Lucinactant
Identification
- Name
- Lucinactant
- Accession Number
- DB04897
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Peptides - Description
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.
- Protein chemical formula
- C 126 H 238 N 26 O 22
- Protein average weight
- 2470.2 Da
- Sequences
>Protein sequence for sinapultide KLLLLKLLLLKLLLLKLLLLK
Download FASTA Format- Synonyms
- ATI-02
- KL4-surfactant
- Categories
- UNII
- Not Available
- CAS number
- 825600-90-6
Pharmacology
- Indication
Intended for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
- Pharmacodynamics
Lucinactant is a new synthetic surfactant containing a protein that mimics human surfactant protein-B, is effective at preventing respiratory distress syndrome (RDS) and related complications in preterm infants. Lucinactant has been shown to have antiinflammatory properties, is resistant to proteolytic degradation and oxidation, and has no potential for transmitting animal-derived diseases. Lucinactant has proven safe and effective in the prevention of RDS in preterm infants and as a treatment for MAS in full-term infants and for adult ARDS.
- Mechanism of action
Pulmonary surfactant is a lipoprotein complex that is produced naturally in the lungs, where it lines the alveolar epithelium and serves to reduce surface tension, which facilitates alveoli expansion and allows gas exchange. Human surfactants contain phospholipids, predominantly dipalmitoylphosphatidylcholine (DPPC), in addition to surfactant proteins A, B, C and D. Surfactant is also a physical barrier to inhaled particle and noxious agents, enhances particle clearance, is involved in host defense against infection and possesses antiinflammatory properties. Several serious respiratory disorders have been associated with a loss or lack of endogenous surfactant. Lucinactant was designed to mimic the essential endogenous human surfactant protein B (SP-B).
- Absorption
- Not Available
- Volume of distribution
- Not Available
- Protein binding
- Not Available
- Metabolism
- Not Available
- Route of elimination
- Not Available
- Half life
- Not Available
- Clearance
- Not Available
- Toxicity
Most common adverse reactions associated with the use of lucinactant are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.
- Affected organisms
- Humans and other mammals
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
References
- General References
- Sinha SK, Lacaze-Masmonteil T, Valls i Soler A, Wiswell TE, Gadzinowski J, Hajdu J, Bernstein G, Sanchez-Luna M, Segal R, Schaber CJ, Massaro J, d'Agostino R: A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome. Pediatrics. 2005 Apr;115(4):1030-8. [PubMed:15805381]
- Moya F, Sinha S, Gadzinowski J, D'Agostino R, Segal R, Guardia C, Mazela J, Liu G: One-year follow-up of very preterm infants who received lucinactant for prevention of respiratory distress syndrome: results from 2 multicenter randomized, controlled trials. Pediatrics. 2007 Jun;119(6):e1361-70. Epub 2007 May 28. [PubMed:17533176]
- Halliday HL, Speer CP: Lucinactant versus poractant-alpha in premature lambs. Pediatrics. 2006 Jun;117(6):2324-5; author reply 2325. [PubMed:16740886]
- Gastiasoro-Cuesta E, Alvarez-Diaz FJ, Rey-Santano C, Arnaiz-Renedo A, Loureiro-Gonzalez B, Valls-i-Soler A: Acute and sustained effects of lucinactant versus poractant-alpha on pulmonary gas exchange and mechanics in premature lambs with respiratory distress syndrome. Pediatrics. 2006 Feb;117(2):295-303. [PubMed:16452346]
- Donn SM: Lucinactant: a novel synthetic surfactant for the treatment of respiratory distress syndrome. Expert Opin Investig Drugs. 2005 Mar;14(3):329-34. [PubMed:15833063]
- Moen MD, Perry CM, Wellington K: Lucinactant: in neonatal respiratory distress syndrome. Treat Respir Med. 2005;4(2):139-45; discussion 146-7. [PubMed:15813666]
- Doyle I: Lucinactant (Discovery Laboratories). IDrugs. 2002 Jul;5(7):696-702. [PubMed:12802703]
- External Links
- PubChem Substance
- 347909842
- ChEMBL
- CHEMBL1963685
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Lucinactant
- FDA label
- Download (267 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 2 Completed Treatment Hypoxemic Acute Respiratory Failure 1 2 Terminated Prevention Chronic Lung Disease of Prematurity / Premature Births / Respiratory Distress Syndrome, Newborn 1 2 Terminated Treatment Respiratory Distress Syndrome (RDS) 1 3 Terminated Treatment Meconium Aspiration Syndrome 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage forms
- Not Available
- Prices
- Not Available
- Patents
Patent Number Pediatric Extension Approved Expires (estimated) US5407914 No 1995-04-18 2013-11-17 US
Properties
- State
- Liquid
- Experimental Properties
- Not Available
Taxonomy
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
Drug created on October 21, 2007 16:23 / Updated on November 02, 2018 06:07