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Difluoromethylornithine
Difluoromethylornithine is a Small molecule drug developed by University of Wisconsin, Madison. It is currently in Phase 2 development. Also known as: DFMO, eflornithine, DFMO, Eflornithine.
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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).
| 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 | Difluoromethylornithine |
|---|---|
| Also known as | DFMO, eflornithine, DFMO, Eflornithine |
| Sponsor | University of Wisconsin, Madison |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors (PHASE1, PHASE2)
- Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas (PHASE1, PHASE2)
- Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC (DFMO) (PHASE1, PHASE2)
- DFMO as Maintenance Therapy for Molecular High/Very High Risk and Relapsed Medulloblastoma (PHASE2)
- Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas (PHASE1, PHASE2)
- An Intermediate Expanded Use Trial of DFMO
- Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PHASE2)
- Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma (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:
- Difluoromethylornithine CI brief — competitive landscape report
- Difluoromethylornithine updates RSS · CI watch RSS
- University of Wisconsin, Madison portfolio CI
Frequently asked questions about Difluoromethylornithine
What is Difluoromethylornithine?
Who makes Difluoromethylornithine?
Is Difluoromethylornithine also known as anything else?
What development phase is Difluoromethylornithine in?
Related
- Manufacturer: University of Wisconsin, Madison — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: DFMO, eflornithine, DFMO, Eflornithine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing