#fda-status
16 pieces tagged fda-status.
The moleculesSermorelin vs ipamorelin vs CJC-1295Sermorelin and CJC-1295 are GHRH analogues; ipamorelin is a five-residue ghrelin-receptor ligand. One had an approved product that was discontinued, two have none. Identity and status side by side.
The moleculesPinealon: the Glu-Asp-Arg tripeptide, and why it is not epitalonThe tripeptide Glu-Asp-Arg by its registry numbers, a comparison table of the short Khavinson-school peptides a buyer actually meets, and an honest count of what has been published about it.
Where the line isGlutathione's US regulatory status, with datesNo approved drug product contains reduced glutathione. What is approved, where glutathione sits on FDA's compounding lists, what the 2022 committee vote decided, and what the two FDA alerts actually say.
Where the line isBremelanotide, Vyleesi and the intranasal program that was never approvedOne FDA-approved application, one route, and no intranasal bremelanotide product ever approved. The dates, the FDA review language that closed the nasal program, and where PT-141 sits in 2026.
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 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.
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 isFDA approved peptides in 2026: a status table with dates and sourcesWhich peptides have an FDA-approved product, which are investigational and which have neither, as of October 21, 2026. Every row carries a date and a primary source, with short answers for ipamorelin and BPC-157.
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.
Where the line isIs BPC-157 legal? FDA status, Category 2 and WADA in 2026BPC-157 is not banned in US law, not FDA approved and not compoundable under 503A. Its Category 2 history, the July 2026 committee vote and WADA S0, each dated to its source, as of October 2026.
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