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Gemcitabine oral - INNOPHARMAX

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Drug Profile

Gemcitabine oral - INNOPHARMAX

Alternative Names: D07001; D07001-F4; Gemcitabine HCl - INNOPHARMAX; Inno-D07001

Latest Information Update: 26 Jun 2026

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At a glance

  • Originator INNOPHARMAX
  • 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.

    Yes - Cholangiocarcinoma
  • New Molecular Entity No

Highest Development Phases

  • Phase III Biliary cancer
  • No development reported Gastrointestinal cancer; Solid tumours
  • Discontinued Lymphoma

Most Recent Events

  • 09 Jun 2026 Phase-III clinical trials in Biliary cancer (Second-line therapy or greater, Combination therapy, Late-stage disease, Inoperable/Unresectable, Metastatic disease) in USA, USA, Taiwan (PO) (NCT06622057)
  • 01 Oct 2024 INNOPHARMAX plans a phase III trial for Biliary cancer (Combination therapy, Second-line therapy, late-stage disease) in Taiwan (PO, Capsule) in April 2025 (NCT06622057)
  • 28 Dec 2023 No recent reports of development identified for phase-I development in Gastrointestinal-cancer(Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Taiwan (PO, Capsule)

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