Supplement maker Elysium to offer six unapproved peptides through doctors

Elysium Health, a New York longevity company best known for its supplement Basis, says it is moving into peptides, short chains of protein building blocks that some people take hoping for recovery or anti-aging effects.¹ The company plans to offer six additional peptides through its prescription service, Elysium Health Rx, and has launched two research programs.¹² The move follows a temporary change in how US health officials enforce the rules on pharmacies that make these substances.¹

This is a business announcement. It does not come with new data on whether the peptides are safe or what they do, and the company itself said human clinical evidence for them is limited.¹

What happened

The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.¹ Elysium said they are expected to be available through Elysium Health Rx by the end of the year, subject to evaluation by independent board-certified physicians.¹ In other words, a doctor would decide whether a given person can get them, rather than customers ordering them off a shelf like a supplement.¹

Alongside the access plan, the company announced two research efforts:¹

• PEER (Peptide Evidence and Evaluation Resource), which will supply high-purity, characterised peptides to universities, hospitals, nonprofits and other qualified institutions through a traceable supply chain.¹
• TIME-PEP, a planned study run through the company’s Aging Research Center. It will look at changes in chemical tags on DNA (so-called epigenetic changes) linked to peptide use, and whether they relate to biological age, a lab estimate of how old the body seems.¹

Co-founder and chief executive Eric Marcotulli said unregulated suppliers and research-use-only products pose “a genuine public health challenge” and argued for higher standards in the legitimate market.¹

The rule change behind it

The trigger was an interim policy from the US Department of Health and Human Services (HHS).¹ Under it, HHS does not intend to take enforcement action against certain compounding pharmacies (known as 503A pharmacies), federal facilities or licensed physicians that make products from the six peptides’ raw ingredients, as long as detailed safeguards are met.¹

The limits matter. The policy does not make the peptides FDA approved, and it does not add them to the official list of ingredients those pharmacies may use. HHS can revisit the decision if safety signals or quality concerns appear.¹

The policy has split opinion. HHS presented it as a way to steer consumers away from research-use-only peptides supplied by foreign manufacturers, and compounding groups welcomed it.¹ Critics say the peptides have not been shown to be safe.¹ Before a July meeting of the FDA’s Pharmacy Compounding Advisory Committee, FDA staff recommended against listing any of seven peptides under review, citing weak characterisation and limited safety and effectiveness data. The committee nonetheless backed the six, and some groups have since asked HHS to hold off on the policy.¹

What this does not show

Nothing in the announcement tells us whether any of these peptides help people live longer or healthier lives. Elysium has not released results for the peptides, and it described human clinical evidence for them as limited.¹ The FDA staff review pointed to the same gap.¹

The legal picture is also narrower than the headline may suggest. Regulators have treated BPC-157 as an unapproved drug that cannot legally be sold as a dietary supplement, and the testing body BSCG says the same of TB-500.¹ The HHS policy does not change that, because making a product under enforcement discretion is not the same as FDA approval.¹

The research programs are plans, not findings. TIME-PEP will measure lab markers of biological age, which are estimates, and the announcement gives no size, timeline or design details for the study.¹

Who is behind it

Elysium was created in 2014 to sell supplements based on scientific research, and it released Basis in 2015.³ Its co-founders were MIT aging researcher Leonard Guarente, who became chief scientist; Eric Marcotulli, a former partner at the venture firm Sequoia Capital, as chief executive; and Dan Alminana, a former JP Morgan Securities vice president, as chief operating officer.³ At launch it said it had a scientific advisory board of more than 30 people, including five Nobel laureates.³

Basis combines the company’s own form of nicotinamide riboside with pterostilbene, and it is designed to raise levels of NAD+, a molecule cells use to make energy.² Elysium also sells a collagen product that pairs collagen peptides with nicotinamide riboside.¹

The company has funded its own human trials of Basis. One, registered by Elysium as sponsor, enrolled 111 people with fatty liver and compared two doses of Basis with a placebo (a dummy pill) over six months.⁴ In 2022 Elysium announced that results were published in the journal Hepatology, reporting lower levels of some liver enzymes linked to inflammation at the recommended dose.² The trial registry record lists the study as completed but shows no results posted there.⁴ That trial was about Basis, not peptides, and says nothing about the new products.

How it fits the wider field

Interest in peptides is rising fast. Google searches for the term have risen by roughly 200% over the past 12 months, according to Google Trends data cited by Nutraceutical Business Review.¹ Supplement brands already sell established peptide ingredients, such as collagen peptides and peptides derived from food proteins.¹

The six peptides in the HHS policy are a different kind of product.¹ Elysium will offer them through independent physicians rather than as supplements, which the trade publication called a notable step for a company that built its name on the supplement side of that line.¹ “Peptide” describes a chemical structure; being one does not make a substance FDA approved or a lawful supplement.¹ The Council for Responsible Nutrition, the US supplement trade association, describes lawful supplements and grey-market peptides as “worlds apart.”¹ The publication warned that blurring that distinction could damage consumer trust in the category.¹

What to watch next

• Whether the six peptides actually become available through Elysium Health Rx by the end of the year, as the company expects.¹
• Whether HHS keeps, changes or pauses the policy, given that some groups have asked it to hold off and that it can revisit the decision if safety or quality concerns emerge.¹
• Details of the TIME-PEP study, including how many people it will enroll and what it will compare, and which institutions sign up for PEER supplies.¹
• Whether any of the peptides gain human trial data strong enough to answer the safety and effectiveness questions FDA staff raised.¹