Data updated: May 26, 2026
OXAYDO (oxycodone hydrochloride)
Pain
Approved 2011-06-17
1
Indication
--
Phase 3 Trials
1
Priority Reviews
14
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-06-17
- Routes
- ORAL
- Dosage Forms
- TABLET
OXAYDO Approval History
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
30 FDA actions from 2011 to 2025
Mar 2016 SUPPL Priority
Mfg
What OXAYDO Treats
1 FDA approvalsOriginally approved for its first indication in 2011 .
- Other (1)
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02536209 | MT-8554-E03 | Ph 1 | completed | A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects |
| NCT04240626 | 1452523 | Ph 4 | active not recruiting | Multimodal Analgesia Effect on Post Surgical Patient |
| NCT03685188 | WCH2018086 | Ph 4 | enrolling by invitation | Oxycodone and Sufentanil for Analgesia in Hip Surgery |
| NCT06444997 | B2024-161R | Ph 4 | not yet recruiting | Efficacy and Safety of Oxycodone Hydrochloride for Long-term Analgesia in ICU Patients |
| NCT02531906 | I 262314 NCI-2015-01338, I 262314 | Ph 1 | completed | Gabapentin, Methadone Hydrochloride, and Oxycodone Hydrochloride in Improving Quality of Life in Patients With Stage II-IV Head and Neck Cancer During Chemoradiation |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT01643772 results posted | OXYC09-CN-102 | Ph 1 | completed | OxyNorm® Capsules (Immediate-Release) Pharmacokinetic (PK) Study |
| NCT02660229 SWITCH results posted | OXI15-KR-401 | Ph 4 | completed | An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion. |
| NCT03254459 results posted | INS005-17-111 | Ph 2 | completed | Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain |
| NCT00626600 | OXI3001 2007-005101-21 | Ph 3 | terminated | A Study to Assess the Safety and Tolerability of Oxycodone Hydrochloride 50mg/mL Administered as an Infusion |
| NCT00801788 | OC-EG-001 | Ph 1 | completed | Single Dose Pharmacokinetics of Egalet® Oxycodone |
| NCT01530542 | K234-10-1001 B4501006 | Ph 1 | completed | A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OXAYDO FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.