NUEDEXTA (dextromethorphan hydrobromide)
NUEDEXTA is indicated for the treatment of Pseudobulbar Affect.
How NUEDEXTA Works
NUEDEXTA is a combination product consisting of dextromethorphan (the active therapeutic moiety) and quinidine (a metabolic inhibitor). Dextromethorphan acts as a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. Because dextromethorphan is rapidly metabolized by the liver, quinidine is included to competitively inhibit the cytochrome P450 2D6 (CYP2D6) enzyme. This inhibition increases and sustains plasma levels of dextromethorphan. The exact mechanism by which this combination exerts its therapeutic effect in patients with PBA is unknown.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-10-29
- Patent Cliff
- 2026
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
NUEDEXTA Approval History
What NUEDEXTA Treats
1 indicationsNUEDEXTA is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pseudobulbar Affect
NUEDEXTA 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?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NUEDEXTA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02651116 CHPA DXM results posted | A6531002 CHPA DXM | Ph 4 | terminated | Dextromethorphan Pediatric Acute Cough Study |
| NCT03480009 DexMab results posted | STUDY19020221 | Ph 3 | completed | Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion |
| NCT01441102 MiDME2 results posted | 110244 11-EI-0244 | Ph 1, Ph 2 | completed | Dextromethorphan for Diabetic Macular Edema |
| NCT02860962 | Pro00052508 | Ph 1 | completed | A Trial of Dextromethorphan for Treatment of Major Depressive Disorder |
| NCT01630811 Nuedexta results posted | CHKI-Nued0911 | Ph 2 | completed | Nuedexta for the Treatment of Adults With Autism |
| NCT01806857 results posted | 2012P001274 3FKVAD | Ph 2 | completed | Clinical Trial Nuedexta in Subjects With ALS |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
| NCT02182336 | 1220.32 | Ph 1 | completed | Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers |
| NCT01017939 | CR017128 COU-AA-015 | Ph 1 | completed | A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT01441986 DXM/AMT | 0533-DXM | Ph 2 | completed | Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects |
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.
NUEDEXTA FDA Label Details
Indications & Usage
FDA Label (PDF)NUEDEXTA is indicated for the treatment of Pseudobulbar Affect.
NUEDEXTA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for NUEDEXTA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 1 active patents
Trial Analysis
- • 11 total trials
- • Stage: Declining
Competitive Landscape
- • 1 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment