Lucinactant

also known as surfactant · SURFAXIN · Aerosurf · ATI 02 · Kl-surfactant · KL4-SURFACTANT

Developed for: respiratory distress syndrome in premature infants · acute respiratory distress syndrome · bronchopulmonary dysplasia · newborn respiratory distress syndrome · acute respiratory failure · COVID-19 · cystic fibrosis · meconium aspiration syndrome
Investigated by: Windtree Therapeutics · National Heart, Lung, and Blood Institute (NHLBI) · BLES Biochemicals Inc. · Cystic Fibrosis Foundation · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Indiana University
+3 more
· NICHD Neonatal Research Network · National Center for Research Resources (NCRR) · University of North Carolina, Chapel Hill

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	SURFAXIN	—	2012-03-06	fda.gov ↗

Trials 13 · a red edge is where a trial was stopped

today

US approved 2012

NCT05714865 · Ph 4 NCT04389671 · Ph 2 NCT04264156 · Ph 2 NCT02636868 · Ph 2 NCT02528318 · Ph 2 NCT02074059 · Ph 2 NCT00934362 · Ph 2 NCT00578734 · Ph 2 NCT00233324 · Ph 3 NCT00215540 · Ph 2 NCT00807235 · Ph 2 NCT00215553 · Ph 2 NCT00004500 · Ph 3

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 210 trials
Phase 2	NCT04389671	Jan 2021 → Feb 2022	COVID-19, acute respiratory distress syndrome	Windtree Therapeutics	Completed	No outcome recorded
Phase 2	NCT04264156	Apr 2020 → Jan 2021	newborn respiratory distress syndrome	Windtree Therapeutics	Terminated	No outcome recorded
Phase 2	NCT02636868	Dec 2015 → Jul 2017	respiratory distress syndrome in premature infants	Windtree Therapeutics	Completed	No outcome recorded
Phase 2	NCT02528318	Aug 2015 → May 2017	respiratory distress syndrome in premature infants	Windtree Therapeutics	Terminated	No outcome recorded
Phase 2	NCT02074059	Feb 2014 → Oct 2015	respiratory distress syndrome in premature infants	Windtree Therapeutics	Completed	No outcome recorded
Phase 2	NCT00934362	Oct 2008 → Aug 2010	cystic fibrosis	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 2	NCT00578734	Jun 2007 → Apr 2010	acute respiratory failure	Windtree Therapeutics	Completed	No outcome recorded
Phase 2	NCT00215540	Feb 2005 → Jul 2006	bronchopulmonary dysplasia, newborn respiratory distress syndrome	Windtree Therapeutics	Terminated	No outcome recorded
Phase 2	NCT00807235	Jan → Aug 2005	respiratory distress syndrome in premature infants	Windtree Therapeutics	Terminated	No outcome recorded
Phase 2	NCT00215553	May 2001 → Feb 2006	acute respiratory distress syndrome	Windtree Therapeutics	Terminated	No outcome recorded
Phase 32 trials
Phase 3	NCT00233324	Feb 2005 → Feb 2009	bronchopulmonary dysplasia, fetal growth restriction, retinopathy of prematurity	NICHD Neonatal Research Network	Completed	No outcome recorded
Phase 3	NCT00004500	Mar 2000 → Nov 2002	meconium aspiration syndrome	Windtree Therapeutics	Terminated	No outcome recorded
Phase 41 trial
Phase 4	NCT05714865	Jun 2023 → Mar 2025	respiratory distress syndrome in premature infants	Indiana University	Completed	No outcome recorded

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT01265589 Comparator	Jan → Dec 2012	—	Third Military Medical University	Unknown	No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 17 sources stand behind the page.

Field	Value	Cited text
Known as	Lucinactant	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00934362 ↗ 10 NCT00578734 ↗ NCT02528318 ↗ NCT00215540 ↗ NCT00215553 ↗ NCT04264156 ↗ NCT00004500 ↗ NCT00807235 ↗ NCT02074059 ↗ NCT02636868 ↗ NCT04389671 ↗
Known as	Aerosurf	“To determine the feasibility and safety of prophylactic aerosolization of a peptide-containing synthetic surfactant, Aerosurf® (lucinactant for inhalation) was delivered by...” PMID 20455772 ↗ Oct 2010
Known as	ATI 02	ChEMBL registry synonym — accepted as the source's own label CHEMBL1963685 ↗
Known as	Kl-surfactant	ChEMBL registry synonym — accepted as the source's own label CHEMBL1963685 ↗
Known as	KL4-SURFACTANT	ChEMBL registry synonym — accepted as the source's own label CHEMBL1963685 ↗
Known as	surfactant	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00233324 ↗ 2 NCT01265589 ↗ NCT05714865 ↗
Known as	SURFAXIN	“Lucinactant is a synthetic surfactant that, in its liquid form (SURFAXIN®), is approved by the United States Food and Drug Administration (NDA 021746) for the prevention of...” NCT04389671 ↗ 1 “The drug component of lucinactant for inhalation is lyophilized lucinactant, a lyophilized form of SURFAXIN® (lucinactant) Intratracheal Suspension.” NCT04264156 ↗
Action	Restore	“Implement surfactant (BLES®) replacement therapy” NCT05714865 ↗
Modality	Peptide	“lucinactant, a synthetic, peptide-containing surfactant” PMID 19117865 ↗ Jan 2009
Route	Other	“Administered via slow intra-tracheal instillation at a dose of 175 mg/kg” NCT00215540 ↗