U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Sinapultide is a synthetic peptide used to mimic human lung surfactant protein B, the most important surfactant protein for a proper functioning of the respiratory system. Protein B lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in respiratory distress syndrome. Sinapultide compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants. Sinapultide was originally developed in the Scripps Research Institute and then licensed to Windtree Therapeutics (formerly Discovery Laboratories, Inc.). Sinapultide is the active ingredient of Lucinactant, a liquid medication to treat infant respiratory distress syndrome. Lucinactant was approved by the FDA in 2012 and sold under the trademark Surfaxin, but in 2015 it was discontinued by Discovery Laboratories, Inc in favor of Aerosurf, another drug containing Sinapultide.

CNS Activity

Curator's Comment: Known to be CNS non-penetrant in rabbits. Human data not available.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Preventing
SURFAXIN

Approved Use

SURFAXIN® (lucinactant) Intratracheal Suspension is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN reduces the incidence of RDS at 24 hours and mortality due to RDS. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.

Launch Date

2012
Preventing
Unknown

Approved Use

Unknown
Palliative
Unknown

Approved Use

Unknown
Primary
Unknown

Approved Use

Unknown
PubMed

PubMed

TitleDatePubMed
Lucinactant: in neonatal respiratory distress syndrome.
2005
A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants.
2005 Apr
A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome.
2005 Apr
Nasal CPAP or intubation at birth for very preterm infants.
2008 Feb 14
Early CPAP versus surfactant in extremely preterm infants.
2010 May 27
Patents

Sample Use Guides

In Vivo Use Guide
Surfaxin should be administered intra-tracheally. The recommended dose of Surfaxin is 5.8 mL per kg birth weight. Up to 4 doses of Surfaxin can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.
Route of Administration: Intratracheal
In Wilhelmy balance and Pulsating bubble spectrometer assays, surfaxin (10 mg phospholipid/mL) decreased surface tension to <10 dynes/cm.
Substance Class Protein
Created
by admin
on Sat Dec 16 17:50:30 GMT 2023
Edited
by admin
on Sat Dec 16 17:50:30 GMT 2023
Protein Sub Type
Sequence Type COMPLETE
Record UNII
040X3AX99T
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
SINAPULTIDE
INN   MART.   MI   USAN  
INN   USAN  
Official Name English
KL4 PEPTIDE
Common Name English
KL4
Code English
ATI 01
Code English
PEPTIDE KL-4
Code English
SINAPULTIDE [MART.]
Common Name English
sinapultide [INN]
Common Name English
L-LYSYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LYSYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LYSYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LYSYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LEUCYL-L-LYSINE
Common Name English
RWJ-45652
Code English
ATI-01
Code English
SINAPULTIDE [MI]
Common Name English
KL-4
Code English
PEPTIDE KL4
Code English
SINAPULTIDE [USAN]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C78273
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
EU-Orphan Drug EU/3/04/217
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
Code System Code Type Description
MERCK INDEX
m9950
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY Merck Index
FDA UNII
040X3AX99T
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
USAN
RR-135
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
NCI_THESAURUS
C152365
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
INN
7636
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
ChEMBL
CHEMBL2103901
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
DRUG BANK
DB11332
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
PUBCHEM
16132243
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
EPA CompTox
DTXSID30160707
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
RXCUI
1440288
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY RxNorm
EVMPD
SUB10530MIG
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
CAS
138531-07-4
Created by admin on Sat Dec 16 17:50:30 GMT 2023 , Edited by admin on Sat Dec 16 17:50:30 GMT 2023
PRIMARY
Related Record Type Details
SALT/SOLVATE -> PARENT
TARGET->MIMETIC
Related Record Type Details
ACTIVE MOIETY
Name Property Type Amount Referenced Substance Defining Parameters References
MOL_WEIGHT:CALCULATED CHEMICAL
Molecular Formula CHEMICAL