Data updated: May 26, 2026
OZOBAX (baclofen)
CNS
Approved 2019-09-18
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-09-18
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- SOLUTION
OZOBAX Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2019 to 2023
What OZOBAX Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
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Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02462317 BacloTox | 10 140 01 2010-022881-28 | Ph 4 | completed | Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment |
| NCT05975684 | STUDY00002491 | Ph 3 | completed | Baclofen for Children With Rumination Syndrome |
| NCT05418049 | 2022-0202 U54HD104461 | Ph 2 | active not recruiting | Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge |
| NCT02596763 BACLOPHONE | 2014_45 2015-002977-40, PHRCI_2015 | Ph 4 | terminated | Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder |
| NCT01604330 BACLOVILLE | P110112 2011-005787-17 | Ph 2, Ph 3 | completed | Baclofen for the Treatment of Alcohol Drinkers |
| NCT05161351 FORWARDS-1 results posted | 21HH6830 | Ph 4 | completed | Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. |
| NCT04471714 | Pro00090588 | Ph 2 | withdrawn | Effects of Baclofen on Presynaptic Inhibition in Humans |
| NCT01743651 | OS440-3002 | Ph 3 | completed | Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis |
| NCT03860662 | MustafaKUPMR | Ph 4 | completed | The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex |
| NCT03034408 | 2015-00160 | Ph 2 | completed | Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects |
| NCT03068897 results posted | 2017-7566 | Ph 4 | completed | Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain |
| NCT02723383 BACLOREA | RC15_0036 | Ph 3 | completed | Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU |
| NCT01265550 results posted | 573 | Ph 3 | completed | A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors |
| NCT01980706 results posted | 12-1743 4R01AA020824-04 | Ph 2 | completed | Efficacy and Safety of High Dose Baclofen for Alcohol Dependence |
| NCT01821560 BAC results posted | 817101 R01DA030394-01A1, PA Depart of Health | Ph 2 | completed | Baclofen Effects in Cigarette Smokers |
| NCT01003249 results posted | IRB00009516 | Ph 4 | terminated | Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen |
| NCT02052440 results posted | 13-2883 | Ph 3 | terminated | Preventing Alcohol Withdrawal Syndrome With Oral Baclofen |
| NCT01751386 results posted | 130040 13-AA-0040 | Ph 2 | completed | Baclofen for Treating Anxiety and Alcoholism |
| NCT01386255 | Baclofen-07-02-0077 1R21DK077678-01 | Ph 4 | withdrawn | Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy |
| NCT02011516 results posted | 818755 CURE CANN | Ph 2 | completed | Baclofen Effects on Marijuana Dependence |
| NCT01937364 BACLOFEN III results posted | EIRH-13-1134 | Ph 2 | terminated | Preventing Alcohol Withdrawal With Oral Baclofen |
| NCT03113396 | S53446 | Ph 4 | completed | Baclofen for Rumination |
| NCT01002105 results posted | AGRIN4CTIL | Ph 4 | completed | Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients |
| NCT02099006 Topicals results posted | 46905 | Ph 2, Ph 3 | completed | Novel Topical Therapies for the Treatment of Genital Pain |
| NCT02529514 | Baclo-Sleep | Ph 4 | suspended | Usage of Baclofen for Sleep Improvement After Cardiac Surgery |
| NCT01008280 BRAC results posted | NURA-014-09S | Ph 4 | completed | Baclofen to Reduce Alcohol Use in Veterans With HCV |
| NCT02298868 results posted | 16306 | Ph 2 | completed | Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study |
| NCT01266655 BACLAD | BACLAD | Ph 2, Ph 3 | completed | Baclofen for the Treatment of Alcohol Dependence |
| NCT01738282 ALPADIR | ALP 2011007/002 | Ph 3 | completed | Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients |
| NCT01076283 results posted | 0906000002 | Ph 2 | completed | A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking |
| NCT01095679 PERIODIBAC | P090207 | Ph 1 | completed | Baclofen and Hypoxia-induced Periodic Ventilation |
| NCT00607542 Best PK/PD | NICHD-2005-13-2 267200603421 | Ph 1, Ph 2 | completed | Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity |
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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.
OZOBAX FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
4 international docs across 1 countries
OZOBAX Patents & Exclusivity
Latest Patent: Aug 2039
Patents (1 active)
US10610502
Expires Aug 30, 2039
Source: FDA Orange Book
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Revenue Insights
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- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.