Ardana begins US study of ARD-07
Scottish drugmaker Ardana has initiated a US registrational study of its oral growth hormone secretagog ARD-07, which is being developed as a treatment for growth hormone deficiency in adults. Earlier this year, the product was granted Orphan Drug status by the US Food and Drug Administration (Marketletter May 28).
The Phase III assessment is designed to compare the agent's safety and effectiveness with that of intravenous L-arginine plus growth hormone releasing hormone. Results are expected later this year. Data from previous studies suggest that ARD-07 stimulates growth hormone secretion in a dose-dependant manner when given either orally or via intraduodenal administration.
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