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Flumetiazid (FLUMETHIAZIDE)

Phase 2 active Small molecule

Flumetiazid (generic name: FLUMETHIAZIDE) is a flumethiazide drug. It is currently in Phase 2 development for Edema, Hypertensive disorder.

Flumethiazide works by blocking the reabsorption of sodium and chloride ions in the kidneys, leading to increased urine production and reduced blood pressure.

Flumethiazide is a small molecule drug in the thiazide diuretic class, originally developed by an unknown entity and currently owned by an unknown entity. It is used to treat edema and hypertensive disorders by promoting the excretion of sodium and water in the urine. The commercial status of flumethiazide is unknown, but it is likely used as a generic medication. Key safety considerations include potential electrolyte imbalances and dehydration. As a thiazide diuretic, flumethiazide works by inhibiting the sodium-chloride cotransporter in the distal convoluted tubule of the kidneys.

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 nameFLUMETHIAZIDE
Drug classflumethiazide
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Imagine your kidneys as filters that remove waste and excess fluids from your blood. Flumethiazide helps these filters work more efficiently by blocking the reabsorption of sodium and chloride ions, which are essential for maintaining fluid balance in the body. This leads to increased urine production and reduced blood pressure, making it easier for the heart to pump blood and reducing the risk of complications from high blood pressure.

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 Flumetiazid

What is Flumetiazid?

Flumetiazid (FLUMETHIAZIDE) is a flumethiazide drug, indicated for Edema, Hypertensive disorder.

How does Flumetiazid work?

Flumethiazide works by blocking the reabsorption of sodium and chloride ions in the kidneys, leading to increased urine production and reduced blood pressure.

What is Flumetiazid used for?

Flumetiazid is indicated for Edema, Hypertensive disorder.

What is the generic name of Flumetiazid?

FLUMETHIAZIDE is the generic (nonproprietary) name of Flumetiazid.

What drug class is Flumetiazid in?

Flumetiazid belongs to the flumethiazide class. See all flumethiazide drugs at /class/flumethiazide.

What development phase is Flumetiazid in?

Flumetiazid is in Phase 2.

Related

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