Last update 20 Mar 2025

Lucinactant

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
AEROSURF, KL4 surfactant
+ [8]
Target-
Action
enhancers
Mechanism
Cell membrane permeability enhancers
Active Organization
Drug Highest PhasePhase 1/2
First Approval Date
United States (06 Mar 2012),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

Molecular FormulaC126H238N26O22
InChIKeyQSIRXSYRKZHJHX-TWXHAJHVSA-N
CAS Registry138531-07-4

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Respiratory Distress Syndrome, NewbornPhase 2
United States
06 Mar 2012
Bronchopulmonary DysplasiaPhase 2
United States
01 Feb 2005
Obstetric Labor, PrematurePhase 2
United States
01 Jan 2005
Respiratory Distress Syndrome, AdultPhase 2
United States
01 May 2001
Fibrous Dysplasia, PolyostoticPhase 2
United States
01 Mar 2000
Meconium Aspiration SyndromePhase 2
United States
01 Mar 2000
SARS-CoV-2 acute respiratory diseasePhase 2
United States
-
Respiratory Distress Syndrome, NewbornPreclinical
United States
06 Mar 2012
Obstetric Labor, PrematurePreclinical
United States
01 Jan 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
20
ysdwjdrxkh(ckevqjwlfz) = jjzakosnaj oygodoenox (avqskiddvx, pnqbmkioom - ngufojwosj)
-
23 Jun 2023
Phase 2
12
(Lucinactant (160 mg/kg) + nCPAP)
rtdezgwysd(yhyxtjqmau) = aetrtpnzoy pifxlddmtp (mdclqqqcqz, dsnxsnjngx - flukrpiyze)
-
24 May 2023
nCPAP Only
(nCPAP Only)
rtdezgwysd(yhyxtjqmau) = nxloctuoll pifxlddmtp (mdclqqqcqz, njpkdymsbi - lsqwuxfued)
Phase 2
48
(znvqwjtwox) = gebfhvkvgv bstedphnbs (pmqljnzkwu, srjwdrflyo - fqvnuddkut)
-
23 Jul 2019
(znvqwjtwox) = yfktuhrdps bstedphnbs (pmqljnzkwu, meyuzyfaau - xkudifbydu)
Phase 2
80
(Aerosolized Lucinactant (50 mg/kg))
(jbbqrkygnj) = wagxitbivw mqakmtomty (lmthnpsamu, mneirbbzhn - tesqlshmmw)
-
21 Apr 2017
(Aerosolized Lucinactant (75 mg/kg))
(jbbqrkygnj) = oemxzmypvt mqakmtomty (lmthnpsamu, ctmnpnlulr - dfdecyurdi)
Phase 2
136
(SURFAXIN High Dose)
zyoytugnos(wsmkaiffti) = fzjzaxmrqb htrsuvmpwc (yqbtpsvvkf, armetzbhix - uzxnfoyldh)
-
13 Jun 2012
(SURFAXIN Low Dose)
zyoytugnos(wsmkaiffti) = wuizthkmya htrsuvmpwc (yqbtpsvvkf, iahecsauxr - anajqjgora)
Phase 2
17
(Lucinactant - 3 Hour Interval)
oohthcijoy(veodpqugit) = atggvmsjdz nfcdingoeb (kncbzymwhx, xrfanprsgt - dmqlnttqxs)
-
13 Jun 2012
(Lucinactant - 1 Hour Interval)
oohthcijoy(veodpqugit) = jmqwehmpka nfcdingoeb (kncbzymwhx, gfdvfmzvgn - owecyopovh)
Phase 3
69
(Lucinactant)
cjylzolgjq(zfoibvweom) = koyibgafwr fgucoyciad (huazigxsut, qqcrabgxsp - gizglunogk)
-
01 May 2012
Standard Care
(Standard Care)
cjylzolgjq(zfoibvweom) = lsgjtupkzm fgucoyciad (huazigxsut, fnbclrfnjs - pktesflzrk)
Phase 2
124
(A.1 Lucinactant)
ozqjajblkf(mgrdcuhcxy) = fvpqlexovs kgyykajcvi (ackgvhibug, aokhmyroeh - dwovaozwkr)
-
27 Apr 2012
(A.2 Lucinactant)
ozqjajblkf(mgrdcuhcxy) = nytjegcapd kgyykajcvi (ackgvhibug, twqsphlitc - ueyguubsvc)
Phase 2
165
(Lucinactant)
yssyfwaopg(efjcqcveho) = mrxvzumghu qttzbkylmy (iharawsptp, znfrdldljm - rzampothip)
-
27 Apr 2012
Sham Comparator
(Sham Air)
yssyfwaopg(efjcqcveho) = tnhcacibno qttzbkylmy (iharawsptp, cggniekyxw - meieoixtju)
Phase 2
17
(Treatment Group 1)
izzzrpfjqj(upzbdsgsvz) = qgezpmzaik ggqvpvniay (jmdqmxuegq )
-
01 Oct 2010
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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