{"slug":"thymogen","seoKey":"thymogen","displayName":"Thymogen","inn":"Oglufanide","codes":["IM-862","NSC-334073"],"synonyms":["Тимоген","Timogen","Oglufanide","Oglufanide disodium","Glufanide disodium","L-alpha-Glutamyl-L-Tryptophan","L-Glu-L-Trp","alpha-Glu-Trp","EW","альфа-глутамил-триптофан"],"legalClass":"rx","identifiers":{"cas":"38101-59-6","pubchemCid":100094,"unii":"4RHY598T5U","inchikey":"LLEUXCDZPQOJMY-AAEUAGOBSA-N","drugbankId":"DB05779","chemblId":"CHEMBL2111029","formula":"C16H19N3O5","molecularWeight":333.34,"sequence":"Glu-Trp"},"approvals":[{"market":"US","status":"investigational","date":"2025-12-08","note":"Never approved, and expressly named as ineligible for compounding. Four queries of the regulator's own databases on 2026-09-20 — the approval database, the national drug code directory, the labelling archive and the recall database — returned no match under either name, while a control query returned one result the same day. The substance did reach the clinic there as an investigational agent: a company ran a phase 3 trial in AIDS-related Kaposi's sarcoma and a university ran phase 1 and phase 2 trials in ovarian and colorectal cancer, all under the development code. No application was ever completed. In a warning letter of 8 December 2025 to a bulk-ingredient distributor the regulator listed it among substances not eligible for pharmacy compounding under section 503A, beside tesofensine, elamipretide and cagrilintide.","source":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/darmerica-llc-716152-12082025"},{"market":"EU","status":"not_approved","note":"Not approved. There is no centralised authorisation, no assessment report, no withdrawn application and no orphan designation: the official medicines dataset and the orphan designations dataset were downloaded and searched in full on 2026-09-20 with no match for any spelling of either name or of the development code. The twenty-three matches for 'glutamyl' in the orphan file all belong to spelled-out sequence names of other, much longer peptides. Two control substances were found in the same file, so the search was working.","source":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines-report_en.xlsx"},{"market":"DE","status":"not_approved","note":"Not approved and not marketable. With neither a European nor a national authorisation, placing it on the market falls under the authorisation requirement of the medicines act. It is not named in the prescription-only annex, which changes nothing: that annex governs the prescription status of authorised substances only. The one near match there is free tryptophan in a defined indication, a different substance. Importing an unauthorised medicine is confined to the narrow single-import route on a prescription through a pharmacy, which does not cover a private order of Russian packs — not even of the forms sold there without a prescription.","source":"https://www.gesetze-im-internet.de/amvv/anlage_1.html"},{"market":"UK","status":"not_approved","note":"No authorisation identified. IMPORTANT CAVEAT: this is not a primary-verified negative finding. The regulator's product search returned HTTP 200 on 2026-09-20 but renders its result list only through client-side scripting, and the search interface behind it answered with HTTP 403, so no result could be read from the working environment. The finding is plausible — the substance appears in no Western regulatory database and has never had a British development programme — but it rests on the absence of any positive trace, not on a register query that ran.","source":"https://products.mhra.gov.uk/search/?search=oglufanide"},{"market":"AU","status":"not_approved","note":"Not scheduled, and no registration identified. The full text of the Poisons Standard of June 2026 was searched on 2026-09-20 with no match for either name or for the development code, while two control substances returned three and six matches, so the search was working. CAVEAT: the register of therapeutic goods was unreachable across repeated attempts, so a registration could be neither confirmed nor excluded. An unregistered therapeutic good may not be supplied there in any case, which in practice places an unapproved research peptide at prescription level.","source":"https://www.legislation.gov.au/F2026L00633"},{"market":"CA","status":"not_approved","note":"Not approved. Three active-ingredient queries of the drug product database on 2026-09-20, under both names and under the amino-acid pair, each returned an empty list, while a control query returned two matches with strengths the same day.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=oglufanide"},{"market":"CH","status":"not_approved","note":"Not approved. The extended list of authorised human medicines, which carries a column of international non-proprietary names, was downloaded and searched in full on 2026-09-20 with no match for any spelling of either name. The ninety-six matches for 'tryptophan' in that file belong to the free amino acid and to infusion and nutrition solutions, not to this dipeptide. Two control substances returned eighteen and nineteen matches.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT00002445","name":"IM862 in AIDS-related Kaposi's sarcoma","phase":"Phase 3","n":200,"status":"COMPLETED"},{"nct":"NCT00003773","name":"IM-862 in recurrent ovarian cancer","phase":"Phase 1","n":43,"status":"COMPLETED"},{"nct":"NCT00006037","name":"Chemotherapy plus IM-862 in metastatic colorectal cancer","phase":"Phase 2","n":18,"status":"TERMINATED"},{"nct":"NCT00017303","name":"Chemotherapy plus IM-862 in resected stage III ovarian cancer","phase":"Phase 2","status":"UNKNOWN"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/100094","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2111029/","https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:73512","https://go.drugbank.com/drugs/DB05779"],"lastVerified":"2026-09-20","version":"1.0","published":true,"locale":"en","title":"Thymogen: what the studies show, status and safety","summary":"Thymogen is a synthetic dipeptide, made of just two amino acids: glutamic acid and tryptophan. Russia has approved it, and the injectable form there is prescription-only; no Western regulator has approved it in any form. Under the names oglufanide and IM-862 the same molecule reached a randomised phase 3 trial in the West and failed it, and six further Western studies ended the same way. Its mirror image, built from the D-forms of the same two amino acids, is a separate Russian medicine that suppresses the immune system instead of stimulating it.","updated":"2026-09-20","url":"https://mypep.app/peptides/thymogen"}