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Synopsis

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4 RELATED EXCIPIENT COMPANIES

5EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 138531-07-4, Ati 01, Kl4 (peptide), Sinapultide [usan:inn], Unii-040x3ax99t, Kl4 peptide
Molecular Formula
C126H238N26O22
Molecular Weight
2469.4  g/mol
InChI Key
QSIRXSYRKZHJHX-TWXHAJHVSA-N

Sinapultide
Sinapultide (also known as KL4 peptide) is a synthetic protein used to mimic human lung surfactant protein B. This protein has a weight of 2469.40. Sinapultide is a 21-residue peptide made up of lysine (K) and leucine (L) residues with the sequence KLLLLKLLLLKLLLLKLLLLK (KL4), in aqueous dispersion with the phospholipids DPPC (dipalmitoylphosphatidylcholine), POPG (palmitoyloleoyl-phosphatidylglycerol), and palmitic acid, to create the drug [lucinactant]. The product was originally developed by the Scripps Research Institute, then licensed to Windtree Therapeutics. Windtree Therapeutics plans a phase III trial for Respiratory distress syndrome in 2018. Respiratory distress syndrome (RDS) is a major cause of mortality and morbidity in preterm infants. Surfactant replacement therapy has been commonly used to prevent and treat RDS in these newborns and is now a standard of care. First-generation synthetic surfactants that were previously used, such as Exosurf did not contain any surfactant protein. This large disadvantage was overcome with animal-derived surfactant products which contain specific proteins but are limited, but must be derived from animal sources. This has led to the development of newer synthetic surfactants such as lucinactant (Surfaxin), which contains sinapultide. Phase 3 clinical trials with Surfaxin show promising results with similar efficacy as animal-derived surfactants while avoiding the use of animal-origin products. Windtree is currently developing aerosolized KL4 surfactant to treat RDS in premature infants, and thereafter, to potentially address a range of indications in neonatal, pediatric and adult critical care patient populations.
1 2D Structure

Sinapultide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2,6-diaminohexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]-4-methylpentanoyl]amino]hexanoic acid
2.1.2 InChI
InChI=1S/C126H238N26O22/c1-69(2)53-90(137-106(153)85(132)43-33-38-48-127)114(161)145-98(61-77(17)18)122(169)149-99(62-78(19)20)118(165)141-91(54-70(3)4)110(157)133-86(44-34-39-49-128)107(154)138-95(58-74(11)12)115(162)146-103(66-82(27)28)123(170)150-100(63-79(21)22)119(166)142-92(55-71(5)6)111(158)134-87(45-35-40-50-129)108(155)139-96(59-75(13)14)116(163)147-104(67-83(29)30)124(171)151-101(64-80(23)24)120(167)143-93(56-72(7)8)112(159)135-88(46-36-41-51-130)109(156)140-97(60-76(15)16)117(164)148-105(68-84(31)32)125(172)152-102(65-81(25)26)121(168)144-94(57-73(9)10)113(160)136-89(126(173)174)47-37-42-52-131/h69-105H,33-68,127-132H2,1-32H3,(H,133,157)(H,134,158)(H,135,159)(H,136,160)(H,137,153)(H,138,154)(H,139,155)(H,140,156)(H,141,165)(H,142,166)(H,143,167)(H,144,168)(H,145,161)(H,146,162)(H,147,163)(H,148,164)(H,149,169)(H,150,170)(H,151,171)(H,152,172)(H,173,174)/t85-,86-,87-,88-,89-,90-,91-,92-,93-,94-,95-,96-,97-,98-,99-,100-,101-,102-,103-,104-,105-/m0/s1
2.1.3 InChI Key
QSIRXSYRKZHJHX-TWXHAJHVSA-N
2.1.4 Canonical SMILES
CC(C)CC(C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)O)NC(=O)C(CCCCN)N
2.1.5 Isomeric SMILES
CC(C)C[C@@H](C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)O)NC(=O)[C@H](CCCCN)N
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 138531-07-4

2. Ati 01

3. Kl4 (peptide)

4. Sinapultide [usan:inn]

5. Unii-040x3ax99t

6. Kl4 Peptide

7. Rwj 45652

8. Peptide Kl4

9. Peptide Kl-4

10. Schembl180504

11. Ati-01

12. Chembl2103901

13. Dtxsid30160707

14. 040x3ax99t

15. Rwj-45652

16. Db11332

17. L-lysine, 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-

18. 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

2.3 Create Date
2007-07-03
3 Chemical and Physical Properties
Molecular Weight 2469.4 g/mol
Molecular Formula C126H238N26O22
XLogP311.9
Hydrogen Bond Donor Count27
Hydrogen Bond Acceptor Count28
Rotatable Bond Count93
Exact Mass2468.83375816 g/mol
Monoisotopic Mass2467.83040333 g/mol
Topological Polar Surface Area775 Ų
Heavy Atom Count174
Formal Charge0
Complexity4880
Isotope Atom Count0
Defined Atom Stereocenter Count21
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Infant respiratory distress syndrome,,,.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Windtrees KL4 surfactant technology produces a synthetic surfactant that is structurally similar to human pulmonary surfactant and contains a proprietary synthetic peptide KL4 (sinapultide), cost a 21-amino acid peptide that is formulated to mimic the essential attributes of the human surfactant protein B (SP-B). This protein is one of four surfactant proteins and is the most important for the adequate function of the respiratory system. Windtree has demonstrated in pre-clinical studies that KL4 surfactant may possess certain other beneficial properties, including alteration of the inflammatory process, antimicrobial properties as well as non-immunogenicity.


5.2 Absorption, Distribution and Excretion

Absorption

Administered directly to the lung, where biophysical effects occur at the terminal airways and alveolar surface. No human pharmacokinetic studies have been done to characterize the absorption, distribution, metabolism, or elimination of this drug.


5.3 Mechanism of Action

Endogenous pulmonary surfactant 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 RDS. Surfaxin, the drug in which this protein is included, compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants. To explore the mechanisms of protection that this sinapultide offers against RDS, in vitro assays were performed with human and murine endothelial cell monolayers, and polymorphonuclear leukocyte (PMN) transmigration in the presence or absence of KL(4)-surfactant or lipid controls was studied. Based on morphology, histopathology, white blood cell count, percentage of PMNs, and protein concentration in bronchoalveolar lavage fluid, the results that showed KL(4)-surfactant, blocked neutrophil influx into alveoli and thus prevented lung injury. Additionally, in vitro assays demonstrated KL(4)-surfactant decreased neutrophil transmigration at the endothelial cell level. KL(4)-surfactant diminished inflammation and lung permeability when compared with controls in both mouse models of lung injury. Evidence suggests the anti-inflammatory mechanism of the KL(4)-peptide is achieved through inhibition of PMN transmigration through the endothelium.


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ABOUT THIS PAGE

Looking for 138531-07-4 / Sinapultide API manufacturers, exporters & distributors?

Sinapultide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sinapultide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sinapultide manufacturer or Sinapultide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sinapultide manufacturer or Sinapultide supplier.

PharmaCompass also assists you with knowing the Sinapultide API Price utilized in the formulation of products. Sinapultide API Price is not always fixed or binding as the Sinapultide Price is obtained through a variety of data sources. The Sinapultide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sinapultide

Synonyms

138531-07-4, Ati 01, Kl4 (peptide), Sinapultide [usan:inn], Unii-040x3ax99t, Kl4 peptide

Cas Number

138531-07-4

About Sinapultide

Sinapultide (also known as KL4 peptide) is a synthetic protein used to mimic human lung surfactant protein B. This protein has a weight of 2469.40. Sinapultide is a 21-residue peptide made up of lysine (K) and leucine (L) residues with the sequence KLLLLKLLLLKLLLLKLLLLK (KL4), in aqueous dispersion with the phospholipids DPPC (dipalmitoylphosphatidylcholine), POPG (palmitoyloleoyl-phosphatidylglycerol), and palmitic acid, to create the drug [lucinactant]. The product was originally developed by the Scripps Research Institute, then licensed to Windtree Therapeutics. Windtree Therapeutics plans a phase III trial for Respiratory distress syndrome in 2018. Respiratory distress syndrome (RDS) is a major cause of mortality and morbidity in preterm infants. Surfactant replacement therapy has been commonly used to prevent and treat RDS in these newborns and is now a standard of care. First-generation synthetic surfactants that were previously used, such as Exosurf did not contain any surfactant protein. This large disadvantage was overcome with animal-derived surfactant products which contain specific proteins but are limited, but must be derived from animal sources. This has led to the development of newer synthetic surfactants such as lucinactant (Surfaxin), which contains sinapultide. Phase 3 clinical trials with Surfaxin show promising results with similar efficacy as animal-derived surfactants while avoiding the use of animal-origin products. Windtree is currently developing aerosolized KL4 surfactant to treat RDS in premature infants, and thereafter, to potentially address a range of indications in neonatal, pediatric and adult critical care patient populations.

Sinapultide Manufacturers

A Sinapultide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sinapultide, including repackagers and relabelers. The FDA regulates Sinapultide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sinapultide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Sinapultide Suppliers

A Sinapultide supplier is an individual or a company that provides Sinapultide active pharmaceutical ingredient (API) or Sinapultide finished formulations upon request. The Sinapultide suppliers may include Sinapultide API manufacturers, exporters, distributors and traders.

click here to find a list of Sinapultide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Sinapultide USDMF

A Sinapultide DMF (Drug Master File) is a document detailing the whole manufacturing process of Sinapultide active pharmaceutical ingredient (API) in detail. Different forms of Sinapultide DMFs exist exist since differing nations have different regulations, such as Sinapultide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Sinapultide DMF submitted to regulatory agencies in the US is known as a USDMF. Sinapultide USDMF includes data on Sinapultide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sinapultide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Sinapultide suppliers with USDMF on PharmaCompass.

Sinapultide GMP

Sinapultide Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Sinapultide GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sinapultide GMP manufacturer or Sinapultide GMP API supplier for your needs.

Sinapultide CoA

A Sinapultide CoA (Certificate of Analysis) is a formal document that attests to Sinapultide's compliance with Sinapultide specifications and serves as a tool for batch-level quality control.

Sinapultide CoA mostly includes findings from lab analyses of a specific batch. For each Sinapultide CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Sinapultide may be tested according to a variety of international standards, such as European Pharmacopoeia (Sinapultide EP), Sinapultide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sinapultide USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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