Last reviewed 2026-05-20 · How we verify

Comparators: simvastatin and ezetimibe

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

Comparators: simvastatin and ezetimibe is a Statin + ezetimibe combination Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hypercholesterolemia / dyslipidemia for cardiovascular risk reduction.

This is a combination therapy using simvastatin (a statin that inhibits HMG-CoA reductase) and ezetimibe (which blocks cholesterol absorption in the intestine) to lower LDL cholesterol through dual mechanisms.

Simvastatin and ezetimibe are two small molecule drugs used to treat conditions such as hypercholesterolemia, prediabetes, inflammation, and cardiovascular risk. They work through different mechanisms, with simvastatin primarily acting as a statin to lower cholesterol levels and ezetimibe inhibiting the absorption of cholesterol in the gut.

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	Comparators: simvastatin and ezetimibe
Sponsor	Organon and Co
Drug class	Statin + ezetimibe combination
Target	HMG-CoA reductase (simvastatin); NPC1L1 transporter (ezetimibe)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Simvastatin reduces cholesterol synthesis in the liver by inhibiting HMG-CoA reductase, while ezetimibe selectively inhibits cholesterol absorption at the intestinal brush border via the Niemann-Pick C1-like 1 (NPC1L1) transporter. Together, they provide complementary lipid-lowering effects that are more potent than either agent alone.

Approved indications

Hypercholesterolemia / dyslipidemia for cardiovascular risk reduction

Common side effects

Myalgia / muscle pain
Elevated liver transaminases
Headache
Gastrointestinal upset

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:

Comparators: simvastatin and ezetimibe CI brief — competitive landscape report
Comparators: simvastatin and ezetimibe updates RSS · CI watch RSS
Organon and Co portfolio CI

Frequently asked questions about Comparators: simvastatin and ezetimibe

What is Comparators: simvastatin and ezetimibe?

Comparators: simvastatin and ezetimibe is a Statin + ezetimibe combination drug developed by Organon and Co, indicated for Hypercholesterolemia / dyslipidemia for cardiovascular risk reduction.

How does Comparators: simvastatin and ezetimibe work?

What is Comparators: simvastatin and ezetimibe used for?

Comparators: simvastatin and ezetimibe is indicated for Hypercholesterolemia / dyslipidemia for cardiovascular risk reduction.

Who makes Comparators: simvastatin and ezetimibe?

Comparators: simvastatin and ezetimibe is developed by Organon and Co (see full Organon and Co pipeline at /company/organon-and-co).

What drug class is Comparators: simvastatin and ezetimibe in?

Comparators: simvastatin and ezetimibe belongs to the Statin + ezetimibe combination class. See all Statin + ezetimibe combination drugs at /class/statin-ezetimibe-combination.

What development phase is Comparators: simvastatin and ezetimibe in?

Comparators: simvastatin and ezetimibe is in Phase 3.

What are the side effects of Comparators: simvastatin and ezetimibe?

Common side effects of Comparators: simvastatin and ezetimibe include Myalgia / muscle pain, Elevated liver transaminases, Headache, Gastrointestinal upset.

What does Comparators: simvastatin and ezetimibe target?

Comparators: simvastatin and ezetimibe targets HMG-CoA reductase (simvastatin); NPC1L1 transporter (ezetimibe) and is a Statin + ezetimibe combination.

Drug class: All Statin + ezetimibe combination drugs
Target: All drugs targeting HMG-CoA reductase (simvastatin); NPC1L1 transporter (ezetimibe)
Manufacturer: Organon and Co — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypercholesterolemia / dyslipidemia for cardiovascular risk reduction

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