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Details:
D-PLEX (doxycycline) is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (SSIs).
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2024
Details:
Doxycycline for Injection, USP is a Protein 30S ribosomal subunit inhibitor, which is used for prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Doxycycline-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2023
Details:
D-PLEX100 (doxycycline), is novel product candidate designed to provide local prolonged anti-bacterial activity directly at surgical site to prevent SSI and,has shown result by significantly decreasing surgical site infections in abdominal surgery with colorectal resection.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2022
Details:
D-PLEX100 (doxycycline), PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent SSIs.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Proceeds from the loan will be used to support global commercialization preparations for the launch of D-PLEX100 for the prevention of abdominal soft tissue surgical site infections (SSIs), as well as further advancement of PolyPid’s OncoPLEX development platform.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kreos Capital VI
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing April 06, 2022
Details:
The designation is based on conclusive positive results from a Phase 2 trial of D-PLEX100 for the prevention of surgical site infections in abdominal colorectal surgery. D-PLEX100 significantly decreased in SSIs of 59% in the Intent to Treat population.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
Research found that eight-week course of the proven leprosy drug dapsone combined with doxycycline and rifampin is effective in improving symptoms in 98% of patients suffering from chronic Lyme disease/Post Treatment Lyme Disease Syndrome (PTLDS).
Lead Product(s): Dapsone,Doxycycline,Rifampicin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
PolyPid's D-PLEX100 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the prevention of post abdominal surgery incisional infections.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
CLS-AX was observed to be well tolerated in all animal species evaluated, with no overt signs of toxicity.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2020
Details:
Zydus Cadila has received approval for its supplemental Abbreviated New Drug Application (SANDA) for Doxycycline Injection USP, 100 mg/Vial from the US FDA.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2020
Details:
SHIELD I is a multicenter, randomized, double blind Phase 3 trial designed to assess the efficacy & safety of D-PLEX100 administered concomitantly with the Standard of Care (SoC) vs SoC-treated control arm, to prevent post- abdominal surgery incisional infection.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: D-PLEX100
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
SHIELD will evaluate D-PLEX100 plus the standard of care (SoC) versus SoC only for the prevention of sternal wound infection post-cardiac surgery.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2020
Details:
The proceeds from the round would be used to finance advanced clinical development of its leading product, D-Plex100.
Lead Product(s): Doxycycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aurum Ventures
Deal Size: $105.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 24, 2020
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