1 available, 1 completed, 1 recruiting. 1 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Recruiting 1 |
Follow lybalvi: new trials by email Literature Review of lybalvi trials Research Report on lybalvi
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 |
| Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder OLZ/SAM, Olanzapine - Schizophrenia, Bipolar I Disorder | Phase 3 | Recruiting | Alkermes, Inc. | 220 | 2022-06-30 | 2026-08-14 |
| 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 (2)
Alkermes, Inc. (3)
United States (3) · Argentina (1) · Brazil (1) · Colombia (1) · Mexico (1)
David McDonnell, MD (1) · Sergey Yagoda, MD, PhD (1)