Last reviewed 2026-04-19 · How we verify

BUDIPINE

Phase 2 active Small molecule

BUDIPINE is a budipine drug. It is currently in Phase 2 development.

Budipine works by blocking potassium channels in the brain, which can help regulate abnormal electrical activity.

Budipine is a small molecule drug that targets the potassium voltage-gated channel subfamily H member 2. It is classified as a budipine drug and its mechanism of action is not FDA approved for any indications. The commercial status of budipine is unknown, and it is not clear if it is patented or available as a generic. Further research is needed to determine its safety and efficacy. Budipine's pharmacokinetic properties, including half-life and bioavailability, are also unknown.

Likelihood of approval

12.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	BUDIPINE
Drug class	budipine
Target	Potassium voltage-gated channel subfamily H member 2, Glutamate [NMDA] receptor
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of your brain's electrical activity like a stormy ocean. Potassium channels help calm the waves, but in some cases, these channels can get overactive and cause problems. Budipine helps block these channels, reducing the stormy activity and potentially treating certain conditions.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BUDIPINE CI brief — competitive landscape report
BUDIPINE updates RSS · CI watch RSS

Frequently asked questions about BUDIPINE

What is BUDIPINE?

BUDIPINE is a budipine drug.

How does BUDIPINE work?

Budipine works by blocking potassium channels in the brain, which can help regulate abnormal electrical activity.

What drug class is BUDIPINE in?

BUDIPINE belongs to the budipine class. See all budipine drugs at /class/budipine.

What development phase is BUDIPINE in?

BUDIPINE is in Phase 2.

What does BUDIPINE target?

BUDIPINE targets Potassium voltage-gated channel subfamily H member 2, Glutamate [NMDA] receptor and is a budipine.

Drug class: All budipine drugs
Target: All drugs targeting Potassium voltage-gated channel subfamily H member 2, Glutamate [NMDA] receptor
Therapeutic area: All drugs in Neuroscience

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