Drugs / Beractant
Beractant
also known as
Survanta · A-60386X · Beractant (Survanta) · Surfactant ta · Survanta (Ross Laboratories)
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 · a red edge is where a trial was stopped
| 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 | ||||||
| Phase 2/3 | NCT02305160 | Apr 2005 → May 2006 | respiratory distress syndrome in premature infants | University of Sao Paulo | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00005774 | May 2000 → Jul 2002 | newborn respiratory distress syndrome | NICHD Neonatal Research Network | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01923844 | Mar 2012 → Apr 2013 | respiratory distress syndrome in premature infants | Ege University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02294630 Comparator | Dec 2014 → Jul 2019 | newborn respiratory distress syndrome | Sood, Beena G., MD, MS | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02774044 Comparator | Jun 2016 → Feb 2019 | respiratory distress syndrome in premature infants | Ramesh K Agarwal | Unknown | No outcome recorded |
| Phase 2/3 | NCT01203358 Comparator | Jan 1991 → Jan 1992 | bronchopulmonary dysplasia, fetal growth restriction | NICHD Neonatal Research Network | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT00146497 Background | Aug 2004 → ? | pulmonary immaturity, respiratory distress syndrome in premature infants | China Medical University Hospital | Terminated | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01537354 Comparator | Jun 2012 → Dec 2013 | respiratory distress syndrome in premature infants | University of Michigan | Withdrawn | No outcome recorded |
| — | 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 |
| 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 ↗ |
| 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 ↗ |