FDA granted Priority Review to PolyPid’s D-PLEX100 NDA for preventing surgical site infections after colorectal surgery, with a PDUFA date of November 28, 2026.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
PolyPid Ltd. has reached a major regulatory milestone after the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for D-PLEX100 and granted the investigational therapy Priority Review for the prevention of surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 28, 2026, approximately one quarter earlier than the company’s previously anticipated first-quarter 2027 timeline.
The agency also reported no filing review issues during its initial assessment, allowing the application to proceed directly into an accelerated six-month review period instead of the standard 10-month review.
D-PLEX100 Targets a Major Unmet Need in Surgical Site Infection Prevention
Surgical site infections remain among the most common postoperative complications after colorectal surgery, contributing to prolonged hospitalization, repeat procedures, higher healthcare costs, and increased morbidity. Despite routine preventive measures, infection rates remain significant, particularly in patients undergoing large-incision abdominal procedures.
D-PLEX100 combines doxycycline with PolyPid’s Kynatrix drug delivery platform, which provides sustained local antibiotic release directly at the surgical site for up to 30 days. The localized approach maintains high antibiotic concentrations where bacterial contamination occurs while minimizing systemic exposure. The prolonged delivery may also prevent infections caused by antibiotic-resistant organisms at the surgical wound.
The investigational therapy previously received FDA Breakthrough Therapy Designation for preventing SSIs in patients undergoing elective colorectal surgery.
Phase 3 SHIELD II Trial Supported the NDA Submission
The NDA is supported by results from the Phase 3 SHIELD II trial (NCT04411199) evaluating D-PLEX100 in patients undergoing abdominal colorectal surgery with large incisions.
The study met its primary endpoint and demonstrated a 60% relative reduction in surgical site infections at a key secondary endpoint compared with standard care (p=0.0013). These findings strengthened evidence supporting the local antibiotic delivery strategy for reducing postoperative infections in a high-risk surgical population.
The company did not report new safety findings in the regulatory update.
Priority Review Accelerates Regulatory Timeline
FDA Priority Review is reserved for therapies that could offer significant improvements in the treatment or prevention of serious conditions. The designation shortens the agency’s review goal from approximately 10 months to six months.
PolyPid Chief Executive Officer Dikla Czaczkes Akselbrad said the acceptance of the NDA with Priority Review, together with the absence of filing review issues, reflects the strength of the company’s regulatory submission and clinical development program. She added that PolyPid and its commercialization partner, Azurity Pharmaceuticals, will continue supporting the FDA review with the goal of making D-PLEX100 available for patients following abdominal colorectal surgery if approved.
Milestone Payment and Commercialization Plans
FDA acceptance of the NDA triggered a $15 million milestone payment from Azurity Pharmaceuticals under the companies’ exclusive U.S. and Canadian commercialization agreement announced earlier this month. The payment completes $30 million in upfront and near-term milestone payments under the partnership.
PolyPid will work with the FDA throughout the review process leading to the November 28, 2026 PDUFA decision. If approved, Azurity plans to launch D-PLEX100 in the United States in early 2027, providing a new locally administered option to help prevent surgical site infections following abdominal colorectal surgery.
Reference
PolyPid Announces FDA Acceptance of NDA with Priority Review for D-PLEX₁₀₀ | Polypid
About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.