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Ezetrol

NVP Healthcare · Phase 1 active Small molecule Quality 12/100

Ezetrol is a Small molecule drug developed by NVP Healthcare. It is currently in Phase 1 development for Familial hypercholesterolemia - heterozygous, Familial hypercholesterolemia - homozygous, Hypercholesterolemia. Also known as: ezetimibe.

Likelihood of approval
9.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameEzetrol
Also known asezetimibe
SponsorNVP Healthcare
TargetSodium/bile acid cotransporter, Niemann-Pick C1-like protein 1, Niemann-Pick C1-like protein 1
ModalitySmall molecule
Therapeutic areaMetabolic
PhasePhase 1

Approved indications

Common side effects

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.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ezetrol

What is Ezetrol?

Ezetrol is a Small molecule drug developed by NVP Healthcare, indicated for Familial hypercholesterolemia - heterozygous, Familial hypercholesterolemia - homozygous, Hypercholesterolemia.

What is Ezetrol used for?

Ezetrol is indicated for Familial hypercholesterolemia - heterozygous, Familial hypercholesterolemia - homozygous, Hypercholesterolemia, Hyperlipidemia, Mixed hyperlipidemia.

Who makes Ezetrol?

Ezetrol is developed by NVP Healthcare (see full NVP Healthcare pipeline at /company/nvp-healthcare).

Is Ezetrol also known as anything else?

Ezetrol is also known as ezetimibe.

What development phase is Ezetrol in?

Ezetrol is in Phase 1.

What are the side effects of Ezetrol?

Common side effects of Ezetrol include Diarrhoea, Headache, Constipation, Myalgia, Nasopharyngitis, Back pain.

What does Ezetrol target?

Ezetrol targets Sodium/bile acid cotransporter, Niemann-Pick C1-like protein 1, Niemann-Pick C1-like protein 1.

Related

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