{"id":"poractant-alfa-curosurf","safety":{"commonSideEffects":[{"rate":null,"effect":"Transient oxygen desaturation"},{"rate":null,"effect":"Bradycardia"},{"rate":null,"effect":"Reflux of surfactant into endotracheal tube"},{"rate":null,"effect":"Pulmonary hemorrhage"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Poractant alfa is an extract of porcine lung surfactant containing phospholipids and surfactant-associated proteins that mimics endogenous pulmonary surfactant. It is administered intratracheally to replace deficient or dysfunctional surfactant in premature infants, thereby reducing alveolar surface tension, preventing alveolar collapse, and improving lung compliance and gas exchange.","oneSentence":"Poractant alfa is a natural pulmonary surfactant that reduces surface tension in the lungs and restores normal respiratory function in neonates with respiratory distress syndrome.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:01:54.874Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Respiratory distress syndrome (RDS) in premature infants"},{"name":"Meconium aspiration syndrome (MAS) in neonates"}]},"trialDetails":[{"nctId":"NCT07261787","phase":"PHASE4","title":"Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minutes Versus 5 Minutes","status":"NOT_YET_RECRUITING","sponsor":"Medical University of Graz","startDate":"2025-12-01","conditions":"Neonates and Preterm Infants, Infant Respiratory Distress Syndrome, Surfactant Deficiency Syndrome Neonatal","enrollment":76},{"nctId":"NCT07098910","phase":"NA","title":"Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam","status":"RECRUITING","sponsor":"Karolinska Institutet","startDate":"2025-09-25","conditions":"Respiratory Distress Syndrome in Premature Infant","enrollment":440},{"nctId":"NCT06491901","phase":"NA","title":"Prospective, Non-Blinded, Randomized Controlled Trial on Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants.","status":"NOT_YET_RECRUITING","sponsor":"Peking University Third Hospital","startDate":"2024-08-01","conditions":"Early Administration of Pulmonary Surfactant Guided by Lung Ultrasound Scores in Very Preterm Infants","enrollment":60},{"nctId":"NCT02772081","phase":"PHASE3","title":"A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-05-18","conditions":"Respiratory Distress Syndrome (RDS)","enrollment":33},{"nctId":"NCT04502433","phase":"PHASE2","title":"Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2021-01-06","conditions":"Acute Respiratory Distress Syndrome","enrollment":22},{"nctId":"NCT03235986","phase":"PHASE2","title":"A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)","status":"TERMINATED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2017-08-28","conditions":"Neonatal Respiratory Distress Syndrome","enrollment":166},{"nctId":"NCT04862377","phase":"PHASE3","title":"Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.","status":"NOT_YET_RECRUITING","sponsor":"Hospital Clinic of Barcelona","startDate":"2021-10-01","conditions":"Bronchopulmonary Dysplasia, Respiratory Distress Syndrome in Premature Infant, Prematurity","enrollment":50},{"nctId":"NCT02452476","phase":"PHASE2","title":"A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-01-21","conditions":"Respiratory Distress Syndrome, Newborn","enrollment":123},{"nctId":"NCT03959384","phase":"PHASE3","title":"Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age","status":"TERMINATED","sponsor":"Azienda Ospedaliera Universitaria Integrata Verona","startDate":"2019-01-09","conditions":"Bronchiolitis, Viral","enrollment":9},{"nctId":"NCT04384731","phase":"PHASE2","title":"Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19","status":"UNKNOWN","sponsor":"Dr Christophe LENCLUD","startDate":"2020-05-29","conditions":"COVID-19, ARDS, Human","enrollment":20},{"nctId":"NCT00501982","phase":"PHASE4","title":"Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2007-03","conditions":"Respiratory Distress Syndrome, Newborn","enrollment":208},{"nctId":"NCT01709409","phase":"PHASE3","title":"A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2013-03","conditions":"Respiratory Distress Syndrome","enrollment":88},{"nctId":"NCT01116921","phase":"NA","title":"Laryngeal Mask Airway (LMA) for Surfactant Administration in Neonates","status":"COMPLETED","sponsor":"University of Minnesota","startDate":"2011-02","conditions":"Respiratory Distress Syndrome","enrollment":103},{"nctId":"NCT01306240","phase":"PHASE3","title":"Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation","status":"TERMINATED","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2011-03","conditions":"Acute Respiratory Distress Syndrome","enrollment":19},{"nctId":"NCT01741129","phase":"PHASE4","title":"Comparison of Effectiveness of Nasal CPAP and Nasal IMV in Early Rescue Surfactant Treatment in Preterm Infants","status":"COMPLETED","sponsor":"Mehmet Yekta","startDate":"2012-11","conditions":"Noninvasive Ventilation for Respiratory Distress Syndrome","enrollment":200},{"nctId":"NCT01537354","phase":"NA","title":"Comparison in Pulmonary Compliance Between Curosurf and Survanta in Preterm Infants With Respiratory Distress Syndrome","status":"WITHDRAWN","sponsor":"University of Michigan","startDate":"2012-06","conditions":"Respiratory Distress Syndrome","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":222,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Poractant alfa (Curosurf®)","genericName":"Poractant alfa (Curosurf®)","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Poractant alfa is a natural pulmonary surfactant that reduces surface tension in the lungs and restores normal respiratory function in neonates with respiratory distress syndrome. Used for Respiratory distress syndrome (RDS) in premature infants, Meconium aspiration syndrome (MAS) in neonates.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}