xanomeline
Trade name: Cobenfy
Small moleculeapproved
Approved
Sep 26, 2024
Clinical trial activity
35 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
7
Phase 2
26
Phase 3
25
Phase 4
2
Earliest trial started Sep 7, 2016 (NCT02831231)
Timeline
2020s
- Jan 1, 2020
Earliest Phase 3 Sponsor(trial)
- Sep 26, 2024
Bristol-Myers Squibb — Earliest FDA Approval
- Sep 26, 2024
Bristol-Myers Squibb — NDA Organization
Indications
Approved for
Mechanism of action
Muscarinic acetylcholine receptor M1 agonist
Muscarinic acetylcholine receptor M4 agonist
Combination products
cobenfy
with trospium
Also known as karx-ec, xanomeline and trospium chloride
Approval history
- approvedSep 26, 2024
Chemistry & pharmacology
Loading structure…
SMILES
CCCCCCOc1nsnc1C1=CCCN(C)C1- Mol. weight
- 281.42 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL21536 ↗
- ChEMBLCHEMBL2336050 ↗
Also known as
- 3-(3-o-hexyl-1,2,5-thiadiazol-4-yl)-1,2,5,6-tetrahydro-1-methylpyridine
- (3-o-hexyloxy)-tztp
- ly246708
- ly246708
- ly 246708
- ly-246708
- ly-246708
- xanomeline
- xanomeline
- xanomeline
- xanomeline
- xanomeline
- xanomeline
- xanomeline
- xanomeline tartaric acid
- xanomeline tartaric acid
- xanomeline tartrate
- xanomeline tartrate
- xanomeline tartrate
- xanomeline tartrate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07257120 | Phase 4 | Apr 14, 2026 | Bristol-Myers Squibb, Karuna Pharmaceuticals |
| NCT07284745 | Phase 3 | Feb 27, 2026 | Bristol-Myers Squibb |
| NCT07285798 | Phase 3 | Feb 27, 2026 | Bristol-Myers Squibb |
| NCT07288567 | Phase 3 | Jan 27, 2026 | Bristol-Myers Squibb |
| NCT07221877 | Phase 4 | Jan 21, 2026 | Bristol-Myers Squibb |
| NCT06937229 | Phase 3 | Dec 1, 2025 | Bristol-Myers Squibb |
| NCT07204418 | Phase 1 | Oct 13, 2025 | Bristol-Myers Squibb, Karuna Pharmaceuticals |
| NCT07140913 | Phase 3 | Oct 8, 2025 | Bristol-Myers Squibb |
| NCT07118215 | Phase 1 | Sep 29, 2025 | Bristol-Myers Squibb, Karuna Pharmaceuticals |
| NCT07061288 | Phase 1 | Sep 3, 2025 | Bristol-Myers Squibb |
| NCT06947941 | Phase 3 | Jul 31, 2025 | Bristol-Myers Squibb |
| NCT06976203 | Phase 3 | Jul 21, 2025 | Bristol-Myers Squibb |
| NCT06929273 | Phase 3 | Jul 18, 2025 | Bristol-Myers Squibb |
| NCT06976216 | Phase 3 | Jul 14, 2025 | Bristol-Myers Squibb |
| NCT06951711 | Phase 3 | Jun 13, 2025 | Bristol-Myers Squibb |
| NCT06951698 | Phase 3 | Jun 11, 2025 | Bristol-Myers Squibb |
| NCT06882785 | Phase 3 | Jun 10, 2025 | Bristol-Myers Squibb |
| NCT06853171 | Phase 1 | Apr 29, 2025 | Bristol-Myers Squibb |
| NCT06572449 | Phase 3 | Dec 31, 2024 | Bristol-Myers Squibb, Karuna Pharmaceuticals |
| NCT06729970 | Phase 1 | Dec 23, 2024 | Bristol-Myers Squibb, Karuna Pharmaceuticals |
Showing 20 of 35 trials
Page 1 / 2
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bristol-Myers Squibb | For profit | 24 | 15 | 3 | 2023 |
| Karuna Pharmaceuticals | For profit | 20 | 20 | 4 | 2016 |
| Medpace, Inc. | For profit | 1 | 0 | 1 | 2016 |
| Zai Lab Pty. Ltd. | For profit | 1 | 0 | 1 | 2023 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers Squibb | For profit | NDA | Sep 26, 2024 |