Last reviewed · How we verify

Epidoxorubicin

Hoffmann-La Roche · Phase 2 active Small molecule Under review

Epidoxorubicin is a Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 2 development for Carcinoma of breast.

Epidoxorubicin is a small molecule used in chemotherapy, specifically for treating breast cancer, including ER+/HER2- breast cancer. It is often used in combination with other medications, such as chemotherapy, for the treatment of breast cancer in patients who have undergone surgery.

Likelihood of approval
16.3% 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).
  • Oncology Phase 2 attrition -2.0pp
    Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
  • Big-pharma sponsor +3.0pp
    Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
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 nameEpidoxorubicin
SponsorHoffmann-La Roche
TargetTyrosine-protein kinase Fyn, 5-hydroxytryptamine receptor 4, Genome polyprotein
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 2

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 Epidoxorubicin

What is Epidoxorubicin?

Epidoxorubicin is a Small molecule drug developed by Hoffmann-La Roche, indicated for Carcinoma of breast.

What is Epidoxorubicin used for?

Epidoxorubicin is indicated for Carcinoma of breast.

Who makes Epidoxorubicin?

Epidoxorubicin is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

What development phase is Epidoxorubicin in?

Epidoxorubicin is in Phase 2.

What does Epidoxorubicin target?

Epidoxorubicin targets Tyrosine-protein kinase Fyn, 5-hydroxytryptamine receptor 4, Genome polyprotein.

Related

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