Lucinactant

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

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Pharmacology

Indication

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

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Contraindications & Blackbox Warnings

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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

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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 Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">

Not Available

Interactions

Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">

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.

• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental
• All Drugs

Drug	Interaction
Integrate drug-drug interactions in your software
Acebutolol	Acebutolol may increase the bradycardic activities of Lucinactant.
Alfentanil	Alfentanil 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.
Atenolol	Atenolol may increase the bradycardic activities of Lucinactant.

Food Interactions

Not Available

Categories

Drug Categories

• Alcohols
• Amino Acids, Peptides, and Proteins
• Biological Factors
• Bradycardia-Causing Agents
• Glycerophosphates
• Glycerophospholipids
• Lipids
• Membrane Lipids
• Peptides
• Pharmaceutical Preparations
• Phosphatidic Acids
• Phospholipids
• Proteins
• Pulmonary Surfactants

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]

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 Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">

Phase	Status	Purpose	Conditions	Count
3	Terminated	Treatment	Meconium Aspiration Syndrome	1
2	Completed	Treatment	Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) / Coronavirus Disease 2019 (COVID‑19)	1
2	Completed	Treatment	Cystic Fibrosis (CF)	1
2	Completed	Treatment	Hypoxemic Acute Respiratory Failure	1
2	Completed	Treatment	Respiratory Distress Syndrome	2

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage Forms

Not Available

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)	Region
US5407914	No	1995-04-18	2013-11-17

Properties

State

Liquid

Experimental Properties

Not Available

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