CHF5633
Also known as: CHF 5633, Poractant synthetic, Synsurf
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Summary
CHF5633 (Poractant synthetic) is a fully synthetic pulmonary surfactant developed by Chiesi Farmaceutici for the treatment of Respiratory Distress Syndrome (RDS) in preterm neonates. It contains synthetic analogues of surfactant proteins SP-B and SP-C combined with phospholipids, offering a potential animal-free alternative to animal-derived surfactants such as poractant alfa.
Mechanism of Action
CHF5633 is a synthetic pulmonary surfactant containing two synthetic peptides (SP-B and SP-C analogues: sinapultide/KL4 analogue and a SP-C analogue) combined with phospholipids (DPPC and POPG). It reduces alveolar surface tension at the air-liquid interface, mimicking the function of endogenous pulmonary surfactant to prevent alveolar collapse during expiration and improve lung compliance in preterm infants.
Routes of Administration
Goals & Uses
- Animal-free surfactant alternativePharmacological / SafetyLow
- Treatment of Neonatal Respiratory Distress Syndrome (RDS)Pulmonary / NeonatalModerate
- Reduction of need for mechanical ventilationPulmonary / NeonatalModerate
Contraindications
- Known hypersensitivity to any componentAllergy / ImmunologicHigh
- Congenital anomalies incompatible with lifeNeonatal / StructuralHigh
Adverse Effects
- Airway obstructionPulmonaryRare
- Oxygen desaturationPulmonaryUncommon
- Pulmonary hemorrhagePulmonaryRare
- BradycardiaCardiovascularUncommon
Drug Interactions
- Inhaled nitric oxideLow
Population Constraints
- Term neonates and pediatric/adult patientsAgeRelative
- Preterm neonates <27 weeks gestational ageNeonatal / Gestational AgeRelative
Regulatory Status
- European UnionInvestigationalInvestigated under EMA oversight; Phase II data published. No marketing authorization granted as of knowledge cutoff.
- United StatesInvestigationalNo FDA approval; IND status assumed for clinical trial conduct.
- United KingdomInvestigationalNo MHRA marketing authorization; clinical research status.
CHF5633 has been evaluated in Phase II clinical trials in preterm infants with RDS. It has not yet received marketing approval from major regulatory agencies (FDA, EMA) as of the knowledge cutoff. Orphan drug designations may apply given the neonatal indication.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is CHF5633?
CHF5633 (Poractant synthetic) is a fully synthetic pulmonary surfactant developed by Chiesi Farmaceutici for the treatment of Respiratory Distress Syndrome (RDS) in preterm neonates. It contains synthetic analogues of surfactant proteins SP-B and SP-C combined with phospholipids, offering a potential animal-free alternative to animal-derived surfactants such as poractant alfa.
What is CHF5633 used for?
CHF5633 is educationally associated with: Animal-free surfactant alternative, Treatment of Neonatal Respiratory Distress Syndrome (RDS), Reduction of need for mechanical ventilation. Educational only — not medical advice.
How is CHF5633 administered?
Recorded routes of administration: Intratracheal.
What are the potential side effects of CHF5633?
Reported adverse effects include: Airway obstruction, Oxygen desaturation, Pulmonary hemorrhage, Bradycardia. This list is not exhaustive — consult a qualified clinician.
Who should avoid CHF5633?
Recorded contraindications: Known hypersensitivity to any component, Congenital anomalies incompatible with life. Consult a qualified clinician before use.