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Doxycycline hyclate controlled release - POLYPID

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Drug Profile

Doxycycline hyclate controlled release - POLYPID

Alternative Names: D-PLEX; D-PLEX-100; Doxycycline/polymer-lipid encapsulation matrix; PLEX-doxycycline

Latest Information Update: 30 Mar 2026

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At a glance

  • Originator POLYPID
  • Class Antibacterials; Collagenases; Skin disorder therapies; Tetracyclines
  • Mechanism of Action Protein 30S ribosomal subunit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Surgical wound infections

Most Recent Events

  • 17 Mar 2026 PolyPid plans to submit a rolling New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Surgical wound infections (Prevention) in March 2026
  • 17 Mar 2026 US FDA grants a waiver of the Prescription Drug User Fee Act (PDUFA) fee for New Drug Application (NDA) for D-PLEX100 in Surgical wound infections
  • 11 Feb 2026 PolyPid receives positive feedback from US FDA following pre NDA meeting

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