Organization (Industry)
Sunstar Americas, Inc. (United States)
ClinicalTrials.gov lists Sunstar Americas, Inc. (United States) as lead sponsor of 10 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
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 0.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Sunstar Americas, Inc. (United States): 10 lead-sponsored trials and 1 legal-entity registration.
Disease areas (8)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Gingivitis | 3 |
| Alveolar Bone Loss | 1 |
| Bone Resorption | 1 |
| Chronic Periodontitis | 1 |
| Dental Plaque | 1 |
Showing 5 of 8 disease areas.
Trials by start year as sponsor or collaborator (9)
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 |
|---|---|
| 2021 | 1 |
| 2020 | 1 |
| 2018 | 1 |
| 2017 | 2 |
| 2016 | 2 |
| 2015 | 1 |
| 2013 | 1 |
| 2012 | 1 |
| 2006 | 1 |
Recruitment duration, a model prediction: none of the 10 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
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 |
|---|---|
| 2 of 4 hit target (n=4) | 20% on time (n=5) |
Journals published in (1)
| Journal | Publications |
|---|---|
| Journal of dental research | 1 |
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 |
|---|---|---|
| 81 | 6 | 2025-10-21 |
FDA warning letters (1)
| Issue date | Letter |
|---|---|
| 2021-12-21 | sunstar-americas-inc-614058-12212021 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 9 |
FDA recalls (6)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| BUTLER Clear Dip, 12 bottles/case | Class II | 2022-01-14 |
| SUNSTAR G.U.M PERIOSHIELD Oral Health Rinse, 300mL, SKU numbers 1775P, 1775R - Product Usage: Help prevent and treat gingivitis caused by plaque build up Significantly reduce bleeding gums Protect teeth and gums from plaque causing bacteria. | Class II | 2021-05-21 |
| SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Class II | 2021-03-23 |
| SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth. | Class II | 2021-02-18 |
| Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 052376-021-04, Sunstar Americas, Inc., Schaumburg, IL | Class II | 2020-12-28 |
Showing 5 of 6 recalls.
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| SUNSTAR AMERICAS, INC. | Schaumburg, US | FDA |
Latest dated events (108)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-10-21 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-12-31 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-09-10 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2023-02-10 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2022-07-05 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 108 events.
Biomarker capability evidence (5)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| GCFC2 | Trial sponsor | Exploratory endpoint in a trial |
| GCFC2 | Trial sponsor | Mentioned in trial text |
| GOPC | Trial sponsor | Mentioned in trial text |
| MBL2 | Trial sponsor | Mentioned in trial text |
| SPAG5 | Trial sponsor | Mentioned in trial text |
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, sec-reported annual financials, financing and grant events, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.