FLEQSUVY (baclofen)
FLEQSUVY is indicated for the treatment of Spasticity; Multiple Sclerosis; Spinal Cord Injuries; Spinal Cord Disease.
How FLEQSUVY Works
FLEQSUVY acts as a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) and likely exerts its effects by stimulating the GABA B receptor subtype. The drug inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing the release of excitatory neurotransmitters from afferent terminals. While the precise mechanism is not fully understood, actions at supraspinal sites may also contribute to the clinical reduction of spasticity.
Details
- Status
- Prescription
- First Approved
- 2022-02-04
- Patent Cliff
- 2037
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
FLEQSUVY Approval History
What FLEQSUVY Treats
4 indicationsFLEQSUVY is approved for 4 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Spasticity
- Multiple Sclerosis
- Spinal Cord Injuries
- Spinal Cord Disease
FLEQSUVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 FLEQSUVY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FLEQSUVY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FLEQSUVY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
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.
FLEQSUVY FDA Label Details
Indications & Usage
FDA Label (PDF)FLEQSUVY is indicated for the treatment of Spasticity; Multiple Sclerosis; Spinal Cord Injuries; Spinal Cord Disease.
FLEQSUVY Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for FLEQSUVY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.