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High-dose anthracycline
High-dose anthracycline is a anthracycline antibiotic Small molecule drug developed by Gruppo Italiano Malattie EMatologiche dell'Adulto. It is currently in Phase 2 development for Acute Myeloid Leukemia, Breast Cancer.
anthracyclines intercalate DNA strands, inhibiting topoisomerase II
High-dose anthracycline, specifically Doxorubicin, is used to treat various conditions including High-Risk Localized Soft Tissue Sarcoma, Breast Cancer, Acute Myelogenous Leukemia, Myelodysplastic Syndromes, and Hormone Receptor Positive HER-2 Negative Breast Cancer. It is a small molecule modality that works through an unknown mechanism, but is often administered in combination with other treatments such as radiotherapy and immunotherapy.
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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 | High-dose anthracycline |
|---|---|
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Drug class | anthracycline antibiotic |
| Target | topoisomerase II |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Anthracyclines work by intercalating DNA strands, which prevents the enzyme topoisomerase II from unwinding DNA during replication. This leads to DNA damage and ultimately cell death.
Approved indications
- Acute Myeloid Leukemia
- Breast Cancer
Common side effects
- Cardiotoxicity
- Myelosuppression
- Neutropenia
Key clinical trials
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 (PHASE3)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010) (PHASE3)
- Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- A Study Combining the Peposertib (M3814) Pill With Standard Chemotherapy in Patients With Ovarian Cancer With an Expansion in High Grade Serous Ovarian Cancer and Low Grade Serous Ovarian Cancer (PHASE1)
- A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011) (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:
- High-dose anthracycline CI brief — competitive landscape report
- High-dose anthracycline updates RSS · CI watch RSS
- Gruppo Italiano Malattie EMatologiche dell'Adulto portfolio CI
Frequently asked questions about High-dose anthracycline
What is High-dose anthracycline?
How does High-dose anthracycline work?
What is High-dose anthracycline used for?
Who makes High-dose anthracycline?
What drug class is High-dose anthracycline in?
What development phase is High-dose anthracycline in?
What are the side effects of High-dose anthracycline?
What does High-dose anthracycline target?
Related
- Drug class: All anthracycline antibiotic drugs
- Target: All drugs targeting topoisomerase II
- Manufacturer: Gruppo Italiano Malattie EMatologiche dell'Adulto — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute Myeloid Leukemia
- Indication: Drugs for Breast Cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing