Last reviewed 2026-04-23 · How we verify

valproid acid plus corticosteroids

University of Sao Paulo · Phase 3 active Small molecule

valproid acid plus corticosteroids is a Mood stabilizer, Anti-inflammatory Small molecule drug developed by University of Sao Paulo. It is currently in Phase 3 development for Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis.

Valproic acid is a mood stabilizer that works by reducing the activity of certain brain chemicals, while corticosteroids are anti-inflammatory agents that reduce swelling and inflammation.

Valproic acid is a mood stabilizer that works by reducing the activity of certain brain chemicals, while corticosteroids are anti-inflammatory agents that reduce swelling and inflammation. Used for Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis.

Likelihood of approval

55.3% 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).

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	valproid acid plus corticosteroids
Sponsor	University of Sao Paulo
Drug class	Mood stabilizer, Anti-inflammatory
Modality	Small molecule
Therapeutic area	Neurology, Immunology
Phase	Phase 3

Mechanism of action

Valproic acid is thought to exert its effects by inhibiting the reuptake of certain neurotransmitters, such as serotonin and dopamine, and by reducing the release of excitatory neurotransmitters. Corticosteroids, on the other hand, work by suppressing the immune system's response to inflammation, thereby reducing the production of pro-inflammatory cytokines and mediators.

Approved indications

Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis

Common side effects

Nausea
Dizziness
Weight gain
Hirsutism
Acne
Liver enzyme elevation
Thrombocytopenia
Hypersensitivity reactions

Key clinical trials

Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM) (PHASE3)

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:

valproid acid plus corticosteroids CI brief — competitive landscape report
valproid acid plus corticosteroids updates RSS · CI watch RSS
University of Sao Paulo portfolio CI

Frequently asked questions about valproid acid plus corticosteroids

What is valproid acid plus corticosteroids?

valproid acid plus corticosteroids is a Mood stabilizer, Anti-inflammatory drug developed by University of Sao Paulo, indicated for Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis.

How does valproid acid plus corticosteroids work?

Valproic acid is a mood stabilizer that works by reducing the activity of certain brain chemicals, while corticosteroids are anti-inflammatory agents that reduce swelling and inflammation.

What is valproid acid plus corticosteroids used for?

valproid acid plus corticosteroids is indicated for Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis.

Who makes valproid acid plus corticosteroids?

valproid acid plus corticosteroids is developed by University of Sao Paulo (see full University of Sao Paulo pipeline at /company/university-of-sao-paulo).

What drug class is valproid acid plus corticosteroids in?

valproid acid plus corticosteroids belongs to the Mood stabilizer, Anti-inflammatory class. See all Mood stabilizer, Anti-inflammatory drugs at /class/mood-stabilizer-anti-inflammatory.

What development phase is valproid acid plus corticosteroids in?

valproid acid plus corticosteroids is in Phase 3.

What are the side effects of valproid acid plus corticosteroids?

Common side effects of valproid acid plus corticosteroids include Nausea, Dizziness, Weight gain, Hirsutism, Acne, Liver enzyme elevation.

Drug class: All Mood stabilizer, Anti-inflammatory drugs
Manufacturer: University of Sao Paulo — full pipeline
Therapeutic area: All drugs in Neurology, Immunology
Indication: Drugs for Seizure prevention, Migraine prophylaxis, Inflammatory conditions such as asthma and rheumatoid arthritis

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