Neonatal respiratory distress syndrome - Pipeline Insight, 2025

DelveInsight’s, “Neonatal respiratory distress syndrome - Pipeline Insight, 2025,” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Neonatal respiratory distress syndrome pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Neonatal respiratory distress syndrome Understanding

Neonatal respiratory distress syndrome: Overview

Neonatal respiratory distress syndrome, or RDS, is a common cause of respiratory distress in a newborn, presenting within hours after birth, most often immediately after delivery. RDS primarily affects preterm neonates, and infrequently, term infants. The incidence of RDS is inversely proportional to the gestational age of the infant, with more severe disease in the smaller and more premature neonates. While treatment modalities, including antenatal corticosteroids, surfactants, and advanced respiratory care of the neonate, have improved the outcomes for patients affected by RDS, it continues to be a leading cause of morbidity and mortality in the preterm infant. Neonatal respiratory distress syndrome (RDS) occurs from a deficiency of surfactant, due to either inadequate surfactant production, or surfactant inactivation in the context of immature lungs. Prematurity affects both these factors, thereby directly contributing to RDS. Since the definition of neonatal respiratory distress syndrome is imprecise, prompt diagnosis and treatment require an overall assessment of prenatal and delivery history to identify perinatal risk factors, clinical presentation, radiographic findings, and evidence of hypoxemia on blood gas analysis. The goals of optimal management of neonatal respiratory distress syndrome include decreasing incidence and severity using antenatal corticosteroids, followed by optimal management using respiratory support, surfactant therapy, and overall care of the premature infant.

""Neonatal respiratory distress syndrome - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Neonatal respiratory distress syndrome pipeline landscape is provided which includes the disease overview and Neonatal respiratory distress syndrome treatment guidelines. The assessment part of the report embraces, in depth Neonatal respiratory distress syndrome commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Neonatal respiratory distress syndrome collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Neonatal respiratory distress syndrome.
• In the coming years, the Neonatal respiratory distress syndrome market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics that are working to assess challenges and seek opportunities that could influence Neonatal respiratory distress syndrome R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• A detailed portfolio of major pharma players who are involved in fueling the Neonatal respiratory distress syndrome treatment market. Several potential therapies for Neonatal respiratory distress syndrome are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Neonatal respiratory distress syndrome market size in the coming years.
• Our in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Neonatal respiratory distress syndrome) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Neonatal respiratory distress syndrome Emerging Drugs Chapters

This segment of the Neonatal respiratory distress syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Neonatal respiratory distress syndrome Emerging Drugs

• AEROSURF: Windtree Therapeutics

AEROSURF® is drug-device combination that incorporates lucinactant to treat premature infants suffering from respiratory distress syndrome a complication with preterm births due to the infant’s lungs lacking endogenous surfactant. AEROSURF® allows for the non-invasive delivery of surfactant in order to avoid the well-known complications associated with invasive administration, intubation and ventilation using its proprietary aerosol delivery system (ADS). Data from Phase 2 trials have demonstrated that AEROSURF has the potential to improve lung function in premature infants with RDS.

• AP-002: Aerogen Pharma

AP-002 is a nasally inhaled surfactant based on a combination of Lyomark’s Alveofact® (bovine lung surfactant) and Aerogen’s next generation “PDAP™” delivery technology. The partners expect AP-002 to set a new standard in the treatment of RDS, since it will enable surfactant administration via the nose and complement current first line therapy with nasal continuous positive airway pressure ventilation (nCPAP). AP-002 is anticipated to reduce the need for sedation, invasive intubation and mechanical ventilation, all features of current surfactant treatment methods associated with adverse side effects and the potential to exacerbate chronic lung disease in preterm infants. According to the company’s pipeline, it is in Phase II stage of clinical trial evaluation to treat respiratory distress syndrome (RDS) in premature infants.

Further product details are provided in the report……..

Neonatal respiratory distress syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Neonatal respiratory distress syndrome drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Neonatal respiratory distress syndrome

There are approx. 3+ key companies which are developing the therapies for Neonatal respiratory distress syndrome. The companies which have their Neonatal respiratory distress syndrome drug candidates in the most advanced stage, i.e. phase II include, Windtree Therapeutics.

• Phases

DelveInsight’s report covers around 3+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Neonatal respiratory distress syndrome pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous
• Molecule Type

Products have been categorized under various Molecule types such as

• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Neonatal respiratory distress syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Neonatal respiratory distress syndrome therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Neonatal respiratory distress syndrome drugs.

Neonatal respiratory distress syndrome Report Insights

• Neonatal respiratory distress syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Neonatal respiratory distress syndrome Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Neonatal respiratory distress syndrome drugs?
• How many Neonatal respiratory distress syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Neonatal respiratory distress syndrome?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Neonatal respiratory distress syndrome therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Neonatal respiratory distress syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Windtree Therapeutics
• Aerogen Pharma
• Chiesi Farmaceutici S.p.A.
• Human Life CORD Japan

Key Products

• AEROSURF
• AP-002
• CHF5633
• Neonatal respiratory distress syndrome mesenchymal stem cell therapy

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