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68Ga-FAPi-46
68Ga-FAPi-46 is a Radiopharmaceutical diagnostic imaging agent Small molecule drug developed by Peter MacCallum Cancer Centre, Australia. It is currently in Phase 2 development. Also known as: Gallium-68-FAPi-46.
A gallium-68 labeled tracer that binds to fibroblast activation protein (FAP) expressed on cancer-associated fibroblasts for PET imaging.
68Ga-FAPi-46 is a PET/CT imaging agent used to study conditions such as nasopharyngeal cancer, pleural mesothelioma, and cancer. It is labeled with gallium-68 and is a fibroblast activation protein inhibitor.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | 68Ga-FAPi-46 |
|---|---|
| Also known as | Gallium-68-FAPi-46 |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Drug class | Radiopharmaceutical diagnostic imaging agent |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
68Ga-FAPi-46 is a radiolabeled small molecule inhibitor that selectively binds to FAP, a serine protease highly expressed on cancer-associated fibroblasts in the tumor stroma. Upon binding, the gallium-68 isotope enables visualization of FAP-expressing tissues through positron emission tomography (PET) imaging.
Approved indications
Common side effects
Key clinical trials
- Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT (NA)
- FAPI-PET Value for the Initial Screening of Pancreatic and Biliary Cancers (PHASE2)
- 68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases (NA)
- The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389 on FAP Occupancy in the Liver in Participants With Advanced Liver Fibrosis. (PHASE1)
- 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease (EARLY_PHASE1)
- Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer (PHASE2)
- Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers (PHASE1)
- Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- 68Ga-FAPi-46 CI brief — competitive landscape report
- 68Ga-FAPi-46 updates RSS · CI watch RSS
- Peter MacCallum Cancer Centre, Australia portfolio CI
Frequently asked questions about 68Ga-FAPi-46
What is 68Ga-FAPi-46?
How does 68Ga-FAPi-46 work?
Who makes 68Ga-FAPi-46?
Is 68Ga-FAPi-46 also known as anything else?
What drug class is 68Ga-FAPi-46 in?
What development phase is 68Ga-FAPi-46 in?
Related
- Drug class: All Radiopharmaceutical diagnostic imaging agent drugs
- Manufacturer: Peter MacCallum Cancer Centre, Australia — full pipeline
- Also known as: Gallium-68-FAPi-46
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing