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Trials & Filings

Aeterna Zentaris Submits NDA for AGHD Compound

Small molecule induces growth hormone release

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Aeterna Zentaris has submitted an NDA to the FDA for its ghrelin agonist, macimorelin acetate (AEZS-130). Phase III data have demonstrated that the compound has the potential to become the first orally-approved product that induces growth hormone release to evaluate adult growth hormone deficiency (AGHD), with accuracy comparable to available intravenous and intramuscular testing procedures.

Macimorelin acetate is a novel orally-active small molecule that stimulates the secretion of growth hormone. The company has completed a Phase III trial for use in evaluating AGHD, and the compound has received Orphan Drug Designation by the FDA for this use. Macimorelin acetate is also in a Phase II trial as a treatment for cancer-induced cachexia.

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