SOFIE
Dallas, TX
Works in GI & liver · Oncology
SOFIE is a clinical trial sponsor based in Dallas, TX. It has 2 active clinical trials with 400 planned participants, in GI & liver and Oncology. Since 2021 it has completed 2 trials and stopped 0 early. Its FDA record on file shows 1 inspection.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 2 active trials
| Stage | Trial | Status |
|---|---|---|
Questions about SOFIE
No warning letter naming SOFIE is on file. FDA has published 1 inspection classification naming it.
FDA has posted 1 inspection classification naming SOFIE. The latest inspection ended on 2026-04-21 and was classified VAI (voluntary action indicated). FDA posts a classification after its review, often months after the inspection ended.
SOFIE is lead sponsor of 2 active clinical trials on ClinicalTrials.gov, with 400 planned participants, in GI & liver, Oncology. Since 2021 it has completed 2 trials and stopped 0 early.
SOFIE is based in Dallas, TX. The address is the one on its FDA records or ClinicalTrials.gov registrations, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with SOFIE; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-10-01.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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