Last reviewed · How we verify
Trisenox
Trisenox is a marketed drug developed by the German AML Cooperative Group, primarily indicated for the treatment of acute myelomonocytic leukemia, FAB M4. The drug's key composition patent is set to expire in 2028, providing a clear timeline for potential generic competition. With no specific revenue data or key trial results available, the primary risk remains the loss of exclusivity and market share post-patent expiry.
At a glance
| Generic name | Trisenox |
|---|---|
| Sponsor | German AML Cooperative Group |
| Target | Potassium voltage-gated channel subfamily H member 2, Thioredoxin reductase 1, cytoplasmic |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Acute myelomonocytic leukemia, FAB M4
- Acute promyelocytic leukemia, FAB M3
Common side effects
- Nausea
- Cough
- Fatigue
- Pyrexia
- Headache
- Abdominal pain
- Vomiting
- Tachycardia
- Diarrhea
- Dyspnea
- Hypokalemia
- Leukocytosis
Serious adverse events
- Hepatic toxicity (Grade 3-4)
- Thrombocytopenia > 15 days (Grade 3-4)
- Neutropenia > 15 days (Grade 3-4)
- Differentiation syndrome
- Pneumonia
- Infection
- QT prolongation
- Neurotoxicity
- Fatal adverse reactions
- Abnormal liver tests
Key clinical trials
- Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia (PHASE3)
- ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma. (PHASE1)
- Continuous Versus Intermittent cARdiac Electrical moNitorinG (NA)
- A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301) (PHASE3)
- Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia (PHASE2)
- Evaluate the Pharmacokinetics of Oral Arsenic Trioxide Solution Under Fasting and Fed Conditions, to Compare Intravenous Arsenic Trioxide, in Acute Promyelocytic Leukemia (PHASE1)
- Venetoclax Combined With ATRA and ATO in Hyperleukocytic Acute Promyelocytic Leukemia (NA)
- Oral Arsenic (ATO) in Low-risk Myelodysplastic Syndromes (MDS) (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:
- Trisenox CI brief — competitive landscape report
- Trisenox updates RSS · CI watch RSS
- German AML Cooperative Group portfolio CI