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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: 18 Sep 2026

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At a glance

  • Originator University of Heidelberg
  • Developer GE Healthcare; SOFIE; University Medical Center Groningen; University of California
  • Class Antineoplastics; Gallium radioisotopes; 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 III Adult respiratory distress syndrome; Post acute COVID 19 syndrome
  • 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

  • 14 Sep 2026 Mayo Clinic plans a phase I trial for Interstitial lung disease (Diagnosis) in USA (IV) in October 2026 (NCT07817563)
  • 28 Aug 2026 Rigshospitalet plans a phase II trial for Sarcoma (In infants, In Children, In adolescents, Diagnosis) in Denmark (IV) (CTIS-2025-524874-41-00)
  • 01 Jun 2026 University hospital in Nantes plans a phase II trial for Transthyretin related hereditary amyloidosis in France (IV) (CTIS2025-523616-36-00)

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