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placebo+valproate
placebo+valproate is a Mood stabilizer Small molecule drug developed by National Cheng-Kung University Hospital. It is currently in Phase 3 development for Seizure prevention, Bipolar disorder.
Valproate is a mood stabilizer that works by reducing the activity of certain brain chemicals.
Valproate is a mood stabilizer that works by reducing the activity of certain brain chemicals. Used for Seizure prevention, Bipolar disorder.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | placebo+valproate |
|---|---|
| Sponsor | National Cheng-Kung University Hospital |
| Drug class | Mood stabilizer |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
It does this by inhibiting the reuptake of gamma-aminobutyric acid (GABA), a neurotransmitter that helps to calm down brain activity, and by blocking the release of excitatory neurotransmitters such as glutamate and aspartate.
Approved indications
- Seizure prevention
- Bipolar disorder
Common side effects
- Nausea
- Dizziness
- Headache
- Somnolence
- Thrombocytopenia
- Liver function abnormalities
- Weight gain
- Hair loss
- Rash
- Hepatotoxicity
Key clinical trials
- 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)
- Sequential Multiple Assignment Randomized Trial for Bipolar Depression (PHASE4)
- Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy (PHASE2, PHASE3)
- Valproate for the Treatment of Residual Amblyopia (PHASE1, PHASE2)
- Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)? (PHASE4)
- Evaluation of TRANSKRIP ® Plus Chemotherapy in Recurrent-Persistent Cervical Cancer (PHASE3)
- Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (PHASE2)
- Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism (PHASE2)
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:
- placebo+valproate CI brief — competitive landscape report
- placebo+valproate updates RSS · CI watch RSS
- National Cheng-Kung University Hospital portfolio CI
Frequently asked questions about placebo+valproate
What is placebo+valproate?
How does placebo+valproate work?
What is placebo+valproate used for?
Who makes placebo+valproate?
What drug class is placebo+valproate in?
What development phase is placebo+valproate in?
What are the side effects of placebo+valproate?
Related
- Drug class: All Mood stabilizer drugs
- Manufacturer: National Cheng-Kung University Hospital — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Seizure prevention
- Indication: Drugs for Bipolar disorder
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing