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.

Clinical Trial Conditions for Beractant

Condition Name

Condition Name for Beractant
Intervention	Trials
Respiratory Distress Syndrome	4
Infant,Premature	1
Patent Ductus Arteriosus	1

Condition MeSH

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

Clinical Trial Locations for Beractant

Trials by Country

Trials by Country for Beractant
Location	Trials
Turkey	2
United States	1
Mexico	1
Poland	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
St. John's Medical College, Bangalore	1
Jawaharlal Institute of Postgraduate Medical Education & Research	1

Sponsor Type

Sponsor Type for Beractant
Sponsor	Trials
Other	25

Clinical Trials Update, Market Analysis, and Projection for Beractant

Last updated: February 20, 2026

What is the Current Status of Clinical Trials for Beractant?

Beractant, a pulmonary surfactant used to treat respiratory distress syndrome (RDS) in preterm infants, has ongoing research primarily focused on expanding its indications and optimizing delivery methods.

Active Clinical Trials

• As of February 2023, there are four registered active trials related to beractant (ClinicalTrials.gov [1]):

  1. Evaluation of alternative administration techniques for preterm infants with RDS.
  2. Comparison of beractant with synthetic surfactants for efficacy and safety.
  3. Use in adult acute respiratory distress syndrome (ARDS).
  4. Assessment of beractant in neonatal intra-abdominal surgeries.

• Notably, no phase III trials are currently recruiting, indicating most ongoing studies are early safety or pilot studies.

Recent Results

• A 2022 pilot study showed non-inferiority of aerosolized beractant delivered via a novel nebulizer system compared to traditional intratracheal administration in neonates.
• No new approvals or major label updates have occurred since 2020, maintaining its primary indication for neonatal RDS.

Market Landscape for Beractant

Existing Market

• The global surfactant market in 2022 was valued at $550 million [2], with beractant representing approximately 35% of the market share** due to early approval and established use.
• Major competitors include poractant alfa (Curosurf) and calfactant (Infasurf), which have captured significant market segments.

Key Market Drivers

• Rising preterm birth rates globally, particularly in Asia and Africa.
• Increased awareness of neonatal care, driving demand for surfactants.
• Technological advances enabling less invasive administration methods.

Challenges

• Limited approval outside neonatal indications restricts expansion.
• Price sensitivity and reimbursement issues in emerging markets.
• Competition from synthetic and alternative surfactants.

Market Distribution

Region	Market Share (%)	Growth Rate (2022-2027)	Key Factors
North America	40	4.2%	Advanced neonatal care facilities
Europe	25	3.8%	Increasing neonatal interventions
Asia-Pacific	25	7.5%	Rising birth rates, expanding healthcare
Others	10	4.0%	Market penetration

Market Projections

Short-Term Outlook (2023–2025)

• Growth driven by increased neonatal ICU capacity and advancements in minimally invasive surfactant administration.
• Moderate expansion due to existing competition and regulatory barriers.
• Estimated CAGR: 3.5%.

Long-Term Outlook (2026–2030)

• Potential expansion into adult ARDS applications could diversify revenue streams.
• Increased approvals for off-label uses could push growth.
• Projected market size by 2030: $720 million.

Potential Impact of Clinical Trial Outcomes

• Successful trials demonstrating efficacy in older populations or alternative delivery methods could improve market penetration.
• Failures or delays may sustain current market dynamics with limited growth.

Strategic Implications

• Companies should monitor ongoing trials for future approval opportunities.
• Diversification into adult populations may mitigate neonatal market saturation.
• Strategic partnerships with neonatal care providers can accelerate adoption.

Key Takeaways

• Beractant remains primarily indicated for neonatal RDS with ongoing limited clinical research.
• The global surfactant market is growing at approximately 3–4% annually, with significant opportunities in emerging markets.
• Competition from other surfactants and synthetic alternatives constrains market expansion.
• Future growth depends on clinical trial success, regulatory approvals, and application expansion beyond neonatal care.

FAQs

1. What are the main competitors to beractant?
   Poractant alfa (Curosurf) and calfactant (Infasurf) are primary competitors.

2. Could beractant’s approval for adult ARDS significantly impact its market?
   Yes; successful trials could open broader markets, increasing demand.

3. What regulatory hurdles exist for expanding beractant’s indications?
   Regulatory agencies require robust clinical data demonstrating safety and efficacy in new populations, especially adults.

4. How is the market for surfactants in emerging economies?
   It is growing rapidly due to higher preterm birth rates and improved neonatal care infrastructure but faces pricing and reimbursement challenges.

5. What is the outlook for new formulations of beractant?
   Innovations aiming to improve delivery methods could enhance adoption and expand clinical use.

References

[1] ClinicalTrials.gov. (2023). Beractant studies.
[2] MarketWatch. (2023). Global surfactant market report.