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nitrocamptothecin
nitrocamptothecin is a Small molecule drug developed by Alliance for Clinical Trials in Oncology. It is currently in Phase 2 development.
Nitrocamptothecin is a small molecule with a modality of a topoisomerase inhibitor. It has been studied in clinical trials for various conditions, including lung diseases, cancer, and endometrial cancer, with one completed study using aerosolized liposomal 9-nitro-20(S)-camptothecin.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | nitrocamptothecin |
|---|---|
| Sponsor | Alliance for Clinical Trials in Oncology |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study of Rubitecan in Cancer Patients With Renal or Hepatic Dysfunction (PHASE1)
- Orathecin + Gemcitabine Versus Placebo + Gemcitabine in Chemonaive Non-Resectable Pancreatic Cancer (PHASE2, PHASE3)
- Nitrocamptothecin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy (PHASE2)
- Nitrocamptothecin in Treating Patients With Recurrent Non-small Cell Lung Cancer (PHASE2)
- Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas (PHASE2)
- Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery (PHASE2)
- Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas (PHASE3)
- Nitrocamptothecin in Treating Patients With Metastatic Melanoma (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:
- nitrocamptothecin CI brief — competitive landscape report
- nitrocamptothecin updates RSS · CI watch RSS
- Alliance for Clinical Trials in Oncology portfolio CI
Frequently asked questions about nitrocamptothecin
What is nitrocamptothecin?
Who makes nitrocamptothecin?
What development phase is nitrocamptothecin in?
Related
- Manufacturer: Alliance for Clinical Trials in Oncology — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing