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[18F]FAPI-74 PET/CT
[18F]FAPI-74 PET/CT is a PET imaging agent Small molecule drug developed by SOFIE. It is currently in Phase 3 development for Visualization of tumors expressing fibroblast activation protein (FAP).
This drug is a PET imaging agent that targets the fibroblast activation protein (FAP) for the visualization of tumors.
This drug is a PET imaging agent that targets the fibroblast activation protein (FAP) for the visualization of tumors. Used for Visualization of tumors expressing fibroblast activation protein (FAP).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | [18F]FAPI-74 PET/CT |
|---|---|
| Sponsor | SOFIE |
| Drug class | PET imaging agent |
| Target | Fibroblast activation protein (FAP) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FAP is a type II transmembrane glycoprotein that is overexpressed in various types of cancer. [18F]FAPI-74 is a radiolabeled peptide that selectively binds to FAP, allowing for the visualization of tumors expressing this protein.
Approved indications
- Visualization of tumors expressing fibroblast activation protein (FAP)
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- [18F]FAPI-74 PET/CT CI brief — competitive landscape report
- [18F]FAPI-74 PET/CT updates RSS · CI watch RSS
- SOFIE portfolio CI
Frequently asked questions about [18F]FAPI-74 PET/CT
What is [18F]FAPI-74 PET/CT?
How does [18F]FAPI-74 PET/CT work?
What is [18F]FAPI-74 PET/CT used for?
Who makes [18F]FAPI-74 PET/CT?
What drug class is [18F]FAPI-74 PET/CT in?
What development phase is [18F]FAPI-74 PET/CT in?
What does [18F]FAPI-74 PET/CT target?
Related
- Drug class: All PET imaging agent drugs
- Target: All drugs targeting Fibroblast activation protein (FAP)
- Manufacturer: SOFIE — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Visualization of tumors expressing fibroblast activation protein (FAP)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing