Last reviewed · How we verify
lithium plus valproate
Lithium and valproate together modulate neuronal signaling and gene expression through distinct pathways to stabilize mood and reduce manic or depressive episodes.
Lithium and valproate together modulate neuronal signaling and gene expression through distinct pathways to stabilize mood and reduce manic or depressive episodes. Used for Bipolar disorder (acute mania or maintenance treatment), Treatment-resistant bipolar depression.
At a glance
| Generic name | lithium plus valproate |
|---|---|
| Sponsor | University of Sao Paulo |
| Drug class | Mood stabilizer combination |
| Target | GSK-3, inositol monophosphatase, histone deacetylase, GABA signaling |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Lithium inhibits inositol monophosphatase and glycogen synthase kinase-3 (GSK-3), affecting intracellular signaling cascades and neuroprotective pathways. Valproate inhibits histone deacetylase and enhances GABAergic neurotransmission while modulating gene expression. The combination is used in bipolar disorder to achieve synergistic mood stabilization.
Approved indications
- Bipolar disorder (acute mania or maintenance treatment)
- Treatment-resistant bipolar depression
Common side effects
- Tremor
- Weight gain
- Sedation
- Gastrointestinal disturbance
- Polyuria/polydipsia
- Cognitive impairment
Key clinical trials
- A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine (PHASE3)
- The Combination of Pharmacotherapy and Cognitive Behavioral Psychotherapy Under the Recovery Perspective. (PHASE1)
- Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. (PHASE4)
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (PHASE3)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. (PHASE3)
- Development and Application of Precision Treatment Strategies for Common Mental Disorders (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- lithium plus valproate CI brief — competitive landscape report
- lithium plus valproate updates RSS · CI watch RSS
- University of Sao Paulo portfolio CI