Is Domagrozumab legal in the United States?

A properly powered phase 2 in 120 boys with Duchenne muscular dystrophy. The primary endpoint missed by 0.27 seconds at p equals 0.94, no secondary clinical endpoint differed, and both trials were terminated.

This is the most definitive negative result in the myostatin field, and it is definitive because the trial was well built. 120 ambulatory boys with Duchenne muscular dystrophy, 80 on ascending doses up to 40 mg/kg and 40 on placebo, two 48-week periods, with a functional primary endpoint and an open-label extension.

Mechanism: A humanised monoclonal antibody against myostatin, same target and pathway as stamulumab and landogrozumab. Dosed intravenously in this programme at 5, 20 and 40 mg/kg, higher than the earlier antibodies, on the reasoning that the earlier failures reflected insufficient potency.

Regulatory history: Never approved. Both phase 2 trials carry status TERMINATED on ClinicalTrials.gov.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Domagrozumab at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.