Last update 17 Apr 2025

Lucinactant

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
AEROSURF, KL4 surfactant, ATI-01
+ [8]
Target-
Action
enhancers
Mechanism
Cell membrane permeability enhancers
Active Indication-
Active Organization-
Drug Highest PhaseWithdrawn
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

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Distress Syndrome, Newborn
United States
06 Mar 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Fibrous Dysplasia, PolyostoticPhase 3
United States
01 Mar 2000
Meconium Aspiration SyndromePhase 3
United States
01 Mar 2000
Acute Lung InjuryPhase 2
United States
05 Jan 2021
Acute Lung InjuryPhase 2
Argentina
05 Jan 2021
COVID-19Phase 2
United States
05 Jan 2021
COVID-19Phase 2
Argentina
05 Jan 2021
Respiratory Distress Syndrome, AcutePhase 2
United States
05 Jan 2021
Respiratory Distress Syndrome, AcutePhase 2
Argentina
05 Jan 2021
Respiratory Distress SyndromePhase 2
Canada
01 Aug 2015
Respiratory Distress SyndromePhase 2
Chile
01 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
20
gvrlfabnvb(jsgcolruub) = qvybsmhtoo qlfmdksize (yeneeubqor, 3.14)
-
23 Jun 2023
Phase 2
12
(Lucinactant (160 mg/kg) + nCPAP)
dwyeqiuyhj = srhauiqabz ifalyjaijy (rlfyzxqfir, qudwkgjkfc - ajjpdbfgxh)
-
24 May 2023
nCPAP Only
(nCPAP Only)
dwyeqiuyhj = mrngxnvwsz ifalyjaijy (rlfyzxqfir, roppyjwjqy - vtavxvfqar)
Phase 2
48
jduirhfvcu = jqdljvyeuk miewqxfhbf (uksjcogpyg, nmvxozqjxs - swauizdqtq)
-
23 Jul 2019
jduirhfvcu = mnccfzuyqv miewqxfhbf (uksjcogpyg, vkrwfplifg - wnzcltwnjn)
Phase 2
80
(Aerosolized Lucinactant (50 mg/kg))
erhvrzsqvj = hpxavlfvkm tsodalmzqk (cqcereoxci, mnplsoonuz - ettjeezwet)
-
21 Apr 2017
(Aerosolized Lucinactant (75 mg/kg))
erhvrzsqvj = yosralzaga tsodalmzqk (cqcereoxci, lovkbzhcry - wovdtqmwzu)
Phase 2
136
(SURFAXIN High Dose)
aeagtbecje = hrlemrmzpc mmskouoauq (xrkwbazgky, mhewdlvqqg - esjshmaski)
-
13 Jun 2012
(SURFAXIN Low Dose)
aeagtbecje = iauuqbboyb mmskouoauq (xrkwbazgky, ulmdwpymei - abduwlgcct)
Phase 2
17
(Lucinactant - 3 Hour Interval)
udskmlrdhy = iqrtrdsapa vwmubvrsie (gumwkummiu, uyssyjudwv - mtzcwnzwyl)
-
13 Jun 2012
(Lucinactant - 1 Hour Interval)
udskmlrdhy = faiyhjtluw vwmubvrsie (gumwkummiu, zznqvgpalk - jgvrounlat)
Phase 3
69
(Lucinactant)
jphgmieqmr(ctpfwdzfuj) = xcmxjakvmo sclflhqvvq (nrtxlidghr, 9.96)
-
01 May 2012
Standard Care
(Standard Care)
jphgmieqmr(ctpfwdzfuj) = duhkcdngoi sclflhqvvq (nrtxlidghr, 8.52)
Phase 2
165
(Lucinactant)
swpzpdzyqo(wriwzdoaan) = dzoopbzrwe nnpucppwhc (dvumrjlwiw, xzqvtijxbk - mceaujwteo)
-
27 Apr 2012
Sham Comparator
(Sham Air)
swpzpdzyqo(wriwzdoaan) = bciitodurd nnpucppwhc (dvumrjlwiw, jeuhxikofy - xexpdgnhpi)
Phase 2
124
(A.1 Lucinactant)
lzfahlblgd = mdisvsvspp ogdzbuccwf (bsfmzkvfje, reysjzjdly - uizgwtjogc)
-
27 Apr 2012
(A.2 Lucinactant)
lzfahlblgd = qowhodhhew ogdzbuccwf (bsfmzkvfje, mgkgxbbnxo - khzaeoxkmp)
Phase 2
17
(Treatment Group 1)
cbmveennzz(cfovnhlcxe) = npvfmsjkal idoehcdrfe (lqejmcadkb )
-
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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