Radicava

(Edaravone)

ApprovedSmall molecule

Shionogi

Radicava is one of 218 small molecule programs targeting Acute Myocardial Infarction. It is currently in Approved.

Indications

Total Trials

Active Trials

217

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acute Myocardial InfarctionActive, not recruiting

Brain InjuryActive, not recruiting

NecrosisActive, not recruiting

Kidney TransplantActive, not recruiting

Amyotrophic Lateral SclerosisActive, not recruiting

Optic NeuritisActive, not recruiting

Ischemic StrokeActive, not recruiting

Aortic DissectionActive, not recruiting

Acute Myocardial InfarctionApproved

Active, not recruiting

Brain InjuryPhase 2

Active, not recruiting

NecrosisPhase 2

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Amyotrophic Lateral SclerosisPhase 2/Phase 3

Active, not recruiting

Optic NeuritisPreclinical

Active, not recruiting

Ischemic StrokePhase 1

Active, not recruiting

Aortic DissectionPreclinical

Active, not recruiting

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Radicava

Shionogi

Approved

1 2

Simulect

Novartis

Preclinical

15 3

Medrol

Pfizer

Preclinical

12 4

Zinbryta

Roche

Preclinical

6 5

Zemplar

AbbVie

Preclinical

2 6

Sensipar

Amgen

Preclinical

1 7

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1 8

Cysteine Hydrochloride

Novartis

Preclinical

1 9

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

4 10

Jardiance

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Ischemic stroke6 trials

Compound Edaravone Injection for Acute Ischemic Stroke

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 2·NCT01929096·400 enrolled

Edaravone-Sodium Ozagrel Comparative Post-Marketing Study on Acute Ischemic Stroke

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 4·NCT00200356·401 enrolled

Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke

Unknown status·—·Phase 1·NCT01518231·40 enrolled

Show 3 more trials

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT02430350·1,200 enrolled

Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke

Suspended·NNanjing Yoko Biomedical Co., Ltd.·Phase 2·NCT04984577·240 enrolled

Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke

Completed·CCombination Therapy for Acute Ischemic Stroke Study Group·Phase 4·NCT00153946·814 enrolled

Amyotrophic Lateral Sclerosis2 trials

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

Unknown status·IIsfahan University of Medical Sciences·Phase 2/3·NCT03272802·20 enrolled

Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

Completed·TTanabe Pharma America, Inc.··NCT04259255·74 enrolled

Completed·KKumamoto University·Phase 4·NCT00265239·104 enrolled

5 more indications

Optic Neuritis1 trial

Edaravone in the Treatment of Optic Neuritis

Recruiting·FFirst Affiliated Hospital of Guangxi Medical University·N/A·NCT05540262·50 enrolled

Interaction1 trial

Drug-drug Interaction Study Between Edaravone and 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

Completed·NNanjing Yoko Biomedical Co., Ltd.·Phase 1·NCT04218513·24 enrolled

Kidney Transplant1 trial

Edaravone on the Ischemia-Reperfusion(I/R) Injury in Kidney Transplantation Patients

Unknown status·XXijing Hospital·N/A·NCT02644915·150 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS

Unknown status·RRuijin Hospital·Phase 2·NCT04391361·30 enrolled

Aortic dissection1 trial

Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection

Unknown status·—·N/A·NCT01894334·220 enrolled

Regulatory

FDA Approval Timeline[4]

May 5, 2017

RADICAVA

NDA NDA209176

May 12, 2022

RADICAVA ORS

NDA NDA215446

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Edaravone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Edaravone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Edaravone. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA215446). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Radicava. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Shionogi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Shionogi

Patent Landscape[5]

Patent Cliff

Nov 1, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12599586Nov 1, 2039

10987341Nov 1, 2039

12285409Nov 1, 2039

11241416Nov 1, 2039

11957660Nov 1, 2039

7 more patents

11826352Nov 1, 2039

11478450Nov 1, 2039

12527769Nov 12, 2041

12194025Nov 12, 2041

12569469Nov 12, 2041

12478611Nov 12, 2041

12310946Nov 12, 2041

Radicava

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Ischemic stroke6 trials

Amyotrophic Lateral Sclerosis2 trials

Brain Injury1 trial

Necrosis1 trial

Acute Myocardial Infarction1 trial

Optic Neuritis1 trial

Interaction1 trial

Kidney Transplant1 trial

Effectiveness1 trial

Aortic dissection1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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