Poractant alfa

Overview

Poractant alfa is a pulmonary surfactant marketed as Curosurf in the United States and Canada. It is used to treat Respiratory Distress Syndrome (RDS) in premature infants with an endogenous pulmonary surfactant deficiency. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C). The phospholipid content of the extract consists primarily of phosphatidylcholine and dipaImitoylphosphatidylcholine. Poractant alfa is a creamy white suspension of this extract in 0.9% sodium chloride solution. It contains no preservatives.

Indication

Poractant alfa is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.

Associated Conditions

Respiratory Distress Syndrome

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Prophylactic Minimally Invasive Surfactant Evaluation	2023/08/23	NCT06007547	Phase 4	Recruiting	NorthShore University HealthSystem
Poractant Alfa (Curosurf®)) -- Effect in Adult Patients Diagnosed With 2019 Novel Coronavirus (SARS-COV-19; (Covid-19)) Acute Respiratory Distress Syndrome (ARDS)	2020/08/06	NCT04502433	Phase 2	Terminated	Chiesi Farmaceutici S.p.A.
Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19	2020/05/12	NCT04384731	Phase 2	UNKNOWN	Dr Christophe LENCLUD
Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy	2019/11/29	NCT04181255	Phase 1	Terminated	University of Michigan
Efficacy and Safety of Curosurf® in Patients Invasively Ventilated for Severe Bronchiolitis Under 12 Months of Age	2019/05/22	NCT03959384	Phase 3	Terminated	Azienda Ospedaliera Universitaria Integrata Verona
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.	2018/05/11	NCT03521063	Phase 4	UNKNOWN	Hospital Central "Dr. Ignacio Morones Prieto"
Comparison of Curosurf and Infasurf in the Treatment of Preterm Infants With Respiratory Distress Syndrome	2016/07/15	NCT02834624	Not Applicable	Completed	University of Missouri-Columbia
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration	2016/05/13	NCT02772081	Phase 3	Terminated	Chiesi Farmaceutici S.p.A.
A Double Blind, Randomized, Controlled Study to Evaluate CHF 5633 (Synthetic Surfactant) and Poractant Alfa in Neonates With Respiratory Distress Syndrome (RDS) (POC)	2015/05/22	NCT02452476	Phase 2	Completed	Chiesi Farmaceutici S.p.A.
Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage	2013/05/22	NCT01860014	Not Applicable	Completed	Dr. Sami Ulus Children's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Curosurf	Chiesi USA, Inc.	10122-510	ENDOTRACHEAL	80 mg in 1 mL	5/2/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Poractant Alfa Injection	CHIESI FARMACEUTICI S.P.A.	国药准字HJ20181201	化学药品	注射剂	9/10/2020
Poractant Alfa Injection	CHIESI FARMACEUTICI S.P.A.	国药准字HJ20181202	化学药品	注射剂	9/10/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CUROSURF poractant alfa 240mg/3mL intratracheal suspension vial	99515	Chiesi Australia Pty Ltd	Medicine	A	2/28/2005
CUROSURF poractant alfa 120mg/1.5mL intratracheal suspension vial	99514	Chiesi Australia Pty Ltd	Medicine	A	2/28/2005

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