Last reviewed 2026-05-24 · How we verify

Comparator: fluvastatin

Organon and Co · Phase 3 active Small molecule ✓ Verified May 2026

Comparator: fluvastatin is a Statin (HMG-CoA reductase inhibitor) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk, Primary and secondary prevention of coronary heart disease.

Fluvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.

Fluvastatin is a small molecule used to treat hypercholesterolemia. It is a comparator in clinical trials, often compared to other statins such as atorvastatin.

Likelihood of approval

56.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	Comparator: fluvastatin
Sponsor	Organon and Co
Drug class	Statin (HMG-CoA reductase inhibitor)
Target	HMG-CoA reductase
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Fluvastatin is a competitive inhibitor of HMG-CoA reductase, which catalyzes the conversion of HMG-CoA to mevalonate in the cholesterol biosynthetic pathway. By blocking this enzyme, fluvastatin decreases hepatic cholesterol production, leading to upregulation of LDL receptors on hepatocytes and increased clearance of LDL cholesterol from the bloodstream. This results in reduced plasma LDL cholesterol concentrations and improved lipid profiles.

Approved indications

Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk
Primary and secondary prevention of coronary heart disease

Common side effects

Myalgia (muscle pain)
Headache
Dyspepsia
Elevated liver enzymes (ALT/AST)
Rhabdomyolysis

Key clinical trials

A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808) (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:

Comparator: fluvastatin CI brief — competitive landscape report
Comparator: fluvastatin updates RSS · CI watch RSS
Organon and Co portfolio CI

Frequently asked questions about Comparator: fluvastatin

What is Comparator: fluvastatin?

Comparator: fluvastatin is a Statin (HMG-CoA reductase inhibitor) drug developed by Organon and Co, indicated for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk, Primary and secondary prevention of coronary heart disease.

How does Comparator: fluvastatin work?

Fluvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.

What is Comparator: fluvastatin used for?

Comparator: fluvastatin is indicated for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk, Primary and secondary prevention of coronary heart disease.

Who makes Comparator: fluvastatin?

Comparator: fluvastatin is developed by Organon and Co (see full Organon and Co pipeline at /company/organon-and-co).

What drug class is Comparator: fluvastatin in?

Comparator: fluvastatin belongs to the Statin (HMG-CoA reductase inhibitor) class. See all Statin (HMG-CoA reductase inhibitor) drugs at /class/statin-hmg-coa-reductase-inhibitor.

What development phase is Comparator: fluvastatin in?

Comparator: fluvastatin is in Phase 3.

What are the side effects of Comparator: fluvastatin?

Common side effects of Comparator: fluvastatin include Myalgia (muscle pain), Headache, Dyspepsia, Elevated liver enzymes (ALT/AST), Rhabdomyolysis.

What does Comparator: fluvastatin target?

Comparator: fluvastatin targets HMG-CoA reductase and is a Statin (HMG-CoA reductase inhibitor).

Drug class: All Statin (HMG-CoA reductase inhibitor) drugs
Target: All drugs targeting HMG-CoA reductase
Manufacturer: Organon and Co — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypercholesterolemia and dyslipidemia for reduction of cardiovascular risk
Indication: Drugs for Primary and secondary prevention of coronary heart disease

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