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

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Synonyms

ATI-02
KL4-surfactant

Categories

UNII

5BSH2G9BH8

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

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.

Drug	Interaction
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Acebutolol	Acebutolol may increase the bradycardic activities of Lucinactant.
Agmatine	Lucinactant may increase the bradycardic activities of Agmatine.
Alfentanil	Alfentanil may increase the bradycardic activities of Lucinactant.
Alprenolol	Alprenolol may increase the bradycardic activities of Lucinactant.
Amiodarone	Amiodarone may increase the bradycardic activities of Lucinactant.
Amlodipine	Amlodipine may increase the bradycardic activities of Lucinactant.
Anisodamine	Lucinactant may increase the bradycardic activities of Anisodamine.
Aranidipine	Lucinactant may increase the bradycardic activities of Aranidipine.
Arotinolol	Lucinactant may increase the bradycardic activities of Arotinolol.
Atenolol	Atenolol may increase the bradycardic activities of Lucinactant.

Additional Data Available

Extended Description

Extended description of the mechanism of action and particular properties of each drug interaction.

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Severity

A severity rating for each drug interaction, from minor to major.

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Evidence Level

A rating for the strength of the evidence supporting each drug interaction.

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Action

An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions

Not Available

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
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

Phase	Status	Purpose	Conditions	Count
1, 2	Not Yet Recruiting	Treatment	Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) / Novel Coronavirus Infectious Disease (COVID-19)	1
2	Active Not Recruiting	Treatment	Respiratory Distress Syndrome	1
2	Completed	Treatment	Cystic Fibrosis (CF)	1
2	Completed	Treatment	Hypoxemic Acute Respiratory Failure	1
2	Recruiting	Treatment	Respiratory Distress Syndrome, Newborn	1
2	Terminated	Prevention	Chronic Lung Disease of Prematurity / Premature Births / Respiratory Distress Syndrome, Newborn	1
2	Terminated	Prevention	Respiratory Distress Syndrome	1
2	Terminated	Treatment	Acute Respiratory Distress Syndrome (ARDS)	1
2	Terminated	Treatment	Respiratory Distress Syndrome	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)
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US5407914	No	1995-04-18	2013-11-17

Additional Data Available

Filed On

The date on which a patent was filed with the relevant government.

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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 March 01, 2020 19:29