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CANFOSFAMIDE
CANFOSFAMIDE is a canfosfamide drug. It is currently in Phase 3 development.
Canfosfamide works by cross-linking DNA, preventing cancer cells from replicating and ultimately leading to cell death.
Canfosfamide is a small molecule chemotherapeutic agent in the canfosfamide drug class. Its target is unknown, and it has not been FDA approved for any indications. As a chemotherapeutic agent, canfosfamide works by interfering with DNA replication and cell division, ultimately leading to cell death. The commercial status of canfosfamide is unclear, and it may be patented or available as a generic product. Key safety considerations include its short half-life of 0.28 hours.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | CANFOSFAMIDE |
|---|---|
| Drug class | canfosfamide |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine canfosfamide as a molecular 'glue' that attaches to DNA, making it impossible for cancer cells to make copies of themselves. This prevents the cancer cells from growing and dividing, eventually leading to their death. By targeting the DNA of cancer cells, canfosfamide can help slow or stop the growth of tumors.
Approved indications
Common side effects
Key clinical trials
- Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer (PHASE3)
- TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer (PHASE2)
- TLK286 in Treating Patients With Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (PHASE2)
- Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma (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:
- CANFOSFAMIDE CI brief — competitive landscape report
- CANFOSFAMIDE updates RSS · CI watch RSS
Frequently asked questions about CANFOSFAMIDE
What is CANFOSFAMIDE?
How does CANFOSFAMIDE work?
What drug class is CANFOSFAMIDE in?
What development phase is CANFOSFAMIDE in?
Related
- Drug class: All canfosfamide drugs
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing