Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Oxycodone clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 7 trials in our Canada, USA, China, Netherlands, Sweden, Mexico and Australia registers that name Oxycodone as an intervention. Synced 9 Nov 2026
7Current trials
7Recruiting now
7Lead sponsors
7Country registers
At a glance

Oxycodone is named as an intervention in 7 current clinical trials in our Canada, USA, China, Netherlands, Sweden, Mexico and Australia registers. 7 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Viatris Inc (1). The most-studied condition is Healthy. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Oxycodone is approved

All regulators →

Of the three regulators tracked here, the first to approve Oxycodone was Canada, on 4 Jan 1996. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
26 Oct 1998
Roxicodone
NDA020932 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
4 Jan 1996
Oxycontin
Notice of Compliance 4605
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Oxycodone patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Oxycodone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Xtampza Er, Oxycodone Hydrochloride, Oxycontin
  • 25 listed patents; the last listed expires 2 Sep 2036 (US 9737530).
See the Orange Book listing for NDA 208090
Patents and exclusivities above are pooled across 6 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Oxycodone

All medicines →
ENNHS England
£29.7m
1,865,974 items dispensed, Sep 2025 to Aug 2026
-4% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$112.8m
3,132,653 prescriptions in 2025 · OxyContin, Oxycodone Hydrochloride, Oxycodone Hydrochloride
-15% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Oxycodone works

All drug targets →
  • Mu opioid receptor agonist Agonist
    Target: OPRM1 opioid receptor mu 1
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • Back painPhase 3
  • Inguinal herniaPhase 3
  • Low back painPhase 3
  • Nausea and vomitingPhase 3
  • Neck painPhase 3
  • Cancer painPhase 3
  • Chronic back painPhase 3
  • Constipation disorderPhase 3
  • NephrolithiasisPhase 3
  • Opiate dependencePhase 3
26 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL656, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7093, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Oxycodone

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Oxycodone

ATC code
N02AA05
ChEMBL
CHEMBL656
DrugBank
DB00497
PubChem CID
5284603
CAS number
76-42-6
FDA UNII
CD35PMG570
Wikidata
Q407535
Wikipedia
Oxycodone

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting7100%

Trials by phase

  • Phase 4343%
  • Not applicable229%
  • Observational229%
01

Clinical trials of Oxycodone

7 trials
StudyPhaseStatusLead sponsorRegisters
Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone
NCT06186141 · ClinicalTrials.gov ↗ · Patient-Controlled Analgesia
Phase 4 Recruiting Murdoch Childrens Research Institute Australia
Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)
NCT07001709 · ClinicalTrials.gov ↗ · Prostate Cancer, Pain Cancer
Phase 4 Recruiting Deventer Ziekenhuis Netherlands
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
NCT07813026 · Healthy
Phase 4 Recruiting Viatris Inc USA
Anesthetics and Analgesics in Children
NCT03427736 · ClinicalTrials.gov ↗ · Anesthesia, Pain
Observational Recruiting Chi Dang Hornik Canada
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
NCT03511118 · ClinicalTrials.gov ↗ · Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
Observational Recruiting Duke University Canada, Mexico
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
NCT03756961 · ClinicalTrials.gov ↗ · Obesity, Pain, Postoperative
Not applicable Recruiting Göteborg University Sweden
Effect of Liposomal Bupivacaine TAPB Combined With Oxycodone PCIA on Postoperative Gastrointestinal Recovery in Patients Undergoing Major Abdominal Surgery
NCT07651722 · ClinicalTrials.gov ↗ · Postoperative Pain, Postoperative Ileus
Not applicable Recruiting Tianjin First Central Hospital China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Oxycodone in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Oxycodone. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
POISON – Perioperative Safety and Effective Opioid Dosing in Chronic Opioid Use – a Randomized Clinical Study
2026-526719-13-00 · Anesthesia and Analgesia
Phase 4 Authorised Region Hovedstaden Denmark
03

Oxycodone across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

28 single-substance products containing Oxycodone on the HPRA medicines list.

All 28 Irish products →

Supply shortages

No entry for Oxycodone in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Oxycodone

12 conditions
Healthy1Postoperative Pain1Postoperative Ileus1Prostate Cancer1Pain Cancer1Obesity1Pain, Postoperative1Anesthesia1Pain1Lactating Women on Select DOI1Breastfed Infants of Mothers on Select DOI1Patient-Controlled Analgesia1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Viatris Inc1
Tianjin First Central Hospital1
Deventer Ziekenhuis1
Göteborg University1
Chi Dang Hornik1
Duke University1
Murdoch Childrens Research Institute1
06

By country register

RegisterTrialsRecruiting
Clinical trials in Canada22
Clinical trials in USA11
Clinical trials in China11
Clinical trials in Netherlands11
Clinical trials in Sweden11
Clinical trials in Mexico11
Clinical trials in Australia11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Oxycodone trials

How many clinical trials are testing Oxycodone?

7 current trials in our Canada, USA, China, Netherlands, Sweden, Mexico and Australia registers name Oxycodone as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Oxycodone trials recruiting patients?

Yes. 7 of the 7 trials are recruiting: 2 with sites in Canada, 1 with sites in USA, 1 with sites in China, 1 with sites in Netherlands, 1 with sites in Sweden, 1 with sites in Mexico and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Oxycodone clinical trials?

Viatris Inc (1), Tianjin First Central Hospital (1), Deventer Ziekenhuis (1) and Göteborg University (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Oxycodone licensed in Ireland?

Yes. The HPRA medicines list includes 28 single-substance products containing Oxycodone, for example Dancex SR 10 mg Prolonged-Release Tablets (Rowex Limited,). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Oxycodone shortage?

Not in the lists we track: Oxycodone has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Oxycodone works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Oxycodone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Oxycodone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.