Peptide Graded

Aviptadil

Does Aviptadil work?

Yes, in one controlled trial of about 460 patients, which found no benefit.

BSome human evidenceIn clinical trialsas of 2026-10-26

For the use it became known for, respiratory failure in COVID-19, the decisive evidence is TESICO, a randomized placebo-controlled trial of about 460 patients that was stopped for futility with no difference in recovery or 90-day mortality. A properly conducted negative randomized trial is grade B evidence against the claimed benefit; the immunology citations are reviews of the natural peptide, not studies of the drug. 4611

The sponsor's own phase 2b/3 trial in 2020 and 2021 reported mixed results. The FDA declined its requests for emergency use authorisation. It said the data did not meet the standard. 79

The independent test came from ACTIV-3b/TESICO, a National Institutes of Health trial. The Lancet Respiratory Medicine published it in 2023. Patients had COVID-19 with acute hypoxaemic respiratory failure. Researchers randomized them to intravenous aviptadil or placebo. They stopped enrolment for futility after about 460 patients. The main outcome was a six-category recovery scale at 90 days. It showed no benefit (odds ratio 1.10, 95% confidence interval 0.79 to 1.54). Mortality at 90 days was 37% with aviptadil and 36% with placebo. 11

Evidence checklist

  • Randomised controlled trial TESICO, placebo-controlled, stopped for futility
  • Human study over 100 people About 460 patients in TESICO
  • More than one research group Main trial run by the sponsor's network
  • Clinical outcomes, not surrogate markers 90-day recovery and mortality measured
  • Human safety data beyond case reports Monitoring board found no new concerns

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More on Aviptadil

Citations

  1. Said and Mutt 1970, Science: polypeptide with broad biological activity isolated from small intestine pubmed.ncbi.nlm.nih.gov
  2. PMC 2023: independent analysis of aviptadil COVID-19 evidence pmc.ncbi.nlm.nih.gov
  3. PMC 2021: VIP receptors VPAC1 and VPAC2 pmc.ncbi.nlm.nih.gov
  4. Goetzl 2002, Regulatory Peptides: immunoeffector and immunoregulatory activities of VIP pubmed.ncbi.nlm.nih.gov
  5. Couvineau 2012, Br J Pharmacol: VPAC receptor structure and pharmacology pubmed.ncbi.nlm.nih.gov
  6. Amino Acids 2013: VIP, a neuropeptide with pleiotropic immune functions pubmed.ncbi.nlm.nih.gov
  7. The Pharma Letter: FDA declines EUA for aviptadil in critical COVID-19 thepharmaletter.com
  8. GlobeNewswire 2020: Fast Track designation for RLF-100 (aviptadil) globenewswire.com
  9. NRx Pharmaceuticals 10-Q, Q1 2022: FDA declined emergency use request sec.gov
  10. All Wales Therapeutics and Toxicology Centre: aviptadil/phentolamine (Invicorp) recommendation awttc.nhs.wales
  11. ACTIV-3b/TESICO 2023, Lancet Respiratory Medicine: aviptadil and remdesivir for COVID-19 respiratory failure doi.org

Reference information only, not medical advice. Drawn from the Aviptadil article, fact-checked against the cited sources. No dosing anywhere on this site.