Last reviewed 2026-04-22 · How we verify

Active comparator1 : Ezetimibe / Rosuvastatin

Hanlim Pharm. Co., Ltd. · Phase 3 active Small molecule

Active comparator1 : Ezetimibe / Rosuvastatin is a Combination lipid-lowering agent (ezetimibe/statin) Small molecule drug developed by Hanlim Pharm. Co., Ltd.. It is currently in Phase 3 development for Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction.

This combination reduces LDL cholesterol through dual inhibition of cholesterol absorption (ezetimibe) and hepatic cholesterol synthesis (rosuvastatin).

This combination reduces LDL cholesterol through dual inhibition of cholesterol absorption (ezetimibe) and hepatic cholesterol synthesis (rosuvastatin). Used for Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction.

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	Active comparator1 : Ezetimibe / Rosuvastatin
Sponsor	Hanlim Pharm. Co., Ltd.
Drug class	Combination lipid-lowering agent (ezetimibe/statin)
Target	NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin)
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Ezetimibe selectively inhibits cholesterol absorption in the small intestine by blocking the Niemann-Pick C1-like 1 (NPC1L1) transporter. Rosuvastatin is a statin that inhibits HMG-CoA reductase, the rate-limiting enzyme in hepatic cholesterol synthesis. Together, they provide complementary mechanisms to lower LDL cholesterol and reduce cardiovascular risk.

Approved indications

Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction

Common side effects

Myalgia
Elevated liver enzymes
Headache
Gastrointestinal disturbance

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:

Active comparator1 : Ezetimibe / Rosuvastatin CI brief — competitive landscape report
Active comparator1 : Ezetimibe / Rosuvastatin updates RSS · CI watch RSS
Hanlim Pharm. Co., Ltd. portfolio CI

Frequently asked questions about Active comparator1 : Ezetimibe / Rosuvastatin

What is Active comparator1 : Ezetimibe / Rosuvastatin?

Active comparator1 : Ezetimibe / Rosuvastatin is a Combination lipid-lowering agent (ezetimibe/statin) drug developed by Hanlim Pharm. Co., Ltd., indicated for Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction.

How does Active comparator1 : Ezetimibe / Rosuvastatin work?

This combination reduces LDL cholesterol through dual inhibition of cholesterol absorption (ezetimibe) and hepatic cholesterol synthesis (rosuvastatin).

What is Active comparator1 : Ezetimibe / Rosuvastatin used for?

Active comparator1 : Ezetimibe / Rosuvastatin is indicated for Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction.

Who makes Active comparator1 : Ezetimibe / Rosuvastatin?

Active comparator1 : Ezetimibe / Rosuvastatin is developed by Hanlim Pharm. Co., Ltd. (see full Hanlim Pharm. Co., Ltd. pipeline at /company/hanlim-pharm-co-ltd).

What drug class is Active comparator1 : Ezetimibe / Rosuvastatin in?

Active comparator1 : Ezetimibe / Rosuvastatin belongs to the Combination lipid-lowering agent (ezetimibe/statin) class. See all Combination lipid-lowering agent (ezetimibe/statin) drugs at /class/combination-lipid-lowering-agent-ezetimibe-statin.

What development phase is Active comparator1 : Ezetimibe / Rosuvastatin in?

Active comparator1 : Ezetimibe / Rosuvastatin is in Phase 3.

What are the side effects of Active comparator1 : Ezetimibe / Rosuvastatin?

Common side effects of Active comparator1 : Ezetimibe / Rosuvastatin include Myalgia, Elevated liver enzymes, Headache, Gastrointestinal disturbance.

What does Active comparator1 : Ezetimibe / Rosuvastatin target?

Active comparator1 : Ezetimibe / Rosuvastatin targets NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin) and is a Combination lipid-lowering agent (ezetimibe/statin).

Drug class: All Combination lipid-lowering agent (ezetimibe/statin) drugs
Target: All drugs targeting NPC1L1 transporter (ezetimibe); HMG-CoA reductase (rosuvastatin)
Manufacturer: Hanlim Pharm. Co., Ltd. — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypercholesterolemia and dyslipidemia for cardiovascular risk reduction

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