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Placebo (for Ezetimibe)
Placebo (for Ezetimibe) is a Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Control arm in Phase 3 trial for Ezetimibe (cholesterol-lowering agent).
Placebo is an inert substance with no active pharmacological mechanism.
Placebo is an inert substance with no active pharmacological mechanism. Used for Control arm in Phase 3 trial for Ezetimibe (cholesterol-lowering agent).
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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.
| 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 | Placebo (for Ezetimibe) |
|---|---|
| Sponsor | Sanofi |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Placebo serves as a control comparator in clinical trials and contains no active pharmaceutical ingredient. It is used to establish the efficacy of the active drug (Ezetimibe in this case) by comparison against a non-therapeutic baseline, allowing researchers to distinguish true drug effects from placebo response and natural disease progression.
Approved indications
- Control arm in Phase 3 trial for Ezetimibe (cholesterol-lowering agent)
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Enlicitide (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018/CORALreef AddOn) (PHASE3)
- Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides (PHASE4)
- INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2) (NA)
- Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART) (PHASE3)
- A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C. (PHASE1)
- Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy. (PHASE3)
- 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)
- A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (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:
- Placebo (for Ezetimibe) CI brief — competitive landscape report
- Placebo (for Ezetimibe) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Placebo (for Ezetimibe)
What is Placebo (for Ezetimibe)?
How does Placebo (for Ezetimibe) work?
What is Placebo (for Ezetimibe) used for?
Who makes Placebo (for Ezetimibe)?
What development phase is Placebo (for Ezetimibe) in?
Related
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Control arm in Phase 3 trial for Ezetimibe (cholesterol-lowering agent)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing