Have peptides been approved?

I read the news and came away confused. It said the FDA had given the green light to seven peptides, BPC-157 among them, and then something about a next stage. Next stage of what, it didn't say.

So I went to find out, because the question has already reached me a few times and it will come again.

What happened in July

The FDA has a committee that deals with compounding pharmacies, the ones that prepare formulas instead of selling ready made boxes. In July this year that committee voted on seven peptides and recommended six: BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon. The seventh, DSIP, was turned down.

The vote was about whether these substances can go on a list that lets American pharmacies compound them on prescription. Drug approval is a different thing. An approved drug has been through human trials, it has a leaflet, a dose, a list of side effects, and someone answerable for it.

And it has not even got there yet. The vote is advisory, the FDA still has to write the rule, and that usually takes six months to a year. Until then nothing has changed.

The FDA's own scientists spent months going through the files and concluded that none of the seven met the agency's evidence standard. The committee recommended six of them anyway. On BPC-157, TB-500 and KPV the result was eight votes in favour to six against, so it was not any sort of consensus either.

What the studies actually are

I will take BPC-157, which is the one everybody asks about.

There are plenty of studies, over a hundred, and some are interesting: tendons healing better, wounds closing faster, the gut protected from anti-inflammatories. Almost all of them were done in rats.

In humans, to this day, there is not one published randomised controlled trial. For any indication at all. What gets passed around as a human study is a 2025 paper with two people and no control group.

Two.

In February this year the first properly designed phase 2 trial started recruiting. It will take a while to give results, and that is when this is worth coming back to.

If you compete, that settles it

BPC-157 has been on the World Anti-Doping Agency list since 2022, under non approved substances. TB-500 has been there since 2018. Growth hormone secretagogues, CJC-1295, ipamorelin, sermorelin, sit under peptide hormones.

Banned at all times, in and out of competition, no grey area. If you compete in any federated sport, that is where this ends for you.

And over here

None of these peptides is authorised by Infarmed or by the European medicines agency. They are not medicines and they are not supplements either. They are sold online with a label saying "for research", and it is that label that keeps them outside the reach of medicines law.

In practice it means this: nobody is guaranteeing what is inside the vial. Not the dose, not the purity, not whatever else came along with it. You buy from a website, you get a vial, and the information you have about it comes from that same website.

Approved peptides exist, and plenty of them

Worth saying, otherwise peptide starts to sound like a black market word.

Insulin is a peptide. Semaglutide and tirzepatide are peptides. In January this year the Wegovy tablet came out, the first oral GLP-1 approved for weight loss, with 16.6 per cent average weight loss in the trial behind it. FDA approved peptides run to about 130.

The difference is in the road they took to get there. Human trials, with thousands of people, over years, and an agency going through those results before the thing reaches the pharmacy.

What I tell the people who ask me

Plenty of clients come to me with this question, and I will be straight with you about what I answer.

On the science side, there is not enough proof. That is what is above.

Then there is what people tell me. I have people describing very good injury recoveries, fast ones, and people saying they got better from digestive or gut problems they had been carrying for a long time. And so far not one of them has reported any side effect to me.

There is one thing to keep in mind though, which is the power of suggestion. Someone who buys a vial to get better from something is already expecting to get better, and that brings a dose of placebo with it. It makes people jump to conclusions, and after that it is hard to separate what the peptide did from what rest, time, physiotherapy or a change in training did.

There are also health professionals who, rightly or wrongly, have been recommending this to their patients.

What I would tell you is to gather all the information and make the decision yourself. What I have done here is leave you some of it, to help.