CLINICAL TRIALS PROFILE FOR CALFACTANT

All Clinical Trials for calfactant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00506532 ↗	The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study	Unknown status	Rabin Medical Center	Phase 2/Phase 3	2005-01-01	1. Working Hypothesis: The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients. 2. Aims of the Study: The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.
NCT00569530 ↗	Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide	Completed	Mallinckrodt	Phase 3	2008-01-01	The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
NCT00569530 ↗	Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide	Completed	ONY	Phase 3	2008-01-01	The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
NCT00569530 ↗	Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide	Completed	Roberta Ballard	Phase 3	2008-01-01	The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
NCT00569530 ↗	Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide	Completed	University of California, San Francisco	Phase 3	2008-01-01	The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
NCT00628134 ↗	Self-dispersing Liquids as Aerosol Drug Carriers	Completed	Cystic Fibrosis Foundation	N/A	2008-03-01	Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.
NCT00628134 ↗	Self-dispersing Liquids as Aerosol Drug Carriers	Completed	Cystic Fibrosis Foundation Therapeutics	N/A	2008-03-01	Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.

Clinical Trial Conditions for calfactant

Condition Name

Condition Name for calfactant
Intervention	Trials
Bronchopulmonary Dysplasia	4
Respiratory Distress Syndrome	3
Chronic Pulmonary Insufficiency of Prematurity	1
Surfactant	1

Condition MeSH

Condition MeSH for calfactant
Intervention	Trials
Respiratory Distress Syndrome	7
Respiratory Distress Syndrome, Newborn	5
Respiratory Distress Syndrome, Adult	5
Bronchopulmonary Dysplasia	5

Clinical Trial Locations for calfactant

Trials by Country

Trials by Country for calfactant
Location	Trials
United States	64
Canada	3
New Zealand	2
Israel	2
Italy	1

Trials by US State

Trials by US State for calfactant
Location	Trials
Texas	5
New York	5
Illinois	5
California	5
Tennessee	4

Clinical Trial Progress for calfactant

Clinical Trial Phase

Clinical Trial Phase for calfactant
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for calfactant
Clinical Trial Phase	Trials
Completed	7
NOT_YET_RECRUITING	2
Unknown status	2

Clinical Trial Sponsors for calfactant

Sponsor Name

Sponsor Name for calfactant
Sponsor	Trials
University of California, San Francisco	3
ONY	2
Roberta Ballard	2

Sponsor Type

Sponsor Type for calfactant
Sponsor	Trials
Other	24
Industry	3
NIH	1

Calfactant: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 25, 2026

Calfactant (calf lung surfactant extract) is an established surfactant replacement used for neonatal respiratory distress syndrome (RDS). The clinical and commercial landscape in developed markets is shaped by: (i) limited new entrants in “natural” surfactant formulations, (ii) concentrated hospital purchasing, (iii) formulary churn driven by neonatal intensive care unit (NICU) protocols, and (iv) the practical constraint that neonatal surfactant use depends on birth incidence, NICU length-of-stay practices, and guideline-based adoption rather than typical chronic-disease prescribing dynamics.

What is calfactant and what is its current clinical positioning?

Calfactant is a porcine-derived lung surfactant used as replacement therapy in preterm neonates with respiratory distress syndrome. Its clinical role centers on improving lung function and survival outcomes in the target neonatal population, with administration typically following NICU protocolized dosing and timing relative to ventilation status.

Indication and use setting

• Indication: Neonatal respiratory distress syndrome (surfactant replacement in preterm neonates).
• Setting: NICUs and perinatal centers under hospital protocols.

Clinical endpoints that historically drive adoption

Surfactant products are generally evaluated on endpoints that include:

• reduction in oxygen/ventilator requirements
• improvement in oxygenation indices
• reduction in air leak syndromes and/or air leak-related mortality
• reduction in mortality in eligible high-risk cohorts

(These endpoints are standard in neonatal RDS surfactant trials; the selection varies by protocol and era.)

What does the latest clinical-trials activity show?

A reliable “latest update” requires a current, verifiable registry snapshot (ClinicalTrials.gov, EU Clinical Trials Register, and other public sources) tied to calfactant-specific entries. In the absence of a complete registry snapshot in the provided inputs, a complete and accurate trial-by-trial update cannot be produced under strict reporting requirements.

No further clinical-trials detail is provided here.

How does the market for calfactant typically behave?

Surfactant replacement is a niche but recurring acute-care market with several structural characteristics:

Market drivers

• Preterm birth incidence: The pool of eligible neonates correlates with regional preterm birth rates.
• NICU capacity and surfactant protocols: Use depends on local clinical pathways, availability, and reimbursement.
• Formulary switching constraints: Switching in NICU practice is slower than in chronic care due to staff training, dosing protocols, and internal outcomes tracking.

Market friction points

• Hospital contracting and tendering: Purchases are negotiated at institutional level.
• Supply chain reliability: Neonatal dosing volumes can create critical logistics needs.
• Competing surfactant classes: Synthetic and other animal-derived surfactants compete on perceived efficacy, safety profile, ease of administration, and contracting price.

Competitive set structure (high-level)

Calfactant competes within the broader neonatal RDS surfactant category, which includes:

• animal-derived extracts
• synthetic surfactant formulations
• combination or modified preparations

The competitive intensity is driven by procurement pricing, evidence generation in local subpopulations, and guideline uptake.

What is the practical commercial outlook for calfactant?

Calfactant is an incumbent product category where demand is maintained by:

• continued use in eligible NICUs
• procurement relationships and retention once a hospital adopts a product
• replacement therapy durability (no “treatment course” churn beyond acute episodes)

The product’s commercial ceiling is typically constrained by:

• survivability outcomes that determine the size of the eligible cohort under evolving standards
• reductions in preterm incidence through public health interventions
• shifts toward alternative surfactants when formularies update

What does this imply for revenue and volume projections?

A defensible market projection requires baseline revenue/volume, geography, pricing, unit dose assumptions, and competitor share movements. None of those numeric anchors are provided in the input. Under strict requirements for accuracy, a numeric forecast cannot be produced.

No forecast figures are presented.

Key constraints and decision points for R&D and investment

If you are evaluating new entrants

• The bar is high because neonatal RDS surfactant adoption follows institutional outcomes and procurement stability.
• Demonstrating clinically meaningful endpoints in the relevant NICU setting is necessary but not sufficient; supply reliability and tender competitiveness matter as much as trial data.

If you are evaluating calfactant as an incumbent

• Growth is more likely to come from geographic penetration and contract renewals than from large new prescribing expansions.
• Substitution risk exists when hospitals update to alternative surfactant products with stronger local contracting economics or protocol alignment.

Key Takeaways

• Calfactant is a mature neonatal surfactant replacement product used for preterm neonatal RDS under NICU protocols.
• Market behavior is acute-care and institution-led, with adoption constrained by formulary switching and procurement dynamics rather than chronic prescribing.
• A precise clinical-trials update and numeric market projection cannot be completed from the provided information without current registry and baseline market anchors.

FAQs

1. What is calfactant used for?
   It is used as surfactant replacement therapy in neonatal respiratory distress syndrome.

2. Where is calfactant administered?
   In NICUs and perinatal centers under hospital neonatal protocols.

3. What typically determines adoption in hospitals?
   Formulary placement, tender pricing, staff workflow, and observed outcomes in that NICU.

4. How fast can calfactant market share change?
   Generally slowly because neonatal practice is protocol-driven and switching has operational and outcomes validation steps.

5. What data is required to build a defensible market projection?
   Baseline market size by geography, dosing/volume assumptions, pricing, and competitor share and tender dynamics.

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References

[1] FDA. Labeling information for calfactant (calf lung surfactant extract). U.S. Food and Drug Administration (access through product labeling).
[2] EMA. Product information and assessment reports related to calfactant (where applicable). European Medicines Agency.
[3] ClinicalTrials.gov. Calfactant-related clinical studies (registry entries and results). U.S. National Library of Medicine.