Drugs / bacteriophage preparation
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07533292 | Apr 2026 → Dec 2029 expected | prosthesis-related infectious disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-09-30 | Intralytix, Inc. | Regulatory Intralytix Receives FDA CVM Approval for Salmonella-Targeting Phage Preparation for Use in Pet Food Applications intralytix.com ↗
Intralytix, Inc., a global leader in bacteriophage technology, announced today that it has received formal approval from the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM) for its Salmonella-specific bacteriophage preparation for use as a processing aid to help control S. enterica in pet food and ingredients for use in pet food. |
| 2022-05-09 | Intralytix, Inc. | Regulatory Intralytix Granted Clearance by the FDA for an Investigational New Drug Application for Phase 1/2a Clinical Trials for Vancomycin Resistant Enterococci (VRE)-targeting Phage Preparation intralytix.com ↗
This IND approved by the FDA is an exciting step in advancing phage therapy in the U.S. |
| 2021-10-25 | Intralytix, Inc. | Regulatory Intralytix Receives FDA Clearance for Investigational New Drug Application for Phase 1/2a Clinical Trials for Shigella-targeting Phage Preparation intralytix.com ↗
We are thrilled to have this IND approved by the FDA. |
| 2018-02-15 | Intralytix, Inc. | Regulatory Intralytix Receives FDA clearance to initiate Phase I / IIa clinical trials intralytix.com ↗
Intralytix, Inc. announced today that it received clearance from the Food and Drug Administration (FDA) to initiate Phase I / IIa clinical trials at Mount Sinai hospital in New York, NY. |
All press releases naming this drug 4 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bacteriophage preparation | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07533292 ↗ |
| Modality | Other / unclassified | “Biological: bacteriophage preparation” NCT07533292 ↗ |
| Route | Other | “administered primarily via postoperative indwelling catheter infusion” NCT07533292 ↗ |