Delving into the Latest Updates on Calfactant with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms

Bovactant, Calf lung surfactant extract (CLSE), Calfactant (USAN)

+ [1]

Target-

Action

enhancers

Mechanism

Cell membrane permeability enhancers

Therapeutic Areas

Respiratory DiseasesOther Diseases

Active Indication

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Inactive Indication

Acute Lung InjuryBronchiolitis

Originator Organization

ONY, Inc.

Active Organization

ONY, Inc.

Inactive Organization

ONY Agency LLC

Drug Highest PhaseApproved

First Approval Date

United States (01 Jul 1998),

Respiratory Distress Syndrome

RegulationOrphan Drug (United States)

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This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
The main questions it aims to answer are:
* Do the combined drugs improve the respiratory severity score (RSS)
* Is the combination safe
Participants will receive three doses of the study drug.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Wisconsin Madison

NCT03748173

/ TerminatedPhase 1

Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants

Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

Start Date12 Jan 2019

Sponsor / Collaborator

ONY, Inc.

NCT03058666

/ CompletedPhase 3

Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Start Date29 Mar 2017

Sponsor / Collaborator

ONY, Inc.

100 Clinical Results associated with Calfactant

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100 Translational Medicine associated with Calfactant

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100 Patents (Medical) associated with Calfactant

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134

Literatures (Medical) associated with Calfactant

01 Jan 2025·Journal of Perinatology

High vs low CPAP strategy with aerosolized calfactant in preterm infants with respiratory distress syndrome

Article

Author: Gerday, E ; Kaluarachchi, D C ; Lasarev, M R ; Guthrie, S O ; Zapata, H A ; Minton, S ; Bahr, T

BACKGROUNDOptimal CPAP strategy to prevent CPAP failure defined as need for endotracheal intubation is unknown.OBJECTIVETo evaluate the risk of CPAP failure in infants treated with high vs low CPAP strategy while receiving aerosolized calfactant in the AERO-02 clinical trial and AERO-03 expanded access program.METHODSInfants born between 29 0/7 to 36 6/7 weeks were included. Comparisons were made between low and high CPAP groups (Low, 4-7 cm H₂O; High, 8-10 cm H₂O).RESULTSCPAP failure and pneumothorax were not different between the groups. Odds of CPAP failure were not different after adjustment for baseline characteristics (OR = 0.61; 95% CI: 0.29, 1.24).CONCLUSIONWe found no difference in CPAP failure among infants who received aerosolized calfactant that were treated with high vs low CPAP strategy. Efficacy of high CPAP strategy with aerosolized surfactant treatment needs to be evaluated in future studies.

01 Oct 2024·American Journal of Physiology-Lung Cellular and Molecular Physiology

Comparative biophysical study of clinical surfactants using constrained drop surfactometry

Article

Author: Zuo, Yi Y.

A thorough investigation into the biophysical properties of four animal-derived clinical surfactant preparations was conducted through constrained drop surfactometry under physiologically relevant conditions. This comparative study unveiled unique in vitro biophysical characteristics among these clinical surfactants, establishing correlations between their chemical composition, lateral film structure, and biophysical functionality. The acquired knowledge offers essential insights for the precise and personalized design of clinical surfactant for the treatment of respiratory distress syndrome and other respiratory conditions.

01 Jun 2024·The Journal of Pediatric Pharmacology and Therapeutics

Comparison of Efficacy and Pharmacoeconomic Outcomes Between Calfactant and Poractant Alfa in Preterm Infants With Respiratory Distress Syndrome

Article

Author: Schumann, Caitlin ; Le, Jennie ; Bui, Annie ; Jones, Treva ; Schwendeman, Clair

OBJECTIVESIn order to evaluate the impact of the surfactant of choice selection, primary end points were to compare the average number of doses per patient, need for mechanical ventilation on day 3, hospital length of stay, and in-hospital mortality between calfactant and poractant alfa in preterm infants with respiratory distress syndrome (RDS). Secondary outcomes included administration complications, development of bronchopulmonary dysplasia (BPD), and estimated average per patient cost among the study population.METHODSA retrospective chart review was performed at a level IV neonatal intensive care unit between January 2020 and December 2021 to compare the efficacy, safety, and pharmacoeconomic outcomes following a surfactant of choice switch from calfactant to poractant alfa in preterm infants with RDS.RESULTSFinal analysis included 253 premature infants with gestational age (GA) between 22 and 36 weeks who met inclusion criteria. A total of 118 patients who received calfactant required higher average number of doses, 1.5 vs 1.3 doses (p = 0.031), and had more administration complications than 135 patients who received poractant alfa (10.2 vs 2.2%, p = 0.008). The need for redosing, mechanical ventilation on day 3, hospital length of stay, in-hospital mortality, and development of BPD were comparable between both groups. However, the estimated average per patient cost for poractant alfa was 32% higher than calfactant ($1,901 vs $1,439, p <0.001).CONCLUSIONSDespite the pharmacoeconomic disadvantage, preterm infants who received poractant alfa needed fewer doses and were less likely to have administration complications compared with those who received calfactant.

100 Deals associated with Calfactant

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External Link

KEGG	Wiki	ATC	Drug Bank
D03317	Calfactant	R07AX	DB06415

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Respiratory Distress Syndrome, Newborn	Turkey	-	31 Oct 2018
Respiratory Distress Syndrome, Newborn	Malaysia	-	31 Oct 2018
Respiratory Distress Syndrome	United States	ONY, Inc.	01 Jul 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bronchiolitis	Phase 2	United States	ONY, Inc.	12 Jan 2019
Bronchiolitis	Phase 2	United States	ONY Agency LLC	12 Jan 2019
Acute Lung Injury	Phase 1	United States	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02834624 (NEOSURF, CTgov)	Not Applicable	Respiratory Distress Syndrome	30	calfactant (Calfactant)	mrprgsefwx(gqwwwuoaep) = kymxxksplm leewatrznd (bfzfixmtzm, uzevggtpua - tnyxjiogge) View more	-	06 Jun 2017
				Poractant alfa (Poractant Alfa)	jeyxjnekfv(mpmvxjyjko) = soysagegsv xcttgoxzqs (hqniqsodph, reyrfvrheq - ekbqajzwvu) View more
NCT00569530 (TOLSURFPilot, CTgov)	Phase 3	Bronchopulmonary Dysplasia \| Surfactant Dysfunction	85	Infasurf (ONY Inc.) (Treatment Surfactant (Infasurf) ONY, NY)	qleiqwakig(abtjeffrqy) = nsgmgczoag zodmkilusn (ervtbbuwtd, zjmlgibrue - rbehqmmvoq) View more	-	28 Jun 2016
				Sham (Sham (no Treatment))	qleiqwakig(abtjeffrqy) = tskzehdfrj zodmkilusn (ervtbbuwtd, gbptteorzp - hitzdmtvwi) View more