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Sanctura (TROSPIUM)
Sanctura works by blocking the action of a chemical called acetylcholine at the M3 receptor in the bladder muscle, reducing muscle contractions and urgency.
Sanctura (Trosipium) is a small molecule cholinergic muscarinic antagonist developed by Allergan, targeting the M3 muscarinic acetylcholine receptor. It is used to treat bladder muscle dysfunction, including overactive bladder, increased urinary frequency, urge incontinence, and urgent desire to urinate. Sanctura was FDA approved in 2004 and is now off-patent with multiple generic manufacturers. The drug has a half-life of 5 hours and bioavailability of 10%. It is a commercial option for patients with overactive bladder symptoms.
At a glance
| Generic name | TROSPIUM |
|---|---|
| Sponsor | AbbVie |
| Drug class | Cholinergic Muscarinic Antagonist |
| Target | Muscarinic acetylcholine receptor M3 |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
| First approval | 2004 |
Mechanism of action
Trospium chloride tablets is muscarinic antagonist.Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
Approved indications
- Bladder muscle dysfunction - overactive
- Increased Urinary Frequency
- Urge incontinence of urine
- Urgent desire to urinate
Common side effects
- Dry mouth
- Constipation
- Headache
- Abdominal pain upper
- Fatigue
- Flatulence
- Dry eyes
- Urinary retention
- Dyspepsia
- Tachycardia
- Vision blurred
- Abdominal distension
Key clinical trials
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) (PHASE3)
- A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1) (PHASE3)
- A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) (PHASE3)
- Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (PHASE3)
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) (PHASE3)
- A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sanctura CI brief — competitive landscape report
- Sanctura updates RSS · CI watch RSS
- AbbVie portfolio CI