April 17, 2023

For the Treatment of ALS, Edaravone

RADICUT® Oral Suspension 2.1% Now Available in Japan
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative
Director: Akihiro Tsujimura; hereinafter, “MTPC”), a member of the Mitsubishi ChemicalGroup, announced today that MTPC has launched RADICUT® Oral Suspension 2.1%
(generic name: edaravone, RADICUT Oral Suspension) for the treatment of patients withamyotrophic lateral sclerosis (ALS) in Japan, following the NHI price listing on March15,2023.
RADICUT Oral Suspension contains the same active ingredient as edaravone forintravenous infusion (Japanese product name: Radicut® Injection 30 mg and Radicut®
Bag for I.V. Infusion 30 mg) for the treatment of ALS.
RADICUT Oral Suspension is formulated for patients with ALS, and a dosage is 5mL,
which is administered once a day using an oral dosing syringe.
Formerly, edaravone could only be administered via intravenous infusion in Japan.
MTPC Group has developed the oral suspension formulation as a new treatment option
for ALS patients to reduce burdens on people living with ALS such as injection pain andoutpatient visits.
In the U.S., where the same oral suspension formulation of edaravone (U.S. productname: RADICAVA ORS®) was approved on May 12, 2022, RADICAVA ORS® has beenhighly evaluated for its benefits of reducing the burdens related to injections and enabling
administration via a feeding tube*.
MTPC Group is pleased to provide RADICUT Oral Suspension as a new treatment optionthat has reduced the burdens on ALS patients in Japan.
*https://www.mt-pharma.co.jp/news/2023/info230317.html

Contact:
Mitsubishi Chemical Group Corporation
Corporate Communications Division
Osaka Corporate Communications Department+81-6-6205-5119

1/3

Product Summary

Product Name: RADICUT® Oral Suspension 2.1%
Nonproprietary Name: edaravone
Indications: Inhibition on progression of functional disorders in amyotrophic lateralsclerosis (ALS)
Dosage and Administration:
The usual adult dosage is 5 mL (105 mg of edaravone), which is administered orally
once a day in the fasted state.
Usually, the duration of administration and cessation of this drug are combined in 1
cycle of treatment for 28 days and the cycle should be re-peated. This drug isconsecutively administered for 14 days in the duration of administration followed bycessation for 14 days in the 1st cycle, and from the 2nd cycle, this drug is
administered for 10 of 14 days in the duration of administration followed bycessation for 14 days.
Package: bottle: 35mL (orange), 50mL (green)
Drug price:

35mL

96,316.50 yen

50mL

137,595.00 yen

Date of regulatory approval: December 23, 2022
Date of NHI price listing: March 15, 2023
Date of launch: April 17,2023
Manufacturer and distributor: Mitsubishi Tanabe Pharma Corporation

2/3

■Amyotrophic Lateral Sclerosis: ALS
ALS is an idiopathic neurodegenerative disease in which motor neurons selectivelydegenerate and vanish. Muscle strength declines throughout the entire body, including
the extremity, facial, and respiratory muscles, and muscular atrophy progresses. Whilethe cause for the majority of cases is not well understood but may involve genetic andenvironmental factors. It is one of the most well-known neuromuscular diseases andincidence is approximately two in 100,000 people per year worldwide.
■Edaravone
Edaravone is a free radical scavenger discovered by MTPC. It was approved by theMinistry of Health, Labour and Welfare in April 2001 for the treatment of patients withacute cerebral infarction and is marketed in Japan under the product name of Radicut®.
The indication of ALS has been approved in 11 countries including Japan in June 2015,
South Korea in December 2015, the U.S. in May 2017, Canada in October 2018, andSwitzerland in January 2019.
Edaravone (oral suspension) for the treatment of ALS was approved in the U.S. in May
2022 and in Canada in November 2022.
■RADICUT® Oral Suspension 2.1%
The two major clinical studies conducted to obtain the approval of RADICUT Oral
Suspension 2.1% as follows:
MT-1186-J03
A Phase 1 study, comparing pharmacokinetics of edaravone oral suspension 2.1%and edaravone injection in healthy adult subjects
Hidetoshi Shimizu, Yukiko Nishimura, Youichi Shiide, et al.
Bioequivalence Study of Oral Suspension and Intravenous Formulation ofEdaravone in Healthy Adult Subjects
Clinical Pharmacology in Drug Development 2021;10(10):1188-1197
MT-1186-A01
A Phase 3 study, multicenter, open-label, safety study of oral edaravone
administered over 48 weeks in subjects with ALS.
Angela Genge, Gary L. Pattee, Gen Sobue, et al.
Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic
lateral sclerosis after 48 weeks of treatment
Muscle & Nerve.2023;67:124-129

3/3