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Last reviewed 2026-06-10 · How we verify

Respiratory distress syndrome in the newborn — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Respiratory distress syndrome in the newborn (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Respiratory distress syndrome in the newborn, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	First approval
Surfaxin	LUCINACTANT	Discovery Labs	lucinactant	2012-01-01
Curosurf	PORACTANT ALFA	Chiesi Usa Inc	Surfactant [EPC]	1999-01-01
Infasurf	CALFACTANT	ONY	Surfactant [EPC]	1998-01-01
Survanta	BERACTANT	AbbVie	Surfactant [EPC]	1991-01-01
L-Dipalmitoyl Lecithin	COLFOSCERIL PALMITATE	GSK	colfosceril palmitate	1990-01-01
Cetanol	CETYL ALCOHOL	GSK	cetyl alcohol	1990-01-01
Alevaire	TYLOXAPOL	GSK	tyloxapol	1990-01-01
Curosurf	Curosurf	Jean Michel Hascoet
Infasurf	Infasurf	Children's Hospital of Philadelphia
Survanta	Survanta	NICHD Neonatal Research Network

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

GSK · 3 drugs in Respiratory distress syndrome in the newborn
Chiesi Usa Inc · 1 drug in Respiratory distress syndrome in the newborn
Children's Hospital of Philadelphia · 1 drug in Respiratory distress syndrome in the newborn
Discovery Labs · 1 drug in Respiratory distress syndrome in the newborn
Jean Michel Hascoet · 1 drug in Respiratory distress syndrome in the newborn
NICHD Neonatal Research Network · 1 drug in Respiratory distress syndrome in the newborn
AbbVie · 1 drug in Respiratory distress syndrome in the newborn
ONY · 1 drug in Respiratory distress syndrome in the newborn

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Every new regulatory action, PDUFA date, or trial completion in Respiratory distress syndrome in the newborn:

Cite this brief

Drug Landscape (2026). Respiratory distress syndrome in the newborn — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/respiratory-distress-syndrome-in-the-newborn. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing