Product Description
ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.
Mechanisms of Action: D2 Antagonist,OPR Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: Bipolar Disorder | Schizophrenia
Known Adverse Events: Bipolar Disorder | Amnesia | Back Pain | Dizziness | Headache | Pain Unspecified | Paresthesia | Tremor | Schizophrenia | Asthenia | Constipation | Dyspepsia | Weight Gain
Company: Alkermes
Company Location: DUBLIN 4 L2 00000
Company CEO: Richard F. Pops
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Austria, Bulgaria, Ireland, Israel, Italy, Korea, Poland, Puerto Rico, Russia, Serbia, Ukraine, United Kingdom, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Bipolar Disorder|Psychotic Disorders|Schizophrenia|Weight Gain
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
ALKS 3831-A313 | P3 |
Enrolling by invitation |
Schizophrenia|Bipolar Disorder |
2027-09-01 |
|
ENLIGHTEN-Youth | P3 |
Recruiting |
Bipolar Disorder|Schizophrenia|Weight Gain |
2026-09-01 |
|
ALK3831-A308 | P3 |
Completed |
Bipolar Disorder|Psychotic Disorders|Schizophrenia |
2023-09-06 |
|
ALKS 3831-A311 | P1 |
Completed |
Bipolar Disorder |
2023-08-11 |
43% |