Solnatide
Also known as: AP301, TIP peptide, TNF-alpha-derived TIP peptide
Summary
Solnatide (AP301) is an investigational synthetic peptide designed to treat pulmonary edema, particularly acute respiratory distress syndrome (ARDS) and ventilator-associated pneumonia (VAP). It stimulates alveolar fluid clearance by activating ENaC in lung epithelial cells and has anti-inflammatory properties via LOX-1 antagonism. It is administered as an inhaled formulation.
Mechanism of Action
Solnatide is a synthetic peptide mimicking the lectin-like domain of TNF-alpha. It binds to the ectodomain of the epithelial sodium channel (ENaC) and activates it, promoting alveolar fluid clearance. It also antagonizes LOX-1, reducing inflammatory signaling and edema formation in the lung.
Routes of Administration
Goals & Uses
- Anti-inflammatory effects in lungImmunomodulationLow
- Alveolar fluid clearance in ARDSPulmonary/critical CareModerate
- Treatment of pulmonary edemaPulmonary/critical CareModerate
- Reduction of ventilator-associated conditionsPulmonary/critical CareLow
Contraindications
- Hypersensitivity to solnatide or excipientsAllergy/hypersensitivityHigh
- Severe airway obstruction incompatible with inhalationPulmonaryModerate
Adverse Effects
- Hypersensitivity reactionsImmunologicRare
- Local airway irritationRespiratoryCommon
- CoughRespiratoryCommonPersistent or episodic cough
- BronchospasmRespiratoryUncommon
Drug Interactions
- DiureticsLowMay worsen dehydration or electrolyte imbalance
- Inhaled corticosteroidsLow
Population Constraints
- Pediatric patientsAgeRelative
- Severely immunocompromised patientsImmunologicalRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionInvestigationalEMA Orphan Drug Designation granted for ARDS; Phase II trials conducted in Europe
- United StatesInvestigationalNot FDA-approved; investigational status only
- United KingdomInvestigationalNo MHRA approval; investigational use only
Solnatide has received Orphan Drug Designation from the EMA for ARDS. It has undergone Phase II clinical trials in Europe. Not approved by FDA or EMA for any indication as of the knowledge cutoff.
Evidence & Sources
No sources recorded yet.