RADICAVA ORS

Peak

edaravone

Gland Pharma

NDAORALSUSPENSIONPriority Review

Approved

May 2022

Lifecycle

Peak

Competitive Pressure

15/100

Clinical Trials

Data completeness

4/8 — Partial

Priority Review

Drug data last refreshed 23h ago · AI intelligence enriched 3w ago

AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data

RADICAVA ORS (edaravone) is an oral suspension approved in May 2022 for the treatment of amyotrophic lateral sclerosis (ALS). The product represents an oral formulation alternative to the original intravenous RADICAVA, offering improved patient convenience and compliance. While the exact mechanism of action in ALS remains unknown, edaravone demonstrates bioequivalent systemic exposure to the IV formulation at a 105 mg oral dose. It is positioned as a disease-modifying therapy option in the limited ALS treatment landscape.

$0.3BPart D

15.5 years to LOE

Mechanism of Action

Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (9)

NCT06674460Phase 3Recruiting

Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease

Started Aug 2025

600 enrolled

Cerebral Small Vessel DiseaseIschemic Stroke

NCT05323812Phase 2Completed

ASURE: Alzheimer Study Using oRal Edaravone

Started Mar 2023

61 enrolled

Alzheimer Disease

NCT05151471Phase 3Terminated

Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

Started Jan 2022

202 enrolled

ALS

NCT05178810Phase 3Completed

Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis

Started Oct 2021

313 enrolled

Amyotrophic Lateral Sclerosis

NCT04569084Phase 3Terminated

Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

Started Nov 2020

384 enrolled

ALS

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

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Why This Matters for Your Career

$294M Medicare spend — this is a commercially significant brand

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Career Relevance

RADICAVA ORS creates opportunities for brand managers, medical science liaisons (MSLs), and field sales representatives focused on specialty neurology and rare disease markets, particularly ALS patient communities. Success in this role requires deep understanding of ALS patient needs, healthcare provider relationships with neurologists, and ability to navigate complex formulary and payer landscapes for specialty drugs. Currently 1 open role is linked to this product, suggesting steady but limited hiring activity consistent with a niche specialty pharmaceutical position.

Company

Gland Pharma

India - Hyderabad

See all Gland Pharma products →

External Resources

Official Product Website

Patient information & support programs

ClinicalTrials.gov

Active clinical trials for this drug

DailyMed

Full prescribing information