CHF5633

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.