Organization (Industry)
Tris Pharma (United States)
ClinicalTrials.gov lists Tris Pharma (United States) as lead sponsor of 22 trials. It has 26 active development programs and 4 approved assets.
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: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Tris Pharma (United States): 22 lead-sponsored trials and 1 legal-entity registration.
Disease areas (20)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Pain | 12 |
| Attention Deficit Disorder with Hyperactivity | 7 |
| Chronic Pain | 4 |
| Diabetes Mellitus | 3 |
| Diabetic Neuropathies | 3 |
Showing 5 of 20 disease areas.
Trials by start year as sponsor or collaborator (12)
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 |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 1 |
| 2024 | 3 |
| 2022 | 2 |
| 2019 | 2 |
| 2018 | 1 |
| 2017 | 1 |
| 2014 | 1 |
| 2013 | 6 |
| 2012 | 2 |
Showing 10 of 12 years.
Recruitment duration, a model prediction: none of the 22 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (26)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| GRT6005 | Pain | Phase 3 | 6 |
| Oxycodone HCL IR | Pain | Phase 3 | 1 |
| Cebranopadol 400 ug | Acute Pain | Phase 3 | 1 |
| Cebranopadol 400 ug | Pain | Phase 3 | 1 |
| Oxycodone HCL IR | Acute Pain | Phase 3 | 1 |
Showing 5 of 26 active programs.
Approved assets (4)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Amphetamine Extended Release Suspension [Dyanavel] | 1 |
| Pregabalin | 1 |
| MORPHINE | 1 |
| Tapentadol | 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 |
|---|---|
| 71% hit target (n=7) | 43% on time (n=7) |
Journals published in (5)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of child and adolescent psychopharmacology | 2 |
| Anesthesiology | 1 |
| European journal of pain (London, England) | 1 |
| Journal of pain and symptom management | 1 |
| The Journal of clinical psychiatry | 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 |
|---|---|---|
| 71 | 16 | 2025-11-04 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 16 |
FDA recalls (8)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone bitartrate and 8 mg chlorpheniramine maleate per 5 mL), 16 fl. oz. (473 mL) bottle, Rx only, Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852, NDC 27808-086-02. | Class II | 2019-07-11 |
| Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23. | Class II | 2019-01-15 |
| infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-24. | Class II | 2019-01-15 |
| Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 1 FL OZ (30 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39961 3, NDC 50428-1252-4. | Class II | 2019-01-15 |
| infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7. | Class II | 2018-11-26 |
Showing 5 of 8 recalls.
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Tris Pharma Inc | Monmouth Junction, US | FDA, Health Canada | |
| Tris Pharma, Inc. | Cranbury, US | FDA |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| Premier Research | Uses vendor | 1 |
Latest dated events (119)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-09-15 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-11-21 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-11-04 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-07 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-03-18 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 119 events.
Biomarker capability evidence (14)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CORO2A | Trial sponsor | Primary endpoint in a Phase 3 trial |
| KIF22 | Trial collaborator | Named in trial inclusion criteria |
| AKR1C4 | Trial sponsor | Named in trial exclusion criteria |
| AMPH | Trial sponsor | Named in trial exclusion criteria |
| AMPH | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 14 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, 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.