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Temozolomide + TACE
Temozolomide + TACE is a alkylating agent Small molecule drug developed by Taizhou Hanzhong biomedical co. LTD. It is currently in Phase 3 development for Glioblastoma.
Temozolomide is an alkylating agent that works by interfering with DNA replication in cancer cells, while TACE is a minimally invasive procedure that involves the insertion of a catheter to deliver chemotherapy directly to the tumor.
Temozolomide is a small molecule DNA inhibitor used in cancer treatment. It is being studied in combination with Transcatheter Arterial Chemoembolization (TACE) for the treatment of stage IV melanoma that has metastasized to the liver.
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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 | Temozolomide + TACE |
|---|---|
| Sponsor | Taizhou Hanzhong biomedical co. LTD |
| Drug class | alkylating agent |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Temozolomide is a type of chemotherapy medication that belongs to the class of alkylating agents. It works by attaching an alkyl group to the DNA of cancer cells, which prevents them from replicating and eventually leads to cell death. TACE, on the other hand, is a procedure that allows for the direct delivery of chemotherapy to the tumor site, increasing the concentration of the medication and reducing the side effects.
Approved indications
- Glioblastoma
Common side effects
- Nausea
- Vomiting
- Fatigue
- Hair loss
- Anemia
Key clinical trials
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:
- Temozolomide + TACE CI brief — competitive landscape report
- Temozolomide + TACE updates RSS · CI watch RSS
- Taizhou Hanzhong biomedical co. LTD portfolio CI
Frequently asked questions about Temozolomide + TACE
What is Temozolomide + TACE?
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What drug class is Temozolomide + TACE in?
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Related
- Drug class: All alkylating agent drugs
- Manufacturer: Taizhou Hanzhong biomedical co. LTD — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Glioblastoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing