Is Nemifitide legal in the United States?

A pentapeptide antidepressant injected daily for 5 to 10 days, tested in three small placebo controlled trials (52, 55 and 81 people) between 2000 and 2006 whose positive findings rest on post hoc plasma level groupings, a single post-treatment timepoint and a severity subgroup. No confirmatory trial was published and development stopped.

Nemifitide is a synthetic five amino acid peptide, a modified analogue of melanocyte inhibiting factor (MIF-1), developed by Innapharma as a rapid acting antidepressant given by subcutaneous injection in short courses. It was called INN 00835 in early papers and briefly netamiftide.

Mechanism: In people, the only mechanistic measurement is a 1999 study reporting a change in platelet serotonin uptake in treated patients, and the pharmacokinetics: rapid absorption, a half-life of 15 to 30 minutes, dose proportional exposure and no accumulation over five daily doses. How a peptide that is gone from the blood within an hour would produce a mood effect lasting weeks was never established.

Regulatory history: Not FDA approved. Development ceased after phase 2; no trial registered on ClinicalTrials.gov; no regulatory submission located.

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 Nemifitide 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.