THERAPY DOSSIER · th-70f3413226e8

Sodium valproate

Drug · Succinate semialdehyde dehydrogenase inhibitor

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This record is classified as “NO TRAUMA TRANSLATION”. Read the indication and notes below for the specific context.

Evidence & regulatory context

Mechanism: Succinate semialdehyde dehydrogenase inhibitor
Target: Succinate semialdehyde dehydrogenase (CHEMBL1911)
Injury models: Ischaemia-reperfusion
Reported indication: Epilepsy (seizure disorders), bipolar mania, and migraine prophylaxis
First approval: 1996
Development stage: Approved for epilepsy/bipolar; not for the acute (TBI) injury tested
ChEMBL record: CHEMBL433 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: Sodium valproate; Valproate sodium; Epilim; Depacon; Orfiril; Episenta
Note: Not recorded

Clinical trials 8

1 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT01326663 ↗Injury indicationNAunknown

Divalproex Sodium for Affective Lability and Alcohol Use Following Traumatic Brain Injury

TBI · Alcoholism · Irritable Mood

Enrolment: 50 · Results not recorded

NCT03652974 ↗PHASE4completed

Plasma Cytokine Parameters in Clozapine-Resistant Schizophrenia (Sodium Valproate + Clozapine)

Schizophrenia

Enrolment: 145 · Results not recorded

NCT02100644 ↗PHASE4completed

Valproate Dose Reduction by Introducing Lamotrigine in Japanese Women With Epilepsy

Epilepsy

Enrolment: 33 · Results not recorded

NCT00257972 ↗PHASE3completed

Aripiprazole With Valproate or Lithium in Mania in Bipolar I Disorder

Bipolar Disorder

Enrolment: 400 · Results not recorded

NCT00974012 ↗PHASE1completed

Relative Bioavailability of 500 mg Divalproex Sodium Extended Release Tablets

Healthy

Enrolment: 24 · Results not recorded

NCT06211283 ↗PHASE1completed

Bioavailability of Orfiril Long 500 mg (Sodium Valproate) Prolonged Release Minitablets

Food-drug Interaction

Enrolment: 28 · Results not recorded

NCT00810680 ↗NAunknown

Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Enrolment: 10 · Results not recorded

NCT00570219 ↗NAcompleted

Effect of Valproate Treatment on Withdrawal Severity in Benzodiazepine Dependent Patients

Substance Withdrawal Syndrome

Enrolment: 30 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 31630884 ↗2019Reported benefit

Sodium Valproate Improves Skin Flap Survival via Gamma-Aminobutyric Acid and Histone Deacetylase Inhibitory System.

RatIschaemia-reperfusionOther / unspecifiedSprague-DawleyMaleIntraperitonealAcute treatment 50, 100, 150 or 300 mg/kg; chronic treatmen…Acute treatment 1 h before flap surgery; chronic treatment daily for 2 weeks

Model: Random-pattern skin flap with ischaemic necrosis in rats

Sodium valproate 100 mg/kg significantly reduced the length of skin necrosis in both acute (P < 0.05) and chronic (P < 0.01) treatment, increased weight gain (P < 0.05) and accelerated skin healing (P < 0.001). Bicuculline increased necrosis length and, at a subeffective dose, prevented the protect…

Extraction: extract · Supplied extraction confidence: 0.8. Machine-extracted fields require source verification.

Record at a glance

Study window: 2019–2019
Corpus tranches: 1980-1989 · 2011-2020
Species: Rat
Physical-trauma evidence: Not flagged
Repurposed: Approval pre-dates corpus studies
Combination: Not flagged
Withdrawal flag: Not flagged
Dataset: 2026-08-25

Safety narrative

Reported finding

FDA boxed warnings: hepatotoxicity, teratogenicity (neural tube defects, reduced IQ), and pancreatitis

The supplied narrative describes a warning, adverse event, restriction or clinical finding. Context and indication must be checked in the original sources; this is not an independent safety assessment.

Sources & provenance

ChEMBL (EMBL-EBI) CHEMBL433 max_phase 4, first_approval 1996
ClinicalTrials.gov NCT01326663 (TBI), NCT00257972 (bipolar mania)
FDA valproate label - boxed warnings hepatotoxicity/teratogenicity/pancreatitis

How records are classified

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