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# PolyPid NDA Accepted for Preventing Surgical Site Infection
- URL: https://www.fdaweb.com/polypid-nda-accepted-for-preventing-surgical-site-infection/
- Published: 2026-07-29T12:00:00.000Z
- Updated: 2026-09-14T13:44:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161537

FDA has accepted for priority review a PolyPid NDA for D-PLEX100 for the prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. The agency set a user fee review action target date of 11/28.

The company says D-PLEX100 is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site with the goal of preventing abdominal surgical site infections. “Following the administration of D-PLEX100 into the surgical site, PolyPid's delivery technology, Kynatrix, is designed to pair with active pharmaceutical ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site,” the company says.

The submission is based on data from the Phase 3 SHIELD II trial where D-PLEX100 demonstrated positive results in achieving its primary endpoint and a 60% relative risk reduction at the secondary endpoint in SSI incidence following abdominal colorectal surgery with large incisions, according to PolyPid.