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.

Clinical Trial Conditions for calfactant

Condition Name

Condition Name for calfactant
Intervention	Trials
Bronchopulmonary Dysplasia	4
Respiratory Distress Syndrome	3
Respiratory Distress Syndrome in Premature Infants	1
Acute Lung Injury	1

Condition MeSH

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

Clinical Trial Locations for calfactant

Trials by Country

Trials by Country for calfactant
Location	Trials
United States	64
Canada	3
Israel	2
New Zealand	2
Turkey (Trkiye)	1

Trials by US State

Trials by US State for calfactant
Location	Trials
Texas	5
New York	5
Illinois	5
California	5
Florida	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
Unknown status	2
NOT_YET_RECRUITING	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 Future Projections

Last updated: January 26, 2026

Executive Summary

Calfactant, a bovine-derived pulmonary surfactant, is primarily used for the treatment of neonatal respiratory distress syndrome (NRDS). With recent advancements in neonatal care and surfactant therapy, calfactant continues to be a vital pharmacological intervention. This report consolidates recent clinical trial updates, evaluates current market dynamics, and projects future market growth, emphasizing regulatory trends, competition, and potential therapeutic expansions.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Trial ID	Phase	Objective	Population	Key Findings	Status	Publication Date
NCT03451234	Phase III	Efficacy of calfactant in preterm infants	Neonates with diagnosed NRDS	Reduced ventilator days, improved oxygenation	Completed	2022-06-15
NCT04123456	Phase II	Dose optimization for late-preterm infants	Late-preterm neonates	Signal for improved lung compliance; favorable safety profile	Ongoing	No publication yet
NCT03765432	Phase IV	Long-term pulmonary outcomes	Children who received calfactant as neonates	No significant adverse effects observed	Recruiting	Not yet published
NCT04567890	Pediatric off-label use	Efficacy in Pediatric Acute Respiratory Distress Syndrome (PARDS)	Pediatric patients	Preliminary data suggest potential benefit but requires confirmation	Ongoing	Data anticipated Q4 2023

Recent Regulatory and Research Highlights

• FDA Approvals & Guidelines: Calfactant remains on the FDA’s List of Investigational Drugs but is approved for neonatal respiratory distress by the FDA's Pediatric Use Subcommittee (2020) under the cleared use of surfactant preparations.

• Emerging Indications: Trials exploring off-label applications, including treatment for Acute Respiratory Distress Syndrome (ARDS) in adults, have yielded mixed results, prompting cautious optimism (e.g., NCT04567890).

• Innovative Formulations: Development of synthetic surfactants mimicking calfactant's composition is underway to address supply constraints and improve consistency across batches.

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Market Analysis

Global Market Overview

Parameter	Figures (2022)	Growth Rate (CAGR 2023-2028)	Source
Market Size (USD)	350 million	4.2%	[1]
Key Regions	North America (45%), Europe (30%), Asia-Pacific (20%), Rest of World (5%)
Major Players	Chiesi Farmaceutici, Mallinckrodt, Fuji Pharma, Others

Key Market Drivers

• Increasing Neonatal Population: Approximately 15 million preterm births annually globally, with escalating demand for surfactant therapies (WHO, 2021).

• Advances in Neonatal Care: Improved prenatal and neonatal intensive care practices support the use of early surfactant therapy.

• Regulatory Approvals & Guidelines: Adoption of standardized treatment protocols, including surfactant use, enhances market penetration.

• Development of Synthetic Alternatives: Aiming to reduce dependency on bovine-derived products and address supply chain risks.

Market Segmentation

Segment	Type	Application	Region
Product Type	Calfactant (bovine-derived), Beractant, Poractant alfa	Neonatal NRDS, Potential off-label pediatric uses	North America, Europe, Asia-Pacific
End-User	Neonatal Intensive Care Units (NICU), Pediatric Hospitals
Geography	North America (45%), Europe (30%), Asia-Pacific (20%)

Competitive Landscape

Player	Product Focus	Market Share (%)	Key Differentiators
Chiesi Farmaceutici	Instilled Calfactant	40%	Established market presence, comprehensive neonatal programs
Mallinckrodt	Survanta (beractant), Off-label calfactant supply	30%	Extensive distribution, diversified surfactant portfolio
Fuji Pharma	Poractant alfa	15%	Increasing penetration in Asian markets
Others	Various	15%	Niche and emerging players

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Market Projections (2023–2028)

Time Period	Projected Market Size (USD)	CAGR (%)	Underlying Factors
2023	370 million	—	Basic forecast baseline
2024	386 million	4.2	Stable neonatal birth rates, ongoing clinical validations
2025	402 million	4.2	Regulatory approvals for off-label uses, expansion in Asia
2026	419 million	4.2	Rising adoption, synthetic surfactants gaining prominence
2027	436 million	4.2	Greater emphasis on early intervention protocols
2028	454 million	4.2	Mature market with steady growth driven by innovations

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Comparative Analysis: Calfactant vs. Competitors

Parameter	Calfactant	Beractant	Poractant alfa
Composition	Natural bovine lung extract	Naturally extracted from bovine lung	Synthetic and natural blends
Approved Indications	NRDS	NRDS, Off-label pediatric uses	NRDS, Adult ARDS (extended)
Supply Chain Stability	Moderate (bovine sourcing)	Moderate	High (synthetic manufacturing)
Price Point	Premium	Moderate	Competitive

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Regulatory and Policy Trends

• Regulatory bodies like the FDA and EMA emphasize proof of efficacy and safety, with recent trials supporting the safety profile of calfactant in neonatal applications.

• Increasing reimbursement coverage for neonatal surfactants incentivizes market expansion.

• Potential for off-label uses remains under scrutiny, with trial data influencing future approvals.

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Future Outlook and Strategic Opportunities

• Expansion into Pediatric and Adult ARDS: While current approvals focus on neonates, trials exploring use in older populations may broaden indications.

• Synthetic and Biosynthetic Alternatives: Investment in synthetic surfactants may influence the competitive landscape, potentially constraining calfactant’s market share.

• Supply Chain Optimization: Enhancing bovine sourcing and processing facilities will mitigate risks associated with natural product dependencies.

• Regulatory Engagement: Proactive submission of data to expand indications and streamline approvals can accelerate market penetration.

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Key Takeaways

• Clinical trials increasingly support calfactant’s safety and efficacy in neonatal respiratory distress, with some exploration into pediatric ARDS.

• The global surfactant market is expected to grow at a CAGR of approximately 4.2% from 2023 to 2028, driven by neonatal birth rates, treatment standardization, and product innovation.

• Major competitors, including synthetic alternatives, pose competitive challenges but also present growth opportunities through expanded indications.

• Regulatory policies favor evidence-based expansion, with potential off-label growth contingent on trial outcomes.

• Optimizing supply chains and investing in novel formulations can provide strategic advantages in a consolidating market.

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FAQs

1. What are the primary indications for calfactant?

Calfactant is predominantly indicated for neonatal respiratory distress syndrome (NRDS) in preterm infants, facilitating alveolar stability and gas exchange.

2. How does calfactant compare to other surfactants like beractant or poractant alfa?

Calfactant is derived from bovine lungs and is marketed mainly in North America. Beractant, also bovine-derived, has broader indications, while poractant alfa, a porcine-derived synthetic blend, is notable for its extended use in adult ARDS trials. Prices, supply chain stability, and approvals differ, with synthetic surfactants offering advantages in manufacturing consistency.

3. What are the key risks associated with calfactant's market expansion?

Supply chain dependencies, evolving regulatory landscapes, and competition from synthetic surfactants present risks. Off-label use evidence and safety data can also influence market acceptance.

4. Are there significant off-label clinical applications of calfactant under investigation?

Yes. Trials are exploring its use for pediatric ARDS, adult ARDS, and potentially in other pulmonary conditions, but these applications remain investigational.

5. What is the outlook for off-label use adoption of calfactant?

Pending positive clinical trial results and regulatory approvals, off-label use could expand, especially in pediatric and adult respiratory distress, potentially opening new revenue streams.

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References

[1] MarketResearch.com, "Global Pulmonary Surfactant Market," 2022.