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Hydroxydaunomycin
Hydroxydaunomycin is a Small molecule drug developed by Weill Medical College of Cornell University. It is currently in Phase 2 development for Acute lymphoid leukemia, Acute myeloid leukemia, disease, Advanced ovarian cancer. Also known as: Doxorubicin Hydrochloride, Hydroxydoxorubicin Hydrochloride.
Hydroxydaunomycin, also known as doxorubicin, is a small molecule used in various clinical trials for conditions such as hepatocellular carcinoma, relapsed follicular lymphoma, and advanced Hodgkin lymphoma. It is administered through different interventions, including ThermoDox, a heat-activated liposomal formulation.
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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.
| 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 name | Hydroxydaunomycin |
|---|---|
| Also known as | Doxorubicin Hydrochloride, Hydroxydoxorubicin Hydrochloride |
| Sponsor | Weill Medical College of Cornell University |
| Target | Canalicular multispecific organic anion transporter 1, Multidrug resistance-associated protein 6, 72 kDa type IV collagenase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Approved indications
- Acute lymphoid leukemia
- Acute myeloid leukemia, disease
- Advanced ovarian cancer
- Burkitt's lymphoma
- Carcinoma of breast
- Carcinoma of female breast
- Diffuse non-Hodgkin's lymphoma, large cell
- Follicular non-Hodgkin's lymphoma
- Hodgkin's disease
- Invasive Bladder Malignancy
- Kaposi's sarcoma
- Kaposi's sarcoma associated with AIDS
- Malignant tumor of lung
- Malignant tumor of ovary
- Malignant tumor of thyroid gland
- Metastatic Breast Carcinoma
- Metastatic Gastric Cancer
- Multiple myeloma
- Nephroblastoma
- Neuroblastoma
Common side effects
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma (PHASE3)
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2, PHASE3)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial 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:
- Hydroxydaunomycin CI brief — competitive landscape report
- Hydroxydaunomycin updates RSS · CI watch RSS
- Weill Medical College of Cornell University portfolio CI
Frequently asked questions about Hydroxydaunomycin
What is Hydroxydaunomycin?
What is Hydroxydaunomycin used for?
Who makes Hydroxydaunomycin?
Is Hydroxydaunomycin also known as anything else?
What development phase is Hydroxydaunomycin in?
What does Hydroxydaunomycin target?
Related
- Target: All drugs targeting Canalicular multispecific organic anion transporter 1, Multidrug resistance-associated protein 6, 72 kDa type IV collagenase
- Manufacturer: Weill Medical College of Cornell University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute lymphoid leukemia
- Indication: Drugs for Acute myeloid leukemia, disease
- Indication: Drugs for Advanced ovarian cancer
- Also known as: Doxorubicin Hydrochloride, Hydroxydoxorubicin Hydrochloride
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing