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EXATECAN
EXATECAN is a exatecan drug. It is currently in Phase 3 development.
EXATECAN works by inhibiting topoisomerase I, an enzyme involved in DNA replication and repair.
EXATECAN is a small molecule drug in the exatecan class, originally developed by and currently owned by . It is used to treat certain conditions, but its exact target and approved indications are unknown. The drug has a half-life of 6.7 hours, but its bioavailability and commercial status are not publicly available. EXATECAN's safety profile and potential side effects are not well-documented, and it is unclear whether it is patented or available as a generic medication.
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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 | EXATECAN |
|---|---|
| Drug class | exatecan |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine your DNA is a long piece of string that needs to be unwound so that new cells can grow. Topoisomerase I is the enzyme that helps to unwind this string. EXATECAN blocks this enzyme, which can prevent cancer cells from growing and dividing.
Approved indications
Common side effects
Key clinical trials
- Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers (PHASE1)
- Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors (PHASE1)
- Anti-GD2 ADC M3554 in Advanced Solid Tumors (PHASE1)
- AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors (PHASE1)
- HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (PHASE2)
- T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases (PHASE2)
- Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors (PHASE1)
- A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer (PHASE1,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:
- EXATECAN CI brief — competitive landscape report
- EXATECAN updates RSS · CI watch RSS
Frequently asked questions about EXATECAN
What is EXATECAN?
How does EXATECAN work?
What drug class is EXATECAN in?
What development phase is EXATECAN in?
Related
- Drug class: All exatecan drugs
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing