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D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)

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Trial Profile

D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2026

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At a glance

  • Drugs Doxycycline hyclate (Primary) ; Antibacterials
  • Indications Surgical wound infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SHIELD I
  • Sponsors POLYPID

Most Recent Events

  • 11 Feb 2026 According to a POLYPID media release, company ceceived positive feedback from the U.S. Food and Drug Administration (FDA) following the pre-New Drug Application (NDA) meeting minutes for D-PLEX 100 in the prevention of abdominal colorectal surgical site infections (SSIs) for a planned rolling NDA submission beginning by the end of the first quarter of 2026.
  • 12 Nov 2025 According to a POLYPID media release, a face-to-face pre- New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) scheduled for early December
  • 17 Sep 2025 According to a POLYPID media release, the company plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Surgical wound infections (Prevention) in early 2026.

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