#fda-status
15 pieces tagged fda-status.
- Where the line isWhat FDA reads on a website before it calls a research product a drugThe 'research use only' label is not what FDA reads. Its 2024 to 2026 warning letters spell out what is: claims, calculators, diluents sold alongside vials, and customer reviews. Here is the rule and the letters in their own words.
- Where the line isWhere research peptides sit on the WADA Prohibited ListFDA status and WADA status are different questions with different answers. Where BPC-157, TB-500, the GHRPs, the GHRH analogues, ipamorelin and Melanotan II sit on the 2026 Prohibited List, and what strict liability means.
- The moleculesTB-500 and thymosin beta-4 are not the same moleculeThymosin beta-4 is a 43-residue protein. TB-500 is a seven-residue synthetic fragment of it. Here is the identity of each, the thymosin alpha-1 mix-up, and the status of all three as of September 2026.
- The moleculesSermorelin, tesamorelin, ipamorelin and CJC-1295 comparedThree of these are GHRH analogues; ipamorelin is a five-residue ghrelin-receptor ligand. One had an approved product that was discontinued, one has an approved product on the market, two have none. Identity and status side by side.
- The moleculesSemax and Selank: two heptapeptides and their US statusSemax (MEHFPGP) is four residues of ACTH plus a Pro-Gly-Pro tail; Selank (TKPRPGP) is the tetrapeptide tuftsin plus the same tail. Where each came from, what the spelling variants mean, and their status as of September 2026.
- Where the line isRetatrutide is investigational: what that status meansRetatrutide (LY3437943) is Eli Lilly's single-peptide agonist of the GIP, GLP-1 and glucagon receptors, with no FDA-approved product as of September 2026. What 'investigational' means, and why a research vial is not the trial drug.
- The moleculesNAD+, 5-amino-1MQ and glutathione: which are peptides?Three catalog staples that share a shelf with peptides. Only one is a peptide. What each molecule actually is, from PubChem, and why the distinction changes what a certificate should show.
- The moleculesMelanotan II, PT-141 and afamelanotide: one parent, three analoguesAfamelanotide, Melanotan II and bremelanotide all descend from the 13-residue hormone alpha-MSH. Two became approved drugs; Melanotan II never did. Structures, lineage, FDA's own words on MT-II, and status as of September 2026.
- The moleculesGHK-Cu: why the powder is blue and what copper peptide meansGHK-Cu is the tripeptide glycyl-histidyl-lysine holding one copper(II) ion. The copper is what makes it blue, what makes it a different molecule from GHK, and what its two INCI names are about. Status as of September 2026.
- Where the line isApproved, investigational, or neither: a status table for 27 peptidesOne table, three statuses. Which peptides have an FDA-approved product, which are in a sponsor's trial program, and which have neither, with the compounding category and WADA line for each, as of September 21, 2026.
- The moleculesEpithalon, epitalon and the word bioregulatorOne tetrapeptide, four spellings, and a term that is not a pharmacological class. What AEDG is, where it came from, what the Khavinson school means by bioregulator, and its US status as of September 21, 2026.
- The moleculesCJC-1295 with DAC and without: what the drug affinity complex changesCJC-1295 is a 30-residue GHRH analogue carrying a maleimide group that bonds to serum albumin. The version sold without DAC is a different, 29-residue molecule. Identity, lineage and 2026 status.
- Where the line isCategory 1, Category 2 and the 503A bulks list in 2026Twelve peptides left FDA's Category 2 in April, GHK-Cu went back into Category 1 in May, and an advisory committee voted in July. None of it put a peptide on the 503A bulks list. A dated tracker.
- The moleculesCagrilintide is an amylin analogue, not a GLP-1Cagrilintide descends from the pancreatic hormone amylin, not from GLP-1. What the molecule is, how it was engineered, why it is paired with semaglutide in trials, and its status as of September 21, 2026.
- Where the line isBPC-157 in 2026: not banned, not approved, not compoundableThree separate questions get asked as one. BPC-157 is not a controlled substance, is not an FDA-approved drug, and has no lawful 503A compounding pathway. What the molecule is and where each answer comes from, dated.
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