COBENFY (trospium chloride)
COBENFY is indicated for the treatment of Schizophrenia.
How COBENFY Works
The efficacy of xanomeline is thought to be due to its agonist activity at M1 and M4 muscarinic acetylcholine receptors in the central nervous system. Trospium chloride functions as a muscarinic antagonist that targets receptors in peripheral tissues. Because trospium chloride does not readily cross the blood-brain barrier, it is used to reduce the peripheral adverse effects associated with xanomeline's muscarinic activation without interfering with its central therapeutic effects.
Details
- Status
- Prescription
- First Approved
- 2024-09-26
- Patent Cliff
- 2039
- Revenue
- $55M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
COBENFY Approval History
What COBENFY Treats
1 indicationsCOBENFY is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Schizophrenia
COBENFY 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.
Drugs Similar to COBENFY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07063342 | CN012-0043 U1111-1321-3511 | Ph 1 | recruiting | A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants |
| NCT01166438 ABC results posted | PFDN 17 2U01HD041249, 2U10HD041250 | Ph 3 | completed | Anticholinergic vs. Botox Comparison Study |
| NCT02831231 | KAR-001 | Ph 1 | completed | Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium |
| NCT01922115 ACE results posted | 13-1352 | Ph 4 | completed | The Effect of Anticholinergics on Cognitive Function in the Elderly |
| NCT01178827 results posted | MA-SXR-09-005 | Ph 4 | completed | Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial |
| NCT00863551 results posted | MA-SXR-09-001 SMART Trial | Ph 4 | completed | Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial |
| NCT01089751 results posted | GMA-SXR-09-004 | Ph 4 | completed | Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily |
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.
COBENFY FDA Label Details
Indications & Usage
FDA Label (PDF)COBENFY is indicated for the treatment of Schizophrenia.
COBENFY Patents & Exclusivity
Patents (11 active)
Exclusivity
Pro Intelligence Preview
Deep insights for COBENFY
Revenue Insights
- • Q4-2025: $55M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 99 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.