No FDA rule has changed the legal status of the seven peptides the agency reviewed in July 2026. This page is the dated record of what has actually happened, newest first, each entry linked to the government document behind it. Where a meeting happened and FDA published nothing after it, the entry says exactly that.
What matters first
Peptides reviewed in July 2026
7
Legal-status changes
0
Dated entries
8
Source standard
Government document for every published change
What an advisory committee review actually changes
A committee reviewing a substance does not make it legal. It does not ban it either. People get this wrong in both directions. Almost every confident claim about “the FDA decision” on peptides falls apart once you know which step is which.
The 503A bulks list
A compounding pharmacy can start from a raw ingredient only if that ingredient meets one of three conditions:
it has a US Pharmacopeia monograph
it is a component of an approved drug
it appears on the 503A bulks list, which the government maintains
The seven peptides FDA reviewed in July 2026 have no monograph, and none of them is a component of an approved drug. The bulks list is the only route open to them. That is what the meeting was about.
What the committee does, and what it does not do
The Pharmacy Compounding Advisory Committee gives advice. FDA puts it this way: “Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.” A vote suggests whether something belongs on the list. It is not a rule and it is not a ban. It changes nobody’s legal position on the day it happens.
Who decides, and when
FDA decides afterwards. It writes a regulation and publishes it in the Federal Register. The agency’s own briefing document says FDA “does not intend to issue a final determination on the issues at hand”. It will first weigh the committee’s input and finish every review. Until that regulation exists, nothing has changed, whatever anyone said in the room.
What “unapproved” means for something sold today
It means no agency has checked whether it works, how much to take, how pure it is, or what it does over years. That is a gap in what anyone knows. It is not a finding that the substance is dangerous, and not a finding that it is safe. It is also why the research compound guides here carry no dosing chart. And “pharmaceutical grade” is a seller’s phrase, not a legal status.
Changelog
Newest first.
No outcome published
FDA has published no final outcome from the July 2026 peptide review
FDA has published no written minutes, transcript, vote record or final outcome from the July meeting. That was still true on September 20, 2026, when we last opened every source on this page. So this tracker states no final outcome.
FDA’s event-materials page links archived broadcasts for both days and lists the briefing documents, questions, final agenda, committee roster and FDA slide decks. The broadcasts are a record of the meeting, not a final FDA decision. FDA has published no written outcome document on that page. A Federal Register search on docket FDA-2025-N-6895 still returns one document: the April notice announcing the meeting.
FDA’s briefing document proposed leaving all seven peptides off the 503A bulks list
FDA went into the meeting proposing that none of the seven peptides join the 503A bulks list. Its briefing document sets out fourteen numbered proposals, a free base and an acetate form for each peptide. Every one of them reads that FDA “is proposing that” the substance “NOT be included on the 503A Bulks List”.
The same document says FDA “does not intend to issue a final determination on the issues at hand”. FDA will first weigh the advisory committee’s input and finish every review. Footnotes record that the nominator withdrew the nominations for several of these substances, and that FDA chose to present them to the committee anyway. A proposal in a briefing document is the agency’s position going into a meeting, not a decision.
Seven peptides went before the advisory committee on July 23-24, 2026
The Federal Register notice set the meeting for July 23 and 24, 2026 at FDA’s White Oak Campus in Silver Spring, Maryland. Day one covered BPC-157, KPV, TB-500 and MOTs-C. Day two covered Emideltide (also called delta sleep-inducing peptide, DSIP), Semax and Epitalon. The notice names the use FDA evaluated for each one:
BPC-157 — ulcerative colitis
KPV — wound healing and inflammatory conditions
TB-500 — wound healing
MOTs-C — obesity and osteoporosis
Emideltide — opioid withdrawal, chronic insomnia and narcolepsy
Semax — cerebral ischemia, migraine and trigeminal neuralgia
Epitalon — insomnia
The committee took each peptide in two forms, free base and acetate. FDA has since posted its presentation decks for both days.
Public comment docket FDA-2025-N-6895 closed on July 22, 2026
The Federal Register notice opened a public docket for the meeting. The docket closed on July 22, 2026, the day before the first session. FDA said it would not consider anything filed late. You can read the comments on regulations.gov under that docket number.
FDA updated the meeting page and ran both days longer. July 23 moved from a 4:30 p.m. finish to 6:20 p.m. Eastern. July 24 moved from 3:50 p.m. to 4:15 p.m. Eastern. The same update revised the start times for public oral presentations.
We log a schedule change because it is the kind of edit that quietly invalidates a page written from the original notice.
FDA renewed the committee’s charter through April 25, 2028
FDA renewed the Pharmacy Compounding Advisory Committee for another two years. The new charter expires on April 25, 2028. The committee that reviews these substances therefore keeps going until then.
The Federal Register notice announced the peptide review and opened the docket
FDA published the meeting notice at 91 FR 20465. The notice established docket FDA-2025-N-6895 and asked for comment on bulk drug substances nominated for the section 503A bulks list. It is the primary record for the meeting’s dates, location, agenda and the substances under review.
An earlier draft of this page cited a different docket number. That was wrong. We corrected it to the number printed in the notice.
FDA has announced a further peptide review for before the end of February 2027
FDA says it will hold another meeting before the end of February 2027. It has not set a date. Its advisory-committee page names five substances for that review:
Cathelicidin (LL-37)
GHK-Cu
Dihexa acetate
Melanotan II
Mechano Growth Factor, Pegylated (PEG-MGF)
FDA says the time and location will follow in the coming months. No date, no docket and no Federal Register notice exist for it yet. Full-text searches of the Federal Register for GHK-Cu, Dihexa and PEG-MGF each return zero documents. The page carried a content-current date of April 15, 2026 when we retrieved it.
Pitocin is a US brand of synthetic oxytocin injection. The product reviewed here contains 10 units per milliliter. It is made for infusion into a vein (IV) or injection into a muscle.
Safety and notice boundaries — 6 paragraphs
The Pitocin label displays an Important Notice above its approved uses. It says not to induce elective labor without a medical need. The label’s XML files classify this as a Boxed Warning Section, with LOINC code 34066-1.
Both details matter: the visible title is “Important Notice,” and the formal label category is a boxed warning.
To induce or strengthen labor, the label requires IV use in a hospital with adequate medical supervision. Too much womb activity can harm the pregnant patient and fetus. The label also warns of water intoxication.
This is a risk especially with continuous infusion and fluid taken by mouth. Severe cases have included convulsions, coma and maternal death.
In SOARS-B, the overall rate and severity of adverse events were similar in both groups. That was one monitored trial in children and teens with autism. It does not establish a complete safety profile for the spray.
It also does not replace the pregnancy-care warnings for the injection.
Enclomiphene citrate is an oral drug. It was studied in men with secondary hypogonadism. The trials checked hormone levels.
The separate 16-week Phase III studies also measured sperm concentration.
Current US database check — September 7, 2026 — 5 paragraphs
The Drugs@FDA data page gave September 4, 2026 as its latest weekday update. The 12-table archive was downloaded and searched on September 7, 2026. It had no enclomiphene, Androxal or EnCyzix match.
As a positive control, its Products table did have nine clomiphene rows. A clomiphene product is not an enclomiphene-only product.
A fresh exact openFDA active-ingredient query for ENCLOMIPHENE returned HTTP 404. Its body said NOT_FOUND and No matches found. A fresh DailyMed query returned HTTP 200.
That result was empty, with total_elements: 0.
No enclomiphene-only product was found in the current US databases checked on September 7, 2026. This search result does not establish worldwide status. It does not decide if compounding is allowed. It is neither legal guidance nor a clinical recommendation.
Tesofensine is a small-molecule oral drug. It blocks reuptake of norepinephrine, dopamine and serotonin. It is not a peptide.
It is not a GLP-1 receptor agonist.
Current study and regulatory status — 8 paragraphs
The current trial search returns 13 records. Of these, 11 are completed and two withdrawn. None is recruiting, active or Phase 3.
The two withdrawn Tesomet trials enrolled no people. Both the hypothalamic-obesity trial and Prader-Willi trial cite financing as the reason. Their planned groups are not exposures or results.
No product was found in these current US databases. That does not establish worldwide approval status. It supplies no approval, approved use, label or recommended dose.
An April 2026 announcement points to a live viewer for current registration. The registration viewer did not respond during the September 7, 2026 check. The opinion does not prove current Mexican registration.
Ibutamoren mesylate is studied as MK-677, MK-0677, MK0677, and LUM-201. It is an oral growth-hormone secretagogue, meaning it prompts the body to raise its own growth hormone and insulin-like growth factor 1 (IGF-1). It is not recombinant human growth hormone.
It is not a selective androgen receptor modulator (SARM).
Current study and US regulatory status — 12 paragraphs
One was terminated, and one is recruiting. The recruiting record is a Phase 3 study in children with growth-hormone deficiency. It uses the LUM-201 name.
It does not supply adult sarcopenia, anti-aging, or post-fracture evidence. Research is continuing in children with growth-hormone deficiency.
FDA describes Drugs@FDA as its approved-product database. We checked its September 4, 2026 data page and 12-table archive. No match appeared, regardless of letter case, for ibutamoren, MK-677, MK-0677, MK0677, LUM-201, or L-163,191.
The archive does contain somatropin records. Those confirm that the search can find entries. They refer to different injected drugs.
The exact DailyMed search found two historical ibutamoren-mesylate powder SPL records. They are dated 2016 and 2017. The result was not zero.
But those records do not prove FDA approval. No ibutamoren product was found in the current US approval sources checked. Another growth-hormone drug cannot lend it an approval or dose.
That includes somatropin.
FDA’s 2024 review says ibutamoren mesylate is not in an FDA-approved drug. The review recommended against adding ibutamoren mesylate to the 503A bulk-drug-substances list. The review found too little evidence of meaningful clinical benefit.
It also raised safety concerns. These include high blood glucose and raised liver enzymes. They include swelling, fluid overload, and congestive heart failure.
This was an agency review for an advisory-committee proceeding. It is not presented as a later final rule.
Gonadorelin is a lab-made form of gonadotropin-releasing hormone (GnRH). Studies in people tested two uses. A one-time dose tests hormone release from the pituitary gland.
For treatment, a pump sends small pulses to replace weak signals from the hypothalamus, a part of the brain. The people studied had specific disorders that affect reproduction.
Historical human products and current marketing status — 6 paragraphs
A historical FDA medical review describes gonadorelin hydrochloride under NDA 018123. It says the drug was approved in 1982 for diagnostic use. A later FDA reproductive-drug review describes gonadorelin acetate under NDA 019687.
It says that drug was approved for women with hypothalamic amenorrhea. Its IV pump product was discontinued for commercial and technical reasons. The FDA reviews show how the drug was used in people in the past.
They do not show that it is sold today.
FDA describes Drugs@FDA as its database of approved products. Its September 4, 2026 data page and 12-table archive list three gonadorelin-hydrochloride products under NDA 018123 and two gonadorelin-acetate products under NDA 019687. All have marketing status Discontinued.
The exact openFDA ingredient query returns the same two applications. Both list the products as Discontinued.
Discontinued describes whether the product is sold; it does not by itself mean FDA withdrew approval. The US sources reviewed show no human product now on the market.
Cerebrolysin is a biological mixture made from pig (porcine) brain proteins. Controlled digestion breaks the proteins down into small peptides and amino acids. This is not one synthetic peptide with a single sequence, so no single molecular weight describes the mixture.
Current research and US regulatory checks — 6 paragraphs
Four were recruiting, three terminated and two not yet recruiting. One each was withdrawn, enrolling by invitation, and active but not recruiting. A registry entry describes a study that is planned or recorded.
It is not a result or an approval decision.
FDA describes Drugs@FDA as its approved-product database. Its September 4, 2026 data page and 12-table archive contain no case-insensitive match for cerebrolysin. They also contain none for cerebroprotein hydrolysate or porcine brain.
The US sources reviewed showed no product, and a GSRS or UNII identity record is not proof of approval. This finding applies only to those US databases; it says nothing about whether the drug is approved or sold in other countries.
CagriSema combines cagrilintide and semaglutide in a research treatment given under the skin once weekly. The key REDEFINE trial groups had two target amounts: 2.4 mg cagrilintide plus 2.4 mg semaglutide. Each amount belongs to a separate drug; adding them would obscure the dose of each component.
Current US regulatory status — 6 paragraphs
The sponsor’s December 18, 2025 announcement reports an FDA New Drug Application. It names 2.4 mg cagrilintide plus 2.4 mg semaglutide once weekly for weight management. It says CagriSema was not then approved in the US or EU.
This establishes what the sponsor reported. It is not an FDA approval action. It gives no public NDA number that this review can independently verify.
FDA describes Drugs@FDA as its approved-product database. We checked its September 4, 2026 data page and 12-table archive. The search found no match, regardless of letter case, for CagriSema, cagrilintide, or cagrilintide-semaglutide.
These current US sources showed no approved CagriSema or cagrilintide product. That does not cancel the reported pending filing. It does not predict an FDA decision.
It does not give the combination a semaglutide approval.
Larazotide acetate is a peptide with eight amino acids. Sources also call it AT-1001 or INN-202. CeDLara names the sponsor’s Phase 3 celiac-disease trial.
AT1001 can mean a different drug in other trials. Fabry-disease records use it for migalastat hydrochloride. That drug is unrelated.
Current US regulatory status — 3 paragraphs
FDA describes Drugs@FDA as its approved-product database. We checked its September 4, 2026 data page and 12-table archive. No match appeared, regardless of letter case, for larazotide, larazotide acetate, CeDLara, or AT-1001.
Current US sources showed no approved larazotide product. The FDA substance record establishes identity, not approval. These search results make no claim about another country.
Triptorelin is a gonadotropin-releasing hormone agonist. FDA distinguishes triptorelin base, triptorelin pamoate and triptorelin acetate. The current US products found for people are Trelstar and Triptodur.
Both use the pamoate salt in a depot, which releases the drug over time.
Current US products and the animal drug OvuGel — 7 paragraphs
FDA describes Drugs@FDA as its approved-product database. Its September 4, 2026 data page and 12-table archive list three prescription Trelstar products. They contain 3.75, 11.25 or 22.5 mg base equivalent per vial.
They also list one prescription Triptodur product at 22.5 mg base equivalent per vial. All four contain triptorelin pamoate. An exact openFDA ingredient query returns the same four human applications.
A current DailyMed search returns Trelstar, Triptodur and two OvuGel label records. The reviewed current OvuGel animal label lists an over-the-counter animal drug. It states “Not for Use in Humans” and identifies NADA 141-339.
OvuGel contains 100 micrograms of triptorelin base per mL. The drug is present as the acetate salt. The label gives a 2 mL amount placed in the vagina of weaned sows.
This is part of swine insemination. The 100 micrograms per mL refers to the base drug, not the acetate salt. These are different amounts.
The animal strength, volume, route and use do not apply to people.
The current Drugs@FDA archive showed no approved human triptorelin-acetate product. This finding does not affect the approved pamoate products or say whether acetate products are approved elsewhere.
Compounded tirzepatide now faces tight limits. FDA declared the shortage over in late 2024. It has proposed dropping tirzepatide from the 503B bulks list.
That leaves one narrow lane: 503A compounding for a named patient with a documented clinical need.
FDA has approved the branded pens, and the oral tablet Rybelsus.
Full regulatory record — 1 paragraph
FDA declared the semaglutide shortage resolved in February 2025. Mass compounding has wound down since. FDA has also proposed dropping it from the 503B bulks list.
Cagrilintide is still in trials and is not FDA-approved.
Full regulatory record — 1 paragraph
The REDEFINE trials pair it with semaglutide in one shot called CagriSema. There is no approved cagrilintide product or dose. The amounts below come from studies, not a dosing guide.
FDA has not approved survodutide, also called BI 456906.
Full regulatory record — 2 paragraphs
Phase 3 SYNCHRONIZE trials study obesity. A separate phase 2 program studies MASH, a form of liver disease. No dosing label exists, and any product sold today is unapproved.
Not FDA-approved, and not legal to compound for people.
Full regulatory record — 3 paragraphs
Two parties asked FDA to allow BPC-157 in compounding, and both later withdrew. FDA’s page now lists it under substances nominated but withdrawn, which it describes as once in category 2. The agency found too little data to know whether it would harm people.
FDA took it to the Pharmacy Compounding Advisory Committee anyway on 23 July 2026, and its briefing document says so. Ulcerative colitis was the use reviewed. A withdrawal is not a finding against the drug.
It closes a route and settles nothing about safety.
It sells in two forms, and their own labels state they are not substitutable. Egrifta SV holds 2 mg per vial and gives 1.4 mg once daily. Its label directs Sterile Water, and use right away.
Egrifta WR holds 11.6 mg per vial and gives 1.28 mg once daily. Its label directs Bacteriostatic Water, then discard 7 days after mixing. Dose, diluent, vial count and storage all differ.
A number read off one form does not describe the other.
FDA has approved this molecule, but only as Vyleesi.
Full regulatory record — 2 paragraphs
Vyleesi is a prescription autoinjector holding a ready-made solution. Its label has no powder vial and no reconstitution step anywhere in it. Research-grade PT-141 sold as a lyophilized powder is not that product, and no approved label stands behind it.
The label caps use at one dose in 24 hours. It advises against more than 8 doses a month. It rules the drug out entirely in uncontrolled hypertension or known cardiovascular disease.
One product name covers two substances here, and the difference is not cosmetic.
Full regulatory record — 2 paragraphs
With the affinity complex the peptide lasts days; without it, minutes. So a protocol, a quantity or a risk written for one does not describe the other. Buyers routinely cannot tell which they hold.
The company that created the long-acting form dropped it, leaving no sponsor, no investigational filing and no pharmacopeial standard for either version.
Wellness clinics offer this peptide widely, in the words of prescribed medicine.
Full regulatory record — 3 paragraphs
The law does not back that up. Ipamorelin is not a component of any approved drug product. FDA lists ipamorelin acetate twice on its compounding page.
It sits in category 2 under 503B, added 29 September 2023. It also sits under substances nominated but withdrawn, and FDA’s own note explains the double entry. The advisory committee took it up on 29 October 2024, for growth hormone deficiency and slow gut recovery after surgery.
A withdrawn nomination is not a finding against the drug.
The parent protein reached clinical development, which is why this compound sounds better sourced than it is.
Full regulatory record — 3 paragraphs
Those programs ran as eye drops, gels and an intravenous cardiac formulation. None of them was a vial, and none reached approval. FDA lists the LKKTETQ fragment under substances nominated but withdrawn, once in category 2.
It cited aggregation risk and no human exposure data. The nominator withdrew, and FDA still took it to the advisory committee on 23 July 2026. Wound healing was the use reviewed.
Anti-doping rules prohibit it by name at all times.
Under the name copper tripeptide-1, this molecule is a known cosmetic ingredient.
Full regulatory record — 2 paragraphs
That framework reviews neither whether it works nor how much gets into the body. Its clearance says nothing about an injection. One US regulator has looked at this molecule, and only at the injection.
FDA’s entry covers injectable routes explicitly, citing aggregation, impurities and limited human data. Whoever asked for it later withdrew, so FDA files it under nominated but withdrawn. The route stays open: FDA has named GHK-Cu for a compounding committee meeting before the end of February 2027.
Today’s market came from the withdrawal of the branded product, not from any finding against it.
Full regulatory record — 2 paragraphs
The branded medicine left the market, and its removal was not a safety action. A medicine pulled that way leaves a compounding pathway open. That is why this peptide sits on pharmacy formularies while its neighbors here do not.
The pathway governs how a pharmacy prepares it, not what it achieves. FDA has separately told a seller so in writing. Labeling stock for research use only does not change what a product is, where the surrounding site markets it for people.
Everything published on MOTS-c is preclinical or observational.
Full regulatory record — 3 paragraphs
That means mouse studies and cell work. It also means human data linking natural blood levels to age and fitness. No trial has reported giving it to people.
FDA’s advisory committee took it up on 23 July 2026, for obesity and osteoporosis. The nominator had already withdrawn, and FDA went ahead anyway. FDA, not the committee, proposed against adding it to the 503A bulks list.
This compound has an unusual regulatory footprint for a research peptide.
Full regulatory record — 2 paragraphs
It failed as a drug candidate, then found a second life as a food and supplement ingredient. It later became publicly contentious in Australia, in a sports-supplements investigation. The question there was whether it counted as a prohibited substance.
Anti-doping authorities concluded that it was not. None of that shows it works: a substance can be legal, on sale and useless at once.
A compounding pharmacy can prepare them, but that does not mean FDA reviewed the finished product for safety, effectiveness or quality before it was sold. The human studies in this record used IV infusions under supervision. They do not establish how an injection under the skin should be used.
The research here is mostly in Russian, and it comes from one group.
Full regulatory record — 3 paragraphs
That is a provenance problem, not a language one. Findings no one else has repeated carry the weight of one lab’s claim. The human lifespan result people quote here is not this peptide’s.
It belongs to Epithalamin, the bovine pineal extract that the same two institutes tested. Epitalon holds no approval, no investigational application and no pharmacopeial entry in any Western jurisdiction. Telomerase activation is also not plainly desirable.
University studies have given kisspeptin-10 to people under ethics review.
Full regulatory record — 2 paragraphs
Their doses were scaled to body weight and used to map hormones, not to set a treatment dose. FDA placed it in category 2 of its interim 503A compounding policy on September 29, 2023. It is not on the withdrawn list.
An FDA committee reviewed it for low hormone function in men on October 29, 2024, but a review is not an approval.
DSIP has an international generic name, emideltide.
Full regulatory record — 3 paragraphs
FDA listed it for a compounding-committee review on 24 July 2026. It went up as a candidate for the section 503A bulk drug substances list. The uses under review were opioid withdrawal, chronic insomnia and narcolepsy.
Those are the three the 1980s papers examined. That review asks whether pharmacists may compound it at all. It is not an approval.
No company has filed to market it anywhere. Material sold under this name ships for lab research. So what is in the vial rests on a seller’s certificate, not on a standard anyone enforces.
No sponsor holds an approval for hexarelin anywhere, and no trial program stands behind it.
Full regulatory record — 2 paragraphs
In December 2025 FDA named the acetate salt in a warning letter to an ingredient broker. The letter listed the salt among substances FDA treats as off-limits for human drug compounding. So FDA has looked at the route by which this reaches pharmacies, rather than leaving it alone.
Anti-doping rules separately bar secretagogues as a class at all times.
The commercial supply of this analogue exists to serve bioprocessing.
Full regulatory record — 3 paragraphs
Catalogues list it as a research and manufacturing reagent, not as a medicine. No regulator anywhere has reviewed it for use in people. A ClinicalTrials.gov search returns no registered study of it.
That is a weaker position than an unapproved drug, which at least has a trial running. Insulin-like growth factors and their releasing factors sit on the World Anti-Doping Agency prohibited list at all times. A reagent-grade certificate speaks to a bioreactor.
PEGylation is a chemical modification, not a formulation choice.
Full regulatory record — 3 paragraphs
So the conjugate and the native splice variant are different substances, and evidence about one does not transfer to the other. No sponsor has filed to test either. Neither appears in any pharmacopeia.
No label a buyer sees says how much PEG is attached. FDA has looked at it, though. Somebody put it forward for compounding and then withdrew, so FDA files it under nominated but withdrawn.
It is also one of five named for a compounding committee meeting before the end of February 2027.
The body makes LL-37, but that does not make a product approved.
Full regulatory record — 2 paragraphs
No regulator has approved it as a drug. FDA lists it under substances nominated but withdrawn. The agency cites immune reactions, limited safety data and harm seen in animals.
FDA plans to review LL-37 at a compounding meeting before the end of February 2027. No date or docket exists yet.
So nothing about alpha-MSH research carries over to this tripeptide, in law or in evidence. No regulator has approved it, and no pharmacopeia lists it. FDA lists KPV under substances nominated but withdrawn, once in category 2.
The agency recorded no human exposure data for it, by any route. The nominator withdrew, and FDA took it to the advisory committee on 23 July 2026 regardless. The uses reviewed were wound healing and inflammatory conditions.
An approval elsewhere is real evidence, and it is not an American one.
Full regulatory record — 2 paragraphs
The review standard, the permitted claims and the safety follow-up all belong to the jurisdiction that granted it. The practical gap shows up in the vial. Trials dissolve 1.6 mg of powder in 1 mL and inject that.
Research vials sold under this name hold 5 mg or 10 mg. So one 10 mg vial holds more than six trial doses. Any quantity quoted from the approved labeling describes a different container entirely.
FDA grants those on a marker rather than on how people function, and the marker here was knee extensor strength. Whether the approval stands depends on a confirmatory trial that has not reported. The approval covers Barth syndrome in people weighing at least 30 kg, and nothing else.
Material sold online as SS-31 is not that product. Forzinity is a ready-to-use solution at 80 mg per mL. The research vials hold a powder to be mixed, and no regulator has examined what is in them.
Russia’s State Register of Medicines lists two Semax registrations in force, both nasal drops in a 3 mL vial, one at 0.1% and one at 1%, and both prescription-only.
Full regulatory record — 2 paragraphs
The line goes back to registrations first granted in December 2006. It is classed there as a nootropic. The vials sold elsewhere are a form that registration says nothing about.
FDA has approved nothing under this name. No Semax study appears on ClinicalTrials.gov, and the indexed literature holds no systematic review and no meta-analysis. The one paper indexed as a randomized trial describes itself as open-label.
Selank is reported to be registered in Russia as an anxiety treatment, and that could not be confirmed at the register itself.
Full regulatory record — 2 paragraphs
Every English source stating it traces back to a study in mice. FDA has approved nothing under this name and holds no label for it. No Selank study appears on any trial registry.
English reviews that describe a human side-effect profile for it cite a rat experiment. Material sold under this name has been recovered in seized preparations, and no regulator anywhere has examined what is in a vial.
No agency has approved melanotan II, and no company holds a license for it anywhere this site can attest.
Full regulatory record — 2 paragraphs
It is sold online as a research chemical. A 2017 review reports that multiple national health organizations have issued safety warnings about it, and that is the review’s statement rather than ours — we could not reach any regulator’s own page on 13 August 2026, so this record names no country. A related but different molecule, afamelanotide, is approved for a small number of conditions.
It is not this one, and its trials are not this one’s.
This is the one compound on this site approved somewhere and not here.
Full regulatory record — 3 paragraphs
China approved mazdutide in June 2025 for weight, and in September 2025 for type 2 diabetes. It is sold there as Xinermei. That approval governs a Chinese pharmacy and nothing else.
FDA has approved no mazdutide product, and a Drugs@FDA search on 13 August 2026 found nothing under any of its four names. The drug is dispensed under supervision several thousand miles away. Anything reaching a US reader outside that is unapproved and unchecked.
No schedule is copied from the Chinese label, because nobody here has read it.
FDA has approved nothing under this name, and no Pinealon study appears on any trial registry anywhere.
Full regulatory record — 2 paragraphs
Nearly the whole literature comes from one institute in St Petersburg and the journals around it. The same senior author runs through it, and the patents are in the same hands. That is not a language problem.
A finding nobody independent has repeated carries the weight of one lab’s claim. The one published human quantity was a capsule people swallowed, twice a day, so nothing stands behind putting this in a syringe.
FDA has approved nothing under this name and holds no label for it.
Full regulatory record — 2 paragraphs
No study of this peptide appears on any trial registry, and the single published study used human tissue in a dish rather than people. Do not read across from GHK-Cu: that molecule differs by one amino acid and has two controlled human trials, a long cosmetic-ingredient history and an FDA compounding entry scoped to injection. None of that record belongs to this one.
Anything sold under this name is an unapproved substance no regulator has examined.
VK2735 is not FDA-approved and has no prescribing label.
Full regulatory record — 1 paragraph
The published numbers are from a short dose-finding trial, not an approved schedule. Its tablet and injection programs use different doses and must not be read as one regimen.
It has no prescribing label or established dose. Its weight, liver and alcohol studies enrolled different groups and measured different results. The findings cannot be swapped between them.
The public PERFORMA update does not publish a dose. Starting phase 3 does not mean a drug is approved.
It has no FDA-approved product or dosing label. Registered studies do not establish a treatment benefit, dose, safety profile, availability date or price.
It has no prescribing label or approved dose. The amounts below belong to monitored study groups and are not a schedule for personal use. A recruiting Phase 3 study has no results yet.
It has no approved product, prescribing schedule, retail price or availability date. The Phase 1 findings come from small groups followed for four weeks. The Phase 2 figures come from a sponsor release, while ClinicalTrials.gov posts no results for that study.
It has no approved product, prescribing schedule, retail price or availability date. The amounts below belong to a monitored Phase 1 study and are not instructions for personal use.
Petrelintide is investigational and has no FDA-approved product, prescribing schedule, retail price or availability date.
Full regulatory record — 1 paragraph
The results come from separate research studies and are group averages, not a forecast for one person. The Phase 2 result is conference material reported by the company, not a peer-reviewed paper.
How we keep this page honest
Entries come from the Federal Register, fda.gov and federal dockets. We never build one from trade press or a seller’s summary. The July 2026 meeting sits under docket FDA-2025-N-6895. That docket search is how we confirm the “no outcome published” entry above: it returns the April meeting notice and nothing since.