Organization (Industry)
Meridian Bioscience (United States)
ClinicalTrials.gov lists Meridian Bioscience (United States) as lead sponsor of 27 trials. It has 4 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 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Meridian Bioscience (United States): 27 lead-sponsored trials and 1 legal-entity registration.
Disease areas (22)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Fibrosis | 6 |
| Fatty Liver | 5 |
| Non-alcoholic Fatty Liver Disease | 5 |
| Carcinoma, Hepatocellular | 3 |
| Liver Neoplasms | 3 |
Showing 5 of 22 disease areas.
Trials by start year as sponsor or collaborator (15)
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 |
|---|---|
| 2023 | 1 |
| 2022 | 1 |
| 2019 | 1 |
| 2018 | 3 |
| 2017 | 4 |
| 2016 | 3 |
| 2015 | 4 |
| 2014 | 5 |
| 2013 | 1 |
| 2012 | 1 |
Showing 10 of 15 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Approved assets (4)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Esomeprazole | 1 |
| Omeprezole (Losec) | 1 |
| Lansoprazole | 1 |
| Magnesium Pantoprazole | 1 |
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 |
|---|---|
| 60% hit target (n=5) | 2 of 4 on time (n=4) |
Journals published in (16)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Hepatology (Baltimore, Md.) | 13 |
| Journal of hepatology | 6 |
| Alimentary pharmacology & therapeutics | 5 |
| The American journal of gastroenterology | 5 |
| Gastroenterology | 3 |
Showing 5 of 16 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 9 | 0 | 2018-01-02 |
FDA warning letters (1)
| Issue date | Letter |
|---|---|
| 2025-12-22 | meridian-bioscience-inc-720826-12222025 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 3 |
FDA recalls (15)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300 | Class II | 2025-12-05 |
| Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay | Class II | 2025-10-07 |
| Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay | Class II | 2025-10-07 |
| Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312 | Class II | 2023-10-19 |
| Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012 | Class II | 2023-10-19 |
Showing 5 of 15 recalls.
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| MERIDIAN BIOSCIENCE, INC. | Cincinnati, US | FDA |
Organization relationships (3)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Hadassah Medical Organization | Co sponsors trial with | 3 |
| The University of Texas System | Co sponsors trial with | 1 |
| Government of the United States of America | Co sponsors trial with | 1 |
Latest dated events (62)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-12-22 | FDA warning letter | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-05 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-10-07 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-10-07 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2023-10-19 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
Showing 5 of 62 events.
Biomarker capability evidence (82)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ALB | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial sponsor | Named in trial inclusion criteria |
| ALB | Trial collaborator | Named in trial inclusion criteria |
| CBR1 | Trial sponsor | Named in trial inclusion criteria |
| CORIN | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 82 evidence rows.
On Scientist.com
Meridian Bioscience (United States) is listed as a research supplier in the Scientist.com network.
Meridian Bioscience provides diagnostic products, reagents, proficiency testing materials, and quality assurance.
- Website
- www.meridianbioscience.com
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, sec-reported annual financials, financing and grant events, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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