Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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)

Next Previous
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: 28 Aug 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

  • 12 Aug 2026 According to a POLYPID media release, during the second quarter of 2026, the Company held productive and positive meetings with the EMA Rapporteur and Co-Rapporteur, aligning on the timeline and requirements for the planned MAA submission.
  • 13 May 2026 According to a POLYPID media release, company plans submission of the MAA to the EMA for D-PLEX 100 under the Centralized Procedure on the basis of therapeutic innovation in the third quarter of 2026.
  • 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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top