Last reviewed · How we verify
Paclitaxel (X)
Paclitaxel (X) is a Taxane; microtubule stabilizer Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Metastatic carcinoma of the ovary, Breast cancer (metastatic and adjuvant), Non-small cell lung cancer. Also known as: TAXOL®.
Paclitaxel stabilizes microtubules by binding to β-tubulin, preventing their depolymerization and causing cell cycle arrest and apoptosis in cancer cells.
Paclitaxel is used to treat various types of cancer, including non-small cell lung cancer, endometrial cancer, and recurrent epithelial ovarian, fallopian, or peritoneal carcinoma. It is often administered in combination with other medications, such as carboplatin, as part of clinical trials to evaluate its safety and efficacy.
-
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. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Paclitaxel (X) |
|---|---|
| Also known as | TAXOL® |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Taxane; microtubule stabilizer |
| Target | β-tubulin / microtubules |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Paclitaxel is a microtubule-stabilizing agent that binds to the β-tubulin subunit of microtubules, preventing their normal dynamic instability. This stabilization disrupts mitotic spindle formation and cell division, leading to G2/M phase arrest and triggering apoptosis in rapidly dividing cancer cells. It is effective against a broad range of solid tumors.
Approved indications
- Metastatic carcinoma of the ovary
- Breast cancer (metastatic and adjuvant)
- Non-small cell lung cancer
- Kaposi's sarcoma
- Gastric adenocarcinoma
Common side effects
- Neutropenia
- Peripheral neuropathy
- Myalgia/arthralgia
- Alopecia
- Nausea/vomiting
- Diarrhea
- Hypersensitivity reactions
Key clinical trials
- Testing the Addition of Radium Therapy (Radium-223 Dichloride) to the Usual Chemotherapy Treatment (Paclitaxel) for Advanced Breast Cancer That Has Spread to the Bones (PHASE2)
- Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer (PHASE3)
- Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma (PHASE1, PHASE2)
- Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE3)
- Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma (PHASE2)
- Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel (PHASE1)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- A Study to Learn About the Study Medicine PF-07985045 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Change in a Gene. (PHASE1)
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:
- Paclitaxel (X) CI brief — competitive landscape report
- Paclitaxel (X) updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Paclitaxel (X)
What is Paclitaxel (X)?
How does Paclitaxel (X) work?
What is Paclitaxel (X) used for?
Who makes Paclitaxel (X)?
Is Paclitaxel (X) also known as anything else?
What drug class is Paclitaxel (X) in?
What development phase is Paclitaxel (X) in?
What are the side effects of Paclitaxel (X)?
What does Paclitaxel (X) target?
Related
- Drug class: All Taxane; microtubule stabilizer drugs
- Target: All drugs targeting β-tubulin / microtubules
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic carcinoma of the ovary
- Indication: Drugs for Breast cancer (metastatic and adjuvant)
- Indication: Drugs for Non-small cell lung cancer
- Also known as: TAXOL®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing