CLINICAL TRIALS PROFILE FOR LUCINACTANT

All Clinical Trials for lucinactant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004500 ↗	Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome	Terminated	Windtree Therapeutics	Phase 3	2000-03-01	OBJECTIVES: Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
NCT00215540 ↗	SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.	Terminated	Windtree Therapeutics	Phase 2	2005-02-01	SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).
NCT00215553 ↗	KL₄Surfactant Treatment in Patients With ARDS	Terminated	Windtree Therapeutics	Phase 2	2001-05-01	Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
NCT00578734 ↗	Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old	Completed	Windtree Therapeutics	Phase 2	2007-06-01	Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).
NCT00807235 ↗	Feasibility Study of Aerosolized Surfaxin in the Prevention of Respiratory Distress Syndrome (RDS) in Premature Infants	Terminated	Windtree Therapeutics	Phase 2	2005-01-01	To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
NCT00934362 ↗	Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease	Completed	Cystic Fibrosis Foundation	Phase 2	2008-10-01	Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.

Clinical Trial Conditions for lucinactant

Condition Name

Condition Name for lucinactant
Intervention	Trials
Respiratory Distress Syndrome	3
Meconium Aspiration	1
Premature Birth	1
Respiratory Distress Syndrome, Newborn	1

Condition MeSH

Condition MeSH for lucinactant
Intervention	Trials
Respiratory Distress Syndrome, Newborn	6
Respiratory Distress Syndrome, Adult	6
Respiratory Distress Syndrome	5
Syndrome	3

Clinical Trial Locations for lucinactant

Trials by Country

Trials by Country for lucinactant
Location	Trials
United States	35
Poland	14
Canada	5
Chile	4
Colombia	2

Trials by US State

Trials by US State for lucinactant
Location	Trials
California	4
Pennsylvania	4
North Carolina	4
Rhode Island	2
Oregon	2

Clinical Trial Progress for lucinactant

Clinical Trial Phase

Clinical Trial Phase for lucinactant
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	8

Clinical Trial Status

Clinical Trial Status for lucinactant
Clinical Trial Phase	Trials
Terminated	4
Completed	3
Recruiting	2

Clinical Trial Sponsors for lucinactant

Sponsor Name

Sponsor Name for lucinactant
Sponsor	Trials
Windtree Therapeutics	9
Cystic Fibrosis Foundation	1
Cystic Fibrosis Foundation Therapeutics	1

Sponsor Type

Sponsor Type for lucinactant
Sponsor	Trials
Industry	9
Other	3
NIH	1

Last updated: May 21, 2026

cinactant Clinical Trials Update, Market Analysis, and Revenue Projection (2026-2036)
Lucinactant (surfactant replacement therapy; investigational) remains in development for preterm and other neonatal respiratory indications. Public clinical and regulatory milestones are insufficient to produce a complete, citation-backed trials-and-market forecast with defensible year-by-year launch timing, penetration, and revenue ranges.

What is lucinactant’s clinical trial status in 2025-2026?

Lucinactant is in late-stage clinical development focused on neonatal respiratory distress related to surfactant dysfunction. Publicly available information needed for a complete update (trial identifiers, arms, enrollment status, top-line results timing, and protocol amendments) is not provided here, so the clinical status cannot be converted into a structured “what happened, what’s next” update.

Which trials for lucinactant are most likely to drive FDA review?

A defensible answer requires trial registry links and outcome data (primary endpoint results, subgroup analyses, safety signals, and timing of database lock and submission). That information is not available in the input.

What endpoints and safety risks are most relevant for neonatal surfactant therapies?

Key endpoints typically include oxygenation/ventilatory support outcomes, mortality, and incidence of bronchopulmonary dysplasia or other neonatal complications. A lucinactant-specific safety profile requires sourced trial data.

How does lucinactant compare with Surfaxin, calfactant, beractant, and other surfactant competitors?

A useful competitive comparison must be grounded in (1) indication match, (2) delivery formulation (animal-derived vs synthetic, excipient profile), (3) administration method (e.g., bolus vs rescue strategy), (4) dosing regimen, and (5) trial results. Without sourced lucinactant trial outcomes and competitor label/trial outcomes, a quantified comparison cannot be completed.

Is lucinactant a replacement therapy or a differentiated delivery platform?

Determination of differentiation requires the mechanism-of-action detail, formulation characteristics, and clinical comparators used in lucinactant trials. Not provided.

When does lucinactant lose exclusivity and what does the generic/biosimilar risk look like?

A complete exclusivity and IP expiration analysis requires the patent estate with filing/priority dates, jurisdictional coverage, and listed Orange Book or patent linkage status. None of that is provided here, so exclusivity timing and generic entry risk cannot be produced.

Do any Paragraph IV challenges exist for lucinactant?

No sourced FDA Orange Book listing and no filed ANDA Paragraph IV notices are provided, so this cannot be stated.

Is lucinactant regulated as an established drug product or a biological?

Regulatory classification depends on active ingredient characterization and FDA review pathway. Without official regulatory pathway information, a biosimilar risk assessment cannot be completed.

What is the Orange Book status of lucinactant and what listings affect launch timing?

Orange Book status requires product name, NDA/BLA number, and listed patents (drug substance and drug product). None is provided.

What formulations are protected by lucinactant patents?

A formulation protection map requires patent numbers, assignees, claims (composition, dosing, manufacturing, device/administration compatibility), and jurisdiction. Not provided.

What is the market size and addressable patient population for lucinactant?

A market model requires at minimum:

• target geography (US, EU5, UK, Japan, etc.)
• epidemiology: preterm birth rates, gestational age distribution, RDS incidence
• current standard of care utilization rates
• expected payer constraints and hospital uptake dynamics
• competitor market shares and substitution feasibility

No such inputs are provided, and without citations the analysis cannot be completed within the constraints.

How much revenue could lucinactant generate under base-case adoption scenarios?

A credible projection needs launch timing (NDA/BLA submission and approval window), label breadth, dosing (units per course), price assumptions (WAC/net), and penetration curve assumptions. These determinants are not provided.

What commercial milestones determine lucinactant’s investment case?

Key milestones typically include:

• phase completion and top-line outcome publication
• FDA meeting outcomes and CMC readiness
• NDA/BLA submission timing and filing acceptance
• label definition (population and endpoints)
• pediatric/confirmatory plan requirements

Without sourced timeline events, this cannot be turned into a “milestones-to-revenue” table.

Key Takeaways

• Lucinactant is investigational and clinical development for neonatal respiratory indications continues, but a precise 2025-2026 trials update requires sourced protocol-level and outcome-level information.
• Market sizing and revenue projection require launch timing, label assumptions, dosing, pricing, and adoption curves. None of these are provided in the input.
• A defensible IP/exclusivity and generic risk assessment needs Orange Book/BLA identifiers and patent estate details. None are provided here.

FAQs

1. What is lucinactant’s mechanism of action and target patient population?
2. Which clinical endpoints are most likely to drive FDA approval for lucinactant in neonatal respiratory distress?
3. How does lucinactant’s dosing and administration strategy compare with existing surfactant therapies?
4. What regulatory pathway (NDA vs BLA) is lucinactant expected to follow?
5. What factors determine hospital formulary adoption for neonatal surfactant products like lucinactant?

References

1. (No sources cited because the required clinical, regulatory, and commercial inputs were not provided.)