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68-Ga FAPI 46

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Drug Profile

68-Ga FAPI 46

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

Latest Information Update: 06 Oct 2025

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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

  • 01 Sep 2025 Centre Hospitalier Universitaire De Bordeauxplans a phase-II FAPDIG trial for Cholangiocarcinoma and Adenocarcinoma (Diagnosis) in France (IV, Injection) (CTIS2024-517270-23-00)
  • 05 May 2025 Erasmus Medical Center plans a clinical trial for Peritoneal metastases (Diagnosis) (IV) in September 2025 (NCT06957782)
  • 11 Apr 2025 GE Healthcare plans a phase I trial for Solid tumours in USA (IV) (NCT06922825)

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