TheraRadar
Data updated: May 26, 2026

BACLOFEN

GABA A Agonists
CNS Approved 1988-07-21

BACLOFEN is indicated for the treatment of Spasticity; Multiple Sclerosis; Spinal Cord Injury; Spinal Cord Disease.

Source: FDA Label • PHARMOBEDIENT • gamma-Aminobutyric Acid-ergic Agonist
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How BACLOFEN Works

Baclofen is a selective agonist at the gamma-aminobutyric acid-B (GABA-B) receptors. It acts primarily at the spinal cord level to inhibit both monosynaptic and polysynaptic reflex transmission. This is achieved by hyperpolarizing afferent terminals, which leads to the inhibition of excitatory neurotransmitter release (such as glutamate and aspartate). By reducing excitatory input to alpha motor neurons, baclofen decreases muscle spasticity and associated symptoms.

Source: FDA Label
35
Indications
--
Phase 3 Trials
37
Years on Market

Details

Status
Discontinued
First Approved
1988-07-21
Routes
ORAL, INTRATHECAL
Dosage Forms
TABLET, INJECTABLE, SOLUTION, SUSPENSION

Companies

PHARMOBEDIENT Sun Pharma HIBROW HLTHCARE WATSON LABS IMPAX NORTHSTAR HLTHCARE SOMERSET THERAPS LLC MAIA PHARMS INC Aurobindo Pharma RUBICON RESEARCH RISING MANKIND PHARMA IVAX SUB TEVA PHARMS YILING PH HEALTH UNICHEM OXFORD PHARMS AMNEAL REGCON HOLDINGS HERITAGE MICRO LABS Teva ANI PHARMS USL PHARMA LANNETT CO INC ZYDUS LIFESCIENCES ANDAS 5 HOLDING
Active Ingredient: BACLOFEN

BACLOFEN Approval History

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Original
New Indication
New Form
Label Update
256 FDA actions from 1988 to 2025
Nov 2025 SUPPL
Mfg · Manufacturing (CMC)
Jun 2025 SUPPL
Mfg · Manufacturing (CMC)
Mar 2025 SUPPL
Label · Labeling

What BACLOFEN Treats

4 indications

BACLOFEN is approved for 4 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Spasticity
  • Multiple Sclerosis
  • Spinal Cord Injury
  • Spinal Cord Disease
Source: FDA Label

BACLOFEN Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DIROXIMEL FUMARATE
ZYDUS
2025 4 indic.
ONTRALFY
FIDELITY BIOPHARMA
2024 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in BACLOFEN's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BACLOFEN treats. First-in-class if their pivotal trials read out positive.

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

Drugs Similar to BACLOFEN

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

FLEQSUVY
BACLOFEN
3 shared
AZURITY
Shared indications:
SpasticityMultiple SclerosisSpinal Cord Disease
OZOBAX DS
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3 shared
METACEL PHARMS LLC
Shared indications:
SpasticityMultiple SclerosisSpinal Cord Disease
RYANODEX
DANTROLENE SODIUM
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EAGLE PHARMS
Shared indications:
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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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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.

BACLOFEN FDA Label Details

Indications & Usage

FDA Label (PDF)

BACLOFEN is indicated for the treatment of Spasticity; Multiple Sclerosis; Spinal Cord Injury; Spinal Cord Disease.

Looking for the branded version?

GABLOFEN

Full clinical data, patents, trials, and competitive landscape for baclofen.

See GABLOFEN

Data Sources

FDA Approval: ANDA077181 → Label: DailyMed → Trials: ClinicalTrials.gov →

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