Last reviewed 2026-05-22 · How we verify

SPC ezetimibe/rosuvastatin

Sanofi · Phase 3 active Small molecule Under review

SPC ezetimibe/rosuvastatin is a Cholesterol absorption inhibitor/statin Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Hypercholesterolemia, Mixed dyslipidemia.

Ezetimibe inhibits the absorption of cholesterol in the small intestine, while rosuvastatin inhibits HMG-CoA reductase to reduce cholesterol production in the liver.

SPC ezetimibe/rosuvastatin is a single pill combination used to treat hypercholesterolemia. It works as a small molecule inhibitor of the enzyme 3-hydroxy-3-methylglutaryl-coenzyme A reductase, which is involved in cholesterol production.

Likelihood of approval

59.3% 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.
Big-pharma sponsor +3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	SPC ezetimibe/rosuvastatin
Sponsor	Sanofi
Drug class	Cholesterol absorption inhibitor/statin
Target	NPC1L1/HMG-CoA reductase
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Ezetimibe works by binding to the Niemann-Pick C1-like 1 (NPC1L1) protein in the small intestine, preventing the absorption of cholesterol from the diet. Rosuvastatin, on the other hand, is a statin that inhibits the enzyme HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By inhibiting this enzyme, rosuvastatin reduces the liver's production of cholesterol, leading to a decrease in circulating cholesterol levels.

Approved indications

Hypercholesterolemia
Mixed dyslipidemia

Common side effects

Muscle pain
Liver enzyme elevations
Diarrhea

Key clinical trials

A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy (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:

SPC ezetimibe/rosuvastatin CI brief — competitive landscape report
SPC ezetimibe/rosuvastatin updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about SPC ezetimibe/rosuvastatin

What is SPC ezetimibe/rosuvastatin?

SPC ezetimibe/rosuvastatin is a Cholesterol absorption inhibitor/statin drug developed by Sanofi, indicated for Hypercholesterolemia, Mixed dyslipidemia.

How does SPC ezetimibe/rosuvastatin work?

Ezetimibe inhibits the absorption of cholesterol in the small intestine, while rosuvastatin inhibits HMG-CoA reductase to reduce cholesterol production in the liver.

What is SPC ezetimibe/rosuvastatin used for?

SPC ezetimibe/rosuvastatin is indicated for Hypercholesterolemia, Mixed dyslipidemia.

Who makes SPC ezetimibe/rosuvastatin?

SPC ezetimibe/rosuvastatin is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

What drug class is SPC ezetimibe/rosuvastatin in?

SPC ezetimibe/rosuvastatin belongs to the Cholesterol absorption inhibitor/statin class. See all Cholesterol absorption inhibitor/statin drugs at /class/cholesterol-absorption-inhibitor-statin.

What development phase is SPC ezetimibe/rosuvastatin in?

SPC ezetimibe/rosuvastatin is in Phase 3.

What are the side effects of SPC ezetimibe/rosuvastatin?

Common side effects of SPC ezetimibe/rosuvastatin include Muscle pain, Liver enzyme elevations, Diarrhea.

What does SPC ezetimibe/rosuvastatin target?

SPC ezetimibe/rosuvastatin targets NPC1L1/HMG-CoA reductase and is a Cholesterol absorption inhibitor/statin.

Drug class: All Cholesterol absorption inhibitor/statin drugs
Target: All drugs targeting NPC1L1/HMG-CoA reductase
Manufacturer: Sanofi — full pipeline
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Hypercholesterolemia
Indication: Drugs for Mixed dyslipidemia

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