Peptides approved so far have limited human research

COLUMBIA, Mo. (KMIZ)

Peptide-based medicines are not new, but a new market is emerging and growing quickly.

In the 1920s, insulin became one of the earliest and most important peptide therapies, helping people manage diabetes. Since the Food and Drug Administration started regulating it in the '40s, the organization has approved numerous peptide-based drugs such as GLP-1 medications used to treat diabetes and obesity.

In 2005, the FDA approved Byetta, marking the beginning of the GLP-1 era for treating Type 2 diabetes. In 2014, Saxenda was approved for weight management and weight loss.

Since 2017, popular injectable semaglutides like Ozempic and tirzepatides like Wegovy, Mounjaro and Zepbound have hit the scene. They're used for diabetes and weight loss and have all gained FDA approval.

Many of the peptides filling the emerging market are not regulated, leaving consumers to determine whether the treatments are safe. But regulators have begun to OK some for public use.

FDA approval is a rigorous process. 

For drug companies to sell drugs in the United States, they must be tested. The company then sends the findings to the Center for Drug Evaluation and Research, and a team of physicians, statisticians, chemists, pharmacologists and other scientists reviews the proposal.

If the review finds the drug's health benefits outweigh the known risks, it is approved for sale.

The drug company must do laboratory testing or animal testing to discover how the drug works and whether it's likely to be safe for humans. If so, a series of tests on humans starts.

FDA approval means the drug's effects have been reviewed by the Center for Drug Evaluation and Research and have been found to have more benefits than risks. A structured framework is applied for this process.

• FDA reviewers analyze the purpose and intended use of the drug and evaluate the current treatment landscape.
• FDA reviewers evaluate the clinical benefit and risk information provided by the drug maker. Uncertainties from imperfect and incomplete data are taken into account.
• Assess strategies for managing risks. FDA approval is needed for the drug label; sometimes a Risk Management and Mitigation Strategy is applied.

In some instances, accelerated approval can be given to promising therapies that treat a serious and life-threatening condition. For example, HIV/AIDS medications and some cancer-targeting drugs got accelerated approval.

Now, demand for peptides is stretching beyond diabetes and weight loss.

"There's peptides for everything," said Dr. Phillip Rohde, medical director at Retuva Medical Spa in Columbia. "Peptides have recently gained a lot of notoriety; they're all over social media, all over Facebook."

"It's a gold rush market right now," said peptide user Foster McCormick, of Columbia.

Under the Biden administration in 2023, the FDA categorized more than a dozen peptides in Category 2 of the Section 503A Bulk Drugs List, prohibiting their use in compounding and citing significant safety concerns.

But in February 2026, Health and Human Services Secretary Robert F. Kennedy Jr. said many of the peptides on the Category 2 list would be reconsidered for reclassification to the Category 1 list, while also removing 12 peptides from Category 2.

In July, the Pharmacy Compounding Advisory Committee for the Food and Drug Administration recommended adding six peptides to a drug compounding list. Placement on the list would allow licensed compounding pharmacies to legally prepare and dispense these peptides with a prescription. 

They recommend BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax be added to an approved list of ingredients that specialty pharmacies can use to make custom medications. The committee rejected a seventh peptide, Emideltide.

Several new members of the PCAC have ties to businesses or clinics involved in peptide therapies.

Each of these peptides has limited human studies and is primarily researched on rodents and animals.

“When you see something that has only said ‘using rats’, that means it has not been adequately studied in humans,” said Dr. Regina DiPietro. 

The FDA still has to complete the formal rulemaking process on whether these substances will be added to the 503A Bulks List. Products sold online for research use are not approved for human use.

While the FDA describes their intended use, many of these peptides are being explored for other uses.

BPC-157 research also looks at tendon and ligament healing, muscle recovery, digestive health and inflammation and tissue protection. TB-500 research and use on social media and med spas focus on recovery and muscle and tissue regeneration.

KPV research centers on inflammation in gut healing and inflammatory bowel conditions, immune modulation and skin inflammation. MOTS-c researchers are exploring its role in cellular energy in metabolism and insulin sensitivity, weight and body composition, exercise capacity and healthy aging.

Shabbir Safdar, executive director and certified fraud examiner with Partnership for Safe Medicines, said the typical person is not familiar with the complicated and thorough process medicine goes through to be deemed safe.

"Because we're not familiar with that, when people start selling these peptides, which are basically substances that have never been through an FDA approval, in most cases they forgot that there's a whole safety process and an efficacy process that test these things before they get to the consumer," said Safdar. " They've never been through, like, an 11,000-person trial where you identify, 'Do they grow muscle but also grow cancer?'"

There are also hundreds of different kinds of "grey market" peptides that people are taking that lack FDA approval.

You can get these peptides at wellness or medical spas, distributors and online. You can even find them on social media apps like TikTok. Some social media influencers have discount codes for people to buy peptides.

Grand View Research estimates the peptide therapeutics market is estimated to make $164 billion in 2026 and skyrocket to nearly $300 billion in 2033 in the United States.