Last reviewed · How we verify

Azosemid (AZOSEMIDE)

Phase 3 active Small molecule

Azosemid (generic name: AZOSEMIDE) is a azosemide drug. It is currently in Phase 3 development for Congestive heart failure.

Azosemide works by inhibiting the reabsorption of sodium and chloride ions in the kidneys.

Azosemide, a small molecule drug in the azosemide class, is used to treat Congestive heart failure. Its mechanism of action is not well-documented, but it is believed to work by inhibiting the reabsorption of sodium and chloride ions in the kidneys, leading to increased urine production and reduced fluid buildup in the body. The commercial status of azosemide is unclear, but it is not widely available in the US market. Key safety considerations include its low bioavailability of 10%, which may affect its efficacy. Further research is needed to fully understand its pharmacological properties.

Likelihood of approval
56.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameAZOSEMIDE
Drug classazosemide
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

Think of it like a sponge: when you squeeze a sponge, water comes out. Azosemide helps the kidneys squeeze out excess water and salt by blocking the tiny tubes where they're reabsorbed, allowing more to be excreted in the urine.

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 Azosemid

What is Azosemid?

Azosemid (AZOSEMIDE) is a azosemide drug, indicated for Congestive heart failure.

How does Azosemid work?

Azosemide works by inhibiting the reabsorption of sodium and chloride ions in the kidneys.

What is Azosemid used for?

Azosemid is indicated for Congestive heart failure.

What is the generic name of Azosemid?

AZOSEMIDE is the generic (nonproprietary) name of Azosemid.

What drug class is Azosemid in?

Azosemid belongs to the azosemide class. See all azosemide drugs at /class/azosemide.

What development phase is Azosemid in?

Azosemid is in Phase 3.

What are the side effects of Azosemid?

Common side effects of Azosemid include Cardiac failure, Renal impairment, Cardiac failure chronic, Hepatic function abnormal, Cerebral infarction, Blood pressure decreased.

Related

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