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Razoxin (RAZOXANE)

Phase 2 active Small molecule Under review

Razoxin (generic name: RAZOXANE) is a drug. It is currently in Phase 2 development for Doxorubicin Induced Cardiomyopathy, Extravasation Injury from Anthracycline Injection.

Razoxin works by chelating iron and preventing the formation of free radicals that damage heart tissue.

Razoxin is a small molecule with the synonyms ICI 59118, ICI-59118, ICRF 159, ICRF-159, NSC-129943, and RAZOXANE. It is being studied in clinical trials for various types of cancer, including Ewing's Sarcoma, Neuroblastoma, Rhabdomyosarcoma, Hepatoblastoma, Sarcoma, and Soft Tissue Sarcoma.

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 nameRAZOXANE
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 2

Mechanism of action

Think of Razoxin like a magnet that attaches to iron and prevents it from causing harm. When anthracycline chemotherapy agents are used, they can release iron that damages the heart. Razoxin helps to bind to this iron and prevent it from causing damage.

Approved indications

Common side effects

No common side effects on file.

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 Razoxin

What is Razoxin?

Razoxin (RAZOXANE) is a Small molecule drug, indicated for Doxorubicin Induced Cardiomyopathy, Extravasation Injury from Anthracycline Injection.

How does Razoxin work?

Razoxin works by chelating iron and preventing the formation of free radicals that damage heart tissue.

What is Razoxin used for?

Razoxin is indicated for Doxorubicin Induced Cardiomyopathy, Extravasation Injury from Anthracycline Injection.

What is the generic name of Razoxin?

RAZOXANE is the generic (nonproprietary) name of Razoxin.

What development phase is Razoxin in?

Razoxin is in Phase 2.

Related

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