Beractant

also known as Survanta · A-60386X · Beractant (Survanta) · Surfactant ta · Survanta (Ross Laboratories)

Developed for: respiratory distress syndrome in premature infants · newborn respiratory distress syndrome · lower respiratory tract disorder
Investigated by: China Medical University Hospital · Ege University · Ministry of Health, Brazil · NICHD Neonatal Research Network · National Center for Research Resources (NCRR) · University of Sao Paulo

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	US (FDA)	SURVANTA	—	1991-07-01	fda.gov ↗

Trials 4

today

US approved 1991

NCT01923844 · Ph 4 NCT01723683 · Ph 2 NCT02305160 · Ph 2/3 NCT00005774 · Ph 3

1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 21 trial
Phase 2	NCT01723683	Feb 2012 → Jan 2013	respiratory distress syndrome in premature infants	China Medical University Hospital	Unknown	No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3	NCT02305160	Apr 2005 → May 2006	respiratory distress syndrome in premature infants	University of Sao Paulo	Completed	Missed primary
Phase 31 trial
Phase 3	NCT00005774	May 2000 → Jul 2002	newborn respiratory distress syndrome	NICHD Neonatal Research Network	Terminated	No outcome recorded Stop: Enrollment
Phase 41 trial
Phase 4	NCT01923844	Mar 2012 → Apr 2013	respiratory distress syndrome in premature infants	Ege University	Completed	No outcome recorded
Comparator or background therapy9 trials
Phase 1/2	NCT02294630 Comparator	Dec 2014 → Jul 2019	newborn respiratory distress syndrome	Sood, Beena G., MD, MS	Completed	No outcome recorded
Phase 2/3	NCT02774044 Comparator	Jun 2016 → Feb 2019	respiratory distress syndrome in premature infants	Ramesh K Agarwal	Unknown	Missed primary
Phase 2/3	NCT01203358 Comparator	Jan 1991 → Jan 1992	bronchopulmonary dysplasia, fetal growth restriction	NICHD Neonatal Research Network	Completed	No outcome recorded
Phase 4	NCT01941524 Comparator	Mar 2013 → Jun 2015	newborn respiratory distress syndrome	Poznan University of Medical Sciences	Completed	No outcome recorded
Phase 4	NCT00767039 Comparator	Jan 2005 → Sep 2008	patent ductus arteriosus, respiratory distress syndrome in premature infants	Alan Fujii	Terminated	Met primary Stop: Enrollment
Phase 4	NCT00146497 Background	Aug 2004 → ?	pulmonary immaturity, respiratory distress syndrome in premature infants	China Medical University Hospital	Terminated	No outcome recorded
—	NCT01537354 Comparator	Jun 2012 → Dec 2013	respiratory distress syndrome in premature infants	University of Michigan	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT01852461 Comparator	Aug 2011 → Dec 2012	peripheral ischemia	Dr. Sami Ulus Children's Hospital	Completed	No outcome recorded
—	NCT01860014 Comparator	Mar 2010 → Jan 2011	lower respiratory tract disorder	Dr. Sami Ulus Children's Hospital	Completed	No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

Field	Value	Cited text
Known as	Beractant	“Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6...” NCT01923844 ↗ 6 “Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.” NCT01537354 ↗ “Aerosolized Beractant in neonatal respiratory distress syndrome: A randomized fixed-dose parallel-arm phase II trial.” PMID 33338661 ↗ Dec 2020 NCT01852461 ↗ NCT01860014 ↗ NCT01941524 ↗ NCT00767039 ↗
Known as	A-60386X	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201624 ↗
Known as	Beractant (Survanta)	“Beractant (Survanta)” NCT01852461 ↗
Known as	Surfactant ta	ChEMBL registry synonym — accepted as the source's own label CHEMBL1201624 ↗
Known as	Survanta	“Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6...” NCT01923844 ↗ 7 “Survanta® (Beractant, Abbot Laboratories, Columbus, OH) Surfactant will be administered by respiratory therapist not involved in patient's care.” NCT01537354 ↗ “surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose)” NCT00146497 ↗ “Surfactant (Survanta©, Abbott, USA) 100 mg/kgBW” NCT01723683 ↗ “surfactants: Survanta® or Curosurf®” PMID 25628188 ↗ Oct 2014 “Survanta” NCT00005774 ↗ NCT01203358 ↗ NCT02774044 ↗
Known as	Survanta (Ross Laboratories)	“Survanta (Ross Laboratories)” NCT01203358 ↗
Modality	Other / unclassified	“two different natural surfactant preparations” NCT01852461 ↗
Route	Other	“early endotracheal instillation of Surfactant-Budesonide (S/B) mixture” NCT00146497 ↗