Necrotizing Enterocolitis - Pipeline Insight, 2025

DelveInsight's, "Necrotizing Enterocolitis - Pipeline Insight, 2025" report provides comprehensive insights about 4+ companies and 4+ 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.

Geography Covered:

• Global coverage

Necrotizing Enterocolitis: Understanding

Necrotizing Enterocolitis: Overview

Necrotizing enterocolitis (NEC) is a devastating disease that affects mostly the intestine of premature infants. The wall of the intestine is invaded by bacteria, which cause local infection and inflammation that can ultimately destroy the wall of the bowel (intestine). Such bowel wall destruction can lead to perforation of the intestine and spillage of stool into the infant's abdomen, which can result in an overwhelming infection and death. Necrotizing enterocolitis, typically occurring in babies between three and twelve days after birth but sometimes presenting many weeks later, manifests with a range of symptoms that can vary for each baby. Common symptoms include abdominal distention (swelling), bloody stools, poor feeding or feeding intolerance, bile-colored (green) vomiting or gastric drainage, signs of infection such as lethargy (sluggishness) and apnea (cessation of breathing), and temperature instability.

Necrotizing enterocolitis is caused by bacterial invasion into the intestinal wall. This leads to inflammation and cellular destruction of the wall of the intestine. If unrecognized and untreated, an intestinal perforation may occur, causing spillage of intestinal contents into the peritoneum and resulting in peritonitis. The specific mechanism and cause of this bacterial invasion are not yet understood. In premature neonates, gastrointestinal tract immaturity is believed to play a role in the pathogenesis of necrotizing enterocolitis.

The single most important test required to make the diagnosis is an abdominal plain film series including anterior-posterior and left lateral decubitus views. Findings of dilated loops of bowel, pneumatosis intestinalis, and portal venous air is diagnostic for necrotizing enterocolitis. An abdominal radiograph is a valuable tool for tracking the progression of the disease as well. In most cases, this should be repeated serially every 6 hours until definitive treatment has occurred.

Treatment begins with standard resuscitation based on the patient's vital signs. The first intervention when necrotizing enterocolitis is suspected is to stop all enteral feedings and maintain the patient NPO. A nasogastric tube should be placed for decompression of the dilated bowels. Intravenous antibiotics should be started, with broad-spectrum coverage. The suggested antibiotic regimen includes ampicillin, gentamicin, and either clindamycin or metronidazole. Laparotomy is the standard approach, and surgery is as conservative as possible, with removal only of portions of unquestionably necrotic or perforated intestine in an attempt to preserve as much intestine as possible.

"Necrotizing Enterocolitis - Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the mechanism of action. 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

IBT is currently developing its lead drug candidate IBP-9414 to prevent NEC in premature infants. IBP-9414 contains the active substance Lactobacillus reuteri, which is a co-evolved human bacterial strain naturally present in breast milk. Lactobacillus reuteri is a live bacteria known to be anti-inflammatory, anti-pathogenic and beneficial to gut motility. IBP-9414 is formulated with close considerations of age-appropriateness of the vulnerable target population of preterm infants. In June 2016, IBT commenced the Safety and Tolerability study. In late 2017, the results demonstrated a similar safety and tolerability profile in the active group as in the placebo group. IBTs clinical Phase III study of its drug candidate IBP-9414 for the prevention of necrotizing enterocolitis and improvement of feeding tolerance in premature infants, the Connection Study, started in July 2019.

• ST266: Noveome Biotherapeutics

ST266 is a cell-free sterile biologic solution containing hundreds of proteins and other factors at physiologic levels. It is made by culturing a novel population of human amnion-derived cells. Using a proprietary culturing method, these cells produce a unique array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation. Extensive preclinical studies have shown that ST266's multiple components result in a variety of anti-inflammatory and neuroprotective responses. Currently, the drug is in Phase 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. 4+ 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

DelveInsight's report covers around 4+ 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• 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 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
• Infinant Health

Key Products

• IBP-9414
• ST 266
• INF108