Many Americans would love a drug that makes them fitter, sharper, and more attractive. The peptides industry aims to oblige, and sales may soon be off to the races, courtesy of the Trump Administration and its chief peptides backer, Health Secretary Robert F. Kennedy Jr.
Peptides are short-chain amino acids that are formulated into drugs. Insulin is a peptide. So are GLP-1s like Ozempic. Legions of other peptides are on the market in the "wellness" industry, promoted for everything from athletic performance to skin care, mental focus, and "romantic connection" -- the latter pitched by a startup called Feel Peptides.
Compounding pharmacies make some peptides, but many are manufactured without much oversight with ingredients mainly sourced from China. They've soared in popularity online, often sold to consumers without a prescription, designated for "research use."
The FDA may soon step into that gray market, allowing compounding pharmacies to produce and sell more peptides. An FDA advisory panel is scheduled to hold hearings in late July on whether to recommend seven substances for inclusion on a list of approved bulk ingredients that compounders may use to create peptide drugs.
Several popular peptides are under review. BPC-157, for instance, is the poster child for muscle and tissue repair. Others include TB-500, popularly paired with BPC-157 in a "wolverine stack" to recover from workout injuries, and MOTs-C, marketed for metabolism benefits.
Five more peptides are up for review by early next year. The FDA panel is evaluating each peptide for uses -- like BPC-157 for ulcerative colitis -- that don't necessarily match up with what they're known for online.
Kennedy has has said he's a "big fan" of peptides and indicated he wants the FDA to regulate more of their production. The advisory panel review "begins to restore regulated access and will immediately begin shifting demand away from the black market," he said on X.
The advisory panel includes several physicians involved in peptides. At least six doctors on the panel are involved in peptides therapy and some have posted content about the drugs, according to their disclosures and websites.
The FDA isn't obligated to take the panel's recommendations, an FDA spokesperson said. "All committee members underwent the same ethics review and vetting process required of all FDA advisory committee members," the spokesperson added.
Peptides are contentious in the medical community. A dearth of clinical trial data in humans has long raised concerns. The FDA restricted compounders from selling certain peptides in 2023, citing safety risks. In a report made public in the past week, FDA staff scientists said the bulk of criteria "weigh against" placing the substances on a list for permitted use in compounded drugs.
Wall Street, for its part, sees a potentially large growth market. Needham analysts estimate an addressable market for non-GLP-1 peptides of $34 billion, up from around $3 billion in annual sales now, assuming FDA permission and other factors fall into place. Investment bank Leerink Partners sees a $2.2 billion market for telehealth companies, based on sales projections of the first seven peptides under review.
The biggest publicly traded beneficiary could be Hims & Hers Health. The telehealth company bought a peptides manufacturing facility last year. Leerink analyst Michael Cherny estimates Hims could capture 20% of the $2.2 billion market. "The Hims chassis should be well-positioned to maximize peptide sales," Cherny says.
Hims says over half the questions it received before its recent earnings call were on peptides. The company doesn't have to be "first to market," CEO Andrew Dudum told investors, but it aims to be "the best."
For now, Hims remains a play on GLP-1s. The stock started taking off in March after the company struck a deal with Novo Nordisk to sell its branded GLP-1s like Ozempic and Wegovy. Shares got another boost Wednesday after Canaccord Genuity and Bank of America raised price targets, citing an improving outlook for branded GLP-1s.
Most analysts see the stock fully valued. Its average rating is a Hold with a target of $29, below recent prices around $38.
Needham analyst Ryan MacDonald has a rare Buy on Hims, but he pegs the fair value at $35. He views recent updates from FDA as mixed, but thinks it's "more likely than not" the agency will permit the peptides, he told Barron's.
Wall Street's caution on Hims reflects another unknown: whether peptides sold for unapproved uses will make the leap from the medical fringes to mainstream consumer adoption.
While there's some clinical evidence for peptides, claimed health benefits tend to rely on preclinical or animal studies and research conducted outside the U.S. -- lacking the kind of rigorous studies the FDA requires to approve a drug. Unlike FDA-approved medications, compounded drugs don't go through the same process in which clinical data is reviewed for safety and efficacy.
The peptides up for FDA review "are in general lacking most or all of that information," says Peter Lurie, a former FDA official and head of the Center for Science in the Public Interest. The FDA's move on peptides could undermine the clinical trial process, he adds, while consumers waste money on products that are ineffective.
While the science is unsettled, scores of companies are gearing up to sell peptides. Privately-held telehealth company Noom recently bought a compounding pharmacy and plans to expand into peptides. "Noom believes that peptide-based therapies should move out of the unregulated gray market and into a legitimate, clinically responsible framework," the company said in a statement.
Gyms may also add peptides to their menus of massages and other add-ons. A gym charging $100 for a monthly membership, for example, could make an additional $100 a month from the same customer with peptides, says Jon Lensing, co-founder and CEO of OpenLoop Health, a telehealth infrastructure company. "It's a significant revenue bump with an already existing audience they control," he says.
Several physicians on the FDA's peptides committee work at longevity clinics and have posted content about peptides. Gabriel Alizaidy describes himself as a "peptide and hormone" educator on LinkedIn and offers consultations for peptide protocols. Asare Christian, another panel member, has posted content called Unlocking Your Potential with Peptide Therapy.
Haleem Mohammed, also on the panel, is chief medical officer for a network of clinics called Gameday Men's Health, which markets peptide and vitamin injections on its website.
The three panel members didn't reply to a request for comment.
Proponents argue there's ample evidence for taking certain peptides. Lee Rosebush, an attorney and co-founder of a nonprofit, the American Academy of Peptide Medicine, has challenged FDA restrictions on peptide compounding. He plans to present at the advisory meeting, telling Barron's, he looks forward "to providing additional clinical information...that shows that safe access to these peptides is possible."
Some investors, after taking peptides themselves, are betting on them financially.
Venture capitalist Brian Sugar started taking GLP-1s for weight loss and then tried BPC-157 tablets. The experience was eye-opening, he says, and he saw mass-market potential in peptides more broadly. He's since invested $1.5 million in Feel Peptides through his firm, Sugar Capital.
"It was very clear to me, after this experience that I went through, that GLP-1 was, as I call it, the amuse-bouche of what's going to be happening," he says.
Other investors say they'd like to see more clinical data before investing in wellness peptides. Joe Horsman, a Ph.D. biochemist and investor at venture capital firm Madrona, has backed biotech companies developing peptide therapies. But Horsman says low clinical evidence for many peptides in the wellness space remains a challenge. "I'd love to see some safety data before we say, 'Go nuts, people.' "
(END) Dow Jones Newswires
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