edaravone

Trade name: radicava

Small moleculeapprovedOrphan Drug ^FDA

Approved

May 5, 2017

Edaravone is a free radical scavenger developed for the treatment of amyotrophic lateral sclerosis. — NCATS

Clinical trial activity

61 trials · 38 clinical orgs · 10 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Apr 1, 2001 (NCT00265239)

Timeline

2000s

Jan 1, 2006
Mitsubishi Tanabe — Earliest Phase 3 Sponsor(trial)
Jan 1, 2009
Mitsubishi Tanabe — Earliest Phase 2 Sponsor(trial)

2010s

Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
May 12, 2015
Orphan Drug Designation
May 5, 2017
Mitsubishi Tanabe — Earliest FDA Approval
May 5, 2017
Mitsubishi Tanabe — NDA Secondary Org
May 5, 2017
Mitsubishi Tanabe — NDA Organization
May 5, 2017
Shionogi — Marketing Organization

2020s

Mar 13, 2024
Zydus Discovery DMCC — Marketing Organization
May 6, 2024
Dr. Reddy's Laboratories — Marketing Organization
May 6, 2024
Gland Pharma Ltd — Marketing Organization
May 6, 2024
Hikma — Marketing Organization
May 6, 2024
LONG GROVE PHARMS — Marketing Organization
Oct 31, 2024
X Gen Pharmaceuticals — Marketing Organization
Oct 31, 2024
PHARMOBEDIENT — Marketing Organization
Dec 23, 2024
Sandoz — Marketing Organization

Indications

Approved for

Mechanism of action

Unspecified targetOTHER
Unknown

Approval history

approvedMay 5, 2017

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NN(C(O)=C1)C2=CC=CC=C2

Mol. weight: 174.1992 g/mol
Lipinski Ro5: Pass
Rule of 3: Yes
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

First in class

Sources

Also known as

1-phenyl-3-methyl-5-oxo-2-pyrazoline
1-phenyl-3-methyl-5-oxo-2-pyrazoline
1-phenyl-3-methyl-5-pyrazolone
2,4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one
2,4-dihydro-5-methyl-2-phenyl-3h-pyrazol-3-one
3h-pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-
3-methyl-1-phenyl-2-pyrazolin-5-one
3-methyl-1-phenyl-2-pyrazolin-5-one
3-methyl-1-phenyl-2-pyrazolin-5-one
3-methyl-1-phenyl-5-pyrazolone
3-methyl-1-phenyl-5-pyrazolone
3-methyl-1-phenylpyrazol-5-one
3-methyl-1-phenylpyrazol-5-one
c.i. developer 1
c.i. developer 1
developer z
developer z
edarabone
edarabone
edaravone
edaravone
edaravone
edaravone
edaravone
edaravone
edaravone
edaravone
edaravone
edaravone
mci 186
mci-186
mci-186
mci-186
mci-186
methylphenylpyrazolone
methylphenylpyrazolone
methylphenylpyrazolone
norantipyrine
norantipyrine
norphenazone
norphenazone
norphenazone
norphenazone
phenylmethylpyrazolone
phenylmethylpyrazolone
phenylmethylpyrazolone
phenyl methyl pyrazolone
phenyl methyl pyrazolone
radicava
radicava
radicut
radicut
radicut

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07252440	Phase 2	Dec 5, 2025	Auzone Biological Technology Pty Ltd
NCT07091994	Phase 4	Aug 1, 2025	Southern Medical University
NCT06674460	Phase 3	Mar 1, 2025	Chinese Academy of Medical Sciences
NCT06757504	Phase 2	Jan 13, 2025	Auzone Biological Technology Pty Ltd, Peking University
NCT06645522	Phase 4	Oct 30, 2024	Jinlin University
NCT07119021	Phase 4	Aug 1, 2024	Capital Medical University, Suzhou First People's Hospital
NCT06315231	Phase 2	Apr 8, 2024	Simcere Pharmaceutical Co., Ltd
NCT06176781	Phase 3	Dec 28, 2023	Simcere Pharmaceutical Co., Ltd
NCT05940883	Phase 1	Sep 6, 2023	Parexel, Simcere Pharmaceutical Co., Ltd
NCT05885919	Phase 3	Jul 1, 2023	Central South University, Simcere Pharmaceutical Co., Ltd, XiangYa School of Medicine
NCT06648304	Phase 3	Apr 25, 2023	Auzone Biological Technology Pty Ltd, People's Liberation Army of China
NCT05866926	Phase 3	Mar 6, 2023	Ferrer Internacional S.A.
NCT05568615	Phase 3	Oct 26, 2022	Mitsubishi Tanabe
NCT05323812	Phase 2	Sep 30, 2022	Treeway B.V.
NCT05540262	N/A	Sep 15, 2022	Hacettepe University
NCT05249920	Phase 3	Mar 18, 2022	Capital Medical University
NCT05151471	Phase 3	Jan 31, 2022	Mitsubishi Tanabe
NCT05178810	Phase 3	Oct 18, 2021	Ferrer Internacional S.A., Stichting TRICALS Foundation, Utrecht University
NCT04984577	Phase 2	Sep 30, 2021	Nanjing Yoko Biomedical Co., Ltd.
NCT05035953	Phase 2	Sep 13, 2021	Fudan University, Shanghai Stroke Association

Showing 20 of 61 trials

Page 1 / 4

Organizations

Research & Development (38)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Mitsubishi Tanabe	For profit	23	23	4	2004
Simcere Pharmaceutical Co., Ltd	For profit	7	5	3	2013
Capital Medical University	Academic/Hospital	5	3	4	2013
Auzone Biological Technology Pty Ltd	For profit	4	4	3	2020
Jiao Tong University	Academic/Hospital	3	2	2	2016
Nanjing Yoko Biomedical Co., Ltd.	For profit	3	3	2	2019
Okayama University	Academic/Hospital	3	0	1	2006
People's Liberation Army of China	Government	3	2	3	2016
Sun Yat-Sen University	Academic/Hospital	3	3	1	2009
Ferrer Internacional S.A.	For profit	2	2	1	2021
Central South University	Academic/Hospital	1	1	1	2023
Chinese Academy of Medical Sciences	Academic/Hospital	1	1	1	2025
CMAX Clinical Research	For profit	1	0	1	2020
Combination Therapy for Acute Ischemic Stroke Study Group	Academic/Hospital	1	1	1	2004
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital	Academic/Hospital	1	0	1	2004
Fudan University	Academic/Hospital	1	1	1	2021
Hacettepe University	Academic/Hospital	1	1	1	2022
Isfahan University	Academic/Hospital	1	1	1	2017
Japan Cardiovascular Research Foundation	Academic/Hospital	1	0	1	2004
Japan Heart Foundation	Academic/Hospital	1	0	1	2001

38 organizations

Page 1 / 2

Marketing (12)

Organization	Org type	Relationship	Date
Dr. Reddy's Laboratories	For profit	MKTG	May 6, 2024
Gland Pharma Ltd	For profit	MKTG	May 6, 2024
Gland Pharma Ltd	For profit	SYN	May 6, 2024
Hikma	For profit	MKTG	May 6, 2024
LONG GROVE PHARMS	For profit	MKTG	May 6, 2024
Mitsubishi Tanabe	For profit	NDA2	May 5, 2017
Mitsubishi Tanabe	For profit	NDA	May 5, 2017
PHARMOBEDIENT	For profit	MKTG	Oct 31, 2024
Sandoz	For profit	MKTG	Dec 23, 2024
Shionogi	For profit	MKTG	May 5, 2017
X Gen Pharmaceuticals	For profit	MKTG	Oct 31, 2024
Zydus Discovery DMCC	For profit	MKTG	Mar 13, 2024