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Gemcitabine controlled release - TARIS Biomedical

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Drug Profile

Gemcitabine controlled release - TARIS Biomedical

Alternative Names: Gemcitabine-releasing intravesical system - TARIS; GemRIS™; JNJ-17000139; JNJ-17000139-AAC; RIS/gemcitabine; TAR-200

Latest Information Update: 23 Jan 2024

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At a glance

  • Originator AstraZeneca; TARIS Biomedical
  • Developer Bristol-Myers Squibb; Janssen Research & Development; TARIS Biomedical
  • Class Amines; Antineoplastics; Deoxyribonucleosides; Fluorinated hydrocarbons; Ketones; Pyrimidine nucleosides; Pyrimidines; Small molecules
  • Mechanism of Action Antimetabolites; DNA synthesis 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

Highest Development Phases

  • Phase III Bladder cancer

Most Recent Events

  • 23 Jan 2024 Janssen Research & Development plans a phase III SunRISe-5 trial for Bladder cancer (Recurrent) in April 2024 (Intravesicular) (NCT06211764)
  • 04 Dec 2023 Gemcitabine controlled release - TARIS Biomedical receives Breakthrough Therapy status for Bladder cancer (Monotherapy, Second-line therapy or greater) in USA
  • 22 Oct 2023 Updated efficacy and adverse events data from the phase II SunRISe-1 trial in Bladder cancer released by Janssen Research & Development
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