Latest signals
What changed
The three most recent source-backed changes linked to this drug.
PsychiatryDrug intelligence
Cobenfy
Xanomeline/Trospium
M1/M4 muscarinic agonist (xanomeline) with a peripheral muscarinic antagonist (trospium). Developed by Bristol Myers Squibb. Clinical, regulatory, and source evidence are connected below.
- Company
- Bristol Myers Squibb
- Target / MOA
- CHRM1 路 CHRM4
- Aliases
- Cobenfy
- Signals
- 20
- Clinical trials
- 5
- Approvals
- 0
- Evidence sources
- 20
Approved uses
What regulators have approved
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.
United States (FDA label)
Label section 1
1 INDICATIONS AND USAGE COBENFY is indicated for the treatment of schizophrenia in adults.
European Union (EMA)
EMA's medicines data lists no marketing authorisation for this medicine.
Regulatory history
Approvals over time
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.
United States
European Union
EMA's medicines data lists no marketing authorisation for this medicine.
Patents and exclusivity
What FDA lists (US)
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.
NDA216158 (Orange Book)
11 listed patents, latest expiry Oct 29, 2039
- US 10238643 路 expires Jul 21, 2030 路 drug product
- US 10265311 路 expires Jul 21, 2030 路 U-3513
- US 10369143 路 expires Jul 21, 2030 路 U-3513
- US 10369144 路 expires Jul 21, 2030 路 drug product, U-3513
- US 10695339 路 expires Jul 21, 2030 路 U-3513
- US 10925832 路 expires Sep 27, 2039 路 drug product
- US 10933020 路 expires Sep 27, 2039 路 drug product, U-3513
- US 11452692 路 expires Sep 27, 2039 路 U-3513
- US 11471413 路 expires Sep 27, 2039 路 U-3513
- US 11890378 路 expires Sep 27, 2039 路 drug product, U-3513
- US 12558317 路 expires Oct 29, 2039 路 drug product
Generics and biosimilars
The Orange Book lists no approved generic (ANDA).
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
Boxed warnings and FDA safety communications
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.
Boxed warning
The current US label has no boxed warning.
FDA Drug Safety Communications
None on FDA's list names this drug.
Clinical trials
Key active studies
A focused view of recently updated studies 路 5 linked records.
A Study to Evaluate the Effect of KarXT on Urological Safety
Bristol-Myers Squibb 路 Updated Oct 19, 2026
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)
Bristol-Myers Squibb 路 Updated Oct 15, 2026
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
Bristol-Myers Squibb 路 Updated Oct 8, 2026
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Karuna Therapeutics, Inc., a Bristol Myers Squibb company 路 Updated Sep 28, 2026
Long-Term Real-World Safety of Cobenfy in Adults With Schizophrenia
Bristol-Myers Squibb 路 Updated Aug 24, 2026
Regulatory timeline
Approvals and agency activity
Verified regulatory records in reverse chronological order.
No regulatory event is available in this snapshot.
Related intelligence
Connected drugs
Records connected through the current intelligence graph.
Source evidence
Where this profile comes from
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.