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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: 21 Mar 2025

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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

  • Preregistration Bladder cancer

Most Recent Events

  • 14 Mar 2025 Janssen Research & Development initiates an pre-approval expanded-access programme for High risk non muscle invasive bladder cancer (Recurrent, Second-line therapy or greater) (NCT06877676)
  • 16 Jan 2025 Preregistration for Bladder cancer (Monotherapy, Second-line therapy or greater) in USA (Intravesicular)
  • 07 Nov 2024 Janssen Research & Development terminates a phase-III trial in Bladder cancer (Combination therapy, Late-stage disease) in USA, Austria, China, France, Greece, Canada, Brazil, Czech Republic, Italy, Japan, Argentina, Australia, Germany, Hungary, South Korea, Mexico, Russia, Spain, Taiwan, Turkey and Ukraine (Intravesicular) for not showing superiority to chemoradiation during a scheduled interim analysis (NCT04658862) (EudraCT2020-002620-36)

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