idebenone Tablets 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #5525
This company is a global Contract Development and Manufacturing Organization (CDMO) with over 25 years of experience in the pharmaceutical industry. They offer a wide range of services, including development and manufacturing of both biologics and small molecules, spanning areas like ATMPs (Advanced Therapies Medicinal Products), RNA therapies, viral vectors, microbiome live biotherapeutics, and traditional oral solid dosage forms. Key therapy areas include oncology, immunology, and infectious diseases. They hold GMP certifications for various facilities across multiple regions, including the EU and North America. The company is committed to sustainability and ethical business practices. They also offer specialized services such as sterile fill & finish, ophthalmics manufacturing, and analytical services.

IDEBENONE

Idebenone is used in the treatment and manages Alzheimer's, Huntington’s, liver, and heart diseases. It also treats some inherited disorders including Leber’s hereditary optic neuropathy, mitochondrial encephalomyopathies that involve nerve and muscle disorders, Duchenne muscular dystrophy, and Friedreich's ataxia, a nervous system disorder producing gait and speech problems, and eventually leading toward heart disease and diabetes. Idebenone is similar to coenzyme Q-10 and a man-made product. Idebenone is sold under brand names Catena, Raxone, Sovrima, among others. Takeda Pharmaceutical Company initially developed it for the treatment of Alzheimer's disease and other cognitive defects but met with limited success. Later, Santhera Pharmaceuticals, a Swiss co investigated it for the treatment of neuromuscular diseases. In 2010, It was tested for Friedreich's ataxia and Duchenne muscular dystrophy but it was not approved for the above in North America or Europe. In 2007, Idebenone was approved by the European Medicines Agency for use in Leber's hereditary optic neuropathy and received its designation as an orphan drug.

Dosage and administration

Idebenone is sold as tablets in 300mg strength and taken orally. In the treatment of Alzheimer's disease, the recommended initial adult dose is 90-120 mg, taken three times a day. In treating inherited Leber's hereditary optic neuropathy, the dose is 300 mg, taken orally three times per day with meals for both children and adults. In children, in the treatment of Duchenne muscular dystrophy, the dose is 900 mg, taken daily for one year.

The price of Idebenone

In the international market, a supply of 20mg of for the ingredient form costs around USD 247. In India, the consumers have to pay a retail price of USD 2.8 for a supply of 10 tablets of 45mg strength.

How does it work?

Idebenone has several actions, some of the actions include stimulation of ATP formation, increasing the antioxidant capacity, scavenging the free radicals, protecting against lipid peroxidation. It also bypasses the dysfunctional complex I of the mitochondrial respiratory chain.

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