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Troxatyl (TROXACITABINE)
Troxatyl (generic name: TROXACITABINE) is a troxacitabine drug. It is currently in Phase 2 development.
Troxacitabine works by inhibiting viral DNA polymerase, which is essential for viral replication.
Troxacitabine is a small molecule used in clinical trials for various conditions, including Hepatocellular Carcinoma, Leukemia, and Neoplasms. It has been studied in combination with other interventions, such as Fostrox and Lenvatinib, in clinical trials.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | TROXACITABINE |
|---|---|
| Drug class | troxacitabine |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like factories that make copies of themselves. Viruses are like tiny invaders that try to take over these factories. Troxacitabine stops the factories from making copies of the invaders by blocking the machines that make the copies.
Approved indications
Common side effects
Key clinical trials
- Fostrox Plus Lenvatinib vs Lenvatinib in Advanced Hepatocellular Carcinoma After First-line Immunotherapy (PHASE2)
- Troxacitabine in Treating Patients With Chronic Myelogenous Leukemia (PHASE2)
- Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML) (PHASE1,PHASE2)
- Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors (PHASE1,PHASE2)
- Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) (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:
- Troxatyl CI brief — competitive landscape report
- Troxatyl updates RSS · CI watch RSS
Frequently asked questions about Troxatyl
What is Troxatyl?
How does Troxatyl work?
What is the generic name of Troxatyl?
What drug class is Troxatyl in?
What development phase is Troxatyl in?
Related
- Drug class: All troxacitabine drugs
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing