Bipolar disorder
Psychiatry· 6 reviewed drugs· 4517 cited findings behind them
What the regulatory reviews cover
The regulatory review documents in this library for Bipolar disorder include Caplyta, Vraylar, Lybalvi, Rykindo, Sycrest, and ADASUVE. These drugs have been reviewed for various aspects of bipolar disorder, such as depressive episodes, manic episodes, and agitation.
Different drugs were studied in different trials, so the figures presented are not head-to-head comparisons. For example, Caplyta showed a MADRS Total Score LS mean difference vs placebo of -4.6. Vraylar demonstrated an LS Mean Change from Baseline in MADRS total score (Cariprazine 1.5 mg vs Placebo) of -14.07 (0.70) vs -11.54 (0.70). Lybalvi reported an LS mean difference from placebo in PANSS total score of -6.4. ADASUVE showed a Change in PEC score from baseline to 2 hours after Dose 1 of -8.0 vs -5.8 placebo (p=0.0004).
The drugs — one cited result each
| Caplyta Johnson & Johnson | MADRS Total Score LS mean difference vs placebo: -4.6 Johnson & Johnson — Caplyta FDA Review (NDA209500, SUPPL 6), p.48 |
| Vraylar AbbVie Inc. | LS Mean Change from Baseline in MADRS total score (Cariprazine 1.5 mg vs Placebo): -14.07 (0.70) vs -11.54 (0.70) AbbVie Inc. — Vraylar FDA Review (NDA204370, SUPPL 9, 2022), p.122 |
| Lybalvi Alkermes plc | LS mean difference from placebo in PANSS total score: -6.4 Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.24 |
| Rykindo SHANDONG LUYE | PANSS total score change from baseline (LY03004): -2.9 SHANDONG LUYE — Rykindo FDA Review, p.208 |
| Sycrest Organon & Co. | PANSS total score change from baseline: -5.27 Organon & Co. — Sycrest EMA EPAR public assessment report (E, p.29 |
| ADASUVE Ferrer Internacional | Change in PEC score from baseline to 2 hours after Dose 1: -8.0 vs -5.8 placebo (p=0.0004) Ferrer Internacional — Adasuve EMA EPAR public assessment re, p.42 |
Different drugs were studied in different trials — these figures are not head-to-head comparisons.
Explore the full evidence
Every finding behind these drugs — searchable, comparable and answerable in plain language — is in the Psychiatry research library →
Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only — not medical or investment advice.