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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR CALFACTANT


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
Cystic Fibrosis 1
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Condition MeSH

Condition MeSH for Calfactant
Intervention Trials
Respiratory Distress Syndrome, Newborn 5
Respiratory Distress Syndrome, Adult 5
Respiratory Distress Syndrome 5
Bronchopulmonary Dysplasia 5
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Clinical Trial Locations for Calfactant

Trials by Country

Trials by Country for Calfactant
Location Trials
United States 63
Canada 3
Israel 2
New Zealand 2
Korea, Republic of 1
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Trials by US State

Trials by US State for Calfactant
Location Trials
Texas 5
New York 5
Illinois 5
California 5
Tennessee 4
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Clinical Trial Progress for Calfactant

Clinical Trial Phase

Clinical Trial Phase for Calfactant
Clinical Trial Phase Trials
Phase 4 1
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Calfactant
Clinical Trial Phase Trials
Completed 7
Unknown status 2
Recruiting 1
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Clinical Trial Sponsors for Calfactant

Sponsor Name

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

Sponsor Type for Calfactant
Sponsor Trials
Other 21
Industry 3
NIH 1
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Calfactant: Clinical Trials, Market Analysis, and Projections

Introduction to Calfactant

Calfactant, also known as Infasurf, is a pulmonary surfactant derived from calf lung extract. It is used to treat respiratory distress syndrome (RDS) in preterm neonates. Here, we will delve into the recent clinical trials, market analysis, and future projections for this critical drug.

Clinical Trials Update

Aerosolized Calfactant for Newborns

A significant clinical trial published in 2020 investigated the use of aerosolized calfactant in newborns with early, mild to moderate respiratory distress. This prospective, multicenter, randomized trial involved 457 infants across 22 NICUs in the United States. The infants were randomly assigned to either receive aerosolized calfactant or usual care.

  • Key Findings: The trial showed that aerosolized calfactant significantly reduced the rates of intubation for surfactant instillation. The intubation rates were 26% in the aerosol group compared to 50% in the usual care group, with a p-value of <0.0001. This reduction in intubation was consistent across most gestational age brackets, except for the lowest (23-24 weeks), where all infants required intubation[1].

Traditional Surfactant Administration

Traditional clinical trials have also demonstrated the efficacy of calfactant when administered intratracheally. Three randomized, active-controlled clinical trials involving 3,098 neonates showed that calfactant reduced the risk of RDS and improved outcomes such as lung compliance, respiratory gas exchange, and survival in preterm lambs and neonates[4].

Market Analysis

Global Pulmonary Surfactant Market

The global pulmonary surfactant market, which includes calfactant, was valued at USD 598.7 million in 2022. This market is expected to grow at a compound annual growth rate (CAGR) of 4.98% from 2023 to 2030[2].

Market Segmentation

  • By Type: The market is segmented into synthetic pulmonary surfactants and animal-derived surfactants, with animal-derived surfactants, such as calfactant, being preferred for their efficacy in treating RDS[2][3].
  • By Application: The primary application is in hospitals, where these surfactants are crucial for treating respiratory distress in preterm infants[2].
  • By Distribution Channel: Hospital pharmacies are the major distribution channels for pulmonary surfactants[2].

Key Players

ONY Biotech, the manufacturer of Infasurf (calfactant), is one of the key players in the pulmonary surfactant market. Other notable players include Boehringer Ingelheim, AbbVie, and Windtree Therapeutics[2][3].

Market Projections

Growth Drivers

The market for pulmonary surfactants, including calfactant, is driven by several factors:

  • Advancements in Surfactant Therapies: Innovations in both synthetic and natural surfactants are improving neonatal outcomes by enhancing lung function and reducing inflammation[5].
  • Increasing Preference for Animal-Derived Surfactants: Animal-derived surfactants like calfactant are preferred due to their superior efficacy in reducing complications such as pneumothorax in preterm infants[3].
  • Research and Development: The COVID-19 pandemic has accelerated research and development in the field, with companies like Windtree Therapeutics conducting Phase 2 studies on lucinactant for severe COVID-19 associated ARDS[3].

Regional Analysis

The United States is a significant market for pulmonary surfactants, driven by the introduction of innovative therapies and advanced diagnostic technologies. Europe, Asia-Pacific, and other regions also contribute substantially to the global market[5].

Future Outlook

Technological Advancements

The future of calfactant and other pulmonary surfactants looks promising with ongoing technological advancements. The development of aerosolized delivery methods, as seen in recent clinical trials, could further reduce the need for intubation and improve patient outcomes[1].

Market Growth

With a projected CAGR of 4.98% from 2023 to 2030, the global pulmonary surfactant market is expected to continue growing. This growth will be fueled by increasing demand for effective treatments for RDS and other respiratory conditions[2].

Key Takeaways

  • Clinical Efficacy: Calfactant has been shown to significantly reduce intubation rates and improve respiratory outcomes in preterm neonates.
  • Market Size and Growth: The global pulmonary surfactant market was valued at USD 598.7 million in 2022 and is expected to grow at a CAGR of 4.98% from 2023 to 2030.
  • Market Drivers: Advancements in surfactant therapies, preference for animal-derived surfactants, and ongoing research and development are key drivers of the market.
  • Regional Importance: The United States is a major market, but other regions also play significant roles in the global market.

FAQs

What is calfactant used for?

Calfactant is used to treat respiratory distress syndrome (RDS) in preterm neonates by improving lung compliance and gas exchange.

How is calfactant administered?

Traditionally, calfactant is administered intratracheally. However, recent trials have explored aerosolized delivery methods to avoid intubation.

What are the benefits of aerosolized calfactant?

Aerosolized calfactant reduces the need for intubation and surfactant instillation, improving respiratory outcomes in preterm infants with mild to moderate RDS.

What is the current market size of pulmonary surfactants?

The global pulmonary surfactant market was valued at USD 598.7 million in 2022.

What is the projected growth rate of the pulmonary surfactant market?

The market is expected to grow at a CAGR of 4.98% from 2023 to 2030.

Which region dominates the pulmonary surfactant market?

The United States has the largest patient pool and represents the biggest market for pulmonary surfactant treatments.

Sources

  1. Aerosolized Calfactant for Newborns With Respiratory Distress - Pediatrics, November 2020.
  2. Global Pulmonary Surfactant Market Report - Cognitive Market Research, December 2023.
  3. Pulmonary Surfactant Market Size, Trends and Forecast to 2030 - Coherent Market Insights.
  4. INFASURF Label - FDA, 2024.
  5. Respiratory Distress Syndrome Market to Reach a CAGR of 4.56% - BioSpace, August 2024.

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