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MONOXERUTIN

Phase 2 active Small molecule

MONOXERUTIN is a drug. It is currently in Phase 2 development for Peripheral venous insufficiency.

Monoxerutin works by improving blood vessel function and reducing inflammation.

Monoxerutin is a small molecule drug with unknown drug class and target. It is used to treat peripheral venous insufficiency, a condition characterized by weakened veins that can lead to swelling and pain. The commercial status of Monoxerutin is unclear, and it is not known if it is patented or available as a generic. Further information on its pharmacokinetics, safety, and efficacy is needed. As a treatment for peripheral venous insufficiency, Monoxerutin is likely to be used in conjunction with other therapies to manage symptoms and prevent complications.

Likelihood of approval
15.3% 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).
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 nameMONOXERUTIN
ModalitySmall molecule
Therapeutic areaHematology
PhasePhase 2

Mechanism of action

Imagine your blood vessels are like roads in your body. When they get damaged or weakened, it's harder for blood to flow through them. Monoxerutin helps to fix these roads by improving their function and reducing inflammation, which can help to alleviate symptoms of peripheral venous insufficiency.

Approved indications

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 MONOXERUTIN

What is MONOXERUTIN?

MONOXERUTIN is a Small molecule drug, indicated for Peripheral venous insufficiency.

How does MONOXERUTIN work?

Monoxerutin works by improving blood vessel function and reducing inflammation.

What is MONOXERUTIN used for?

MONOXERUTIN is indicated for Peripheral venous insufficiency.

What development phase is MONOXERUTIN in?

MONOXERUTIN is in Phase 2.

Related

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