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Normezaton (NORFENEFRINE)

Phase 2 active Small molecule ✓ Verified Jun 2026

Normezaton (generic name: NORFENEFRINE) is a norfenefrine drug. It is currently in Phase 2 development.

Normetazone works by interacting with the body's sympathetic nervous system, which regulates various physiological processes such as heart rate and blood pressure.

Normezaton is a small molecule with synonyms including norfenefrine, norphenylephrine, and WV-569 free base.

Likelihood of approval
13.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameNORFENEFRINE
Drug classnorfenefrine
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Imagine your body's 'fight or flight' response, which is controlled by the sympathetic nervous system. Normetazone may help modulate this response, but exactly how it does this is not yet fully understood. It's like a fine-tuner for your body's automatic responses.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Normezaton

What is Normezaton?

Normezaton (NORFENEFRINE) is a norfenefrine drug.

How does Normezaton work?

Normetazone works by interacting with the body's sympathetic nervous system, which regulates various physiological processes such as heart rate and blood pressure.

What is the generic name of Normezaton?

NORFENEFRINE is the generic (nonproprietary) name of Normezaton.

What drug class is Normezaton in?

Normezaton belongs to the norfenefrine class. See all norfenefrine drugs at /class/norfenefrine.

What development phase is Normezaton in?

Normezaton is in Phase 2.

Related

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