Is Brimapitide legal in the United States?

A 31 residue D-amino acid peptide that blocks the stress kinase JNK. Its phase 3 in sudden hearing loss (256 people) did not meet its primary endpoint, and the two phase 3 trials in post-cataract inflammation (648 people) completed in 2016 with no results posted or published.

Brimapitide is a peptide built from D-amino acids (which resist breakdown) that links a cell penetrating sequence from the HIV TAT protein to a fragment that blocks c-Jun N-terminal kinase, an enzyme that drives programmed cell death after injury. It has had three names in three programmes: D-JNKI-1 in the laboratory, AM-111 at Auris Medical for hearing loss, and XG-102 at Xigen for eye inflammation.

Mechanism: In people, what is established is pharmacokinetic and safety: a single intravenous infusion of 10 to 80 mcg/kg in 24 healthy men gave a half-life of roughly 20 to 40 minutes with mild adverse events not related to dose, and after subconjunctival injection the peptide was undetectable in plasma at doses up to 450 mcg. That the peptide reaches and inhibits JNK in a human cochlea or retina has not been shown directly; it is inferred from the animal work.

Regulatory history: Not FDA approved. Phase 3 in sudden hearing loss did not meet its primary endpoint (2019); two phase 3 trials in post-cataract inflammation completed 2016 with no posted results.

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 Brimapitide 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.