Hims & Hers Health announced plans to offer certain legally manufacturable peptides in 2026, according to statements made by CEO Andrew Dudum during a quarterly results call on Monday. While the company intends to launch these amino acid-based treatments for metabolic function and immune support by the end of the year, investors and analysts told Reuters that these specific offerings are unlikely to drive significant revenue growth in the immediate term.
Peptides are short chains of amino acids used for various purposes, including muscle recovery and anti-aging, though they currently lack approval from the Food and Drug Administration (FDA). The regulatory environment remains in flux; while Health Secretary Robert F. Kennedy Jr. has criticized restrictions on these treatments, FDA staff have stated there is insufficient evidence to support loosening rules for compounding pharmacies that manufacture them.
The company plans to initially sell peptides that are already legal for manufacturing, such as NAD+, sermorelin, and glutathione. Hims & Hers is also conducting stability testing for BPC-157, a peptide used for tissue repair that is currently under FDA review. Analysts noted that because treatments like NAD+ are already available through unauthorized "grey markets," it is difficult to quantify the potential financial impact of a formal launch.
In July, an advisory panel recommended allowing the compounding of six peptides, though FDA staff raised concerns regarding safety and effectiveness. This recommendation is nonbinding, and industry experts reported that final rulemaking from the FDA could take approximately one year. Andrew Dudum stated the company is waiting for "full and final rulemaking" before selling the specific peptides currently under agency review.
A customer would notice the availability of these treatments directly through the Hims & Hers platform once manufacturing and legal hurdles are cleared. However, the timeline for full access remains uncertain. While the company plans an initial launch by the end of 2026, broader access to newer peptides depends on the FDA's final decision, which experts say could take 12 months. Some analysts, like Raul Shah of DocShah Financial, expect the peptide business to take five to 10 years to reach its full potential, potentially generating over $1 billion in revenue in that timeframe.
The move sets a precedent for how telehealth firms navigate the compounding pharmacy market, which allows for the creation of customized medications. If the FDA exercises "enforcement discretion," as suggested by Olympia Pharmaceuticals CEO Mark Mikhael, Hims could potentially launch some treatments earlier than the final rulemaking date. For now, federal workers and health regulators remain focused on the outcome of the FDA review, which will determine the legal standards for compounding these substances nationwide. The next major milestone will be the issuance of final guidance or rulemaking from the FDA, expected within the next year.