Lucinactant

Overview

Lucinactant is a new synthetic peptide-containing surfactant for intratracheal use. It contains sinapultide, a novel, hydrophobic, 21-amino acid peptide (leucine and lysine repeating units, KL4 peptide) designed to mimic human surfactant protein-B (SB-P). More specifically, it mimics the C-terminal amphipathic helical domain of this protein. It also consists of phospholipids (dipalmitoylphosphatidylcholine, DPPC and palmitoyloleoyl phosphatidylglycerol, POPG) and a fatty acid (palmitic acid). It is completely devoid of animal-derived components. FDA approved on March 6, 2012.

Indication

Intended for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19)	2020/05/15	NCT04389671	Phase 2	Completed	Windtree Therapeutics
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age	2015/12/22	NCT02636868	Phase 2	Completed	Windtree Therapeutics
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates	2014/02/28	NCT02074059	Phase 2	Completed	Windtree Therapeutics
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease	2009/07/08	NCT00934362	Phase 2	Completed	University of North Carolina, Chapel Hill
Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants	2008/12/11	NCT00807235	Phase 2	Terminated	Windtree Therapeutics
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old	2007/12/21	NCT00578734	Phase 2	Completed	Windtree Therapeutics
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.	2005/09/22	NCT00215540	Phase 2	Terminated	Windtree Therapeutics
KL₄Surfactant Treatment in Patients With ARDS	2005/09/22	NCT00215553	Phase 2	Terminated	Windtree Therapeutics
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome	1999/10/19	NCT00004500	Phase 3	Terminated	Windtree Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No NMPA approvals found for this drug.

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
No TGA approvals found for this drug.

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