Organization (Industry)
American Regent (United States)
ClinicalTrials.gov lists American Regent (United States) as lead sponsor of 53 trials. It has 34 active development programs and 17 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers American Regent (United States): 53 lead-sponsored trials and 1 legal-entity registration.
Disease areas (39)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Anemia | 35 |
| Iron Deficiencies | 18 |
| Anemia, Iron-Deficiency | 17 |
| Renal Insufficiency, Chronic | 6 |
| Parasomnias | 5 |
Showing 5 of 39 disease areas.
Trials by start year as sponsor or collaborator (19)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 2 |
| 2024 | 2 |
| 2022 | 1 |
| 2019 | 2 |
| 2017 | 3 |
| 2015 | 5 |
| 2014 | 2 |
| 2013 | 5 |
| 2012 | 2 |
| 2011 | 2 |
Showing 10 of 19 years.
Recruitment duration, a model prediction: none of the 53 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (34)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Ferric Carboxymaltose | Restless Legs Syndrome | Phase 3 | 4 |
| Ferric Carboxymaltose | Parasomnias | Phase 3 | 4 |
| Taxoprexin | Melanoma | Phase 3 | 3 |
| Oral Iron + Erythropoietin | Renal Insufficiency, Chronic | Phase 3 | 1 |
| Iron Sucrose + Erythropoietin | Renal Insufficiency, Chronic | Phase 3 | 1 |
Showing 5 of 34 active programs.
Approved assets (17)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Ferric Carboxymaltose | 28 |
| Ferrous Sulfate Tablets | 5 |
| Iron Sucrose | 5 |
| Fixed-dose trace element combination product of zinc, copper, and selenious acid | 2 |
| Tralement | 2 |
Showing 5 of 17 approved assets.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 44% hit target (n=9) | 33% on time (n=6) |
Journals published in (32)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Circulation. Heart failure | 3 |
| Journal of the American College of Cardiology | 3 |
| Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association | 3 |
| American heart journal | 2 |
| Circulation | 2 |
Showing 5 of 32 journals.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 36 |
FDA recalls (8)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 | Class III | 2026-04-16 |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, Mfd for: Civica, Inc., Lehi, UT 84043,Mfd by: American Regent, Inc., New Albany, OH 43064. NDC Carton: 72572-470-10/ NDC Vial: 72572-470-01. | Class II | 2025-04-18 |
| niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 mL Single Dose Vial, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC carton: 0517-0735-10 / NDC Vial: 0517-0735-01] | Class II | 2025-04-18 |
| Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-534-01 (vial), NDC: 49230-534-25 (25 x 5 mL/vial cartons). | Class II | 2024-11-11 |
| Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451, NDC: 49230-530-01 (vial), NDC: 49230-530-10 (10 x 2.5mL/vial cartons), NDC: 49230-530-25 (25 x 2.5mL/vial cartons). | Class II | 2024-11-11 |
Showing 5 of 8 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 7 | 2026-05-01 |
Manufacturing and distribution sites (5)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| American Regent, Inc. | New Albany, US | FDA, Health Canada | |
| American Regent, Inc. | Columbus, US | FDA, Health Canada | |
| American Regent, Inc. | Brea, US | FDA | |
| American Regent, Inc. | Shirley, US | FDA, Health Canada | |
| American Regent, Inc. | Hilliard, US | FDA, Health Canada |
Organization relationships (12)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| M.D. Anderson Cancer Center | Co sponsors trial with | 2 |
| Wayne State University | Co sponsors trial with | 1 |
| Vifor Pharma (Switzerland) | Co sponsors trial with | 1 |
| Government of the United States of America | Co sponsors trial with | 1 |
| Johns Hopkins University | Co sponsors trial with | 1 |
Showing 5 of 12 relationships.
Latest dated events (112)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-05-01 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-16 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-05 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-01-29 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-04-18 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 112 events.
Biomarker capability evidence (103)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| EPO | Trial sponsor | Named in trial inclusion criteria |
| EPO | Trial sponsor | Named in trial inclusion criteria |
| EPO | Trial sponsor | Named in trial inclusion criteria |
| EPO | Trial sponsor | Named in trial inclusion criteria |
| EPO | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 103 evidence rows.
On Scientist.com
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Service areas
American Regent offers filling services, clinical trial supplies, packaging, manufacturing, and stability studies.
- Website
- www.americanregent.com
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Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, us granted patents, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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