Drugs / FAPI-46
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| — | NCT05263700 | Feb 2022 → Feb 2024 | cancer of unknown primary site | Peter MacCallum Cancer Centre, Australia | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-11-10 | SOFIE | Regulatory SOFIE gets greenlight from US FDA to proceed to Phase II Pancreatic Cancer Study sofie.com ↗
Dulles, VA – November 10, 2021 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received clearance to proceed with its Fibroblast Activation Protein Inhibitor (FAPI) clinical trial after completing a 30-day IND review with the FDA. |
| 2021-10-12 | SOFIE | Regulatory SOFIE Submits Investigational New Drug Application to US FDA for Pancreatic Cancer Imaging sofie.com ↗
The IND is for a Phase 2, Multicenter, Single Blind, Non-randomized Study of [68Ga]FAPI-46 PET for imaging patients with Pancreatic Ductal Adenocarcinoma (PDAC). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-06 | SOFIE | SOFIE partners with BAMF Health, diversifying sites for Phase II [68Ga]FAPI-46 study sofie.com ↗ |
| 2021-11-10 | SOFIE | SOFIE gets greenlight from US FDA to proceed to Phase II Pancreatic Cancer Study sofie.com ↗ |
| 2021-10-12 | SOFIE | SOFIE Submits Investigational New Drug Application to US FDA for Pancreatic Cancer Imaging sofie.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | FAPI-46 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05263700 ↗ |