9 completed, 1 available, 1 enrolling by invitation. 6 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 5, Enrolling by invitation 1 |
| Phase 1 | 4 | Completed 4 |
Follow ALKS 3831: new trials by email Literature Review of ALKS 3831 trials Research Report on ALKS 3831
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan LYBALVI - Focus of Study is on Healthy Lactating Women | Phase 1 | Completed | Alkermes, Inc. | 12 | 2022-09-14 | 2023-02-10 |
| Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects OLZ/SAM - Bipolar I Disorder, Schizophrenia | Phase 3 | Enrolling by invitation | Alkermes, Inc. | 236 | 2021-10-22 | 2026-08-14 |
| Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder OLZ/SAM - Bipolar I Disorder | Phase 1 | Completed | Alkermes, Inc. | 7 | 2021-07-22 | 2023-11-22 |
| Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 ALKS 3831 - Schizophrenia, Schizophreniform Disorder | Phase 3 | Completed | Alkermes, Inc. | 523 | 2017-06-15 | 2024-09-26 |
| Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder ALKS 3831, Olanzapine - Schizophrenia, Schizophreniform Disorders | Phase 3 | Completed | Alkermes, Inc. | 426 | 2017-06-08 | 2023-01-19 |
| An Insulin Sensitivity Study in Healthy Subjects ALKS 3831, Olanzapine, Placebo - Healthy Volunteers | Phase 1 | Completed | Alkermes, Inc. | 60 | 2016-09-01 | 2017-08-22 |
| A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia ALKS 3831 - Schizophrenia | Phase 3 | Completed | Alkermes, Inc. | 266 | 2016-08-07 | 2021-07-21 |
| A Phase 1 Safety Study in Adults With Schizophrenia ALKS 3831 - Schizophrenia | Phase 1 | Completed | Alkermes, Inc. | 42 | 2016-06-01 | 2016-09-22 |
| A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study) ALKS 3831, Olanzapine - Schizophrenia | Phase 3 | Completed | Alkermes, Inc. | 561 | 2016-03-02 | 2020-02-10 |
| A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia ALKS 3831 - Schizophrenia | Phase 3 | Completed | Alkermes, Inc. | 281 | 2016-01-20 | 2019-07-26 |
| An Expanded Access Program (EAP) for OLZ/SAM in Pediatric Participants With Schizophrenia or Bipolar I Disorder (ALKS 3831-315) OLZ/SAM - Bipolar 1 Disorder, Schizophrenia Disorder | Available | Alkermes, Inc. | 2026-08-04 |
Schizophrenia (8) · Psychotic Disorders (2) · Body Weight (1)
Alkermes, Inc. (11)
United States (11) · Puerto Rico (3) · Ukraine (3) · Austria (2) · Bulgaria (2) · Ireland (2) · Israel (2) · Italy (2) · Poland (2) · Russia (2) · Serbia (2) · South Korea (2) · United Kingdom (2) · Argentina (1) · Brazil (1)
David McDonnell, MD (4) · Sergey Yagoda, MD, PhD (1)
PMID 30348514, PMID 36226902, PMID 36305696, PMID 36946605, PMID 39630083, PMID 41944743