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Gallium-68 FAPI 46 - GE Healthcare

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Drug Profile

Gallium-68 FAPI 46 - GE Healthcare

Alternative Names: 68Ga-FAPi-46; [68Ga]FAPI-46

Latest Information Update: 23 Feb 2026

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At a glance

  • Originator University of Heidelberg
  • Developer GE Healthcare; SOFIE; University of California
  • Class Antineoplastics; Imaging agents; Quinolines; Radioisotopes; Radiopharmaceutical diagnostics; Small molecules
  • Mechanism of Action Positron-emission tomography enhancers
  • 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 II Malignant-mesothelioma; Pancreatic cancer
  • Phase I/II Sjogren's syndrome
  • No development reported Breast cancer; Cholangiocarcinoma; Gastric cancer; Interstitial lung diseases; Ovarian cancer

Most Recent Events

  • 22 Feb 2026 Academisch Ziekenhuis Maastricht plans phase II trial in Non small cell lung cancer (Diagnosis) in February 2027 (IV) (CTIS2025-523032-39-00)
  • 09 Dec 2025 SOFIE in collaboration with Mayo Clinic plans a early phase I trial for Crohn's disease (Diagnosis) in January 2026 (NCT07273188)
  • 04 Nov 2025 SOFIE completes the phase-II FAPI-46 PDAC trial in Pancreatic cancer (Diagnosis) in USA (IV, Injection) (NCT05262855)

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