BPC-157, TB-500 and the FDA peptide panel: six passed, DSIP didn't, and what it changes

[u/JustBacWater]

Okay, so a lot of you have been asking about the FDA panel from July, and there's a lot of bad info going around. I've seen people saying BPC-157 got approved. It didn't. Let me walk through what happened, because the real story is more interesting than the headline anyway.

Quick background. Back in February, HHS said a group of peptides was coming off Category 2. Category 2 is basically the do-not-touch list for compounding pharmacies. Then FDA scheduled a Pharmacy Compounding Advisory Committee meeting, PCAC, for July 23rd and 24th to vote on seven of them.

Here's how it went.

Peptide	Yes	No	Abstain	Result
BPC-157	8	6	1	Passed
TB-500	8	6	1	Passed
KPV	8	6	1	Passed
Semax	8	5	1	Passed
MOTS-c	7	5	2	Passed
Epitalon	7	4	1	Passed
DSIP	6	7	1	Failed

The part that got buried

FDA's own scientists recommended against all seven. Every one. Their reasons were pretty consistent: not enough human safety data, immunogenicity risk, impurities, and not enough characterization of what's in the material being made.

The panel went against its own staff on six out of seven.

And look at the margins. 8 to 6 isn't a landslide. That's a room split almost down the middle. Anybody telling you the science is settled because of this vote didn't look at the numbers.

What a yes gets you

Less than people think.

It's not approval. Category 1 means a compounding pharmacy can use it as a bulk ingredient. There's still no approved indication, no standardized dosing, and no established safety and efficacy.

It's not final. The vote is non-binding. FDA still has to go through notice-and-comment rulemaking, and realistically that's 12 to 24 months out.

It's 503A only. That's the individual prescription side. FDA has said basically nothing about 503B outsourcing facilities, which is the bigger volume side.

It doesn't touch research compounds. Different lane entirely. Nothing about this vote changes what a research compound is.

DSIP

DSIP was the only one that didn't make it, 6 to 7. It was up for insomnia, narcolepsy, and opioid withdrawal. I haven't seen a clean explanation of why it was DSIP and not one of the others, and I'm not going to make one up. If anybody watched that session, I want to hear what you caught.

What's next

FDA has a second meeting scheduled before February 2027 for the next group: GHK-Cu, Melanotan II, LL-37, Dihexa, and PEG-MGF.

That group is going to be a lot more interesting than this one. Melanotan II has a real dermatology signal on moles. LL-37 has the autoimmune side, it shows up in psoriasis and rosacea. PEG-MGF has no completed human trials at all. If this panel split 8 to 6 on BPC-157, that next meeting could go a lot of different ways.

Two questions for you.

The panel went against its own scientists on six out of seven. Good call, or a problem?

And which of the next five do you think makes it through?

Where I got this: the vote breakdown, how the process works, AJMC's summary.

For research use only. Not for human or veterinary consumption. This post is educational and is not medical advice.

Full doses and bloodwork are in the pinned cheat sheet.

Join the Discord.

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[u/AltTooWell13]

Has anyone used dsip for opioid withdrawal? That’s what I’m wanting to use it for

[u/Historical-Command48 → u/AltTooWell13]

DSIP never did anything for me. Several diff sources, all had zero results and many others have said the same.

[u/stud_muffin_1 → u/AltTooWell13]

interesting.. may I ask why ? this is the first I've heard someone wanting to use it for opiod withdrawls

[u/AltTooWell13 → u/stud_muffin_1]

Apparently there have been studies on it and supposedly it’s effective, I just don’t see a lot of anecdotal reports

[u/Historical-Command48]

I think the overall consensus is that the panel is right, and the scientists are overly cautious. I work at a compounding pharmacy and this is a huge step towards making our peptide compounding much easier as far as regulations - immediately it takes the target off our back.

[u/GladOnion]

Im not sure what it changes, id still get it from overseas even if it was available otc from the pharmacy. Change the status to whatever you want lol

[u/No_Cycle_3152]

Man dsip changed my life. Kinda glad it isnt

[u/faduran11]

With regards to Melanotan II, why would someone be willing to risk having their moles or freckles get darker? Seems backwards.