{"slug":"vip","seoKey":"vip","inn":"aviptadil","displayName":"VIP","codes":["RLF-100","WHO 7644"],"synonyms":["aviptadil","vasoactive intestinal peptide","vasoactive intestinal polypeptide","vasoactive intestinal octacosapeptide","aviptadilum","aviptadil acetate","RLF-100","Zyesami"],"legalClass":"rx","identifiers":{"cas":"40077-57-4","pubchemCid":53314964,"unii":"A67JUW790C","inchikey":"VBUWHHLIZKOSMS-RIWXPGAOSA-N","chemblId":"CHEMBL1981592","formula":"C147H237N43O43S","molecularWeight":3326.8,"sequence":"HSDAVFTDNYTRLRKQMAVKKYLNSILN"},"approvals":[{"market":"DE","status":"approved_rx","note":"Approved and prescription-only, but only as a fixed combination with phentolamine mesilate for injection; no single-substance product exists. National authorisation number 91159.00.00, granted through the mutual recognition procedure DK/H/2351/001 with Denmark as reference member state; the marketing authorisation holder is EVOLAN PHARMA AB. The exact date the authorisation was granted could not be evidenced from the accessible registers.","source":"https://www.ema.europa.eu/en/documents/psusa/aviptadil-phentolamine-mesilate-list-nationally-authorised-medicinal-products-psusa00010814202202_en.pdf"},{"market":"EU","status":"not_approved","note":"No centralised European authorisation has ever existed, and no centralised application was ever withdrawn: four independent primary queries on 2026-09-17 — the union register of valid authorisations, the register of no longer valid ones, and the agency datasets of assessment reports and of withdrawn applications — each returned zero matches against working control substances. This is not a contradiction of the national entries: the substance is authorised nationally in Germany, Denmark, Finland, France and Sweden through mutual recognition, the usual route for older and small products. The agency does run the substance in its coordinated safety review, procedure PSUSA/00010814/202202.","source":"https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm"},{"market":"UK","status":"approved_rx","note":"Approved and prescription-only, with an additional specialist restriction: national formulary guidance classes the product as requiring initiation by a urologist, with continuation by general practitioners. Product licence PL 44616/0001, marketing authorisation holder EVOLAN PHARMA AB; the assessment body records market availability from November 2015, and clinical use at a British centre is independently documented for 2025. CAVEAT: the regulator's product database serves its results only through JavaScript, so no own register extract with a current status could be pulled; the authorisation is evidenced from the European collective document, the assessment and the formulary papers.","source":"https://www.ema.europa.eu/en/documents/psusa/aviptadil-phentolamine-mesilate-list-nationally-authorised-medicinal-products-psusa00010814202202_en.pdf"},{"market":"US","status":"not_approved","date":"2022-07-01","note":"Not approved: queries of the approved-drugs dataset on 2026-09-17, by generic name and by active ingredient, each returned no match, so there is neither a new drug application nor an abbreviated one nor a biologics licence. Two applications for emergency use authorisation in COVID-19 were refused, in November 2021 and on 2022-07-01, and an application for an accelerated review status was refused alongside the first. The substance is nevertheless in circulation as a compounding raw material: the drug code directory holds three bulk-ingredient registrations, two of them from the past fifteen months, and the substance sits in category 1 of the list of bulk substances nominated for compounding — under evaluation, not on the final cleared list. Neither is an approval.","source":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22aviptadil%22"},{"market":"CA","status":"not_approved","note":"Not approved. The official drug product interface returned an empty list on 2026-09-17; control queries run through the same interface on the same day returned four matches for the combination partner and fifty-one for a comparable peptide, so the interface was working and the negative finding holds.","source":"https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=aviptadil"},{"market":"CH","status":"not_approved","note":"Not approved; the extended list of authorised human medicines was searched in full on 2026-09-17 and holds no entry for the substance. Notably the combination partner is absent from the Swiss list as well. Control terms in the same file returned matches for comparable substances.","source":"https://www.swissmedic.ch/dam/swissmedic/de/dokumente/internetlisten/erweiterte_ham_ind.xlsx.download.xlsx/Erweiterte_Arzneimittelliste%20HAM.xlsx"},{"market":"AU","status":"unknown","note":"Not verifiable. The register of therapeutic goods was unreachable from the working environment on 2026-09-17: direct calls broke off without a status code even at a ninety-second limit, and the fetch service timed out after sixty seconds — for the control query as much as for the substance itself. The full text of the current Poisons Standard could not be read either, so it could not be checked whether the substance is captured there by name or as a class. NO register extract exists, and no negative finding is claimed.","source":"https://www.tga.gov.au/resources/artg"}],"devStage":"approved","strongestEvidence":"rct_phase3","wada":{"status":"not_listed","listYear":2026,"source":"https://www.wada-ama.org/en/prohibited-list"},"trials":[{"nct":"NCT04843761","name":"ACTIV-3b/TESICO: the large independent placebo-controlled trial, arm stopped for futility","phase":"Phase 3","n":473,"status":"COMPLETED"},{"nct":"NCT04311697","name":"Manufacturer trial in COVID-19 respiratory failure; primary endpoint missed","phase":"Phase 2b/3","n":196,"status":"COMPLETED"},{"nct":"NCT04360096","name":"Inhaled programme in severe COVID-19 (terminated, sponsor decision)","phase":"Phase 2/3","n":144,"status":"TERMINATED"},{"nct":"NCT05137795","name":"Follow-on inhaled programme, withdrawn before enrolment","phase":"Phase 3","n":0,"status":"WITHDRAWN"},{"nct":"NCT04844580","name":"Inhaled treatment in COVID-19 (Turkey), nine centres","phase":"Phase 2","n":80,"status":"COMPLETED"},{"nct":"NCT04453839","name":"Expanded access programme, not a controlled trial","status":"NO_LONGER_AVAILABLE"},{"nct":"NCT00004494","name":"Earliest registered trial: ARDS and sepsis, from 1998","phase":"Phase 1","n":18,"status":"COMPLETED"},{"nct":"NCT00464932","name":"Chronic obstructive pulmonary disease with pulmonary hypertension","n":34,"status":"COMPLETED"},{"nct":"NCT01563757","name":"Observational study of endogenous peptide levels in children with single ventricle physiology","n":20,"status":"COMPLETED"},{"nct":"NCT04260035","name":"Long-lasting infusion in episodic migraine; the main safety data come from here","n":21,"status":"COMPLETED"},{"nct":"NCT01471990","name":"Head-to-head comparison with PACAP38 under magnetic resonance imaging","n":24,"status":"COMPLETED"},{"nct":"NCT03989817","name":"Long-lasting infusion in healthy volunteers","n":12,"status":"COMPLETED"},{"nct":"NCT00272896","name":"Haemodynamic and headache-inducing effect of intravenous infusion in migraineurs","n":12,"status":"COMPLETED"},{"nct":"NCT00255320","name":"Experimentally induced headache in healthy volunteers","n":12,"status":"COMPLETED"}],"sameAs":["https://pubchem.ncbi.nlm.nih.gov/compound/53314964","https://pubchem.ncbi.nlm.nih.gov/compound/16132300","https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1981592/"],"lastVerified":"2026-09-17","version":"1.0","published":true,"locale":"en","title":"VIP (aviptadil): what the trials show, status and safety","summary":"VIP is a messenger peptide the body makes itself; the synthetic drug substance carries the name aviptadil. As part of a fixed injectable combination it is an approved, prescription-only medicine in Germany, Denmark, Finland, France, Norway, Sweden and the United Kingdom. Its second life, as a candidate for COVID-19, ended in failure. The manufacturer's trial missed its primary endpoint, and the American regulator refused emergency use twice. The large independent trial was stopped for futility and found no difference from placebo.","updated":"2026-09-17","url":"https://mypep.app/peptides/vip"}