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ALK-3831

Alternative Names: alk-3831, alk3831, alk 3831, Lybalvi, alks-3831, alks 3831, alks3831
Latest Update: 2024-11-07
Latest Update Note: News Article

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

Map of Global Clinical Trials for ALK-3831

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%

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