OXAYDO (oxycodone hydrochloride) · ZYLA
OXAYDO is FDA-approved to treat 1 condition (same as ROXYBOND).
Details
- Status
- Discontinued
- First Approved
- 2011-06-17
- Routes
- ORAL
- Dosage Forms
- TABLET
OXAYDO Approval History
What OXAYDO Treats
1 indicationsOXAYDO is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as ROXYBOND (same active ingredient).
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| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
FDA Label (PDF)OXAYDO is FDA-approved to treat 1 condition — same approved indications as ROXYBOND.
Track OXAYDO with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.