Article: Clofazimine

Clofazimine is a fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619).

History

Clofazimine, initially known as B663, was first synthesised in 1954 by a team led by Dr Vincent Barry at Trinity College, Dublin as an anti-tuberculosis drug. The drug proved ineffective against tuberculosis but in 1959 a researcher named Chang identified its effectiveness against leprosy. After clinical trials in Nigeria and elsewhere during the 1960s, some sponsored by the Swiss pharmaceutical company Giegy, the product was launched in 1969 as Lamprene.

The U.S. government named Clofazimine an orphan drug in June 1986. Giegy gained FDA approval for the drug in December 1986.

Supply

Clofazimine is marketed as the drug Lamprene® by Novartis Pharmaceuticals, a corporate descendant of Geigy. One of the only suppliers of Clofazimine Active Pharmaceutical Ingredient in the world is Sangrose Laboratories, located at Mavelikara in the southern Indian state of Kerala.

Metabolism

Clofazimine has a very long half life time (t1/2) about 70 days.