Aviptadil
Also known as: Phentolamine/VIP, RLF-100, Vasoactive Intestinal Peptide, VIP, ZYESAMI
Summary
Aviptadil is a synthetic vasoactive intestinal peptide (VIP) being investigated primarily for acute respiratory distress syndrome (ARDS) and respiratory failure, including COVID-19-associated ARDS. It has demonstrated potential to reduce pulmonary inflammation, protect alveolar cells, and improve oxygenation. Originally studied for erectile dysfunction and pulmonary arterial hypertension, its development has pivoted to critical respiratory conditions.
Mechanism of Action
Synthetic form of vasoactive intestinal peptide (VIP) that binds to VPAC1 and VPAC2 receptors, producing vasodilation, bronchodilation, and immunomodulatory effects; inhibits cytokine storm by reducing TNF-alpha, IL-6, and other pro-inflammatory mediators; protects alveolar type II cells from apoptosis and supports surfactant production
Routes of Administration
Goals & Uses
- Erectile dysfunctionSexual HealthLow
- Sarcoidosis-related respiratory failureRespiratoryLow
- COVID-19-associated respiratory failureInfectious Disease / RespiratoryModerate
- Cytokine storm suppressionImmunomodulationModerate
- Pulmonary arterial hypertension (PAH)Cardiovascular / PulmonaryLow
- Acute Respiratory Distress Syndrome (ARDS)RespiratoryModerate
Contraindications
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
- Hypersensitivity to VIP or aviptadilAllergyHigh
- Uncontrolled cardiac arrhythmiasCardiovascularModerate
- Severe hypotensionCardiovascularHigh
Adverse Effects
- Injection site reactionsLocalUncommon
- HypotensionCardiovascularCommonLow blood pressure
- FlushingVascularCommonWarmth and redness of the skin
- TachycardiaCardiovascularUncommonAbnormally fast heart rate
- NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
- DiarrheaGastrointestinalUncommonLoose or frequent stools
Drug Interactions
- Antihypertensive agentsModerate
- CorticosteroidsLow
- Vasopressors (e.g., norepinephrine)Low
- Phosphodiesterase-5 inhibitors (e.g., sildenafil)High
Population Constraints
- Renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Patients with pre-existing severe hypotensionCardiovascularRelative
- Pregnant womenReproductiveRelative
- Elderly patients (≥65 years)Age RelatedRelative
Regulatory Status
- European UnionInvestigationalOrphan drug designation for pulmonary arterial hypertension; Invicorp (VIP + phentolamine) approved in some EU countries for erectile dysfunction
- United StatesInvestigationalFDA Breakthrough Therapy Designation for COVID-19-associated respiratory failure; not approved for any indication; studied under multiple IND applications
- United KingdomInvestigationalNo current UK approval; investigational status for respiratory indications
Received FDA Breakthrough Therapy Designation for treatment of COVID-19-associated respiratory failure. Not currently FDA-approved for any indication. Studied under Emergency Use Authorization context during COVID-19 pandemic. Orphan drug designation in EU for pulmonary arterial hypertension.
Evidence & Sources
No sources recorded yet.