Necrotizing Enterocolitis - Pipeline Insight, 2025

This “Necrotizing Enterocolitis - Pipeline Insight, 2025” report provides comprehensive insights about 2+ companies and 2+ pipeline drugs in Necrotizing Enterocolitis 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.

Necrotizing Enterocolitis: Understanding

Necrotizing Enterocolitis: Overview

Necrotizing enterocolitis (NEC) is a severe and often life-threatening condition that primarily affects neonates, particularly those who are premature or have low birth weight. It is characterized by inflammation of the intestinal tissue, which leads to bacterial invasion, cellular damage, and subsequent necrosis of the colon and intestines. As the disease progresses, it can cause intestinal perforation, leading to peritonitis, sepsis, and, in some cases, death, with mortality rates reaching up to 50%. The clinical presentation of NEC is often nonspecific, with common signs such as poor feeding, vomiting, lethargy, and abdominal tenderness, making it essential for clinicians to maintain a high index of suspicion when these symptoms are observed in neonates. Early diagnosis and intervention are crucial to improving outcomes for affected infants.

NEC is caused by bacterial invasion into the intestinal wall, leading to inflammation, cellular damage, and necrosis of the affected tissue. If left unrecognized or untreated, this can progress to intestinal perforation, resulting in the leakage of intestinal contents into the peritoneal cavity and causing peritonitis. While the exact mechanism behind this bacterial invasion remains unclear, it is believed that the immaturity of the gastrointestinal tract in premature neonates plays a significant role in the pathogenesis of NEC. Factors such as underdeveloped gut motility, impaired intestinal blood flow, and an immature immune response are thought to contribute to the increased susceptibility of preterm infants to this devastating condition. Additionally, the use of artificial feeding methods, such as formula feeding or early introduction of enteral nutrition, has been associated with a higher incidence of NEC, further suggesting the role of gut microbiota and feeding practices in its development. Despite ongoing research, the precise interactions between these factors and the initiation of NEC remain complex and not fully understood.

The exact cause of NEC remains not fully understood, but it is believed to result from a combination of factors. Prematurity is the most significant risk factor, as the immature gastrointestinal tract in preterm infants is more susceptible to injury and infection. The underdeveloped immune system, impaired blood flow to the intestines, and insufficient gut motility contribute to the development of NEC. Bacterial invasion of the intestinal wall triggers inflammation, leading to tissue damage and necrosis. Formula feeding, especially with high osmotic strength formulas, has been identified as a contributing factor, as it may disrupt the delicate balance of the gut microbiota, making the intestines more prone to infection. Additionally, genetic factors may play a role, influencing susceptibility to NEC in some infants. Other potential causes include hypoxic events, such as those seen with congenital heart defects, which can impair blood flow to the intestines, further increasing the risk of NEC.

Diagnosis of NEC typically begins with clinical suspicion based on the presentation of signs such as abdominal distension, poor feeding, and lethargy in a neonate, particularly those who are premature. Imaging studies like abdominal X-rays, which can show Pneumatosis intestinalis (gas within the bowel wall) or free air indicating perforation, are essential for confirming the diagnosis. Blood tests may reveal signs of infection or systemic inflammation. Once NEC is suspected, treatment begins with resuscitation, including airway, breathing, and circulation support, fluid resuscitation for hypotension, and mechanical ventilation if needed. Enteral feedings are stopped, and intravenous antibiotics with broad-spectrum coverage are started. Total parenteral nutrition is provided, and in cases of worsening condition or bowel perforation, surgical intervention may be necessary. Laparotomy is typically performed, focusing on the removal of necrotic tissue while preserving as much bowel as possible. In some cases, peritoneal drains may be used if surgery is contraindicated due to the patient’s instability.

'Necrotizing Enterocolitis- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Necrotizing Enterocolitis pipeline landscape is provided which includes the disease overview and Necrotizing Enterocolitis treatment guidelines. The assessment part of the report embraces, in depth Necrotizing Enterocolitis 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, Necrotizing Enterocolitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Necrotizing Enterocolitis R&D. The therapies under development are focused on novel approaches to treat/improve Necrotizing Enterocolitis.

Necrotizing Enterocolitis Emerging Drugs Chapters

This segment of the Necrotizing Enterocolitis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.

Necrotizing Enterocolitis Emerging Drugs

IBP-9414: Infant Bacterial Therapeutics

IBP-9414 is a new biological entity, containing the active substance Lactobacillus reuteri, which is a human bacterial strain naturally present in breast milk. Lactobacillus reuteri is a live bacterium known to be anti-inflammatory, anti-pathogenic and beneficial to gut motility and gut mucosa maturity. All of these factors aid in preventing NEC which is characterized by excess inflammation and pathogenic activity as well as inhibition of gut motility and maturation. IBP-9414 aims at preventing necrotizing enterocolitis to occur in premature infants and to improve the feeding, growth and wellbeing of vulnerable infants. Currently, the drug is in Phase III stage of its development for the treatment of Necrotizing Enterocolitis.

ST266: Noveome Biotherapeutics

ST-266 is a therapeutic candidate for Necrotizing Enterocolitis, developed by Noveome Biotherapeutics. It is a cell-free sterile biologic solution containing hundreds of proteins derived from amnion-derived cells, which has demonstrated significant potential in preclinical studies to prevent and treat NEC. The drug works by inhibiting Toll-like receptor 4 (TLR4) signaling, reducing intestinal inflammation, and promoting gut remodeling. Noveome has received Orphan Drug Designation for ST-266. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Necrotizing Enterocolitis.

Necrotizing Enterocolitis: Therapeutic Assessment

This segment of the report provides insights about the different Necrotizing Enterocolitis drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Necrotizing Enterocolitis

• There are approx. 2+ key companies which are developing the therapies for Necrotizing Enterocolitis. The companies which have their Necrotizing Enterocolitis drug candidates in the most advanced stage, i.e. Phase III include, Infant Bacterial Therapeutics.

Phases

The report covers around 2+ 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

Necrotizing Enterocolitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Necrotizing Enterocolitis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Necrotizing Enterocolitis 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 Necrotizing Enterocolitis drugs.

Necrotizing Enterocolitis Report Insights

• Necrotizing Enterocolitis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Necrotizing Enterocolitis 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 Necrotizing Enterocolitis drugs?
• How many Necrotizing Enterocolitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Necrotizing Enterocolitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Necrotizing Enterocolitis 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 Necrotizing Enterocolitis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Infant Bacterial Therapeutics
• Noveome Biotherapeutics
• Siolta Therapeutics

Key Products

• IBP-9414
• ST266
• STMC-106

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