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Taxol (paclitaxel)
Taxol (paclitaxel) is a microtubule inhibitor small molecule developed by HQ SPCLT PHARMA and currently owned by Hq Spclt Pharma. It targets the tubulin beta-3 chain and was FDA approved in 1992 for various cancer indications. As an off-patent medication, Taxol is available from multiple generic manufacturers. Key safety considerations include its low bioavailability and moderate half-life of 11 hours. Taxol is used to treat several types of cancer, including breast, ovarian, and cervical cancer.
At a glance
| Generic name | paclitaxel |
|---|---|
| Sponsor | Pfizer |
| Drug class | Microtubule Inhibitor [EPC] |
| Target | Tubulin beta-3 chain |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1992 |
| Annual revenue | 368 |
Approved indications
- Carcinoma of breast
- Carcinoma of fallopian tube
- Hypertensive disorder
- Kaposi's sarcoma
- Malignant tumor of cervix
- Malignant tumor of ovary
- Malignant tumor of peritoneum
- Metastatic Breast Carcinoma
- Non-small cell lung cancer
- Ocular hypertension
- Open-angle glaucoma
- Secondary malignant neoplasm of pancreas
Boxed warnings
- WARNING Paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H 2 antagonists (see DOSAGE AND ADMINISTRATION ). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm 3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1,000 cells/mm 3 . In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving paclitaxel.
Common side effects
- Neutropenia
- Neuropathy peripheral
- Disease progression
- Anaemia
- Myelosuppression
- Metastases to liver
- Metastases to bone
- Neutrophil count decreased
- Flushing
- Erythema
- Thrombocytopenia
- Leukopenia
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8034375 | 2026-08-13 | Method of Use |
| 9511046 | 2034-01-12 | Method of Use |
| 9393318 | 2032-03-04 | Method of Use |
| 9597409 | 2032-03-04 | Method of Use |
| 8268348 | 2026-02-21 | Method of Use |
| 9101543 | 2026-02-21 | Method of Use |
| 7758891 | 2026-02-21 | Method of Use |
| 8034375*PED | 2027-02-13 | Compound |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Taxol CI brief — competitive landscape report
- Taxol updates RSS · CI watch RSS
- Pfizer portfolio CI