Differentiators
Why Intralytix
From the first FDA-approved phage food safety product to AI-powered phage discovery platforms, Intralytix pioneers the science of bacterial control across food safety, environmental sanitation, veterinary applications, human therapeutics, and probiotics.
Regulatory Firsts
- First company in the world to receive FDA and USDA approvals for phage-based food safety products.
- Largest portfolio of FDA-approved phage food safety products: 6 in the U.S., with 3 also approved in Canada and Israel.
- First and only company to receive FDA Center for Veterinary Medicine (CVM) approval for a phage-based product for pet food safety.
- Exceptional regulatory expertise and track record: multiple regulatory approvals/clearances from FDA CFSAN, FDA CBER, FDA CVM, USDA FSIS, and EPA.
Platforms & Intellectual Property
- Pioneer in microbiome-modulating approaches: PhageBiotix™ and SuperBiotix™ platforms.
- Proprietary AI/ML-enabled platforms: PhageSelector™ for phage discovery and cocktail design, and PhageEngine™ for phage AI/ML-guided manufacturing process optimization and scale-up.
- Strong intellectual property portfolio: 17 issued patents, several pending patent applications, and extensive proprietary know-how.
- Established and expanding nutraceutical portfolio: several products on the market and more in development, leveraging Intralytix’s proprietary IP and know-how.
Clinical Trials
- EcoActive Phase 1/2a at Mt. Sinai Medical Center (New York) and Johns Hopkins University (Baltimore). Focused on AIEC and Crohn's disease.
- ShigActive Phase 1/2a at UMD. Funded by the NIAID, NIH. Focused on Shigella spp. / bacterial dysentery.
- VRELysin Phase 1/2a at UPMC. Phase I completed. Focused on vancomycin-resistant Enterococci (VRE).
- Observational clinical trial at the Eliava Institute in Tbilisi, Georgia. Focused on Group B Strep and women's health.
Manufacturing
- In-house cGMP manufacturing (21 CFR 117 compliant).
- 1,500L scale fermentation and downstream processing.
- Commercial scale spray drying capabilities.
- High-throughput screening capability (data-connected liquid handling robots).
- Artificial intelligence (AI) supports scale-up operations.
Certifications
- Kosher, Halal, and "organic" compliant.
- SQF-certified.
Capabilities
- Product formulation and application guidance.
- Best phages, large targeted strain collection (indexed and searchable).
- Efficacy data with analytics.
- Deep understanding of phage-host infection dynamics.
- Rigorous QA/QC; Certificates of quality.
- Finished goods labeling, tracking, and auditing.
Ready to learn more?
Explore our products, ongoing clinical trials, and peer-reviewed publications — or contact us directly to discuss partnership opportunities.