TheraRadar
Data updated: Sep 20, 2026

LIORESAL (baclofen) · AMNEAL

CNS Approved 1977-11-22

LIORESAL is FDA-approved to treat 8 conditions (same as OZOBAX DS).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
2
Priority Reviews
48
Years on Market

Details

Status
Prescription
First Approved
1977-11-22
Routes
INTRATHECAL, ORAL
Dosage Forms
INJECTABLE, TABLET

Companies

AMNEAL Novartis
Active Ingredient: BACLOFEN

LIORESAL Approval History

1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
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
155 FDA actions from 1977 to 2021 · 1 indication expansions
Dec 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label
Jan 2019 SUPPL
Label · Labeling
FDA Letter Label
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)

What LIORESAL Treats

8 indications

LIORESAL is approved for 8 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as OZOBAX DS (same active ingredient).

Source: FDA Label

AMNEAL's other novel FDA approvals

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

ONGENTYS
2020
OPICAPONE
📋

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NCT04471714 Pro00090588 Ph 2 withdrawn Effects of Baclofen on Presynaptic Inhibition in Humans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
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

LIORESAL FDA Label Details

Indications & Usage

FDA Label (PDF)

LIORESAL is FDA-approved to treat 8 conditions — same approved indications as OZOBAX DS.

Track LIORESAL with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA020075 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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