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Idebenone Pharmaceutical Intermediates
Idebenone Pharmaceutical Intermediates

Idebenone Pharmaceutical Intermediates

Contact : Mr.Thyen------------------------------- Email us at zhangyinglong@ycphar.com Whatsapp : +86 180 3817 6818

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Idebenone


Contact : Mr.Thyen

Email us at zhangyinglong@ycphar.com

Whatsapp : +86 180 3817 6818


Idebenone ( pronounced eye - deb - eh - known, trade names Catena, Raxone, Sovrima, among others ) is a drug that was initially developed by Takeda Pharmaceutical Company for the treatment of Alzheimer's disease and other cognitive defects.

The Swiss company Santhera Pharmaceuticals has started to investigate it for the treatment of neuromuscular diseases. In 2010, early clinical trials for the treatment of Friedreich's ataxia and Duchenne muscular dystrophy have been completed.

Chemically, idebenone is an organic compound of the quinone family. It is also promoted commercially as a synthetic analog of coenzyme Q10(CoQ10).


Uses

Indications that are or were approved in some territories    Nootropic effects and Alzheimer's disease

Idebenone improved learning and memory in experiments with mice. In humans, evaluation of Surrogate endpoints like electroretinography, auditory evoked potentials and visual analogue scales also suggested positive nootropic effects, but larger studies with hard endpoints are missing.

Research on idebenone as a potential therapy of Alzheimer's disease have been inconsistent, but there may be a trend for a slight benefit. In May 1998, the approval for this indication was cancelled in Japan due to the lack of proven effects. In some European countries, the drug is available for the treatment of individual patients in special cases.


Friedreich's ataxia ( Sovrima )

Preliminary testing has been done in humans and found idebenone to be a safe treatment for Friedreich's ataxia ( FA ), exhibiting a positive effect on cardiac hypertrophy and neurological function. The latter was only significantly improved in young patients. In a different experiment, a one - year test on eight patients, idebenone reduced the rate of deterioration of cardiac function, but without halting the progression of ataxia.

The drug was approved for FA in Canada in 2008 under conditions including proof of efficacy in further clinical trials. However, on February 27, 2013, Health Canada announced that idebenone would be voluntarily recalled as of April 30, 2013 by its Canadian manufacturer, Santhera Pharmaceuticals, due to the failure of the drug to show efficacy in the further clinical trials that were conducted. In 2008, the European Medicines Agency ( EMA ) refused a marketing authorisation for this indication. As of 2013 the drug was not approved for FA in Europe nor in the US, where there is no approved treatment.


Indications being explored    Duchenne muscular dystrophy ( Catena )

After experiments in mice and preliminary studies in humans, idebenone has entered Phase II clinical trials in 2005 and Phase III trials in 2009.


Leber's hereditary optic neuropathy ( Raxone )

Leber's hereditary optic neuropathy ( LHON ) is a mitochondrially inherited ( mother to all offspring ) degeneration of retinal ganglion cells ( RGCs ) and their axons that leads to an acute or subacute loss of central vision; this affects predominantly young adult males. Santhera completed a Phase III clinical trial in this indication in Europe with positive results, and submitted an application to market the drug to European regulators in July 2011. In January 2013, the request for marketing authorisation was refused by the EMA.


Other neuromuscular diseases

Phase I and II clinical trials for the treatment of MELAS ( mitochondrial encephalomyopathy, lactic acidosis, and stroke - like episodes ) and primary progressive multiple sclerosis are ongoing as of December 2013.


Life style

Idebenone is claimed to have properties similar to CoQ10 in its antioxidant properties, and has therefore been used in anti - aging on the basis of free - radical theory. Clinical evidence for this use is missing. It has been used in topical applications to treat wrinkles.


 

Specifications

Test Items

Specifications

Result

Aspect

An orange yellow or yellow, crystalline powder.

Orange yellow crystalline powder

Solubility

Insoluble in water, very soluble in methanol, chloroform, freely    soluble in anhydrous alcohol and ethyl acetate.

Conforms

Identification

1. Comply with the standard

Conforms

2. Comply with the standard

Conforms

3. IR spectrum

Conforms

Ep

458--486

461

Melting Range

52—55℃

54-55℃

Loss on drying

≤0.1%

0.03%

Residue on Ignition

≤0.1%

0.02%

Heavy metals

≤10ppm

Conforms

Impurities

≤0.8%

0.5%

Residue Solvents

Hexane ≤0.029%

Conforms

Methanol ≤0.3%

Conforms

Toluene ≤0.089%

Conforms

Assay(HPLC):

≥98.5%, anhydrous substance

99.7%

Packaging and storage: Keep in a well - closed container.



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