Last reviewed 2026-04-20 · How we verify

Mevalon (MEGLUTOL)

Phase 2 active Small molecule

Mevalon (generic name: MEGLUTOL) is a meglutol drug. It is currently in Phase 2 development.

Mevalon works by blocking an enzyme that helps produce cholesterol in the liver.

Mevalon (MEGLUTOL) is a small molecule drug that targets 3-hydroxy-3-methylglutaryl-coenzyme A reductase, an enzyme involved in cholesterol synthesis. It is classified as a meglutol and works by inhibiting this enzyme, thereby reducing the production of cholesterol in the liver. However, due to the lack of available information, its commercial status, approved indications, half-life, bioavailability, and generic manufacturers are unknown. As a result, its use and safety considerations cannot be fully assessed. Further research is needed to determine its potential as a therapeutic agent.

Likelihood of approval

15.3% 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).

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	MEGLUTOL
Drug class	meglutol
Target	3-hydroxy-3-methylglutaryl-coenzyme A reductase
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of your liver like a factory that makes cholesterol. Mevalon is like a traffic cop that stops the factory from producing too much cholesterol by blocking the enzyme that helps make it. This can help lower cholesterol levels in the blood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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:

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

Frequently asked questions about Mevalon

What is Mevalon?

Mevalon (MEGLUTOL) is a meglutol drug.

How does Mevalon work?

Mevalon works by blocking an enzyme that helps produce cholesterol in the liver.

What is the generic name of Mevalon?

MEGLUTOL is the generic (nonproprietary) name of Mevalon.

What drug class is Mevalon in?

Mevalon belongs to the meglutol class. See all meglutol drugs at /class/meglutol.

What development phase is Mevalon in?

Mevalon is in Phase 2.

What does Mevalon target?

Mevalon targets 3-hydroxy-3-methylglutaryl-coenzyme A reductase and is a meglutol.

Drug class: All meglutol drugs
Target: All drugs targeting 3-hydroxy-3-methylglutaryl-coenzyme A reductase
Therapeutic area: All drugs in Metabolic

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