Fujimoto Pharmaceutical Corp. said Wednesday it will begin clinical trials on thalidomide for treatment of bone-marrow cancer as early as August, more than 40 years after the drug -- infamous for causing severe birth defects -- was banned in Japan.

Multiple myeloma patients have been calling for thalidomide's return to the market since its effectiveness in treating the disease was recognized by the medical establishment several years ago.

The drug has been banned in Japan since 1962, after being sold as a sedative and for digestion problems.

Some doctors have been importing the drug for their patients. About 530,000 thalidomide tablets were imported by individuals in fiscal 2003.

People with birth defects caused by their mothers having taken thalidomide during pregnancy are urging that use of the drug be regulated.

Fujimoto Pharmaceutical, based in Osaka Prefecture, said it has received informal approval from 22 hospitals to conduct trials on volunteer patients.

The drugmaker wants to try thalidomide on about 35 patients who have had no success with other treatments and have never used thalidomide before. They are expected to be given the drug over a four-month period.

In February, the Ministry of Health, Labor and Welfare designated thalidomide a priority research drug, or a so-called orphan drug, for bone-marrow cancer, after the company applied for the designation last year.

The government gives the makers of orphan drugs support for research and development, extended market-monopoly status and tax breaks.