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IV paclitaxel
IV paclitaxel is a Taxane; microtubule stabilizer Small molecule drug developed by Athenex, Inc.. It is currently in Phase 3 development for Metastatic breast cancer, Non-small cell lung cancer, Ovarian cancer. Also known as: Taxol Injection.
IV paclitaxel stabilizes microtubules by binding to β-tubulin, preventing their depolymerization and halting cell division.
IV paclitaxel is a small molecule inhibitor of the protein tubulin. It is used to treat various conditions, including breast cancer, metastatic breast cancer, and certain types of ovarian cancer, such as FIGO Stage III Ovarian Cancer 2014.
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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 | IV paclitaxel |
|---|---|
| Also known as | Taxol Injection |
| Sponsor | Athenex, Inc. |
| Drug class | Taxane; microtubule stabilizer |
| Target | β-tubulin |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Paclitaxel is a taxane that binds to the β-subunit of tubulin dimers and promotes microtubule assembly while inhibiting disassembly. This leads to accumulation of stable microtubules and disruption of the normal dynamic reorganization required for mitosis, ultimately triggering apoptosis in rapidly dividing cancer cells.
Approved indications
- Metastatic breast cancer
- Non-small cell lung cancer
- Ovarian cancer
- Kaposi sarcoma
Common side effects
- Neutropenia
- Peripheral neuropathy
- Myalgia/arthralgia
- Alopecia
- Nausea/vomiting
- Mucositis
- Hypersensitivity reaction
Key clinical trials
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50% (PHASE2)
- A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) (PHASE3)
- Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial (PHASE2, PHASE3)
- CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer (PHASE1, PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
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:
- IV paclitaxel CI brief — competitive landscape report
- IV paclitaxel updates RSS · CI watch RSS
- Athenex, Inc. portfolio CI
Frequently asked questions about IV paclitaxel
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Related
- Drug class: All Taxane; microtubule stabilizer drugs
- Target: All drugs targeting β-tubulin
- Manufacturer: Athenex, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic breast cancer
- Indication: Drugs for Non-small cell lung cancer
- Indication: Drugs for Ovarian cancer
- Also known as: Taxol Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing