CLINICAL TRIALS PROFILE FOR BERACTANT

All Clinical Trials for beractant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00767039 ↗	Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants	Terminated	Dey LP	Phase 4	2005-01-01	Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT00767039 ↗	Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants	Terminated	Alan Fujii	Phase 4	2005-01-01	Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the FDA were more concentrated and had a more rapid onset of action. The overall efficacy of newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to infants treated with Survanta, the most commonly used surfactant preparation in the United States. While the data was suggestive, it was not clear that the improvement in survival was reproducible or that Curosurf was responsible for the improved survival rates. The purpose of this study was to investigate the role of Curosurf in improving lung function and survival rates and reducing the complications of prematurity in very premature infants < 30 weeks gestational age at birth.
NCT01852461 ↗	Perfusion Index Variability in Respiratory Distress Syndrome	Completed	Dr. Sami Ulus Children's Hospital	N/A	2011-08-01	Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.
NCT01860014 ↗	Comparison of Two Different Natural Surfactants in the Treatment of Pulmonary Hemorrhage	Completed	Dr. Sami Ulus Children's Hospital	N/A	2010-03-01	The incidence of pulmonary hemorrhage (PH) was about 1.3 per 1,000 live births. PH occurs mainly in preterm ventilated infants with severe respiratory distress syndrome (RDS) who often have a PDA and have received surfactant. Although not clear, the cause of PH is thought to be due to a rapid lowering of intrapulmonary pressure, which facilitates left to right shunting across a patent ductus arteriosus and an increase in pulmonary blood flow. Prospective uncontrolled studies that used surfactant for PH in neonates have shown promising results in treating PH.In this study we aimed to evaluate the effect of two different natural surfactants in neonates with pulmonary hemorrhage.
NCT01923844 ↗	Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide	Completed	Ege University	Phase 4	2012-03-01	Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
NCT01941524 ↗	Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations	Completed	Poznan University of Medical Sciences	Phase 4	2013-03-03	The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.

Clinical Trial Conditions for beractant

Condition Name

Condition Name for beractant
Intervention	Trials
Respiratory Distress Syndrome	4
Infant,Premature	1
Patent Ductus Arteriosus	1
Poor Peripheral Perfusion	1

Condition MeSH

Condition MeSH for beractant
Intervention	Trials
Respiratory Distress Syndrome	6
Respiratory Distress Syndrome, Newborn	6
Respiratory Distress Syndrome, Adult	6
Syndrome	4

Clinical Trial Locations for beractant

Trials by Country

Trials by Country for beractant
Location	Trials
Turkey	2
Poland	1
United States	1
Mexico	1

Trials by US State

Trials by US State for beractant
Location	Trials
Massachusetts	1

Clinical Trial Progress for beractant

Clinical Trial Phase

Clinical Trial Phase for beractant
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for beractant
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Terminated	1

Clinical Trial Sponsors for beractant

Sponsor Name

Sponsor Name for beractant
Sponsor	Trials
Dr. Sami Ulus Children's Hospital	2
Postgraduate Institute of Medical Education and Research, Chandigarh	1
Government Medical College, Chandigarh	1

Sponsor Type

Sponsor Type for beractant
Sponsor	Trials
Other	25

Beractant Market Analysis and Financial Projection

Beractant: Clinical Trials, Market Analysis, and Projections

Introduction to Beractant

Beractant is a pulmonary surfactant used primarily for the treatment and prevention of Respiratory Distress Syndrome (RDS) in premature infants. It works by replenishing lung surfactant, thereby restoring surface activity to the lungs and stabilizing the alveoli against collapse[1].

Mechanism of Action and Pharmacodynamics

Beractant lowers the minimum surface tension on alveolar surfaces during respiration, which is crucial for maintaining lung compliance and preventing alveolar collapse. In vitro studies have shown that beractant can lower surface tension to less than 8 dynes/cm, and in vivo studies have demonstrated its efficacy in improving lung pressure-volume measurements, lung compliance, and oxygenation in premature animals[1].

Clinical Trials and Efficacy

Several clinical trials have evaluated the efficacy and safety of beractant in treating RDS in premature infants. A notable study compared beractant with poractant-alfa and found similar efficacy between the two, although economic considerations, especially in low- and middle-income countries, favor beractant[4].

• Feasibility and Safety: A Phase II clinical trial demonstrated the feasibility and short-term efficacy of aerosolized beractant in preterm infants with RDS, with no serious adverse events reported. The trial also showed that infants receiving aerosolized beractant were less likely to require intubation within 72 hours compared to historical controls[4].

• Retreatment and Outcomes: Another study focused on the risk predictors and outcomes of retreatment with surfactant in very low birth weight preterm infants. This research helps in understanding the optimal use of beractant in clinical settings and its impact on neonatal outcomes[4].

Market Analysis

The lung surfactants market, which includes beractant, is experiencing significant growth driven by several factors.

Market Size and Growth

• The global lung surfactants market was valued at USD 180.44 million in 2022 and is expected to reach USD 245.53 million by 2030, growing at a compound annual growth rate (CAGR) of 4.0% during the forecast period of 2023-2030[2].

• Another report indicates that the market was valued at USD 173 million in 2021 and is projected to reach USD 242.28 million by 2029, further highlighting the growing demand for lung surfactants[5].

Market Segmentation

• By Drug Type: The lucinactant segment accounted for the highest market share in 2022, but beractant remains a significant player in the market due to its efficacy and cost-effectiveness[2].

• By Indication: The respiratory distress syndrome (RDS) segment is expected to contribute significantly to the growth of the lung surfactants market during the forecast period, given the increasing prevalence of RDS in premature infants[2].

• By Distribution Channel: Hospital pharmacies are anticipated to contribute the largest shares to the market growth, reflecting the primary setting where these treatments are administered[2].

• By End Users: Hospitals account for the highest share in the lung surfactants market, underscoring the critical role of these institutions in treating RDS[2].

Regional Outlook

• North America: This region accounted for the highest market share at 36.85% in 2022, valued at USD 66.49 million, and is expected to reach USD 90.82 million by 2030. The U.S. dominates this market with a significant share[2].

• Asia Pacific: This region is expected to boost the market demand for lung surfactants with the highest CAGR, driven by the increasing prevalence of respiratory distress syndrome and other respiratory conditions[2].

Market Projections

Growth Drivers

• The increasing prevalence of respiratory distress syndrome in premature infants is a key driver of the lung surfactants market. Government initiatives and support for neonatal care also contribute to market growth[2].

• The development of new lung surfactant products and advancements in treatment protocols are expected to further boost market growth during the forecast period[2].

Challenges

• One of the significant challenges facing the lung surfactants market is the high cost of these treatments, which can deter market growth, especially in regions with limited healthcare resources[2].

Key Takeaways

• Beractant is a critical treatment for RDS in premature infants, with a proven mechanism of action and efficacy in clinical trials.
• The lung surfactants market is growing, driven by the increasing prevalence of RDS and advancements in treatment options.
• North America currently dominates the market, but the Asia Pacific region is expected to show the highest growth rate.
• High costs remain a challenge, but economic considerations favor beractant in many settings.

FAQs

What is the primary indication for beractant?

Beractant is primarily indicated for the prevention and treatment of Respiratory Distress Syndrome (RDS) in premature infants[1].

How does beractant work?

Beractant works by replenishing lung surfactant, lowering surface tension on alveolar surfaces, and stabilizing the alveoli against collapse[1].

What is the projected market size for lung surfactants by 2030?

The lung surfactants market is expected to reach USD 245.53 million by 2030, growing at a CAGR of 4.0% during the forecast period of 2023-2030[2].

Which region is expected to show the highest growth rate in the lung surfactants market?

The Asia Pacific region is expected to show the highest growth rate in the lung surfactants market due to the increasing prevalence of respiratory distress syndrome and other respiratory conditions[2].

What are the main challenges facing the lung surfactants market?

One of the main challenges is the high cost of lung surfactants, which can deter market growth, especially in regions with limited healthcare resources[2].

Sources

1. DrugBank Online: Beractant: Uses, Interactions, Mechanism of Action.
2. GlobeNewswire: Lung Surfactants Market to Hit US$ 245.53 Million By 2030.
3. Fortune Business Insights: Clinical Trials Market SIZE, SHARE | GROWTH REPORT [2032].
4. Unbound Medicine: Beractant journal articles from PubMed.
5. Data Bridge Market Research: Global Lung Surfactants Market Size, Share & Industry Analysis Report Till 2029.