trospium
trospium: developed by 1 company · 6 clinical trials tracked · 1 FDA decision.
trospium evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could trospium → AGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| Allergan plc (AGN) | Approved |
Clinical Trials (6)
A Prospective, Open-label, Single-arm, Multicenter Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
Primary endpoint: Change in cognitive performance after 24 weeks of treatment, relative to baseline.
A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
Primary endpoint: Time From Randomization to the First Relapse Event
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Primary endpoint: Change from baseline in voiding dynamics (Qmax) over time
A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Primary endpoint: Maximum observed concentration (Cmax) of KarXT in Milk
A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Primary endpoint: Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants
Primary endpoint: Maximum observed concentration (Cmax)
FDA Decisions1 records
Frequently asked questions
Who is developing trospium?
trospium is being developed by Allergan plc.
How many clinical trials involve trospium?
BioSniper tracks 6 clinical trials involving trospium.
What is trospium's latest FDA decision?
The most recent tracked FDA decision for trospium is Approval, dated August 3, 2007.