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Naxofem (NIMORAZOLE)
Naxofem (generic name: NIMORAZOLE) is a nimorazole drug. It is currently in Phase 3 development.
Nimorazole is thought to work by inhibiting the enzyme responsible for DNA synthesis, thereby preventing the growth of cancer cells.
Naxofem, also known as Naxogin, is a small molecule. It has synonyms including Naxogin 500, Nimorazol, Nimorazole, and Nimorazole.
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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 | NIMORAZOLE |
|---|---|
| Drug class | nimorazole |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine your body's cells are like a factory, and DNA synthesis is the process of making new parts. Nimorazole blocks the machine that makes these parts, which can help stop cancer cells from growing and dividing.
Approved indications
Common side effects
Key clinical trials
- Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma (NA)
- Feasibility of Patient Selection and Treatment of Head-neck Cancer With Proton Therapy in Denmark (NA)
- AF CRT +/- Nimorazole in HNSCC (PHASE3)
- NIMRAD (A Randomised Placebo-controlled Trial of Synchronous NIMorazole Versus RADiotherapy Alone in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Not Suitable for Synchronous Chemotherapy or Cetuximab) (PHASE3)
- DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC. (PHASE3)
- DAHANCA 35: Proton Versus Photon Therapy for Head-neck Cancer (NA)
- DAHANCA 33: Image Guided Dose-escalated Radiotherapy to Patients With Hypoxic HNSCC (PHASE2)
- DAHANCA 37. Re-irradiation With Proton Radiotherapy (NA)
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:
- Naxofem CI brief — competitive landscape report
- Naxofem updates RSS · CI watch RSS
Frequently asked questions about Naxofem
What is Naxofem?
How does Naxofem work?
What is the generic name of Naxofem?
What drug class is Naxofem in?
What development phase is Naxofem in?
Related
- Drug class: All nimorazole drugs
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing