Reference table

The nomination tracker

What became of each peptide's nomination to the 503A bulks list?

The answer

Seven dispositions account for every molecule in this index, and the two most often reported as approvals — removal from Category 2 without listing, and withdrawal by the nominators — are the opposite of one.

By Peptide America · Publisher · Reviewed October 2026

A peptide reaches a pharmacy's shelf through a nomination: a party asks the FDA to place a bulk substance on the section 503A list, and the agency sorts the nomination while it reviews. The sorting has more than two outcomes, and the outcomes that are neither a listing nor a prohibition are the ones the market misreads.

This tracker files each molecule by what actually became of its nomination, with the ledger entry that establishes the disposition beside it.

Denominator

The counts below are counts of the substances this index tracks, and nothing more. They are not a total of all peptides nominated to the 503A bulks list; no source this index has verified states such a total, so this page does not print one.

Rows are read from MOLECULES[].status, MOLECULES[].statusLine, MOLECULES[].record[] — the same dated ledger the molecule index renders. No cell on this page is typed by hand.

MoleculeDispositionUS statusWhat the record states
TesamorelinApproved drug product; no bulks nomination requiredFDA-approvedMarch 2025. FDA approves EGRIFTA WR, an eight-fold concentrated formulation reconstituted weekly rather than daily; it replaces EGRIFTA SV.
SemaglutideApproved drug product; no bulks nomination requiredFDA-approvedApril 2026. FDA proposes excluding semaglutide from the 503B bulks list, closing the outsourcing-facility route; patient-specific 503A compounding requires a documented clinical need an approved product cannot meet.
TirzepatideApproved drug product; no bulks nomination requiredFDA-approvedApril 2026. FDA proposes excluding tirzepatide from the 503B bulks list; the lawful remainder is patient-specific 503A compounding with documented clinical need.
SetmelanotideApproved drug product; no bulks nomination requiredFDA-approvedSeptember 2026. Setmelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. An approved product exists, so the question the bulks list answers does not arise for it.
PT-141Approved drug product; no bulks nomination requiredFDA-approvedAugust 2026. The product remains marketed under a new labeler and is recorded as prescription-only in Drugs@FDA. Bremelanotide sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list.
LiraglutideApproved drug product; no bulks nomination requiredFDA-approvedAugust 2026. The shortage entry still reads currently in shortage. Two generic manufacturers report both presentations available; the brand manufacturer reports limited availability, with Saxenda 6 mg/mL available until discontinuation in January 2027 and Victoza 6 mg/mL delayed in shipping with no estimated duration.
ElamipretideApproved drug product; no bulks nomination requiredFDA-approvedSeptember 2026. Elamipretide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one. FDA's drug shortage database holds no entry for it.
AfamelanotideApproved drug product; no bulks nomination requiredFDA-approvedSeptember 2026. Neither afamelanotide nor the name melanotan appears in any of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a marketed product supplies this one.
DulaglutideApproved drug product; no bulks nomination requiredFDA-approvedSeptember 2026. Dulaglutide appears in none of the three categories of the 503A bulks list published May 14, 2026; that list files substances nominated for compounding, and a licensed biologic is supplied by its own manufacturer. FDA's drug shortage database holds no entry for it, in a query whose control on liraglutide returned eleven records with the status Current.
SermorelinCategory 1 of the interim 503A bulks listCompoundable (503A)August 2026. Compounded by 503A pharmacies with a valid prescription; the discontinued approval was withdrawn for commercial, not safety, reasons.
NAD+Category 1 of the interim 503A bulks listCompoundable (503A)August 2026. Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
GlutathioneCategory 1 of the interim 503A bulks listCompoundable (503A)August 2026. Listed in Category 1 of the interim 503A bulks list; pharmacies may compound while FDA review continues.
GHK-CuCategory 1 of the interim 503A bulks listCompoundable (503A)April 2026. FDA removes GHK-Cu from Category 1 of the interim 503A bulks list on April 22, 2026, the nominations withdrawn by the nominators. GHK-Cu was not among the seven peptides reviewed at the July 2026 PCAC meeting.
Vasoactive intestinal peptideCategory 1 of the interim 503A bulks listCompoundable (503A)September 2026. Drugs@FDA holds no approved product with vasoactive intestinal peptide or aviptadil as an active ingredient. The lawful route to a patient is therefore a pharmacy preparation under section 503A, not a manufactured product, and the difference decides what quality obligations attach.
Kisspeptin-10Category 2 of the interim 503A bulks list; compounding barredNo lawful routeAugust 2026. Kisspeptin-10 remains in Category 2 of the 503A list published May 14, 2026, and is the only peptide among the six substances in that category. Placement in Category 2 bars a licensed pharmacy from compounding the substance.
GHRP-2Category 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with GHRP-2 or pralmorelin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. Its position is therefore unchanged by the 2026 meeting.
GHRP-6Category 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with GHRP-6 as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
Mechano growth factorCategory 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with mechano growth factor as an active ingredient, and neither form was among the seven peptides the advisory committee reviewed in July 2026. Two forms of one molecule therefore hold two different dispositions and the same absence of a lawful route.
ARA-290Category 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with cibinetide as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
SecretinCategory 3 of the interim 503A bulks list; nominated without adequate supportFDA-approvedMay 2026. The section 503A bulks list published May 14, 2026 lists Secretin, human 99% in Category 3, the file for substances nominated without adequate support to evaluate. A bulk nomination for a substance that is already the active ingredient of an approved product raises the essentially-a-copy question that section 503A exists to control.
ThymulinCategory 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with thymulin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
L-carnosineCategory 3 of the interim 503A bulks list; nominated without adequate supportNo lawful routeSeptember 2026. Drugs@FDA holds no approved product with carnosine as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026. It is lawfully sold as a dietary supplement, which is a separate regulatory regime carrying its own and much lower evidentiary threshold.
BPC-157Removed from Category 2 without listingPCAC-recommended · pendingApril 2026. FDA removes BPC-157 and eleven other peptides from Category 2 without adding them to Category 1; the removal ends the explicit prohibition but confers no authorization.
MOTS-cRemoved from Category 2 without listingPCAC-recommended · pendingApril 2026. Removed from Category 2 without Category 1 listing.
TB-500Removed from Category 2 without listingPCAC-recommended · pendingApril 2026. Removed from Category 2 without Category 1 listing.
KPVRemoved from Category 2 without listingPCAC-recommended · pendingApril 2026. Removed from Category 2 without Category 1 listing.
SemaxRemoved from Category 2 without listingPCAC-recommended · pendingApril 2026. Removed from Category 2 without Category 1 listing.
EpitalonRemoved from Category 2 without listingPCAC-recommended · pendingApril 2026. Removed from Category 2 without Category 1 listing.
DSIPRemoved from Category 2 without listingNo lawful routeApril 2026. Removed from Category 2 without Category 1 listing.
Melanotan IIRemoved from Category 2 without listingNo lawful routeAugust 2026. FDA still publishes its Category 2 safety finding for the substance among those nominated but withdrawn: compounded drugs containing Melanotan II may pose a risk for immunogenicity, and published case reports discuss melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome, and priapism. The withdrawal removed the substance from the category; it did not retract the finding.
LL-37Removed from Category 2 without listingNo lawful routeAugust 2026. FDA continues to publish the safety finding: it lacks sufficient safety-related information to know whether the drug would cause harm when administered to humans, and nonclinical research findings suggest detrimental effects on male reproduction and that the drug can be pro-tumorigenic in some tissues.
DihexaRemoved from Category 2 without listingNo lawful routeAugust 2026. FDA continues to publish its finding for the substance: it has not identified any human exposure data on drug products containing dihexa acetate administered via any route of administration, and it lacks important information regarding any safety issues raised by the substance, including whether it would cause harm if administered to humans.
PEG-MGFRemoved from Category 2 without listingNo lawful routeAugust 2026. On the list FDA published May 14, 2026, PEG-MGF appears in no category, while the unpegylated substance — mechano growth factor (MGF) — appears in Category 3, the category for substances nominated without adequate support. FDA's published finding for PEG-MGF is that it has identified no human exposure data on drug products containing it by any route.
CJC-1295Nomination withdrawn by its nominatorsNomination withdrawnSeptember 2024. Removed from Category 2 after nominator withdrawal; not added to Category 1.
IpamorelinNomination withdrawn by its nominatorsNomination withdrawnSeptember 2024. The nominators withdraw their nominations of ipamorelin acetate and ipamorelin free base for the section 503A bulks list on September 19, 2024. FDA later files ipamorelin acetate among the substances previously in 503A Category 2 whose nominations were withdrawn.
AOD-9604Nomination withdrawn by its nominatorsNomination withdrawnAugust 2026. AOD-9604 appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding notes serious adverse events that may be associated with the substance, though causality is not clear.
Thymosin alpha-1Nomination withdrawn by its nominatorsNomination withdrawnAugust 2026. Thymosin alpha-1 appears in FDA's table of substances nominated but withdrawn, in no category of the 503A list published May 14, 2026, and in Category 3 of the 503B list — nominated without adequate support. No FDA-approved product containing it exists.
SelankNomination withdrawn by its nominatorsNomination withdrawnAugust 2026. Selank acetate (TP-7) appears in FDA's table of substances nominated but withdrawn and in no category of the 503A list published May 14, 2026. FDA's published finding is that it lacks important information regarding any safety issues raised by selank acetate administered to humans.
CerebrolysinNever nominatedNo lawful routeSeptember 2026. Cerebrolysin appears in no category of the section 503A bulks list published May 14, 2026, in none of the tables on FDA's Category 2 safety-risk page, and nowhere on the section 503B nominations list. Drugs@FDA holds no application for it under any name.
RetatrutideNever nominatedNo lawful routeAugust 2026. Drugs@FDA holds no record of retatrutide as the active ingredient of any drug product, and the substance sits in no category of the 503A bulks list published May 14, 2026 and on no 503B list. It has never been nominated for one.

A withdrawn nomination is the disposition with the least written about it and the most misread; CJC-1295's withdrawal sets out what happened and what it left behind. The research-only page covers both routes into that position, and what removal does not mean covers the other.

Elsewhere in this index

Other tables

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Monographs in this table