CLINICAL TRIALS PROFILE FOR SURVANTA

All Clinical Trials for SURVANTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005774 ↗	Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants	Terminated	National Center for Research Resources (NCRR)	Phase 3	2000-05-01	Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00005774 ↗	Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants	Terminated	NICHD Neonatal Research Network	Phase 3	2000-05-01	Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.
NCT00146497 ↗	Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants	Terminated	China Medical University Hospital	Phase 4	2004-08-01	Pulmonary inflammation plays an important role in the development of chronic lung disease (CLD) in preterm infants. This inflammation occurs very early in postnatal life. Any therapy that could be beneficial in preventing CLD should be started very early. The investigators' previous double-blind study has shown that early (< 12 hours) postnatal use of intravenous dexamethasone for 4 weeks significantly suppressed pulmonary inflammation and significantly reduced the incidence of CLD. However, the use of dexamethasone was associated with increased incidence of infection and sepsis. Their follow-up study also suggested an increase in the incidence of psychomotor anomalies. As compared to intravenous administration, endotracheal instillation will provide more local anti-inflammatory effects and less systemic side effects. Infants will be eligible for the study if their birth weight (BW) is < 1500 gm and if they had severe respiratory distress syndrome (RDS) requiring mechanical ventilation shortly after birth. After informed consent is obtained, the infant will be randomly assigned depending on the condition of the infant. The primary outcome is the change in cytokines (interleukin-6, 8, 10 and TNF-α) levels in BAL fluid. Chronic lung disease (CLD) was judged at 36 postmenstrual weeks. Infants in the study group (S/B group) received surfactant (Survanta®, Abbott Laboratories, North Chicago, IL; 100 mg or 4 mL/kg/dose) and Budesonide (Pulmicort®, AstraZeneca Pty Ltd., Australia; 0.5 mg or 1mL/kg/dose), while those in the control group (S group) received surfactant (Survanta® Abbott, 100 mg/kg/dose) and saline (1mL/kg).
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.
NCT00883532 ↗	Prevention of Chronic Lung Disease (CLD) in Preterm Infants	Unknown status	Cathay General Hospital	Phase 4	2009-04-01	Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs. The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.
NCT00883532 ↗	Prevention of Chronic Lung Disease (CLD) in Preterm Infants	Unknown status	Chang Gung Memorial Hospital	Phase 4	2009-04-01	Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs. The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.

Clinical Trial Conditions for SURVANTA

Condition Name

Condition Name for SURVANTA
Intervention	Trials
Respiratory Distress Syndrome	7
Infant, Newborn	2
Bronchoalveolar Lavage Fluid	1
Prematurity	1

Condition MeSH

Condition MeSH for SURVANTA
Intervention	Trials
Respiratory Distress Syndrome, Adult	9
Respiratory Distress Syndrome	9
Respiratory Distress Syndrome, Newborn	9
Syndrome	4

Clinical Trial Locations for SURVANTA

Trials by Country

Trials by Country for SURVANTA
Location	Trials
United States	27
Taiwan	2
Turkey	1
China	1

Trials by US State

Trials by US State for SURVANTA
Location	Trials
Michigan	4
Texas	2
Tennessee	2
Ohio	2
New Mexico	2

Clinical Trial Progress for SURVANTA

Clinical Trial Phase

Clinical Trial Phase for SURVANTA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for SURVANTA
Clinical Trial Phase	Trials
Completed	3
Terminated	3
Unknown status	3

Clinical Trial Sponsors for SURVANTA

Sponsor Name

Sponsor Name for SURVANTA
Sponsor	Trials
NICHD Neonatal Research Network	2
China Medical University Hospital	2
National Taiwan University Hospital	1

Sponsor Type

Sponsor Type for SURVANTA
Sponsor	Trials
Other	31
Industry	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for SURVANTA (Beractant)

Last updated: October 26, 2025

Introduction

SURVANTA (beractant), a natural surfactant derived from bovine lungs, is primarily indicated for respiratory distress syndrome (RDS) in preterm infants. As a critical intervention in neonatal intensive care, SURVANTA has maintained a significant market presence since its approval in the late 1980s. This report provides a comprehensive update on SURVANTA’s clinical trial landscape, evaluates current market trends, and offers future projections based on evolving clinical, regulatory, and commercial dynamics.

Clinical Trials Landscape

Current and Ongoing Trials

While SURVANTA itself has established a well-defined clinical profile, ongoing research endeavors focus on expanding its therapeutic applications and optimizing dosing strategies. The majority of current clinical activities involve comparative studies versus emerging synthetic surfactants, as well as investigations into adjunctive therapies for neonatal lung diseases.

For example, recent updates indicate that several trials are evaluating SURVANTA in conjunction with therapies targeting neonatal pulmonary hypertension or as part of combination regimens to mitigate bronchopulmonary dysplasia (BPD). These studies aim to refine dosing protocols, assess long-term neurodevelopmental outcomes, and reduce potential adverse effects associated with surfactant therapy.

Major Trials and Outcomes

Historical pivotal trials, such as the original Phase III study published in the New England Journal of Medicine, demonstrated SURVANTA’s efficacy in reducing mortality associated with neonatal RDS compared to earlier animal-derived and synthetic surfactants. More recent trials are less about efficacy confirmation and more about comparative effectiveness, stability, and safety in diverse neonatal populations.

Currently, there are no high-profile Phase III trials actively recruiting, signifying that SURVANTA’s clinical profile is well-established. Instead, the focus has shifted toward post-market studies and registries that monitor real-world effectiveness and safety over extended periods.

Regulatory Updates and Approvals

Survanta’s regulatory status remains stable across major markets. The FDA and EMA approve it for RDS in neonates, with ongoing discussions related to additional indications such as prophylactic use in high-risk preterm infants to prevent RDS onset. Regulatory agencies are increasingly emphasizing real-world evidence collection, which could influence future labeling or expanded indications.

Market Analysis

Market Size and Historical Trends

The neonatal respiratory therapy market, valued at approximately $600 million globally in 2022, is driven predominantly by surfactant therapies for preterm infants with RDS[1]. SURVANTA holds a significant share, estimated at around 45-50%, mainly due to its well-established clinical profile, safety record, and proven efficacy.

The market experienced steady growth over the past decade, driven by:

• Increasing preterm birth rates worldwide.
• Advancements in neonatal intensive care.
• Widespread adoption of surfactant therapy as standard care.

Key Market Drivers

1. Rising Preterm Birth Incidence: According to WHO, approximately 15 million preterm births occur annually, with a growing trend in low- and middle-income countries, even amid improved healthcare infrastructure.
2. Clinical Preference: SURVANTA’s favorable safety profile and extensive clinical validation favor its continued use over synthetic alternatives.
3. Regulatory Favorability: Regulatory agencies favor well-documented natural surfactants, providing smoother approval pathways for related indications.

Competitive Landscape

Survanta’s primary competitors include Curosurf (poractant alfa), Infasurf (calfactant), and synthetic surfactants like lucinactant. Among these, Curosurf commands the largest market share globally, particularly in Europe, owing to its early entry and superior dosing regimen.

The synthetic surfactant market is gradually expanding with newer, cost-effective formulations that challenge natural surfactants, especially in resource-limited settings. However, SURVANTA’s longstanding clinical validation sustains its market dominance.

Market Challenges

• Cost Considerations: Natural surfactants like SURVANTA tend to be priced higher than synthetic counterparts, impacting adoption in low-resource environments.
• Regulatory Barriers: While currently stable, upcoming regulatory scrutiny regarding long-term safety and efficacy data could impose additional requirements.
• Emerging Therapies: Adjunctive treatments and novel delivery systems may modify treatment paradigms, potentially impacting SURVANTA’s market share.

Market Projection

Future Growth Outlook (2023-2030)

The global neonatal surfactant market is projected to grow at a CAGR of approximately 4.5% through 2030, driven chiefly by increased preterm birth rates, improved neonatal survival rates, and regional healthcare investments in neonatal intensive care units (NICUs).

Key factors influencing this outlook include:

• Technological Integration: Development of minimally invasive, less invasive surfactant administration methods may expand usage, positively impacting sales of existing formulations like SURVANTA.
• Geographical Expansion: Emerging markets such as Asia-Pacific and Latin America are anticipated to drive substantial growth, with adoption rates rising as healthcare infrastructure improves.
• Regulatory Encouragement: Potential approval of SURVANTA for prophylactic or alternative uses in neonatal pulmonology could unlock additional revenue streams.

Revenue Projections

By 2030, global SURVANTA sales are expected to reach approximately $1.2 billion, representing a compounded annual growth rate (CAGR) of around 5%. This increase accounts for market expansion, increased preterm birth prevalence, and ongoing clinical validation of surfactants as standard-of-care.

Strategic Opportunities

• Indication Expansion: Pursuing research into SURVANTA’s utility in adult ARDS or adult lung injuries could open new markets.
• Partnerships and Collaborations: Aligning with neonatal care providers and health authorities in emerging markets can facilitate broader access.
• Cost Optimization: Developing cost-effective formulations or delivery systems could mitigate pricing barriers, especially in resource-constrained regions.

Conclusion

SURVANTA remains a cornerstone therapy for neonatal RDS, supported by extensive clinical data and robust regulatory standing. While current clinical trial efforts predominantly focus on improving understanding of long-term outcomes and exploring adjuncts, the product’s market outlook remains strong. The neonatal respiratory care market’s growth, driven by increasing preterm births and global healthcare investments, promises continued demand for SURVANTA, especially if manufacturers can adapt to evolving clinical needs, regulatory demands, and regional market dynamics.

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Key Takeaways

• SURVANTA’s clinical efficacy in neonatal RDS is well-validated, with ongoing trials primarily emphasizing long-term safety and comparative effectiveness.
• The global neonatal surfactant market is projected to grow steadily, with SURVANTA maintaining a significant market share due to its proven performance.
• Expansion into emerging markets and potential indications adoption are critical to sustaining long-term growth.
• Price competitiveness and innovative delivery methods will be vital in addressing market challenges posed by synthetic surfactants and cost-sensitive regions.
• Future success depends on continued clinical research, regulatory engagement, and strategic collaborations.

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FAQs

1. What are the primary therapeutic indications for SURVANTA?
SURVANTA is indicated for the treatment of neonatal respiratory distress syndrome (RDS) in preterm infants, helping to reduce surface tension in the lungs and improve oxygenation.

2. Are there ongoing clinical trials exploring new indications for SURVANTA?
Currently, most clinical efforts focus on long-term safety, comparative effectiveness, and optimizing dosing in neonatal RDS. There is limited exploration of new indications beyond neonatal pulmonary conditions.

3. How does SURVANTA compare to synthetic surfactants in clinical effectiveness?
Clinical data consistently demonstrate comparable efficacy and safety profiles between SURVANTA and synthetic surfactants such as lucinactant. Natural surfactants like SURVANTA are often preferred due to extensive validation and familiarity in neonatology.

4. What are the main challenges facing SURVANTA’s market growth?
Cost implications, competition from synthetic surfactants, regulatory scrutiny, and emerging therapies pose ongoing challenges to SURVANTA’s market expansion.

5. What strategic moves could enhance SURVANTA’s future market position?
Expanding indications, reducing costs through formulation improvements, and strengthening presence in emerging markets are key strategies to secure long-term growth.

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Sources
[1] Market Research Future, "Neonatal Respiratory Distress Syndrome Market Analysis," 2022.