FDA's bulk drug substance safety review lists Selank acetate (also known as TP-7) as a withdrawn compounding nomination. FDA states it lacks important safety information for selank acetate administered to humans and is concerned about immunogenicity related to aggregation and peptide-related impurities for certain routes.[2]
- An evidence gap identified by a regulator is not proof of either safety or harm.
- This regulator source does not itself supply human outcome data for selank; see the separate small comparative clinical study record for that.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· New source relationship identified and added in the peptide-misc batch on 2026-09-09 while rereading the FDA bulk-safety page; proposed addition awaits independent editorial review.