Xanomeline tartrate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2024
- First approval year
- 2024
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Xanomeline tartrate
- Molecular weight
- 431.51
- Structure (SMILES)
- CCCCCCOc1nsnc1C1=CCCN(C)C1.O=C(O)C(O)C(O)C(=O)O
- xanomeline tartrate component of cobenfy
- Xanomeline tartrate component of cobenfy
- cobenfy component xanomeline tartrate
- COBENFY COMPONENT XANOMELINE TARTRATE
- ly 246708 tartrate
- LY-246708 TARTRATE
- ly246708 tartrate
- LY246708 TARTRATE
- Xanomeline (+)-l-hydrogen tartrate
- XANOMELINE (+)-L-HYDROGEN TARTRATE [MI]
- xanomeline l hydrogen tartrate
- xanomeline l hydrogen tartrate mi
- xanomeline tartaric acid
- Xanomeline tartaric acid
- xanomeline tartrate
- Xanomeline tartrate
- XANOMELINE TARTRATE [USAN]
- Xanomeline tartrate [WHO-DD]
- xanomeline tartrate usan
- xanomeline tartrate who dd
- CAS registry numbers
- 152854-19-8
- ChEMBL ID
- CHEMBL2336050
- InChIKey
- SJSVWTMVMBGIHQ-UHFFFAOYSA-N
- RxNorm IDs (RxCUI)
- 2694829
- FDA ingredient codes (UNII)
- B80W7AUT8R
- 71456
- 18177385
- Applicant
- BRISTOL-MYERS
- Approval date
- 26 Sept 2024
- Application number
- NDA216158
- Patents
- 11
- Designations
- 0
- Earliest recorded loss of exclusivity
- 29 Oct 2039
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -meline
Administration routes
- Oral
- Mechanism
- Muscarinic acetylcholine receptor M1 agonist
- Action type
- Agonist
- Target
- Muscarinic acetylcholine receptor M1
- Protein identifier
- P11229
- Mechanism
- Muscarinic acetylcholine receptor M4 agonist
- Action type
- Agonist
- Target
- Muscarinic acetylcholine receptor M4
- Protein identifier
- P08173
- Mechanism
- Muscarinic acetylcholine receptor M1 agonist
- Action type
- Agonist
- Target
- Muscarinic acetylcholine receptor M1
- Mechanism
- Muscarinic acetylcholine receptor M4 agonist
- Action type
- Agonist
- Target
- Muscarinic acetylcholine receptor M4
Investigated indications
- Condition
- Schizophrenia
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005090
- Subject identifier
- D012559
- Condition identifier
- HP_0000713
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005180
- Highest recorded phase
- 2
- Event
- gastrointestinal disorder
- Reports
- 6
- Reporting signal score
- 16.0667
- Event
- nausea
- Reports
- 18
- Reporting signal score
- 28.2082
Trial references
- NCT02831231
- Hydrogen bond acceptors
- 5
- Hydrogen bond donors
- 0
- Polar surface area
- 38.25
- Calculated partition coefficient (ALogP)
- 3.22
- Prodrug
- No
- Chirality
- Achiral
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 7
- Heavy atoms
- 29
- Molecular formula
- C18H29N3O7S
- Monoisotopic mass
- 431.17262145
- Natural product
- No
- Recorded assays
- 15
- Active assays
- 0
- Parasympathomimetics
- Psychotropic Drugs
- Muscarinic Agonists
Related records
Trials (27)
- A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
- A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
- 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)
- A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
- A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
- A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-2)
- A Study to Assess Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Adult Patients With Schizophrenia (EMERGENT-3)
- A Study to Assess Safety and Efficacy of KarXT in Adult Patients With Schizophrenia
- A Study to Assess the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia
- A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses
- A Study to Evaluate the Effect of KarXT on Urological Safety
- A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
- A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
- A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
- An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia
- An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
- An Extension Study to Assess Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-4)
- An Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of KarXT in Adult Patients With Schizophrenia (EMERGENT-5)
- An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia
- An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients
In development for (2)
- Parkinson disease Phase 2
- Schizophrenia Phase 1