Organization (Industry)
Purdue Pharma (Canada)
ClinicalTrials.gov lists Purdue Pharma (Canada) as lead sponsor of 58 trials. It has 4 active development programs and 9 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: 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 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
Logo Purdue Pharma, via Wikimedia Commons, Public domain. Shown to identify the organization; it may be a registered trademark.
This page covers Purdue Pharma (Canada): 58 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (24)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Pain | 34 |
| Osteoarthritis | 13 |
| Chronic Pain | 12 |
| Back Pain | 9 |
| Attention Deficit Disorder with Hyperactivity | 7 |
Showing 5 of 24 disease areas.
Trials by start year as sponsor or collaborator (27)
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 |
| 2023 | 1 |
| 2022 | 3 |
| 2021 | 1 |
| 2020 | 1 |
| 2019 | 2 |
| 2018 | 5 |
| 2017 | 5 |
| 2016 | 4 |
| 2015 | 2 |
Showing 10 of 27 years.
Recruitment duration, a model prediction: none of the 58 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (4)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Naloxone HCl intranasal | Opiate Overdose | Phase 1 | 1 |
| Naloxone HCl intranasal | Opioid-Related Disorders | Phase 1 | 1 |
| Naloxone HCl intranasal | Substance-Related Disorders | Phase 1 | 1 |
| Naloxone HCl intranasal | Drug Overdose | Phase 1 | 1 |
Approved assets (9)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| CONCERTA (OROS methylphenidate hydrochloride) | 2 |
| Nalmefene HCl injection | 2 |
| Naloxone Hydrochloride Injection | 1 |
| Hydromorphone | 1 |
| Buprenorphine | 5 |
Showing 5 of 9 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 |
|---|---|
| 1 of 3 hit target (n=3) | 1 of 3 on time (n=3) |
Journals published in (17)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| The Cochrane database of systematic reviews | 3 |
| Expert opinion on pharmacotherapy | 2 |
| Journal of child and adolescent psychopharmacology | 2 |
| Postgraduate medicine | 2 |
| CNS drugs | 1 |
Showing 5 of 17 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 |
|---|---|---|
| 554 | 45 | 2025-08-26 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 1 |
FDA recalls (3)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Betadine Solution Swabstick Povidone-Iodine Solution USP, 10% Dist.by: Purdue Products LP. Stamford, CT 06901-3431 NDC 67618-153-01 | Class II | 2017-10-05 |
| Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30. | Class III | 2016-03-31 |
| Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 | Class III | 2015-07-13 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Purdue Pharmaceuticals LP | Wilson, US | Health Canada |
Organization relationships (2)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Eisai (Japan) | Co sponsors trial with | 2 |
| Imbrium Therapeutics | Co sponsors trial with | 2 |
Latest dated events (652)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-02-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-12-21 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-10-29 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-10-29 | FDA import refusal | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-08-26 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 652 events.
CLIA clinical laboratory certificates (1)
| Lab | Certificate | Status |
|---|---|---|
| PURDUE PHARMA LP | Certificate of waiver | Terminated |
Biomarker capability evidence (38)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| BCHE | Trial collaborator | Named in trial inclusion criteria |
| CYP3A4 | Trial sponsor | Named in trial inclusion criteria |
| FDPS | Trial sponsor | Named in trial inclusion criteria |
| FES | Trial sponsor | Named in trial inclusion criteria |
| UBR5 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 38 evidence rows.
On Scientist.com
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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, and biomarkers this organization publishes on.
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