Last reviewed 2026-05-28 · How we verify

Regulton (AMEZINIUM METILSULFATE)

Phase 2 active Small molecule ✓ Verified May 2026 Quality 32/100

Regulton (generic name: AMEZINIUM METILSULFATE) is a Monoamine Oxidase Inhibitors drug. It is currently in Phase 2 development.

Regulton works by inhibiting the enzyme monoamine oxidase, which breaks down certain neurotransmitters in the brain.

Regulton is a small molecule medication. It is also known by various synonyms, including Amezinium methyl sulfate.

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	AMEZINIUM METILSULFATE
Drug class	Monoamine Oxidase Inhibitors
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Think of it like a traffic cop at a busy intersection. Monoamine oxidase is like the cop that stops certain 'cars' (neurotransmitters like serotonin and dopamine) from getting through. Regulton is like a sign that says 'go ahead, let the cars through'. This allows more of these neurotransmitters to be available in the brain, which can help improve mood and other symptoms.

Approved indications

No approved indications tracked.

Common side effects

Shunt occlusion

Drug interactions

Alpha/Beta Agonists
Amphetamines
Indirectly Acting Sympathomimetic Amines
Selective Serotonin Reuptake Inhibitors
Serotonin/Norepinephrine Reuptake Inhibitors
Tricyclic Antidepressants
buspirone
dextromethorphan
levodopa
methyldopa
mirtazapine
pethidine

Competitive intelligence

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

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

Frequently asked questions about Regulton

What is Regulton?

Regulton (AMEZINIUM METILSULFATE) is a Monoamine Oxidase Inhibitors drug.

How does Regulton work?

Regulton works by inhibiting the enzyme monoamine oxidase, which breaks down certain neurotransmitters in the brain.

What is the generic name of Regulton?

AMEZINIUM METILSULFATE is the generic (nonproprietary) name of Regulton.

What drug class is Regulton in?

Regulton belongs to the Monoamine Oxidase Inhibitors class. See all Monoamine Oxidase Inhibitors drugs at /class/monoamine-oxidase-inhibitors.

What development phase is Regulton in?

Regulton is in Phase 2.

What are the side effects of Regulton?

Common side effects of Regulton include Shunt occlusion.

Drug class: All Monoamine Oxidase Inhibitors drugs
Therapeutic area: All drugs in Neuroscience

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