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FDA advisers back compounding of semax and epitalon, narrowly reject DSIP

Regulatory

On the second day of its peptide review, the FDA's Pharmacy Compounding Advisory Committee voted 8 to 5 to recommend semax (reviewed for migraine, cerebral ischemia and trigeminal neuralgia) and 7 to 4 for epitalon (reviewed for insomnia) for the 503A bulk substances list. It voted 6 to 7 against emideltide (DSIP), proposed for opioid withdrawal, chronic insomnia and narcolepsy. FDA staff had recommended against all three, and the agency is not bound by the votes.

Sources

  1. 01FDA advisory panel narrowly rejects compounding of one peptide, backs two others(opens the source in a new tab) STAT
  2. 02July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee(opens the source in a new tab) U.S. Food and Drug Administration

Peptides involved

  1. Approved elsewhereSemaxACTH(4-10) fragment analogue (melanocortin-derived neuropeptide)7
  2. Not approvedEpitalonSynthetic pineal tetrapeptide (geroprotector candidate)4 WADA banned
  3. Not approvedDelta sleep-inducing peptideNonapeptide of uncertain physiological role, first described as a sleep factor9 WADA banned