Zandu Pharmaceutical Works became the first Indian company to get a nod from the US Food and Drug Administration (US FDA) for investigational clinical trials in American hospitals for its anti-Parkinson drug HP 200.

HP 200 is sourced from mucuna pruriens, a plant belonging to the leguminous family, and containing high levels of natural dopamine, a neuro-transmitter secreted by the brain and responsible for physical coordination of various body functions. In patients suffering from Parkinson's disease, dopamine dries up with old age, resulting in abnormal jerks in the body, especially of the limbs.

The application for US trials, filed in 1997, was recently approved by the US FDA. The clinical trials are likely to commence in the next three to four months. They may cost about $10 million.

"We would commence IND (investigational new drug) trials in the US once the funds are raised," says K M Parikh, managing director, Zandu Pharmaceuticals. The company expects to raise a part of the required funds through research grants and the balance through internal accruals.

The worldwide market for treatment of Parkinson's disease is in the range of $400-500 million. The US and Europe are the largest markets. Zandu has developed HP 200 solely for exports.

The company is yet to formalise plans for similar investigative trials of the drug in European countries. "The process will probably be easier once we have the required data from the US trials," says Parikh.

If Zandu manages to clear the trials, HB 200 will be the first ayurvedic prescription product in the US.

The company at present sells over-the-counter food supplements through arrangements with certain American companies. Zandu will probably identify an American company for marketing HP 200, once the drug clears the trials, as it does not have a marketing network of its own in the US.