Necrotizing Enterocolitis Clinical Trials Analysis 2025: Probiotics, HMOs, and Regenerative Therapies Advance Prevention and Care | DelveInsight

DelveInsight's "Necrotizing Enterocolitis (NEC) - Clinical Trials Analysis, 2025" highlights an evolving pipeline aimed at reducing NEC incidence and severity in preterm infants. With NEC remaining a leading cause of neonatal morbidity and mortality, clinical studies are shifting toward microbiome-based prevention, human milk-derived biologics, and regenerative approaches.

Probiotic regimens containing Bifidobacterium and Lactobacillus strains are showing consistent efficacy in lowering NEC rates and mortality, driving wider adoption in NICUs. Parallel trials of human milk oligosaccharides (HMOs) are underway, designed to enhance gut maturation and immune protection.

Innovative approaches, such as mesenchymal stem cell-derived therapies and exosomes, are transitioning from preclinical success to early clinical evaluation, with the goal of repairing intestinal injury and enhancing survival. Regulatory momentum is also evident, with the FDA granting orphan and rare pediatric designations in 2025 for microbiome-based candidates like INF108.

The NEC clinical trial landscape features a mix of academic consortia, biotech startups, and established pediatric firms. Upcoming readouts from large-scale probiotic and HMO trials, along with first-in-human regenerative therapies, are expected to shape future standards of NEC prevention and management.

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Key Takeaways from the Necrotizing Enterocolitis Pipeline Report
• DelveInsight's necrotizing enterocolitis pipeline analysis depicts a strong space with 2+ active players working to develop 2+ pipeline drugs for necrotizing enterocolitis treatment.
• The leading necrotizing enterocolitis companies include Infant Bacterial Therapeutics, Noveome Biotherapeutics, Siolta Therapeutics, and others are evaluating their lead assets to improve the necrotizing enterocolitis treatment landscape.
• Key necrotizing enterocolitis pipeline therapies in various stages of development include IBP-9414, ST266, STMC-106, and others.
• In May 2025, Infinant Health announced that the FDA has granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to its investigational drug candidate, INF108, for the prevention of necrotizing enterocolitis in preterm infants.
• In May 2025, the NEC baby formula multidistrict litigation (MDL) added 27 new cases in April, bringing the total to approximately 710 pending cases in federal court, with additional cases in state courts, reflecting ongoing legal challenges for formula manufacturers.
• In May 2025, a U.S. federal judge allowed expert testimony asserting that preterm baby formulas produced by Abbott Laboratories and Mead Johnson can cause NEC, a significant decision as the companies face over 700 federal lawsuits.
• In February 2025, Dr. Venkatesh Sampath received a $2.5 million NIH grant to investigate the mechanisms underlying NEC in premature infants, aiming to enhance understanding and develop preventive strategies.
• In October 2024, the FDA, CDC, and NIH hosted a public workshop titled "Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants," focusing on regulatory and scientific issues related to live biotherapeutic products for NEC prevention.
• In September 2024, the NIH released a report recommending 17 strategies to advance research on NEC, emphasizing the need for a better understanding of disease mechanisms, early diagnosis, and the development of preventive and therapeutic interventions.
• In February 2024, researchers at Lurie Children's Hospital reported that recombinant human insulin-like growth factor 1 and its binding protein-3 (rhIGF-1/BP3) protected neonatal mice from NEC, paving the way for clinical trials targeting NEC prevention in preterm infants.

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Necrotizing Enterocolitis Overview
Necrotizing enterocolitis (NEC) is a severe gastrointestinal disease that primarily affects premature and low-birth-weight infants, characterized by inflammation, bacterial invasion, and necrosis of the intestinal wall. It can rapidly progress to intestinal perforation, peritonitis, sepsis, and death, with mortality rates reaching up to 50%. Symptoms are often subtle and nonspecific, such as poor feeding, vomiting, lethargy, and abdominal distension-necessitating prompt recognition and intervention. While the exact cause remains unclear, NEC is linked to prematurity, immature gut function, impaired blood flow, and a weakened immune system. Bacterial colonization, inflammation, and formula feeding-which may disrupt healthy gut microbiota, are key contributors. Additional risk factors include genetic predisposition, hypoxic injury, and underlying congenital heart disease.

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Necrotizing Enterocolitis Treatment Analysis: Drug Profile
IBP-9414 - Infant Bacterial Therapeutics
IBP-9414 is a novel biological therapy developed to prevent necrotizing enterocolitis (NEC) in premature infants. It contains Lactobacillus reuteri, a beneficial bacterial strain naturally found in breast milk, known for its anti-inflammatory and gut-protective properties. The live bacterium supports gut motility, mucosal maturation, and reduces pathogenic activity-all critical factors in NEC prevention. In addition to reducing NEC risk, IBP-9414 aims to improve feeding, growth, and overall health in vulnerable neonates. The therapy is currently in Phase III development for NEC.

ST266 - Noveome Biotherapeutics
ST266 is an investigational, cell-free biologic therapy being developed by Noveome Biotherapeutics for the treatment of NEC. Derived from amnion-based cells, ST266 contains hundreds of bioactive proteins that work to reduce intestinal inflammation, inhibit TLR4 signaling, and support gut repair. Preclinical data have shown promising protective effects against NEC. The therapy has received Orphan Drug Designation and is currently in Phase I/II clinical trials.

Learn more about the novel and emerging necrotizing enterocolitis pipeline therapies @ https://www.delveinsight.com/report-store/necrotizing-enterocolitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Necrotizing Enterocolitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Necrotizing Enterocolitis Pipeline Report
• Coverage: Global
• Key Necrotizing Enterocolitis Companies: Infant Bacterial Therapeutics, Noveome Biotherapeutics, Siolta Therapeutics, and others.
• Key Necrotizing Enterocolitis Pipeline Therapies: IBP-9414, ST266, STMC-106, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Necrotizing Enterocolitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Necrotizing Enterocolitis Pipeline Therapeutics
6. Necrotizing Enterocolitis Pipeline: Late-Stage Products (Phase III)
7. Necrotizing Enterocolitis Pipeline: Mid-Stage Products (Phase II)
8. Necrotizing Enterocolitis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.