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Mitozantrone
Mitozantrone is a Small molecule drug developed by US Department of Veterans Affairs. It is currently in Phase 2 development for Acute myeloid leukemia, disease, Metastatic Prostate Carcinoma, Relapsing remitting multiple sclerosis.
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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 | Mitozantrone |
|---|---|
| Sponsor | US Department of Veterans Affairs |
| Target | Canalicular multispecific organic anion transporter 1, ATP-binding cassette sub-family G member 2, DNA-(apurinic or apyrimidinic site) lyase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Approved indications
- Acute myeloid leukemia, disease
- Metastatic Prostate Carcinoma
- Relapsing remitting multiple sclerosis
Common side effects
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML (NA)
- Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML (PHASE3)
- A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL (PHASE2)
- A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients
- A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML (PHASE2)
- IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. (PHASE3)
- CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia (PHASE1)
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:
- Mitozantrone CI brief — competitive landscape report
- Mitozantrone updates RSS · CI watch RSS
- US Department of Veterans Affairs portfolio CI
Frequently asked questions about Mitozantrone
What is Mitozantrone?
What is Mitozantrone used for?
Who makes Mitozantrone?
What development phase is Mitozantrone in?
What does Mitozantrone target?
Related
- Target: All drugs targeting Canalicular multispecific organic anion transporter 1, ATP-binding cassette sub-family G member 2, DNA-(apurinic or apyrimidinic site) lyase
- Manufacturer: US Department of Veterans Affairs — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia, disease
- Indication: Drugs for Metastatic Prostate Carcinoma
- Indication: Drugs for Relapsing remitting multiple sclerosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing