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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: 10 Dec 2025

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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

  • 03 Dec 2025 PolyPid held a Pre-NDA meeting with US FDA for NDA submission of Doxycycline hyclate controlled release in Surgical wound infections
  • 12 Nov 2025 Doxycycline hyclate controlled release - POLYPID is available for licensing as of 12 Nov 2025
  • 13 Aug 2025 Adverse events data from a phase III SHIELD II trial in Surgical wound infections released by POLYPID

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