RYZOLT (tramadol hydrochloride) · PURDUE PHARMA
RYZOLT is FDA-approved to treat 1 condition (same as TRAMADOL HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 2008-12-30
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
RYZOLT Approval History
What RYZOLT Treats
1 indicationsRYZOLT is approved for 1 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as TRAMADOL HYDROCHLORIDE (same active ingredient).
Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07440069 TRAMPA | PO-UNAH-49-7-2026 | Ph 4 | recruiting | Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor |
| NCT04991493 | QPOST | Ph 4 | recruiting | Effect of Tramadol on Postoperative Sore Throat After General Anesthesia |
| NCT05125978 CANADÁ | EMS1120 - CANADÁ | Ph 2 | withdrawn | Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain |
| NCT05390905 | HSK21542-303 | Ph 3 | completed | A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment |
| NCT04613830 | 515 | Ph 3 | completed | Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients |
| NCT03775629 | CG100650-1-01 | Ph 1 | completed | Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers |
| NCT03477851 TramIsch | WNOZA/1/2017 | Ph 4 | completed | Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis |
| NCT04178109 | 17200 | Ph 2 | completed | Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach. |
| NCT00737048 results posted | CR015109 JNS013-JPN-03 | Ph 3 | completed | A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain |
| NCT01307020 DEX-TRA 02 results posted | DEX-TRA 02 2010-022798-32 | Ph 2 | completed | Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain |
| NCT00766675 results posted | CR015319 TRAMMAPPAI4033 | Ph 4 | completed | An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain |
| NCT00983736 | BVF-324-302 | Ph 3 | terminated | Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation |
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.
RYZOLT FDA Label Details
Indications & Usage
FDA Label (PDF)RYZOLT is FDA-approved to treat 1 condition — same approved indications as TRAMADOL HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.