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Drugs in development · updated 30 October 2026

[68Ga]Ga-FAPI-46: clinical trials and development status

Other names and codes: Gallium Ga 68 FAPi-46

FDA substance registryNot approved in the USNo EMA authorisation

As of 30 October 2026 [68Ga]Ga-FAPI-46 is in 9 active clinical trials (recruiting or ongoing, phases I–III) for 25 diseases. The most advanced phase is II.

9Active trials
IIMost advanced phase
25Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow [68Ga]Ga-FAPI-46 and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Pancreatic neoplasmII2NCT05518903
Breast neoplasmII1NCT06540872
Head and neck squamous cell carcinomaII1NCT06794372
Intraductal carcinoma of the breastII1NCT06540872
Malignant mesotheliomaII1NCT06790082
MelanomaII1NCT07215182
NeoplasmII1NCT06790082
Pancreatic cancer, adultII1NCT07629609
Pleural diseaseII1NCT06790082
Signet ring cell adenocarcinomaII1NCT07629609
Adrenal gland neoplasmI1NCT04459273
Bladder neoplasmI1NCT04459273
Brain NeoplasmsI1NCT04459273
CholangiocarcinomaI1NCT04459273
Hematologic neoplasmI1NCT04459273
Hepatocellular carcinomaI1NCT04459273
Neoplasms, Unknown PrimaryI1NCT04459273
Neuroendocrine tumorI1NCT04459273
Skin neoplasmI1NCT04459273
Testicular NeoplasmsI1NCT04459273
Thymus neoplasmI1NCT04459273
Thyroid neoplasmI1NCT04459273
Transitional cell carcinomaI1NCT04459273
Uterine cervix neoplasmI1NCT04459273
SarcomaEarly I1NCT04457258

Everything on [68Ga]Ga-FAPI-46

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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