Hims and Hers told investors it plans to begin selling sermorelin, glutathione, and NAD+ before the end of the year, moving a company with nearly three million subscribers into a wellness category built largely on claims that clinical trials have not tested.
Chief executive Andrew Dudum described the plan on the company's second-quarter earnings call, where it reported more than $753 million in revenue, up nearly 40 percent year over year, and raised full-year guidance to a range of $3.1 billion to $3.3 billion. According to Fierce Healthcare, patients seek these compounds for wellness and anti-aging purposes.
The distinction that matters for consumers is between a compound being permitted and a compound being proven. Those are separate questions decided by different processes, and the gap between them is where most of the marketing lives.
The Difference Between Allowed and Demonstrated
Sermorelin is a synthetic fragment of growth hormone-releasing hormone. It has an established diagnostic and therapeutic history in evaluating growth hormone deficiency, particularly in children. That is not the same as evidence that it slows aging, improves body composition, or extends healthspan in healthy adults, which is what drives current demand.
Glutathione is an antioxidant produced by the body. Oral and injectable forms are marketed for skin brightening, detoxification, and general wellness, uses that rest on mechanistic reasoning rather than outcome trials. NAD+ is a coenzyme central to cellular energy metabolism, and interest in it is grounded in laboratory and animal research that has not translated into human trials showing the benefits consumers are told to expect.
None of that makes these compounds fraudulent. It makes them untested for the purposes for which they are being sold. A product can be legally compounded and professionally administered, yet still lack evidence that it does what the buyer wants it to do.
Dudum told analysts the company is developing what he called a best-in-class peptides experience, including U.S. manufactured products, clinically led guidance, and ongoing blood testing. Blood testing is a meaningful addition to a category where much purchasing occurs without any clinical contact, though it does not resolve the underlying question of efficacy.
The Regulatory Line the Company Says It Will Not Cross Yet
A separate set of six peptides discussed at a recent FDA Pharmacy Compounding Advisory Committee meeting is not part of the year-end plan. On the company's earnings call, Dudum said Hims and Hers has begun stability and validation testing of active pharmaceutical ingredients, including BPC-157, at its Menlo Park facility, but will wait for final FDA rulemaking before offering those compounds.
That timeline is not short. Proposed and final rulemaking takes months to years, and there is no guarantee that any particular compound will clear it. NPR has separately examined what it would take to get peptides onto shelves through the compounding pathway.
MedicalDaily reported this week on the parallel market that operates regardless of what regulators decide, where peptides labeled for research use only are sold and self-administered with no consumer protection and no recourse if someone is harmed. A regulated commercial channel with clinician oversight and domestic manufacturing is a different proposition than that of the gray market. It is a better one on safety grounds. It is not the same as a proven one.
The Household Calculation for Consumers Weighing Cost
For a household budget, the practical question is what a monthly subscription buys. Peptide protocols marketed for longevity are typically ongoing rather than time-limited, and they are almost never covered by insurance, which makes them a recurring out-of-pocket cost with no defined endpoint.
Anyone considering one can reasonably ask a prescriber for the specific human trial supporting the specific use being sold, not the mechanism, not animal data, and not a testimonial. If the answer describes how the compound works in theory rather than what happened when it was tested in people, that is the evidence gap in plain view.
The financial context is also worth understanding. Hims and Hers manufactures active pharmaceutical ingredients at a facility in Menlo Park, California, and told investors that testosterone treatment is now scaling faster than any specialty outside weight loss, three quarters after launch. It plans to add injectable and oral testosterone products before the end of the year. Those are business decisions responding to consumer demand, and the company's commercial interest in the category is disclosed openly in its investor materials. Testosterone therapy is drawing similar scrutiny from urologists, who say direct-to-consumer prescribing often skips confirmatory testing and follow-up.
Patients with existing conditions face additional questions. Anyone taking prescription medications, managing diabetes, living with cancer or a cancer history, or pregnant should discuss any peptide with their own clinician before starting, because interactions and contraindications are not established for many of these compounds.
What Should Happen Before the Product's Launch
The FDA has not completed rulemaking on the compounded peptides under consideration, and its decision will shape the broader market next year. Consumers watching this space should track that process rather than company announcements.
Anyone approached with peptide marketing can apply a simple test. Ask whether the claim is supported by a randomized trial in humans measuring the outcome being promised. For sermorelin, glutathione, and NAD+ used for longevity, the honest answer today is that such trials do not exist at the scale needed to support their recommendation.
Independent clinicians reviewing this category have generally landed in the same place: the biology is interesting, the marketing has run ahead of the data, and the people paying for it are absorbing the uncertainty. That does not mean the compounds are useless or that future research will not find benefits. It means the current evidence does not support treating them as established medicine, and consumers spending money on them should know they are early adopters rather than patients receiving proven care. This article is general information and is not medical advice. MedicalDaily will report when the FDA completes rulemaking and when these products reach the market.
Key Questions Answered
What did the company announce? Hims and Hers told investors on its second-quarter earnings call that it plans to offer already-permitted peptides, including sermorelin, glutathione, and NAD+, before the end of the year.
Are these compounds approved for longevity? No. They are permitted for certain uses, but the longevity, anti-aging, and performance claims driving consumer demand are not supported by human outcome trials.
What is Sermorelin normally used for? It is a synthetic fragment of growth hormone-releasing hormone with an established role in the evaluation and treatment of growth hormone deficiency, particularly in children.
Is this different from buying peptides online? Yes. A regulated commercial channel with clinician oversight, domestic manufacturing, and blood testing is safer than research-use-only products sold with no oversight. Neither addresses whether the compounds work for longevity.
What about the peptides awaiting FDA action? Six compounds discussed at an FDA advisory committee meeting are not part of the year-end plan. The company says it will wait for the full and final rulemaking, a process that takes months to years.
What should someone ask a prescriber? Request the specific human trial supporting the specific use being sold. Mechanism, animal data, and testimonials do not answer that question.
Who should be especially cautious? Anyone taking prescription medications, managing diabetes, with a cancer history, or who is pregnant should consult their own clinician before starting any peptide.
