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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR CUROSURF


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All Clinical Trials for Curosurf

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00501982 ↗ Efficacy of Combining Prophylactic Curosurf With Early Nasal CPAP in Delivery Room: the Curpap Study Completed Chiesi Farmaceutici S.p.A. Phase 4 2007-03-01 The primary objective of this study is to compare two methods of post-delivery stabilization and subsequent early respiratory care for reducing the need for MV and related secondary complications, such as BPD, in premature babies at high risk of RDS: 1. Early stabilization on nCPAP 2. Intubation, prophylactic surfactant (Curosurf®) administration shortly after delivery, and rapid extubation to nCPAP. The data obtained from this comparison will be applied to test the hypothesis that preterm neonates at risk of RDS who are treated with prophylactic surfactant + nCPAP show less need for MV when compared to infants who receive nCPAP alone.
NCT00751959 ↗ Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks Completed Altona Children's Hospital N/A 2009-04-01 This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
NCT00751959 ↗ Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks Completed Asklepios Kliniken Hamburg GmbH N/A 2009-04-01 This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
NCT00751959 ↗ Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks Completed Charite University, Berlin, Germany N/A 2009-04-01 This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Curosurf

Condition Name

Condition Name for Curosurf
Intervention Trials
Respiratory Distress Syndrome 11
Respiratory Distress Syndrome, Newborn 6
Bronchopulmonary Dysplasia 5
Infant,Premature 1
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Condition MeSH

Condition MeSH for Curosurf
Intervention Trials
Respiratory Distress Syndrome, Newborn 22
Respiratory Distress Syndrome 22
Respiratory Distress Syndrome, Adult 19
Syndrome 13
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Clinical Trial Locations for Curosurf

Trials by Country

Trials by Country for Curosurf
Location Trials
United States 40
Italy 20
France 3
Canada 1
Mexico 1
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Trials by US State

Trials by US State for Curosurf
Location Trials
Michigan 4
Massachusetts 3
Illinois 3
Texas 2
Pennsylvania 2
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Clinical Trial Progress for Curosurf

Clinical Trial Phase

Clinical Trial Phase for Curosurf
Clinical Trial Phase Trials
Phase 4 8
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Curosurf
Clinical Trial Phase Trials
Completed 9
Recruiting 6
Unknown status 4
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Clinical Trial Sponsors for Curosurf

Sponsor Name

Sponsor Name for Curosurf
Sponsor Trials
Chiesi Farmaceutici S.p.A. 7
NorthShore University HealthSystem 2
University of Florence 2
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Sponsor Type

Sponsor Type for Curosurf
Sponsor Trials
Other 58
Industry 12
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Clinical Trials, Market Analysis, and Projections for Curosurf

Introduction to Curosurf

Curosurf, also known as poractant alfa, is a natural surfactant used extensively in the treatment of Respiratory Distress Syndrome (RDS) in premature infants. Since its introduction in 1992, Curosurf has been evaluated in numerous clinical trials to assess its safety, efficacy, and comparative advantages over other surfactant therapies.

Clinical Trials and Efficacy

Comparative Studies with Other Surfactants

Several clinical trials have compared Curosurf with other surfactant preparations, such as Survanta. A randomized clinical trial involving 75 preterm infants with RDS showed that Curosurf resulted in a more rapid improvement in oxygenation and reduced ventilatory requirements up to 24 hours after treatment initiation compared to Survanta. Infants treated with Curosurf had a higher arterial:alveolar oxygen tension ratio and required lower peak inspiratory and mean airway pressures. Although the study did not find significant differences in mortality and complications, it indicated a trend towards reduced incidence of serious pulmonary and non-pulmonary complications with Curosurf[1].

Another study highlighted that Curosurf, when administered at a higher dose (200 mg/kg), exhibited a significantly lower mortality rate compared to lower doses of Curosurf and Survanta. This study demonstrated a mortality rate of 3.0% for the 200 mg/kg dose of Curosurf, compared to 6.25% for the 100 mg/kg dose of Curosurf and 8.16% for the 100 mg/kg dose of Survanta[3].

Ongoing and Recent Studies

Curosurf has been continuously evaluated in various clinical settings. For instance, a population-based cohort study in Sweden involving 97,377 infants born between 2009 and 2018 analyzed the registered use, off-label use, and omissions of surfactant treatment by gestational age and its associations with outcomes. This study provided valuable insights into the real-world use and effectiveness of Curosurf in very preterm infants[4].

A multicenter, prospective study published in 2019 enrolled infants less than 30 weeks’ gestation and initiated Continuous Positive Airway Pressure (CPAP) within the first 15 minutes after birth. The study analyzed demographic, perinatal, and respiratory parameters to predict the need for surfactant therapy and intubation[4].

Market Analysis

Market Growth and Projections

The respiratory distress syndrome market, driven by advancements in surfactant therapies, is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.56% from 2024 to 2034. This growth is attributed to innovations in synthetic and natural surfactants, which are improving neonatal outcomes by enhancing lung function and reducing inflammation[2].

Market Share and Competitive Landscape

Curosurf has gained significant market share, largely at the expense of Survanta. This shift is attributed to Chiesi Farmaceutici's strong focus on marketing and improving Curosurf, as well as AbbVie's relatively low marketing efforts for Survanta. The lower SP-B level in Survanta has also been a factor in Curosurf's market dominance[3].

Regional Analysis

The major markets for respiratory distress syndrome treatments include the United States, Germany, Spain, Italy, France, the United Kingdom, and Japan. The United States has the largest patient pool and represents the biggest market for these treatments, driven by the introduction of innovative therapies and advanced diagnostic technologies[2].

Key Players and Innovations

Chiesi Farmaceutici

Chiesi Farmaceutici, the manufacturer of Curosurf, continues to invest in research and development to improve surfactant therapies. Recent advancements in Curosurf have further solidified its position in the market[2].

Windtree Therapeutics, Inc.

Windtree Therapeutics is another key player, focusing on synthetic surfactant formulations. Their product, Aerosurf®, aims to deliver aerosolized surfactant non-invasively, reducing the need for mechanical ventilation and associated complications[2].

BioMarck Pharmaceuticals

BioMarck Pharmaceuticals is developing novel therapeutic agents, including an anti-inflammatory peptide, BIO-11006, which is currently in clinical trials for treating acute respiratory distress syndrome (ARDS) and RDS[2].

Future Outlook and Challenges

Need for Further Optimization

Despite the efficacy of Curosurf, there is still room for improvement in lung surfactant formulations. Clinical outcomes, such as mortality rates for low birth weight infants, vary significantly depending on the product used. Higher doses of Curosurf have been associated with better outcomes, highlighting the need for further optimization of surfactant formulations[3].

Regulatory and Economic Considerations

The development of new surfactant therapies is costly and time-consuming, typically taking around 10 years to complete with costs averaging $33.4 million for clinical trials. The market size needs to be substantial to recover these development costs, making it crucial for products to have a significant clinical impact[3].

Key Takeaways

  • Efficacy in Clinical Trials: Curosurf has demonstrated superior efficacy in improving oxygenation and reducing ventilatory requirements compared to other surfactants like Survanta.
  • Market Dominance: Curosurf has gained significant market share due to its clinical superiority and strong marketing efforts by Chiesi Farmaceutici.
  • Innovations and Future Outlook: The market is driven by innovations in surfactant therapies, with a focus on non-invasive delivery methods and further formulation optimization.
  • Regional Market: The United States is the largest market for RDS treatments, driven by innovative therapies and advanced diagnostic technologies.

FAQs

What is Curosurf used for?

Curosurf is used to treat Respiratory Distress Syndrome (RDS) in premature infants by improving lung function and reducing inflammation.

How does Curosurf compare to other surfactants?

Curosurf has been shown to result in more rapid improvement in oxygenation and reduced ventilatory requirements compared to other surfactants like Survanta in clinical trials.

What is the projected market growth for RDS treatments?

The RDS market is expected to grow at a CAGR of 4.56% from 2024 to 2034, driven by advancements in surfactant therapies.

Who are the key players in the RDS market?

Key players include Chiesi Farmaceutici (Curosurf), Windtree Therapeutics (Aerosurf), and BioMarck Pharmaceuticals (BIO-11006).

What are the challenges in developing new surfactant therapies?

Developing new surfactant therapies is costly and time-consuming, requiring significant market size to recover development costs.

How has Curosurf impacted neonatal outcomes?

Curosurf has improved neonatal outcomes by enhancing lung function, reducing inflammation, and lowering mortality rates in preterm infants.

Sources

  1. Randomised clinical trial of two treatment regimens of natural surfactant preparations Curosurf and Survanta in respiratory distress syndrome (RDS). PubMed.
  2. Respiratory Distress Syndrome Market to Reach a CAGR of 4.56% During 2024-2034. BioSpace.
  3. Biotechnology Advances - NSF-PAR. NSF-PAR.
  4. Clinical studies - Curosurf. Curosurf.

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