25% fat), or 2 hours after a caloric supplement (250 calories, eg, protein drink).2
Q: What can my patients expect with their RADICAVA ORS® shipments?
Q: What are the ingredients in RADICAVA ORS®?
The active ingredient in RADICAVA ORS® is edaravone.2
Inactive ingredients include L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.2
Q: What does RADICAVA ORS® taste like?
RADICAVA ORS® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.2,13
Q: With the discontinuation of RADICAVA®, can patients be switched to RADICAVA ORS®?
Yes, if appropriate, patients treated with 60 mg of RADICAVA® may be switched to 105 mg (5 mL) RADICAVA ORS® using the same dosing frequency. Upon switching to RADICAVA ORS®, patients should follow RADICAVA ORS® dosing recommendations with regards to food consumption.2
See Section 2.4 “Switching from RADICAVA to RADICAVA ORS” of the Prescribing Information to learn more.
Have more questions or want to learn more?
Request a visit by a representative
Q: How is RADICAVA ORS® stored?
Patients should store RADICAVA ORS® upright at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light. Discard 15 days after opening the bottle or, if unopened, 30 days from date of shipment indicated on the carton pharmacy label.2
Pharmacies should store RADICAVA ORS® refrigerated between 2°C to 8°C (36°F to 46°F) and protect from light. Do not freeze. Store upright.2
Q: How is RADICAVA ORS® supplied?
RADICAVA ORS® is supplied in a white-to-off-white oral suspension in a multidose, child-resistant 60 mL amber glass bottle. It is supplied as 2 configurations2:
RADICAVA ORS® Maintenance Kit (10-day treatment cycle) includes 1 bottle of 1050 mg/50 mL (105 mg/5 mL dose) with 2 oral dosing syringes and 1 bottle adapter
Access they can count on: strong coverage for RADICAVA ORS® across most insurance types.12,14
Learn more about the Out-of-Pocket Savings Program
This information is provided for educational purposes only; Shionogi Inc. does not guarantee coverage or reimbursement. Formulary status subject to change.
Q: What will the out-of-pocket costs be for my patients?
Low out-of-pocket costs: your patients may have options to lower their medication costs.12,15-17
Q: Who can my patients reach out to for cost and coverage support?
A JourneyMate Insurance & Access specialist can help your patients navigate their coverage for RADICAVA ORS® (edaravone). A JourneyMate Support Program™ Insurance & Access Specialist is here to help your patients:
Coordinate with a Specialty Pharmacy
This team of JourneyMate Support Program™ specialists is here to give your patients additional, dedicated support during treatment with RADICAVA ORS. The program does not provide medical advice and does not take the place of a patient’s doctor.
Get additional support for RADICAVA ORS® through a Specialty Pharmacy.
Q: How can I determine if RADICAVA ORS® is covered by insurance?
RADICAVA ORS® has formulary coverage among major health insurance carriers including ESI, CVS, Express Scripts, Optum, Prime Therapeutics, and VA.
Once you have prescribed RADICAVA ORS® and submitted a BIF to check how your patient’s health insurance covers RADICAVA ORS®, an Insurance & Access Specialist will reach out to the patient to help them understand the insurance process.
Learn more about the JourneyMate Support Program™.
Learn more about the Out-of-Pocket Savings Program.
A JourneyMate Support Program™ Insurance & Access Specialist is provided by UBC on behalf of Shionogi Inc. A JourneyMate Support Program™ Insurance & Access Specialist may provide information obtained from outside sources about a patient's insurance coverage, financial support options, and whether treatment is covered by their health plan. This information does not require a patient or their doctor to use any Shionogi Inc. product. Because the information provided comes from outside sources, a JourneyMate Support Program™ Insurance & Access Specialist cannot guarantee the information will be accurate or complete.
Q: How are the patients who are Veterans being supported?
Veterans with ALS may be eligible for treatment with RADICAVA ORS® (edaravone) and other benefits from VA.21
Q: Is there patient support available?
The JourneyMate Support Program™ helps to give patients and their care partners understanding, answers, and resources to supplement what their doctor provides. Experienced program team members are trained to address their educational needs and provide them with personalized answers and resources for living with ALS.
Learn more about the JourneyMate Support Program™.
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed a Shionogi Inc. product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Shionogi Inc. product. An ALS Clinical Educator is provided by Shionogi Inc. and Momentum Life Sciences and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient's doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient’s doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058.
Q: What evidence and clinical history were used to support the FDA approval of RADICAVA ORS®?
The FDA based their approval on results from multiple studies, including the phase 1 pharmacokinetic study demonstrating that RADICAVA ORS® has equivalent plasma levels to RADICAVA® (edaravone).2
Q: Why was an oral formulation of RADICAVA® created?
RADICAVA ORS® was designed for patients with ALS in mind.
Have more questions or want to learn more?
Request a visit by a representative
AE=adverse event; ALS=amyotrophic lateral sclerosis; ALSFRS-R=ALS Functional Rating Scale–Revised; DEERS=Defense Enrollment Eligibility Reporting System; FDA=Food and Drug Administration; GI=gastrointestinal; NG=nasogastric; PEG=percutaneous endoscopic gastrostomy; UGT=uridine diphosphate glucuronosyltransferase; VA=Veterans Affairs; VHA=Veterans Health Administration.
aIn the pharmacy, store RADICAVA ORS® refrigerated between 2°C and 8°C (36°F–46°F) and protect from light. Do not freeze. Store upright. Patients should store RADICAVA ORS® upright at room temperature between 20°C and 25°C (68°F–77°F) and protect from light. Discard 15 days after opening bottle or, if unopened, 30 days from date of shipment indicated on the carton pharmacy label.2 Return to content
bData on file. Shionogi Inc. As of June 2026. Return to content
cFor eligible patients with commercial insurance. Annual maximum benefit per patient. Additional terms and conditions apply. See full Eligibility Requirements and Terms & Conditions. Return to content
dBased on claims prescriptions dispensed submitted to the Out-of-Pocket Savings Program from January 1, 2025 to November 12, 2025. Return to content
References: 1. 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. 2. RADICAVA and RADICAVA ORS® [package insert]. Florham Park, NJ: Shionogi Inc. 3. 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. 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. Study of oral edaravone in healthy adult males. ClinicalTrials.gov identifier: NCT04481750. Accessed February 20, 2026. https://clinicaltrials.gov/study/NCT04481750 6. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. ClinicalTrials.gov identifier: NCT04176224. Accessed June 23, 2026. https://clinicaltrials.gov/study/NCT04176224 7. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). ClinicalTrials.gov identifier: NCT04481789. Accessed February 20, 2026. https://clinicaltrials.gov/study/NCT04481789 8. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. ClinicalTrials.gov identifier: NCT04254913. Accessed February 20, 2026. https://clinicaltrials.gov/study/NCT04254913 9. Safety study of oral edaravone administered in subjects with ALS. ClinicalTrials.gov identifier: NCT04165824. Accessed February 20, 2026. https://clinicaltrials.gov/study/NCT04165824 10. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. ClinicalTrials.gov identifier: NCT04776135. Accessed February 20, 2026. https://clinicaltrials.gov/study/NCT04776135 11. 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. 12. Data on file. Shionogi Inc. 13. PubChem compound summary for CID 5780, sorbitol. National Center for Biotechnology Information. Accessed July 1, 2026. https://pubchem.ncbi.nlm.nih.gov/compound/Sorbitol#section=Experimental-Properties&fullscreen=true 14. VA formulary advisor. US Department of Veterans Affairs. Accessed May 27, 2026. https://www.va.gov/formularyadvisor/drugs/4041481-EDARAVONE-SUSP-ORAL 15. Cubanski J. A current snapshot of the Medicare Part D prescription drug benefit. KFF. Accessed June 17, 2026. https://www.kff.org/medicare/a-current-snapshot-of-the-medicare-part-d-prescription-drug-benefit 16. Current Veterans disability compensation rates. US Department of Veterans Affairs. Accessed May 27, 2026. https://www.va.gov/disability/compensation-rates/veteran-rates 17. What are Medicare Savings Programs (MSPs)? National Council on Aging. Accessed April 14, 2026. https://www.ncoa.org/article/what-are-medicare-savings-programs-msps 18. Hagan KL, Niles A. Addressing Rx affordability. Pharmaceutical Commerce. Accessed June 17, 2026. https://www.pharmaceuticalcommerce.com/view/addressing-rx-affordability 19. VA makes specially adaptive housing grant eligibility automatic for veterans and servicemembers living with ALS [news release]. US Department of Veterans Affairs. Published March 19, 2014. Accessed May 27, 2026. https://www.va.gov/opa/pressrel/pressrelease.cfm?id=2530 20. Can I get free healthcare and prescriptions as a Veteran? US Department of Veterans Affairs. VA.gov. Accessed April 23, 2026. https://www.va.gov/resources/can-i-get-free-health-care-and-prescriptions-as-a-veteran 21. Federal Benefits for Veterans, Dependents, Survivors, and Caregivers. 2025; Pamphlet 80-25-1. US Department of Veterans Affairs. Accessed May 27, 2026. https://department.va.gov/wp-content/uploads/2024/12/2025-Federal-Benefits-for-Veterans-Dependents-and-Survivors.pdf 22. ALS awareness month. US Department of Veterans Affairs. Accessed May 27, 2026. https://www.va.gov/marion-health-care/stories/als-awareness-month 23. VA caregiver support program. Program of general caregiver support services (PGCSS). US Department of Veterans Affairs. Accessed May 27, 2026. https://www.caregiver.va.gov/CareCaregivers.asp 24. Clinical superiority findings. US Food and Drug Administration. Accessed September 19, 2025. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings
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.
RADICAVA ORS contains 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.
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.
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Shionogi Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available at www.radicavaors.com.
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.
RADICAVA ORS contains 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.
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.
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Shionogi Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information also available at www.radicavaors.com.
© 2026 Shionogi Inc. Florham Park, NJ 07932. All Rights Reserved.
RADICAVA, RADICAVA ORS, and the RADICAVA ORS logo are registered trademarks of Shionogi Inc.
JourneyMate Support Program is a trademark of Shionogi Inc.
All other trademarks are the property of their respective owners.
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