Last reviewed 2026-05-26 · How we verify

SODIUM DIVALPROATE

Sanofi · Phase 3 active Small molecule ✓ Verified May 2026

SODIUM DIVALPROATE is a mood stabilizer Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Epilepsy, Manic episodes associated with bipolar disorder.

Sodium valproate is a mood stabilizer that works by reducing the activity of certain brain chemicals that cause mania and seizures.

Sodium valproate is a small molecule anti-epileptic drug used to treat conditions such as epilepsy. It has also been studied in relation to other conditions including bipolar disorder and drug hypersensitivity syndrome.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Big-pharma sponsor +3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	SODIUM DIVALPROATE
Sponsor	Sanofi
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

Epilepsy
Manic episodes associated with bipolar disorder

Common side effects

Nausea
Dizziness
Headache
Somnolence
Weight gain
Hair loss
Liver function abnormalities
Thrombocytopenia
Allergic reactions
Rash

Key clinical trials

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:

SODIUM DIVALPROATE CI brief — competitive landscape report
SODIUM DIVALPROATE updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about SODIUM DIVALPROATE

What is SODIUM DIVALPROATE?

SODIUM DIVALPROATE is a mood stabilizer drug developed by Sanofi, indicated for Epilepsy, Manic episodes associated with bipolar disorder.

How does SODIUM DIVALPROATE work?

Sodium valproate is a mood stabilizer that works by reducing the activity of certain brain chemicals that cause mania and seizures.

What is SODIUM DIVALPROATE used for?

SODIUM DIVALPROATE is indicated for Epilepsy, Manic episodes associated with bipolar disorder.

Who makes SODIUM DIVALPROATE?

SODIUM DIVALPROATE is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

What drug class is SODIUM DIVALPROATE in?

SODIUM DIVALPROATE belongs to the mood stabilizer class. See all mood stabilizer drugs at /class/mood-stabilizer.

What development phase is SODIUM DIVALPROATE in?

SODIUM DIVALPROATE is in Phase 3.

What are the side effects of SODIUM DIVALPROATE?

Common side effects of SODIUM DIVALPROATE include Nausea, Dizziness, Headache, Somnolence, Weight gain, Hair loss.

Drug class: All mood stabilizer drugs
Manufacturer: Sanofi — full pipeline
Therapeutic area: All drugs in Neurology
Indication: Drugs for Epilepsy
Indication: Drugs for Manic episodes associated with bipolar disorder

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing