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Hydroxydaunorubicin

University of Colorado, Denver · Phase 2 active Small molecule

Hydroxydaunorubicin is a Small molecule drug developed by University of Colorado, Denver. It is currently in Phase 2 development for Acute lymphoid leukemia, Acute myeloid leukemia, disease, Advanced ovarian cancer. Also known as: Adriamycin.

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).
  • 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.
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 nameHydroxydaunorubicin
Also known asAdriamycin
SponsorUniversity of Colorado, Denver
TargetCanalicular multispecific organic anion transporter 1, Multidrug resistance-associated protein 6, 72 kDa type IV collagenase
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 Hydroxydaunorubicin

What is Hydroxydaunorubicin?

Hydroxydaunorubicin is a Small molecule drug developed by University of Colorado, Denver, indicated for Acute lymphoid leukemia, Acute myeloid leukemia, disease, Advanced ovarian cancer.

What is Hydroxydaunorubicin used for?

Hydroxydaunorubicin is indicated for Acute lymphoid leukemia, Acute myeloid leukemia, disease, Advanced ovarian cancer, Burkitt's lymphoma, Carcinoma of breast.

Who makes Hydroxydaunorubicin?

Hydroxydaunorubicin is developed by University of Colorado, Denver (see full University of Colorado, Denver pipeline at /company/university-of-colorado-denver).

Is Hydroxydaunorubicin also known as anything else?

Hydroxydaunorubicin is also known as Adriamycin.

What development phase is Hydroxydaunorubicin in?

Hydroxydaunorubicin is in Phase 2.

What does Hydroxydaunorubicin target?

Hydroxydaunorubicin targets Canalicular multispecific organic anion transporter 1, Multidrug resistance-associated protein 6, 72 kDa type IV collagenase.

Related

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