First Filing For Pioglitazone

27 January 1997

Takeda has filed for approval in Japan for Actos (pioglitazonehydrochloride; formerly AD-4833), one of the new products expected to drive growth at the firm over the next few years. Takeda is seeking approval to market the drug for the management of patients with non-insulin-dependent (type II) diabetes.

Pioglitazone is a member of the thiazolidinedione class of drugs, currently spearheaded by Sankyo's Noscal (troglitazone). Although their mode of action is still not fully characterized, these drugs are thought to enhance the action of insulin and reduce blood glucose levels. Studies on troglitazone have also shown other effects, including lowering cholesterol, reducing glucose output from the hepatic system and inhibiting glucose synthesis.

Takeda claims that pioglitazone has a more potent hypoglycemic action than troglitazone, and is forecasting approval in Japan within two years. The drug is in Phase II studies in Europe and the USA.

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