At a glance
FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 60 of 218 publications on PubMed
Registered clinical trials 23 3 active
Adverse event reports 26 25 classified as serious
- Aviptadil (VIP) is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 218 publications mentioning it, including 60 randomized controlled trials and 48 animal-only studies.
- ClinicalTrials.gov lists 23 registered studies testing it (3 active).
- FDA's adverse event system (FAERS) holds 26 reports mentioning it; 25 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
- All publications 218
- Human (MeSH) 153
- Animal only 48
- Clinical trials 112
- Randomized controlled trials 60
- Systematic reviews & meta-analyses 1
- Case reports 6
- Retracted 0
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- A Heat-Inactivated Two-Strain Lacticaseibacillus paracasei Fermented Milk as a Postbiotic for Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial. Randomized controlled trial 2026 Nutrients
- Clinical Efficacy of Abdominal Massage Combined With Moxibustion for Treatment of Chronic Constipation in Elderly Patients. Randomized controlled trial 2026 Neurogastroenterology and motility
- Response to Letter on "Inhaled Aviptadil for Post-COVID Lung Injury: Early Promise, Future Directions". Unclassified 2026 Medical principles and practice : international journal of the Kuwait University, Health Science Centre
- Methodological Considerations in a Trial of Inhaled Aviptadil for COVID-19 Pneumonia. Unclassified 2026 Medical principles and practice : international journal of the Kuwait University, Health Science Centre
- Inhaled Aviptadil for Post-COVID Lung Injury: Early Promise, Future Directions. Unclassified 2026 Medical principles and practice : international journal of the Kuwait University, Health Science Centre
- Response to Letter on "Methodological Considerations in a Trial of Inhaled Aviptadil for COVID-19 Pneumonia". Unclassified 2026 Medical principles and practice : international journal of the Kuwait University, Health Science Centre
- Food-specific IgG-based elimination diet decreased IL-6, TNF-α, and CGRP and improved symptoms in adults with migraine. Clinical trial 2025 Frontiers in nutrition
- Aviptadil in Acute Respiratory Distress Syndrome-Promise or Mirage? Unclassified 2025 Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine
- Aviptadil Therapy in Acute Respiratory Distress Syndrome Patients: A Systematic Review and Meta-analysis. Review 2025 Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine
- Investigation of vasoactive intestinal peptide expression and significance in a congenital diaphragmatic hernia animal model. Animal study 2025 Pediatric surgery international
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 23
- Active
- 3
- With posted results
- 4
| Study | Status | Phase | Start |
| Biological Profiles of Neuropeptides, Neurotrophins and miRNA in Migraine NCT07832032 Nordlandssykehuset HF | Not yet recruiting | — | September 17, 2026 |
| I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients NCT04488081 QuantumLeap Healthcare Collaborative | Active, not recruiting | Phase 2 | July 31, 2020 |
| Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC) NCT04788277 Thomas Jefferson University | Active, not recruiting | — | February 26, 2020 |
| Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19 NCT05137795 APR Applied Pharma Research s.a. | Withdrawn | Phase 3 | December 15, 2021 |
| Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS NCT04536350 Prof. Dr. Jörg Leuppi | Terminated | Phase 2 | May 18, 2021 |
| Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) NCT06729606 National Institute of Allergy and Infectious Diseases (NIAID) Results posted | Completed | Phase 3 | April 20, 2021 |
| ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 NCT04843761 National Institute of Allergy and Infectious Diseases (NIAID) Results posted | Completed | Phase 3 | April 20, 2021 |
| A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 NCT04844580 Centurion Pharma | Completed | Phase 2 | March 10, 2021 |
| Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 NCT04360096 APR Applied Pharma Research s.a. | Terminated | Phase 2, Phase 3 | February 15, 2021 |
| Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). NCT04433546 PhaseBio Pharmaceuticals Inc. | Terminated | Phase 2 | July 15, 2020 |
Show 13 more studies
| Study | Status | Phase | Start |
| The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) in Episodic Migraine Patients NCT04260035 Danish Headache Center | Completed | N/A | May 19, 2020 |
| Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure NCT04311697 APR Applied Pharma Research s.a. Results posted | Completed | Phase 2, Phase 3 | May 15, 2020 |
| The Effects of a Long-lasting Infusion of Vasoactive Intestinal Peptide (VIP) on Headache, Cranial Hemodynamic and Autonomic Symptoms in Healthy Volunteers NCT03989817 Danish Headache Center | Completed | N/A | June 14, 2019 |
| Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients NCT03898856 The University of Texas Health Science Center, Houston Results posted | Completed | Phase 4 | April 1, 2019 |
| Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH NCT03556020 PhaseBio Pharmaceuticals Inc. | Terminated | Phase 2 | July 15, 2018 |
| A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH NCT03315507 PhaseBio Pharmaceuticals Inc. | Completed | Phase 1 | October 20, 2017 |
| Plastic Bronchitis and Protein Losing Enteropathy in Children With Single Ventricle Physiology NCT01563757 Medical College of Wisconsin | Completed | — | Mar 2012 |
| Effect of PACAP38/VIP on Migraineurs Measured by Magnetic Resonance NCT01471990 Glostrup University Hospital, Copenhagen | Completed | N/A | May 2011 |
| Hemodynamic and Headache-Inducing Effect of Intravenous Vasoactive Intestinal Peptide in Migraineurs NCT00272896 Danish Headache Center | Completed | N/A | Oct 2004 |
| Experimental Headache Induced by Vasoactive Intestinal Polypeptide NCT00255320 Danish Headache Center | Completed | N/A | Dec 2003 |
| Vasoactive Intestinal Peptide in COPD NCT00464932 Medical University of Vienna | Completed | — | Jun 2003 |
| Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis NCT00004494 Stony Brook University | Completed | Phase 1 | Sep 1998 |
| ZYESAMI (Aviptadil) Intermediate Population Expanded Access Protocol (SAMICARE) NCT04453839 APR Applied Pharma Research s.a. | No longer available | — | — |
All 23 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 26
- Serious
- 25
- With death outcome
- 3
Most reported reactions
- Acute abdomen 6
- Euglycaemic diabetic ketoacidosis 5
- Syncope 5
- Vomiting 5
- Flushing 3
- Off label use 3
- Pain 3
- Abortion spontaneous 2
- Maternal exposure during pregnancy 2
- Acute kidney injury 1
- Covid-19 pneumonia 1
- Deep vein thrombosis 1
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.