American Regent, Inc.
Shirley, NY
Works in Cardiovascular · Dermatology · GI & liver · Hematology · Immunology · Metabolic & endocrine · Neurology · Oncology · Psychiatry · Renal & urogenital · Respiratory · Women's health
American Regent, Inc. is a clinical trial sponsor based in Shirley, NY. It has no active clinical trials as lead sponsor; its trials since 2021 were across 12 therapeutic areas. Since 2021 it has completed 20 trials and stopped 7 early. Its FDA record on file shows 1 inspection and 1 recall.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 0 active trials
No active trials with this company as lead sponsor.
Questions about American Regent, Inc
No warning letter naming American Regent, Inc is on file. FDA has published 1 inspection classification and 1 recall naming it.
FDA has posted 1 inspection classification naming American Regent, Inc. The latest inspection ended on 2026-06-18 and was classified VAI (voluntary action indicated). FDA posts a classification after its review, often months after the inspection ended.
Yes. FDA's enforcement reports list 1 recall by American Regent, Inc; the latest, reported on 2026-09-16, is a Class I recall.
American Regent, Inc has no active clinical trials as lead sponsor on ClinicalTrials.gov. Since 2021 it has completed 20 trials and stopped 7 early.
American Regent, Inc is based in Shirley, NY. 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 American Regent, Inc; 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 2025-10-23.
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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