TheraRadar
Data updated: May 30, 2026

RYBIX ODT (tramadol hydrochloride)

Pain Approved 2005-05-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
21
Years on Market

Details

Status
Discontinued
First Approved
2005-05-05
Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

SHIONOGI
Active Ingredient: TRAMADOL HYDROCHLORIDE

RYBIX ODT Approval History

2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2005 to 2010
Aug 2010 SUPPL
Label · Labeling
FDA Letter Label
Jun 2010 SUPPL
Label · Labeling
FDA Letter Label
Jul 2006 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter

What RYBIX ODT Treats

1 FDA approvals

Originally approved for its first indication in 2005 .

  • Other (1)

SHIONOGI's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

FETROJA
2019
CEFIDEROCOL SULFATE TOSYLATE
2 designations
RADICAVA
2017
EDARAVONE
2 designations
📋

Clinical Trial Registry

11 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
NCT05125978 CANADÁ EMS1120 - CANADÁ Ph 2 withdrawn Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain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

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

RYBIX ODT FDA Label Details

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Data Sources

FDA Approval: NDA021693 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.