Is DNSP-11 legal in the United States?

An 11 residue peptide cut from the precursor of GDNF, the growth factor that failed to help Parkinson disease in trials because it could not be delivered. In rats and a small number of macaques it raises dopamine turnover and protects dopamine neurons, including after intranasal dosing. No human has received it.

Glial cell line-derived neurotrophic factor (GDNF) keeps dopamine neurons alive in every animal model of Parkinson disease it has been tried in, and in people it has been a disappointment, largely because a 15 kilodalton protein does not reach the striatum from anywhere it can be safely put. DNSP-11 is one attempt around that problem: an 11 amino acid amidated peptide that a single American neuroscience group (Bradley, Gash and Gerhardt and colleagues) proposed is cleaved from the pro-region of the GDNF precursor, and which in their hands has GDNF-like effects on dopamine neurons despite not binding GDNF's receptor.

Mechanism: In people, nothing has been measured. In cells and rodents, DNSP-11 does not appear to act through the canonical GDNF receptor complex of GFRalpha1 and RET; the 2010 paper notes its effects on cell lines that GDNF does not protect, and the 2014 paper reports ERK1/2 phosphorylation in a dopaminergic cell line as a candidate signalling step.

Regulatory history: Not FDA approved. No human study and no registered trial; animal and cell data only.

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 DNSP-11 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.