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A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection

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A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2025

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At a glance

  • Drugs Amoxicillin/omeprazole/rifabutin (Primary) ; Amoxicillin; Omeprazole
  • Indications Helicobacter pylori infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ERADICATE Hp 2
  • Sponsors RedHill Biopharma

    • Most Recent Events

    • 18 Mar 2025 According to a RedHill Biopharma media release, the company announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of H. pylori infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP). Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the 4Q of 2025.
    • 12 Mar 2024 According to a RedHill Biopharma media release,the company announced the issue of a new U.S. patent covering Talicia as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori (H. pylori) infection (Patent No. 11,931,463 to be issued March 19, 20244)
    • 01 Aug 2023 According to a RedHill Biopharma media release, Gaelan Medical received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin).

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