Drugs / [18F]FAPI-74
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07830771 | Sep 2026 → Sep 2028 expected | pulmonary tuberculosis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07705074 | Aug 2026 → Sep 2029 expected | breast cancer, castration-resistant prostate carcinoma, endometriosis, fibrotic liver disease +12 | Martin Huellner | Not yet recruiting | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT07285993 | Jun 2026 → Dec 2027 expected | invasive lobular breast carcinoma | Randy Yeh | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06503146 | Sep 2025 → Jun 2028 expected | cholangiocarcinoma, gastric cancer, hepatocellular carcinoma, mesothelioma +6 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06568783 | Dec 2024 → Oct 2027 expected | dermatomyositis | Farshad Moradi | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05641896 | Apr 2023 → Jun 2025 | cholangiocarcinoma, colorectal cancer, gastric cancer, hepatocellular carcinoma +1 | SOFIE | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07018661 | Jul 2025 → Jan 2028 expected | gastric adenocarcinoma | Leiden University Medical Center | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07613099 | Sep 2026 → May 2031 expected | acute lung injury, disease related to hematopoietic stem cell transplant, interstitial lung disease, pulmonary arterial hypertension | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase 3 | NCT07217717 | Dec 2025 → Dec 2027 expected | pancreatic ductal adenocarcinoma | SOFIE | Recruiting | No outcome recorded |
| Phase 3 | NCT07217704 | Nov 2025 → Aug 2027 expected | esophageal cancer, gastric cancer, gastroesophageal cancer | SOFIE | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-01-23 | SOFIE | Results SOFIE’s Phase 2 FAPI Study Outcomes Showcased at ASCO GI 2026 sofie.com ↗
The multi-center trial showed that [ 18 F]FAPI-74 PET detects FAP expression and presence of disease in cancers of the gastrointestinal tract, with high positive predictive values for both sensitivity and specificity of metastatic disease. |
| 2025-10-01 | SOFIE | Results SOFIE Biosciences Prepares Launch of Two [18F]FAPI-74 Phase 3 Studies, following successful FDA engagement sofie.com ↗
The trial results demonstrated a 100% positive predictive value for the primary objective of detecting FAP-expressing cells, and a 94% positive predictive value in detecting the presence of disease in cancers of the GI tract. |
| 2022-11-29 | SOFIE | Regulatory SOFIE granted IND for 18F-FAPI in Phase 2 study sofie.com ↗
Dulles, VA – November 29, 2022 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received Investigational New Drug (IND) clearance to proceed with clinical study of [ 18 F]FAPI-74, its lead fluorine-18 labelled Fibroblast Activation Protein Inhibitor (FAPI) product. |
| 2022-10-31 | SOFIE | Regulatory SOFIE submits IND for [18F]-FAPI-74 in Phase 2 study of Gastrointestinal Cancers sofie.com ↗
SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has submitted the IND for [ 18 F]FAPI-74, fluorine 18 labelled radiopharmaceutical targeting Fibroblast Activation Protein (FAP) to the FDA. |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | 18F-FAPI-74 | “To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.” NCT07613099 ↗ |
| Known as | FAPI-74 | “[18F]FAPI-74 is a novel PET radiotracer that binds selectively to FAP, enabling visualization of fibroblast activity.” NCT07705074 ↗ |
| Action | Inhibit | “Radiolabeled fibroblast-activating protein inhibitors (FAPI), targeting stromal cancer-associated fibroblasts, are promising radiotracers.” PMID 41299326 ↗ Nov 2025 |
| Modality | Diagnostic / imaging agent | “radioactive diagnostic agent” NCT05641896 ↗ |
| Route | Intravenous | “intravenously” NCT05641896 ↗ |