Identification

Generic Name
Lucinactant
DrugBank Accession Number
DB04897
Background

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.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Peptides
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
  • Lucinactant

Pharmacology

Indication

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

Pharmacology
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Contraindications & Blackbox Warnings
Contraindications
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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

Adverse Effects
Adverseeffects
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Toxicity

Most common adverse reactions associated with the use of lucinactant are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AcebutololAcebutolol may increase the bradycardic activities of Lucinactant.
AlfentanilAlfentanil may increase the bradycardic activities of Lucinactant.
AmiodaroneAmiodarone may increase the bradycardic activities of Lucinactant.
AmlodipineAmlodipine may increase the bradycardic activities of Lucinactant.
AtenololAtenolol may increase the bradycardic activities of Lucinactant.
BendroflumethiazideBendroflumethiazide may increase the bradycardic activities of Lucinactant.
BepridilBepridil may increase the bradycardic activities of Lucinactant.
BeractantLucinactant may increase the bradycardic activities of Beractant.
BetaxololBetaxolol may increase the bradycardic activities of Lucinactant.
BisoprololBisoprolol may increase the bradycardic activities of Lucinactant.
Interactions
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Food Interactions
Not Available

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
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
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
5BSH2G9BH8
CAS number
825600-90-6

References

General References
  1. 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. [Article]
  2. 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. [Article]
  3. Halliday HL, Speer CP: Lucinactant versus poractant-alpha in premature lambs. Pediatrics. 2006 Jun;117(6):2324-5; author reply 2325. [Article]
  4. 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. [Article]
  5. Donn SM: Lucinactant: a novel synthetic surfactant for the treatment of respiratory distress syndrome. Expert Opin Investig Drugs. 2005 Mar;14(3):329-34. [Article]
  6. Moen MD, Perry CM, Wellington K: Lucinactant: in neonatal respiratory distress syndrome. Treat Respir Med. 2005;4(2):139-45; discussion 146-7. [Article]
  7. Doyle I: Lucinactant (Discovery Laboratories). IDrugs. 2002 Jul;5(7):696-702. [Article]
PubChem Substance
347909842
RxNav
1293254
ChEMBL
CHEMBL1963685
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Lucinactant
FDA label
Download (267 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3TerminatedTreatmentMeconium Aspiration Syndrome1
2CompletedTreatmentCystic Fibrosis (CF)1
2CompletedTreatmentHypoxemic Acute Respiratory Failure1
2CompletedTreatmentRespiratory Distress Syndrome2
2RecruitingTreatmentAcute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) / Coronavirus Disease 2019 (COVID‑19)1
2SuspendedTreatmentRespiratory Distress Syndrome, Newborn1
2TerminatedPreventionChronic Lung Disease of Prematurity / Premature Births / Respiratory Distress Syndrome, Newborn1
2TerminatedPreventionRespiratory Distress Syndrome1
2TerminatedTreatmentRespiratory Distress Syndrome1
2TerminatedTreatmentRespiratory Distress Syndrome, Acute (ARDS)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
Not Available
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US5407914No1995-04-182013-11-17US flag

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at October 21, 2007 22:23 / Updated at February 21, 2021 18:51