Research
Dated entries tracking the regulatory actions that move this market: approvals and their absence, movements on compounding lists, warning letters, shortage status, and annual prohibited-list revisions. Every entry links to the issuing body's own page, because a regulatory claim without its source is not publishable.
11 entries · most recent 22 Jul 2026
Placeholder seed entry recording the source, not an event. The European Medicines Agency publishes decisions on marketing authorisation. Approval status matters to this index because it determines whether the substance in a research-grade vial has an approved counterpart at all — and therefore whether a published trial literature exists for a product that is not the one being sold.
Placeholder seed entry recording the source, not an event. The FDA maintains categorised lists of bulk drug substances nominated for use in compounding, including substances it has evaluated and placed in the category that may not be compounded. Several peptides tracked in this index have appeared in these evaluations. PepIndex records movements between categories here as they are observed; the linked page is the authoritative listing.
Placeholder seed entry recording the source, not an event. Shortage status for approved GLP-1 products materially affects this market: when an approved product is listed as in shortage, compounding of that substance becomes permissible under conditions, and demand shifts toward alternative supply. Resolution of a shortage reverses that. PepIndex records status changes here because they move the whole category.
Placeholder seed entry recording the source, not an event. The FDA publishes warning letters issued to firms, including sellers marketing unapproved products or making disease claims. Where a letter names a vendor tracked in this index, PepIndex records it here and links it from that vendor's profile. No vendor currently in the index has such a letter recorded against it.
Placeholder seed entry recording the source, not an event. The UK regulator has published guidance and enforcement positions on the supply of unlicensed medicines to the public, including substances marketed as research chemicals. Several compounds tracked here have been the subject of public statements. PepIndex records those affecting indexed compounds.
Placeholder seed entry recording the source, not an event. The World Anti-Doping Agency publishes an annual Prohibited List; class S2 covers peptide hormones, growth factors, related substances and mimetics. Several compounds tracked in this index fall within that class or its catch-all clause. The list is revised annually and takes effect on 1 January. PepIndex records revisions affecting indexed compounds here.
The FDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulk drug substances list, finding no clinical need for outsourcing facilities to compound them from bulk now that the GLP-1 shortages are resolved. If finalized, the exclusion would close the last routine legal pathway for large-scale compounded GLP-1s and further narrow the supply of non-branded semaglutide and tirzepatide. The FDA took comments on the proposal through mid-2026 and is reviewing them; a final determination had not been published as of this writing.
The FDA issued warning letters to research-peptide sellers — among them Prime Sciences and Gram Peptides — offering products labeled 'GLP-1-R', 'GLP1-S' and 'GLP1-T' that the agency identified as retatrutide, an investigational drug with no approved product that cannot lawfully be compounded. The letters cite unapproved-new-drug and misbranding violations for promoting the peptides for human use behind 'research use only' labeling, part of a broader 2026 enforcement push against GLP-1 and peptide sellers that also produced dozens of letters to telehealth firms marketing compounded GLP-1s.
The FDA confirmed the semaglutide shortage was resolved and set deadlines for compounders to stop making copies of the branded GLP-1 drug. Because the exemption allowing 503A and 503B facilities to compound semaglutide depended on its shortage status, removal from the list narrows the legal space in which compounded and “research” semaglutide is supplied.
After a short reconsideration, the FDA reaffirmed that the tirzepatide shortage was over, again requiring compounders to wind down production of copies. As with semaglutide, removal from the shortage list removes the basis that permitted compounded tirzepatide, tightening the supply of versions sold outside the approved products.
The FDA warned SwissChems that its semaglutide and retatrutide products — sold as research chemicals but promoted for human weight and metabolic use — are unapproved new drugs and misbranded under the FD&C Act. It is one of a series of letters the agency has issued to vendors offering GLP-1 and research peptides directly to the public.