THE ARISING · Markets & Strategy
Elysium Health Plans Six Additional Peptides Under New HHS Policy
Elysium Health, a longevity supplement company, plans to offer six additional peptides by prescription before the year ends, relying on a new federal enforcement policy.
The peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. They will be offered through Elysium Health Rx, according to the company's November 5 announcement. Access will depend on applicable regulations and an individual evaluation by a board-certified physician.
The opening is a policy, not an approval. The U.S. Department of Health and Human Services issued an interim enforcement-discretion policy covering the six peptides under specified conditions. These include qualified manufacturing, testing, patient-specific prescriptions and adverse-event reporting. The policy does not constitute FDA approval. Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality.
Elysium says the policy matches recommendations it made at a July advisory meeting. That claim is the company's own.
The company is pairing the retail move with two research efforts. The first is the Elysium Peptide Evidence and Evaluation Resource, or PEER. It is meant to give qualified research institutions access to rigorously characterized peptides through a controlled supply chain.
The second is TIME-PEP, a planned study through the company's Aging Research Center. It will look at epigenetic changes, measures of biological age, and possible associations with morbidity and mortality. Elysium says human clinical evidence for these peptides is limited. The announced research program does not establish that the products improve health or extend life.
Whether the six peptides reach Elysium Health Rx by year-end, what TIME-PEP enrolls and measures, and how other longevity companies respond to the HHS conditions.