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ZK 219477
ZK 219477 is a Small molecule drug developed by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. It is currently in Phase 2 development.
ZK 219477, also known as sagopilone, is a small molecule that stabilizes tubulin. It has been studied in clinical trials for various types of cancer, including non-small-cell lung cancer, brain and central nervous system tumors, small cell carcinoma, and prostate cancer.
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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 | ZK 219477 |
|---|---|
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer (PHASE2)
- ZK-Epo Given With Carboplatin in Patients With Recurrent Ovarian Cancer (PHASE2)
- Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer (PHASE2)
- Investigation of Mass Balance of the Test Drug and Major Metabolites (PHASE1)
- Evaluation of a New Agent for Treatment of Advanced Stage Breast Cancer (PHASE2)
- Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer (PHASE2)
- Safety and Efficacy Study of a New Chemotherapy Agent to Treat Metastatic Breast Cancer (PHASE2)
- A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung 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:
- ZK 219477 CI brief — competitive landscape report
- ZK 219477 updates RSS · CI watch RSS
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta portfolio CI
Frequently asked questions about ZK 219477
What is ZK 219477?
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What development phase is ZK 219477 in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing