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FDA peptide vote 2026: the July PCAC result tracker
Across July 23 to 24, 2026, the FDA's Pharmacy Compounding Advisory Committee recommended six of the seven docketed peptides for the 503A compounding list and rejected one. FDA staff had opposed all seven. It is a recommendation, not a legalization: the FDA still decides, and these stay unapproved for now.
Read this before the headlines: a recommendation is not a law
PCAC is an advisory panel. Its vote recommends that the FDA add sixof these peptides to the 503A bulks list, but the FDA makes the final, binding call through separate rulemaking and is not required to agree. The agency's own reviewers had recommended against all seven, citing gaps in characterization, effectiveness and human safety data plus unassessed immunogenicity. Until the FDA acts, none of these peptides is legally compoundable, and none is FDA-approved. Anyone telling you they are “now legal” is wrong.
What is PCAC and why does it matter?
PCAC (the Pharmacy Compounding Advisory Committee) is the expert panel that advises the FDA on which bulk substances pharmacies may legally compound under Section 503A. Its vote is a recommendation, not a final rule. The FDA usually follows it but decides on its own. For peptides, this committee is the gatekeeper between “you can get this from a licensed pharmacy” and “gray market only.”
How did the FDA panel vote on each peptide?
7 peptides were on the July 23 to 24 docket, under docket number FDA-2025-N-6895. 4 were reviewed on July 23 and the remaining 3 on July 24. Here is each one with the review day, the evidence grade we assigned it, and how the committee voted. A recommendation to add is a green light to the FDA, not a legal route on its own. It is also not an approval, which is the confusion behind most searches that reach this page. If you are asking whether KPV is an FDA approved peptide, the answer is no, and the same answer covers every row below: a substance can be recommended for the compounding list and still not be an approved drug, because those are two different decisions under two different statutes.
| Peptide | Reviewed | Evidence grade | PCAC recommendation |
|---|---|---|---|
| Semax | July 24 | C | Panel recommended addition to the 503A list (8 to 5, with 1 abstention) |
| BPC-157 | July 23 | D | Panel recommended addition to the 503A list (8 to 6, with 1 abstention) |
| TB-500 | July 23 | D | Panel recommended addition to the 503A list (8 to 6, with 1 abstention) |
| KPV | July 23 | D | Panel recommended addition to the 503A list (8 to 6, with 1 abstention) |
| MOTS-c | July 23 | D | Panel recommended addition to the 503A list (7 to 5, with 2 abstentions) |
| Epitalon | July 24 | D | Panel recommended addition to the 503A list (7 to 4, with 1 abstention) |
| DSIP (Delta Sleep-Inducing Peptide) | July 24 | D | Panel voted AGAINST addition to the 503A list (6 to 7, with 1 abstention) |
All seven tallies are final. The four recommendations on July 23 and the two on July 24 each passed narrowly, with the committee close to evenly split every time, and DSIP (Delta Sleep-Inducing Peptide) was the only compound the panel declined.
DSIP appears on the FDA agenda under its nominated name, Emideltide. Each substance is docketed in both free-base and acetate form, so the agenda lists fourteen entries for these 7 compounds.
A high grade and a favorable vote are different things. Most of these compounds are Grade D (animal studies only), so an FDA “yes” on the recommendation would make them legally compoundable, not proven to work. See how each grade is assigned on how we grade evidence.
Checking back for the ruling? Get it emailed the day it lands so you do not have to.
How did we get here?
In April 2026 the FDA published a reclassification (Federal Register docket FDA-2025-N-6895) that removed a group of peptides from the 503A Category 2 bulk-substances list, moving them into limbo pending review. That reclassification, plus the political attention around peptides in 2026, is what put these seven compounds in front of PCAC this July. Until the FDA acts on the panel's recommendation, any clinic openly selling the removed peptides is a compliance red flag, not a legal source.
What happens next now that the panel has recommended six of seven?
The decision moves to the FDA. The agency reviews the committee's recommendation and decides whether to add each peptide to the 503A bulks list. There is no fixed deadline, and the FDA is free to agree, decline, or add a compound with conditions. How long that has taken the last two times is measured further down. Two outcomes are on the table:
If the FDA adopts the recommendation
The peptide becomes eligible for 503A compounding, opening a legal, supervised route through licensed pharmacies and telehealth. It still does notmean the peptide is FDA-approved or proven effective. The evidence grade doesn't change, only the access route.
If the FDA declines
No legal compounded route exists, despite the panel's recommendation. Clinics cannot lawfully prescribe it, and it stays gray-market only. That is the current fate of CJC-1295 (nomination withdrawn) and thymosin alpha-1 (voted down in 2024). Our access sections stay empty for those compounds.
Neither outcome has anything to do with whether a peptide is approved somewhere else. A compound can be a licensed drug in another country and still be research-only here, because FDA approval and foreign approval are separate registrations: the cerebrolysin FDA approval status is the clearest case on this site, an approved drug in several countries with real randomized human trials behind it, and no legal supervised US route regardless. The same trap catches a compound the panel actually recommended: readers asking whether the FDA approved Semax in the United States are asking about a drug approved in Russia whose US status the July vote left exactly where it was.
How long does the FDA take to act on a PCAC recommendation?
Nobody can give you a date, and anyone who does is guessing. What can be measured is the agency's own record. Adding a substance to the 503A list takes a full notice-and-comment rulemaking, and the FDA has run that rulemaking exactly twice. Here is how long each one took, read from the Federal Register on August 30, 2026:
| Rulemaking | Proposed rule | Comments closed | Final rule | Elapsed |
|---|---|---|---|---|
| First 503A bulks listDocket FDA-2016-N-3464 | December 16, 2016 | March 16, 2017 | February 19, 2019 | 2 years 2 months (795 days) |
| Second 503A bulks list, amendmentsDocket FDA-2018-N-4845 | September 5, 2019 | December 4, 2019 | None | 6 years 11 months and counting (2,551 days) |
The round that finished took 2 years 2 months from proposed rule to final rule, and the final rule then took effect 30 days after publication. Placed six bulk substances on the list and identified four the agency considered and did not include. That is the complete precedent for what the FDA is now being asked to do with the peptides this panel recommended.
The second round is the more useful one, because it never finished. The FDA proposed it on September 5, 2019, comments closed on December 4, 2019, and 6 years 11 months later the docket still holds that single proposed rule and no final rule at all. We checked the docket itself on August 30, 2026. A proposed rule is not a deadline, and the agency is under no obligation to ever issue the final one.
The July peptides are not yet at step one of that process. On August 30, 2026, 37 days after the panel finished voting, we queried the Federal Register for every FDA document mentioning bulk drug substances published since the month of the vote. It returned count: 3, a GRAS food proposed rule, an animal-drug compounding draft guidance and a 503B paperwork-burden notice, none of them a 503A bulks-list rule. Widening the search to any FDA document mentioning peptides since the vote returns two notices, both unrelated to compounding: a draft guidance on potency assessment of active immunotherapy products, and a product-specific guidances availability notice under Docket FDA-2007-D-0369. No 503A bulks-list proposed rule exists, so the clock in the table above has not started.
How to read this, and how not to
Two rulemakings are a record, not a forecast. We are not predicting when the FDA will act, and this page will never carry an expected date, because there is no primary source that could support one. What the record does establish is the shape of the thing: this is a rulemaking, rulemakings at this agency on this list have run to years rather than weeks, and one of the two has not produced a rule at all. Treat any vendor claiming a peptide is about to become legal as making a claim the Federal Register does not support.
What happens next, and where should you actually be watching?
The section above measures the formal route, and that route is the one the FDA would normally take. It is not the one compounding counsel expects. Jesse Dresser, partner at the law firm Frier Levitt, who represents compounding pharmacies and others in the industry, told NPR on August 3, 2026 that formal rulemaking here would run several months to possibly over a year, and then said this:
“It would actually surprise me if this followed the traditional pathway of formal rulemaking. Whatever options exist to make this a faster process, I think they are going to be leveraged.”
That matters for this page specifically. If you are watching the Federal Register for a proposed rule, you may be watching the one channel the industry expects to be bypassed. Below are the three routes named by practising counsel in that reporting. They are attributed possibilities, not outcomes, and not forecasts we are making. Nothing on this list has happened, and none of them is legal access until the FDA itself acts.
Route 1
Interim placement on the Category One list
The FDA green-lights the peptides in the interim by placing them on the Category One list, giving compounding pharmacies cover to begin making them while the longer rulemaking plays out.
NPR reports this as the likely scenario. It would be an interim step, not a completed rulemaking, so the formal process would still have to run behind it.
Named by Jesse Dresser, partner at Frier Levitt, in NPR, August 3, 2026.
Route 2
The Health Secretary acts directly
Health Secretary Robert F. Kennedy Jr. cites the dangers of the unregulated peptide market as the rationale to immediately place the peptides on a list that permits their compounding.
“this is a unique scenario, unique product, unique industry and unique administration”
Dresser says this route would almost certainly draw a legal challenge, because the authority involved is normally used to remove unsafe products from the market rather than to fast-track them.
Named by Jesse Dresser, partner at Frier Levitt, in NPR, August 3, 2026.
Route 3
The FDA declines to follow its own panel
The agency bucks the committee's recommendations and leaves the status of the peptides unchanged.
“In many ways, the toothpaste is out of the tube here. I think that is absolutely part of the calculus.”
Kundi says this would likely bring lawsuits from the industry, while adding that the agency is clearly attuned to how widely available these products already are.
Named by Abha Kundi, attorney at ArentFox Schiff, focused on FDA regulatory law, in NPR, August 3, 2026.
One voice in that reporting is neither industry nor advocacy. Ilisa Bernstein, former FDA official and pharmacist, an expert on drug and pharmacy policy, put the constraint this way: “I do think that there is significant pressure here, but the FDA needs to follow the data.” She also named what makes the decision consequential either way: “Once the door is open, any pharmacy can compound these products. So it could have a huge presence in the marketplace.”
A green light is not a shelf date
Even after a green light, pharmacies need time to acquire the active ingredients before they can begin compounding. Scott Brunner, chief executive of the industry trade group the Alliance for Pharmacy Compounding, put that lag at two months to nine monthsdepending on the substance: “It's going to create some chaos. It might take two months, it might take nine months, it depends on the substance.” So even the fastest of the routes above ends in a wait, and any countdown that stops at the FDA decision is stopping early. These will also be prescription products from compounding pharmacies, not something to pick up at a retail chain.
What is actually on the federal calendar, as of August 30, 2026
Rather than assume, we query the Federal Register and print what comes back, with the query. Read 38 days after the July 23, 2026 vote:
Has the FDA published anything on bulk drug substances since the vote?
Three documents, and none of them is a 503A bulks-list rulemaking. The oldest is a proposed rule titled Substances Generally Recognized as Safe, published August 11, 2026, which is a food-additive matter. Two more arrived in late August: a draft guidance on compounding animal drugs from bulk substances under CGMP, document 2026-17580, published August 28, 2026, which sits on the animal-drug side of compounding, and the outsourcing-facility paperwork notice described below, document 2026-17676. This count moved from one to three between August 26 and August 30, and the conclusion held: no 503A bulks-list rulemaking has been proposed.
Has a second Pharmacy Compounding Advisory Committee meeting been noticed?
Eight documents mention the committee and none of them notices a meeting. They are renewal notices for three other FDA advisory committees (oncologic drugs, cardiovascular and renal drugs, endocrinologic and metabolic drugs), a Medicaid rule, the FY2027 hospital inpatient payment rule, the FY2027 hospice payment rule, a 340B rebate pilot notice and a proposed rule on medical-use licensing. No second meeting has been noticed.
Does the outsourcing-facility notice scheduled for August 31 move the 503A bulks list?
No. Document 2026-17676 is a Paperwork Reduction Act notice, which means the FDA is asking for comment on its own estimate of how many hours registration and fee reporting cost the outsourcing facilities already doing both. The collection is OMB control number 0910-0776 and the agency is seeking to extend it, so even the paperwork is not new. It runs under section 503B of the FD&C Act, 21 U.S.C. 353b, a separate section from the 503A track this page follows. It proposes no rule and names no substance, and it leaves the question of which drugs a pharmacy may lawfully compound exactly where the July vote left it. As of August 30 it had not been published: the FDA filed it for public inspection on August 28 and the Federal Register has it scheduled for August 31, with comments closing October 30, 2026, under docket FDA-2026-N-8690.
Re-run it: https://www.federalregister.gov/api/v1/documents/2026-17676.json
An absence in the Federal Register is not proof that nothing is happening. It is proof that nothing has been published, which is a different and narrower claim. Two of the three routes above would not begin with a proposed rule at all, so this check can stay empty right up until the status changes.
Does this new FDA peptide notice change what pharmacies can compound?
There is a second regulatory track for peptides, and it runs separately from the compounding question this page tracks. It is the generic-drug approval pathway, and the FDA acted on it recently. On July 29, 2026 the agency published Product-Specific Guidances; Revised Draft Guidances for Industry; Availability, document 2026-15285, 91 FR 47834, under docket FDA-2007-D-0369. That track concerns whether a company may market a generic copy of an already-approved peptide drug. It is a different question from whether a pharmacy may compound one, and it is worth tracking on its own terms.
The notice withdraws an older guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, issued May 2021. That guidance had described when a generic synthetic peptide could reference a listed drug made by recombinant DNA (rDNA) methods. The agency's stated reason for pulling it is that “ it no longer reflects FDA's current scientific thinking.” Its stated plan is: “As noted in the Center for Drug Evaluation and Research guidance agenda, FDA plans to revise and reissue the guidance this year.” So the withdrawal is not the end of the matter; the FDA has said it intends to replace the guidance rather than simply drop it. Comments on the notice close September 28, 2026.
Two different statutes are in play. Generic approval runs under the abbreviated new drug application pathway, 21 U.S.C. 355(j), which governs whether a company may market a generic version of an approved drug. Compounding runs under 21 U.S.C. 353a, the 503A track, which governs whether a pharmacy may make a drug from a bulk substance. The PCAC vote this page tracks sits on that second track. Nothing in this generic-drug notice changes what a compounding pharmacy may lawfully make. On August 2, 2026 we ran both queries side by side: FDA documents mentioning synthetic peptides this year returned count: 1, this notice, while FDA documents on bulk drug substances since the month of the vote still returned count: 0.
The withdrawal is not stated in the notice's abstract. It appears only in the body, in section I, Background. We found it by reading the published full text. A reader who trusts a headline, or the notice's own summary of itself, would not learn that a peptide guidance was pulled at all. That is why this tracker reads the source document rather than the summary, and why a quiet withdrawal can still be a real regulatory event.
The same notice also makes available revised draft bioequivalence guidances for a table of active ingredients. Some of those are compounds this site already grades, including liraglutide, semaglutide and tirzepatide. None of them is one of the peptides the PCAC voted on. The overlap is worth noting, so a reader is not surprised to see familiar names, but it does not connect the two tracks or carry over to the compounding question.
How to read this, and how not to
What you can conclude: the FDA is reworking how it handles generic synthetic peptides, and it has said it plans to reissue the withdrawn guidance. What you cannot conclude: that this changes anything a pharmacy may compound, or that it advanced, stalled, or decided the compounding question. Different statute, different question. The compounding decision still rests with the FDA on the other track.
Is anyone actually running a BPC-157 trial?
The panel recommended BPC-157 over the objection of the FDA's own scientists, and the objection was about evidence. So the question worth asking is not what the committee thought, it is what exists. Every human trial anywhere is supposed to be registered before it enrolls, and that registry is public. We queried it on September 4, 2026 and it returned 4 records for BPC-157. Here is every one of them, and what each one actually is.
| Registry ID | Sponsor | Status | Design | Enrolled | Site |
|---|---|---|---|---|---|
| NCT02637284 | PharmaCotherapia d.o.o. | UNKNOWNlast known: ACTIVE_NOT_RECRUITING | PHASE1, randomized, masking quadrupleregistered as drug | 42estimated | TijuanaMexico |
| NCT07437547BPC-HAMSTR | Hudson Biotech | RECRUITING | PHASE2, randomized, masking quadrupleregistered as drug | 120estimated | ShenzhenChina |
| NCT07752381 | Parlay Wellness | COMPLETED | no declared phase, not randomized, not maskedregistered as dietary supplement | 40actual | Las Vegas, NevadaUnited States |
| NCT07803250 | University of Arkansas | NOT_YET_RECRUITING | PHASE1, randomized, masking quadrupleregistered as drug | 30estimated | Little Rock, ArkansasUnited States |
Read from the ClinicalTrials.gov API on September 4, 2026, HTTP 200. Re-run the query yourself: https://clinicaltrials.gov/api/v2/studies?query.term=BPC-157&countTotal=true. The registry is live, so the count can change on any day a sponsor files.
NCT02637284, PharmaCotherapia d.o.o. with Hospital Angeles Tijuana
A safety and pharmacokinetics study in healthy volunteers, not an efficacy trial. It was properly controlled on paper, and then it stopped reporting: the sponsor has submitted no update since a few days after it first posted, the record still says UNKNOWN, and no results were ever filed. Treat it as an abandoned registration rather than as evidence.
oral tablets, single dose and a two-week repeated-dose arm. Started October 2015 (estimated), primary completion February 2016 (estimated). First posted December 22, 2015, last sponsor update December 17, 2015.
NCT07437547 (BPC-HAMSTR), Hudson Biotech
The only registered efficacy trial of BPC-157 anywhere, and the only one still running. It is the one record on this list built to answer whether the compound works: randomized against placebo, quadruple-masked, in an injury confirmed by MRI rather than self-reported. It is also a single-site study at one hospital, and that site is not in the United States.
subcutaneous injection, once daily for 14 days. Started February 2, 2026 (actual), primary completion February 14, 2027 (estimated). First posted February 27, 2026, last sponsor update February 22, 2026.
NCT07752381, Parlay Wellness with Citruslabs
A supplement study, registered as a dietary supplement rather than a drug, and the weakest design on this list: one group, no placebo, no masking, no randomization and no declared phase. It also reached the public registry after it had already finished, so nobody could have known it was running while it ran. Its own registration says it is a supplement study, and that is how it should be read.
peptide gummies containing 500 micrograms of BPC-157 per serving. Started September 1, 2025 (actual), primary completion November 1, 2025 (actual). First posted August 7, 2026, last sponsor update August 3, 2026.
NCT07803250, University of Arkansas
The first registered trial of BPC-157 that is both sited in the United States and registered as a drug rather than a supplement, and the first whose sponsor attests it is FDA-regulated. It has not opened: the registry lists it as not yet recruiting, with enrollment estimated to begin in 2027 and no results filed. Its design is the strongest on this list on paper, randomized and quadruple-masked against a saline control, and it is still a phase 1 pilot whose stated goal is to inform a larger trial later. A registration is a plan, not a finding, and this one changes nothing about what is known today.
subcutaneous injection, self-administered once daily for 90 days after surgery. Started January 1, 2027 (estimated), primary completion August 1, 2027 (estimated). First posted September 3, 2026, last sponsor update September 1, 2026.
The one date the evidence base can change
February 14, 2027, the estimated primary completion of NCT07437547. That is the earliest date on which a controlled trial of BPC-157 could produce a result, and an estimated date on a recruiting study routinely slips. Until then, nothing about the published evidence for this compound changes, whatever the FDA decides about compounding in the meantime. The two questions move independently, which is why our evidence grade for BPC-157 would not move even on the day the FDA acts.
How to read this, and how not to
Two of these records carry the registry flag isFdaRegulatedDrug: false. That is the sponsor's own answer on its own registration form. It is not a finding by the FDA, it is not a clearance, and it is not a refusal. The oldest record does not answer the question at all. We report who said it because a vendor quoting that flag as regulatory cover is quoting the sponsor, not the agency.
The other thing worth noticing is where these studies are. The only registered efficacy trial runs at a single hospital outside the United States, and the registry currently holds no record of a US-sited trial of BPC-157 registered as a drug at all. A registration is also not a result: none of these records has published findings, so none of them is evidence that the compound works. That is the whole reason the grade is what it is.
Which country regulates the one trial that is still running?
This is the question the vote makes people ask, and the registry answers it in one line. NCT07437547 is sponsored by Hudson Biotech, and its record lists exactly one study site: Peking University Shenzhen Hospital in Shenzhen, China, status recruiting. The registry's central contact for the study is reachable at a +86 telephone number and an email address at beijing-biotech.com. So the trial that the reclassification debate keeps pointing at as the evidence that is coming is being run, and would be regulated, in China.
On oversight the record answers for itself, and it is worth quoting exactly rather than paraphrasing. Its oversight module carries isFdaRegulatedDrug: false and isFdaRegulatedDevice: false, alongside oversightHasDmc: true for an independent data monitoring committee. Read that the way the form is written: the sponsor is stating that this study is not being run under FDA drug regulation. It is not the FDA saying anything, in either direction, and it does not mean the study is unmonitored. What it does mean is that a US reader waiting on this result is waiting on a trial their own regulator is not overseeing.
One limit on what we can tell you, stated rather than glossed: the registry gives the site and the sponsor's attestation, and it does not publish the nationality of anyone enrolled. A single site in China is not a registry statement about who is or is not in the study, and we are not going to turn it into one. The record also still reports no results filed. Read from the ClinicalTrials.gov API at https://clinicaltrials.gov/api/v2/studies/NCT07437547 on August 26, 2026, HTTP 200, registry record version 2026-08-21.
Has anything changed since the vote?
One thing, and it is a registration rather than a result. The same registry query returned 3 records on August 24, 2026 and 4 on September 4, 2026. NCT07803250 was first posted September 3, 2026, sponsored by University of Arkansas, at University of Arkansas for Medical Sciences Medical Center in Little Rock, Arkansas. It is the first BPC-157 record that is both sited in the United States and registered as a drug rather than a supplement, and the first whose oversight module carries isFdaRegulatedDrug: true. Read that the same way as the attestation above: it is the sponsor stating on its own form that the study sits under FDA drug regulation, not the FDA approving anything.
What it does not do is move anything. The registry lists it as not yet recruiting, with enrollment estimated to begin January 1, 2027 and primary completion estimated August 1, 2027, and no results filed. Its own summary is blunter than anything we would write: BPC-157 has not yet been studied in formal human clinical trials
. So the evidence grade does not move, and neither does the legal status, which only the FDA acting can move. A first US trial being planned is a fair thing to know and a bad thing to mistake for a result.
One discrepancy in the record itself, stated rather than tidied away: its structured enrollment field gives 30 participants while its own summary text says twenty. We carry the structured field here, as we do for every row in the table above, and we are not going to resolve a contradiction the sponsor has not resolved. Read at the registry API on September 4, 2026, HTTP 200.
Which peptides are on the next FDA docket?
The next fiveare already named, and that is the whole advantage of knowing now. The FDA's own Pharmacy Compounding Advisory Committee meeting page states it will host a meeting before the end of February 2027, and lists the substances the committee will discuss for the 503A bulks list: GHK-Cu, LL-37 (Cathelicidin), Melanotan-2 (MT-2), Dihexa and PEG-MGF (Pegylated Mechano Growth Factor). That is the agenda from the agency, not a press report of one, which is a change from how this section read a month ago.
Be careful about what that does and does not settle. The list is confirmed; nothing around it is. The FDA says it intends to publish a Federal Register notice and establish a public docket for this meeting “in the near future,” and that the time and location will be scheduled in the coming months. So there is no docket number, no published date, and no open comment period to file into yet. Our own query of the Federal Register database on August 30, 2026 for FDA notices on bulk drug substances, newest first, found nothing touching the 503A list since the July 23 to 24, 2026vote, which is exactly what the FDA's own wording predicts. And being placed on an agenda is one step earlier than being voted on, which is itself one step earlier than being legal. None of these five is compoundable today.
Agenda confirmed by the FDA; meeting date and docket still unpublished. Grades and legal status are read from our peptide records and are current today.
| Peptide | Evidence grade | Legal status today |
|---|---|---|
| GHK-Cu | Grade B | Cosmetic/topical (legal)FDA's agenda names GHK-Cu without specifying a form. This record grades the topical cosmetic lane, which is the legal one. Injectable GHK-Cu is a different product: it has no legal supervised US route, and a 503A bulks listing would be about that compounded form, not about the serum on a shop shelf. |
| LL-37 (Cathelicidin) | Grade C | Not compoundable (research-only) |
| Melanotan-2 (MT-2) | Grade D | Not compoundable (research-only) |
| Dihexa | Grade D | Not compoundable (research-only)FDA's agenda lists this as dihexa acetate, the salt form. Nothing about the listing changes the evidence: it is still animal-only, and the foundational rat papers carry a retraction and an expression of concern. |
| PEG-MGF (Pegylated Mechano Growth Factor) | Grade D | Not compoundable (research-only)FDA's agenda names the pegylated form specifically, not plain MGF, which has its own record here. The parent peptide failed to show activity on myoblasts in the one rigorous cell study, so this is a listing decision about a compound whose underlying biology is unproven. |
Two things are worth knowing before that meeting, because they will not be in the headlines.
LL-37 is the one on this list carrying real human trial data, and it cuts both ways. A phase 1/2a randomized placebo-controlled study in venous leg ulcers, n=34, found lower doses of topical LL-37 healed several-fold faster than placebo. The larger phase 2b multicentric RCT, n=148, was negative on its primary endpoint, with only a post-hoc signal in patients who had large ulcers. A positive small trial and a failed larger one is a mixed record.
The FDA's openFDA database already holds a recall history for one of the five: 2 records for GHK-Cu (copper peptide), read on 2026-07-31 against a database last updated 2026-07-22. Those counts overlap for combination products, so they can never be added together. And a low count is not a clean safety record. A recall is an action against a regulated manufacturer, so a compound no licensed pharmacy may lawfully make cannot generate one in the first place. The full peptide recall record.
Nothing about these five changes because of a future meeting. Each keeps the legal status our records already carry for it, and a recommendation would not change that either. 21 U.S.C. 353a(c)(1) requires the FDA to convene and consult the advisory committee before it issues the regulations that add a substance to the 503A list, which puts every vote, including this one, upstream of the rulemaking. We add each outcome here as the meeting is noticed and voted. For the legal framework behind all of it, see are peptides legal?