D-PLEX100
D-PLEX100 is a locally delivered tetracycline-class antibiotic developed by PolyPid to prevent surgical site infections. The next event is the FDA decision on D-PLEX 100, on Nov 28, 2026 (source).
- Also known as
- D-PLEX 100
- Company
- PolyPid (PYPD) · Developer
- How it works
- Locally delivered tetracycline antibiotic
- Approved
- Not approved in any market we track
Development by disease
| Surgical site infection prevention | Filed |
Upcoming events
Firm dates · a specific day set by the company or regulator
Next 60 days
- Nov 28in 46 daysD-PLEX 100 · FDA decision · Surgical site infection prevention · colorectal surgery
Past results and milestones
- Oct 1, 2026FDA accepted D-PLEX 100 NDA and granted Priority Review status, confirming the August 2026 acceptance milestone and establishing November 28, 2026 as the PDUFA goal date. Source
- Jun 1, 2026Clinical section of NDA submitted, completing the full application on rolling review basis. NDA supported by positive Phase 3 SHIELD II results meeting primary endpoint with 60% relative risk reduction in SSIs (p=0.0013). Source
- Mar 31, 2026NDA submission for D-PLEX 100 initiated on March 31, 2026 with CMC and nonclinical sections filed under Fast Track rolling review; clinical section expected in Q2 2026. Submission follows positive Phase 3 SHIELD II trial results and FDA pre-NDA meeting feedback. Source
- Aug 13, 2025SHIELD II Phase 3 trial successfully met primary efficacy endpoint with statistically significant results (p≤0.005) in 798 patients, demonstrating 58% reduction in SSI rate. All key secondary efficacy endpoints were also met. Source