Peptides are naturally occurring chains of amino acids, which have been used for health and wellness treatments. The current most popular peptides are glucagon-like peptide 1 class (GLP-1s), although gonadotropin-releasing hormone (GnRH) agonists and antagonists have been in use for prostate cancer management since the 1980s and 2000s, respectively.
The U.S. Food and Drug Administration (FDA) will be deciding in July 2026 regarding the safety status of peptides. This article aims to discuss what patients may be hearing about their safety and efficacy before asking their providers.
The Popularity of Peptides
These drugs were often sold in compound pharmacies, with rising popularity amongst social media influencer “gym bros” and “wellness gurus.” These semi-public figures are sometimes commissioned by brands to advertise their product as safe and effective, without much knowledge of the ingredients and efficacy.
On public forum websites such as Reddit or Quora, questions regarding peptides for weight loss, muscle gain, hair growth, etc., are asked daily in subgroups revolving around non-pharmaceutical methods for health and wellness – including penile growth. Many times, these will be sold in the category of supplements and come as a gummy, pill, drink mix packet, or injection.
Peptides are not necessarily dangerous; however, they are far from perfect. In 2023, the FDA listed 19 peptides as unsafe to be dispensed by compounding pharmacies. The decision was made based on the understanding that injectable peptides can cause immune reactions and that peptides have a lack of data supporting safety. This listing led to a shift where wellness companies, multilevel marketing groups, and other “gray market” sellers gained a small monopoly over these substances.
Currently Accepted Peptides in Sexual Health and Erectile Function Management
The only FDA-approved peptide for sexual dysfunction at present is designed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Vyleesi (bremelanotide/PT-141) improves sexual desire by acting as a melanocortin-4 receptor agonist, activating the system that controls sexual arousal.
In men, PT-141 would work similarly and is different from phosphodiesterase-5 inhibitors (PDE5-i) in that there is no involvement of vasodilation or nitric oxide. In phase II clinical trials, PT-141 has had positive effects on erectile function, although adverse events include flushing, nausea, hypertension, and increased blood pressure. Currently, the use of PT-141 in men is off-label and experimental.
A few other peptides are being studied for their efficacy in treating sexual dysfunction. However, these are still on the list of unsafe peptides by the FDA. Patients asking about these options should be made aware that they are not FDA-approved and experimental if used. Patients should be aware of the recorded adverse events and be counseled on all available options for sexual dysfunction management.
Key Takeaways
Resources
Burchfiel, E., Mills, N., Saffati, G., Low, E., Beck, A., Boyne, A. M., Fleming, B., Hernandez, B., Oppenheimer, A., Lipshultz, L. I., & Khera, M. (2025). (349) therapeutic peptides in sexual medicine: A narrative review. The Journal of Sexual Medicine, 22(Supplement_4). https://doi.org/10.1093/jsxmed/qdaf320.344
Damon, A. (2026, April 3). An FDA Reversal on Peptides Could Open the Market to Unsafe Drugs. ProPublica. https://www.propublica.org/article/peptide-safety-fda-compounding-pharmacies
El-Achkar, A., Boyne, A. M., & Lipshultz, L. I. (2026, April 16). Peptides for Sexual Dysfunction: What Clinicians Should Know. AUA News. https://auanews.net/issues/articles/2026/april-2026/peptides-for-sexual-dysfunction-what-clinicians-should-know
Ila, V., Pozzi, E., Gamage, M., & Ramasamy, R. (2025). Intravenous peptides and amino acids for erectile dysfunction: A narrative review of current applications and Future Directions. Expert Opinion on Pharmacotherapy, 26(5), 631–637. https://doi.org/10.1080/14656566.2025.2478912
Somani, S., Jain, S. S., Sarraju, A., Sandhu, A. T., Hernandez-Boussard, T., & Rodriguez, F. (2024). Using large language models to assess public perceptions around glucagon-like peptide-1 receptor agonists on social media. Communications Medicine, 4(1). https://doi.org/10.1038/s43856-024-00566-z
Steinzor, P. (2026, April 16). FDA to Convene Expert Panel on Expanding Access to Peptides Amid Safety, Regulatory Debate. AJMC. https://www.ajmc.com/view/fda-to-convene-expert-panel-on-expanding-access-to-peptides-amid-safety-regulatory-debate
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