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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: 06 Aug 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

  • Preregistration Surgical wound infections

Most Recent Events

  • 29 Jul 2026 US FDA assigns PDUFA action date of 28/11/2026 for Doxycyline hyclate controlled release for Surgical wound infections (Prevention)
  • 29 Jul 2026 US FDA accepts NDA for Doxycycline hyclate controlled release for Surgical wound infections (Prevention, Adjunctive treatment) and grants Priority Review
  • 21 Jul 2026 PolyPid expects US FDA acceptance of NDA in Surgical wound infections in August 2026

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