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Infant acute respiratory distress syndrome is a lung disorder that affects premature infants caused by developmental insufficiency of surfactant production and structural immaturity of the lungs. The symptoms usually appear shortly after birth and may include tachypnea, tachycardia, chest wall retractions (recession), expiratory grunting, nasal flaring and cyanosis during breathing efforts.
GeneticsMultifactorial, Sporadic (not inherited)
Treatments2 FDA approved
Clinical Trials4 registered · 3 recruiting
Clinical Presentation
Built from Human Phenotype Ontology (HPO) phenotype annotations and GeneReviews clinical descriptions. Features represent findings documented across known cases — not an exhaustive list of possible symptoms.
Features include: Pulmonary edema, Disseminated intravascular coagulation, Edema, and Respiratory distress and 5 more.
Organ System
Phenotype Count
Example Features
Lungs and breathing
4
Pulmonary edema, Respiratory distress, Dyspnea
Blood and immune system
Diagnosis
Biomarker and diagnostic research for respiratory distress syndrome in premature infants has been reported in the published literature.
Treatment
Compiled from FDA-approved drug records, orphan drug designations, and FDA Adverse Event Reporting System (FAERS) safety data. GeneReviews management guidance is included where available.
2 FDA-approved treatments are available for respiratory distress syndrome in premature infants, including PORACTANT ALFA (CUROSURF, approved 1999) and CALFACTANT (INFASURF, approved 1998). An additional 5 compounds hold orphan drug designation.
Approved Therapies
Brand Name
Generic Name
Mechanism
Approved
Market Status
Research Landscape
Sourced from ClinicalTrials.gov and PubMed. Publication types are classified using NLM-curated article metadata; research type breakdowns reflect the nature of published work for this disease.
4 clinical trials registered, 3 recruiting. Interventions under study include drug therapy, medical devices, and procedural interventions. Pipeline includes 2 PHASE4, 2 NA. Research is sponsored by a mix of industry and academic institutions.
123 publications have been identified in PubMed for respiratory distress syndrome in premature infants. Research spans Review / Meta-Analysis (54%), Basic Science / Preclinical (16%), and Other (9%).
Research Type
Count
% of Total
Research summaries
66
Data assembled from 7 of 12 sources · Last updated Sep 20, 2026, 10:23 PM UTC
Diseases are connected by shared genes, phenotypes, therapeutic targets, and MONDO disease hierarchy. The Rare badge reflects Kisho's rarity classification — scored from authoritative sources including OMIM, Orphanet, orphan drug designations, clinical trial activity, and published prevalence data.
The following drugs have received orphan drug designation from the FDA for respiratory distress syndrome in premature infants. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name
Generic Name
Sponsor
Designated
Exclusivity End
Designation Status
perfluorooctyl-bromide (PFOB)
perfluorooctyl-bromide (PFOB)
Children’s Hospital of Pennsylvania
2018
—
Designated
SF-RI-1 bovine surfactant for inhalation
SF-RI-1 bovine surfactant for inhalation
Aerogen Pharma Corporation
2018
—
Designated
aerosolized beractant
aerosolized beractant
Beena G. Sood, MD, MS
2013
—
Designated
Lucinactant
Lucinactant
Lee’s Pharmaceutical (HK) Limited
1995
—
Designated
Curosurf
Pulmonary surfactant replacement, porcine
Chiesi USA, Inc.
1993
—
Designated (drug approved for other indication)
Gene therapy approaches for respiratory distress syndrome in premature infants have been reported in the published literature.
Fresh filings and older proposals reveal different tests of clinical evidence, financing needs and readiness for public ownership. Reaching the next trial is one financing challenge. Convincing investors to fund another pivotal study after a setback is another. That is the task facing Tarsier. The Israeli company is developing a steroid-free treatment for inflammatory eye diseases and plans to use IPO cash to fund another phase 3 trial. The filing said the expected net proceeds would fund a phase 3 pancreatic cancer study and phase 2 studies in osteosarcoma and colorectal cancer. Options’ IPO is on hold pending market conditions, a company spokesperson told PharmaVoice this week. The proposed carve-out from its parent company BioVie centers on BIV201, a formulation of terlipressin for complications of advanced liver disease. Andrew Lam, a managing director at Ally Bridge Group, put the discipline more bluntly in July: “They are investing in real drugs and not science projects.” That assessment still holds, Lam said in a recent email, pointing to clinical-stage biotechs in areas of investor interest, including immunology and inflammation, as prominent among companies going public this year. An IPO, in other words, is not graduation day. It is a public funding round — and the company must explain what the money buys. A final IPO prospectus had not appeared in the SEC record reviewed for this story. The biotech’s lead therapy, NanO2, is designed to improve oxygen delivery to tissue, an approach the company is pursuing across glioblastoma, acute ischemic stroke and acute respiratory distress syndrome. Its July filing reported that patients in a phase 2b glioblastoma trial were in follow-up. The funding limit is explicit: NuvOx said the expected proceeds would support active and planned trials and preparation for a pivotal glioblastoma study, but additional capital would be needed to complete the future trials required for an FDA application.
