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BISANTRENE
BISANTRENE is a bisantrene drug. It is currently in Phase 3 development.
Bisantrene works by blocking an enzyme called NAD(P)H dehydrogenase [quinone] 1, which is involved in the production of cholesterol and other steroids.
Bisantrene is a small molecule used in clinical trials for treating various conditions related to Acute Myelogenous Leukemia, including Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, and Refractory Acute Myeloid Leukemia. It has been studied in high and low doses of Bisantrene Dihydrochloride in clinical trials, with one completed trial focusing on its use for Relapsed/Refractory Acute Myelogenous Leukemia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | BISANTRENE |
|---|---|
| Drug class | bisantrene |
| Target | NAD(P)H dehydrogenase [quinone] 1 |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Mechanism of action
Think of it like a traffic cop: the enzyme is directing the flow of molecules to make cholesterol and other important compounds. Bisantrene is like a roadblock that stops this process, which can be helpful in treating certain conditions. However, this can also have unintended consequences, so it's essential to carefully consider the potential benefits and risks.
Approved indications
Common side effects
Key clinical trials
- Bisantrene Combination for Resistant AML (PHASE2)
- A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS (PHASE1)
- Bisantrene for Relapsed /Refractory 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:
- BISANTRENE CI brief — competitive landscape report
- BISANTRENE updates RSS · CI watch RSS
Frequently asked questions about BISANTRENE
What is BISANTRENE?
How does BISANTRENE work?
What drug class is BISANTRENE in?
What development phase is BISANTRENE in?
What does BISANTRENE target?
Related
- Drug class: All bisantrene drugs
- Target: All drugs targeting NAD(P)H dehydrogenase [quinone] 1
- Therapeutic area: All drugs in Metabolic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing