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Cabazitaxel | CAS No: 183133-96-2 | GMP-certified suppliers
A medication that treats metastatic castration‑resistant prostate cancer previously exposed to docetaxel, supporting continued disease control across key global markets.
Therapeutic categories
Primary indications
- Cabazitaxel is indicated, in combination with [prednisone], for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a [docetaxel]-containing treatment regimen
- In Europe and Canada, it can also be used in combination with [prednisolone]
Product Snapshot
- Cabazitaxel is an intravenous oncology small-molecule taxane supplied as solution or solution concentrate for injection
- It is used in combination steroid regimens for metastatic castration‑resistant prostate cancer previously treated with docetaxel
- It is approved in the US, EU, and Canada
Clinical Overview
Cabazitaxel is indicated, in combination with prednisone or prednisolone, for the treatment of metastatic castration‑resistant prostate cancer previously treated with a docetaxel‑containing regimen. Regulatory approvals include the FDA, EMA, and Health Canada. Beyond prostate cancer, preclinical studies demonstrate activity in diverse tumour xenografts, including intracranial glioblastoma models.
Cabazitaxel exerts its pharmacologic effect by binding to the N‑terminal region of beta‑tubulin, promoting polymerization and inhibiting disassembly of microtubules. The resulting stabilization disrupts the dynamic reorganization required for mitosis and interphase cellular transport, leading to cell‑cycle arrest and apoptosis. Its ability to bypass P‑gp efflux supports activity in docetaxel‑resistant tumour models and facilitates some degree of penetration across the blood–brain barrier.
Absorption parameters and specific bioavailability data are not provided in the source material. Cabazitaxel is metabolized primarily by CYP3A isoforms, with contributions from CYP2C8, and is considered a narrow therapeutic index drug. It is also characterized as a substrate and inhibitor of transporters including P‑gp, OATP1B1, and OATP1B3. Transporter interactions and CYP3A modulation are important considerations for co‑administered therapies.
Safety considerations are dominated by myelosuppression, including neutropenia, which requires monitoring and supportive measures. Cabazitaxel is also associated with gastrointestinal toxicity, peripheral neuropathy, and potential cardiotoxicity in line with its classification. Dose adjustments may be needed in the presence of strong CYP3A inhibitors or inducers.
For API procurement, suppliers should provide robust evidence of impurity control, stereochemical integrity, and stability of this highly functionalized taxane, with full traceability and compliance with regional pharmacopoeial and GMP requirements.
Identification & chemistry
| Generic name | Cabazitaxel |
|---|---|
| Molecule type | Small molecule |
| CAS | 183133-96-2 |
| UNII | 51F690397J |
| DrugBank ID | DB06772 |
Pharmacology
| Summary | Cabazitaxel binds β‑tubulin and stabilizes microtubules by promoting polymerization and preventing disassembly, disrupting mitotic and interphase functions. This microtubule stabilization suppresses tumour cell proliferation, including in models resistant to other taxanes. Its low affinity for P‑glycoprotein supports activity in tissues with high efflux transporter expression. |
|---|---|
| Mechanism of action | Microtubules are cytoskeletal polymers that regulate cell shape, vesicle transport, cell signalling, and cell division. They are made up of alpha-tubulin and beta-tubulin heterodimers. Microtubules extend toward the mitotic spindle during mitosis to allow the separation and distribution of chromosomes during cell division.Cabazitaxel binds to the N-terminal amino acids of the beta-tubulin subunit and promotes microtubule polymerization while simultaneously inhibiting disassembly: this results in the stabilization of microtubules, preventing microtubule cell division. Cabazitaxel ultimately blocks mitotic and interphase cellular functions and tumour proliferation. |
| Pharmacodynamics | Cabazitaxel demonstrates a broad spectrum of antitumour activity against advanced human tumours xenografted in mice, including intracranial human glioblastomas.Cabazitaxel has a low affinity to P-glycoprotein, allowing it to penetrate the blood-brain barrier without being subject to extensive P-gp-mediated active efflux.Cabazitaxel works against docetaxel-sensitive tumours and tumour models resistant to docetaxel and other chemotherapy drugs. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin beta-1 chain | Humans | inhibitor |
ADME / PK
| Absorption | Based on the population pharmacokinetic analysis, after an intravenous dose of cabazitaxel 25 mg/m<sup>2</sup> every three weeks, the mean C<sub>max</sub> in patients with metastatic prostate cancer was 226 ng/mL (CV 107%) and was reached at the end of the one-hour infusion (T<sub>max</sub>). The mean AUC in patients with metastatic prostate cancer was 991 ng x h/mL (CV 34%). No major deviation from the dose proportionality was observed from 10 to 30 mg/m<sup>2</sup> in patients with advanced solid tumours. |
|---|---|
| Half-life | Following a one-hour intravenous infusion, plasma concentrations of cabazitaxel can be described by a three-compartment pharmacokinetic model with α-, β-, and γ- half-lives of four minutes, two hours, and 95 hours, respectively. |
| Protein binding | _In vitro_, the binding of cabazitaxel to human serum proteins was 89% to 92% and was not saturable up to 50,000 ng/mL. Cabazitaxel is mainly bound to human serum albumin (82%) and lipoproteins (88% for HDL, 70% for LDL, and 56% for VLDL). The _in vitro_ blood-to-plasma concentration ratio in human blood ranged from 0.90 to 0.99, indicating that cabazitaxel was equally distributed between blood and plasma. |
| Metabolism | More than 95% of cabazitaxel is extensively metabolized in the liver. CYP3A4 and CYP3A5 are responsible for 80% to 90% of drug metabolism, while CYP2C8 is involved to a lesser extent. While cabazitaxel is the main circulating moiety in human plasma, seven metabolites have been detected in plasma, including three active metabolites arising from O-demethylation - [docetaxel], RPR112698, and RPR123142.The main metabolite accounts for 5% of total cabazitaxel exposure. |
| Route of elimination | After a one-hour intravenous infusion [<sup>14</sup>C]-cabazitaxel 25 mg/m<sup>2</sup>, approximately 80% of the administered dose was eliminated within two weeks. Cabazitaxel is mainly excreted in the feces as numerous metabolites (76% of the dose), while renal excretion of cabazitaxel and metabolites account for 3.7% of the dose (2.3% as unchanged drug in urine). Around 20 metabolites of cabazitaxel are excreted into human urine and feces. |
| Volume of distribution | Steady-state volume of distribution (V<sub>ss</sub>) was 4,864 L (2,643 L/m<sup>2</sup> for a patient with a median BSA of 1.84 m<sup>2</sup>). |
| Clearance | Based on the population pharmacokinetic analysis, cabazitaxel has a plasma clearance of 48.5 L/h (CV 39%; 26.4 L/h/m<sup>2</sup> for a patient with a median BSA of 1.84 m<sup>2</sup>) in patients with metastatic prostate cancer. |
Formulation & handling
- Cabazitaxel is a poorly water‑soluble, lipophilic small‑molecule taxane formulated exclusively for intravenous use, typically supplied as a concentrate requiring dilution before administration.
- Formulation relies on solubilizing excipients to maintain stability in aqueous media; handling should minimize adsorption to plastics and ensure compatibility with dilution vehicles.
- As a CYP3A4‑metabolized agent, it is not orally suitable; food interactions are clinically relevant but do not affect parenteral formulation strategy.
Regulatory status
| Lifecycle | Most legacy U.S. patents for the API expired between 2012 and 2016, while a later patent extending to 2031 suggests remaining protection for certain aspects of the product. With availability across the EU, Canada, and the US, the API sits in a largely mature market with limited ongoing exclusivity. |
|---|
| Markets | EU, Canada, US |
|---|
Supply Chain
| Supply chain summary | Cabazitaxel was developed by a single originator company, with subsequent manufacturing supported by multiple producers supplying branded and authorized generic presentations across the US, EU, and Canada. The product has broad global availability, reflected by several branded and non‑originator versions in these markets. While most earlier patents have expired, one United States patent extending to 2031 indicates that some protections remain, allowing both existing and emerging generic competition depending on jurisdiction and patent scope. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 500 mg/kg. |
|---|
- Classified as a cytotoxic taxane
- Requires handling in controlled environments with appropriate protective measures to minimize exposure
- Exhibits moderate acute oral toxicity in rats (LD50 ~500 mg/kg), indicating a need for strict containment to prevent ingestion or aerosolization
Cabazitaxel is a type of Taxanes
Taxanes are a vital subcategory of pharmaceutical APIs (Active Pharmaceutical Ingredients) widely used in the treatment of various types of cancers. These organic compounds are derived from plants, with the most notable source being the Pacific yew tree (Taxus brevifolia). Taxanes exhibit potent anticancer properties, making them an essential component of many chemotherapy regimens.
One of the most well-known taxanes is paclitaxel, which acts by inhibiting cell division and promoting cell death in cancer cells. Paclitaxel is employed in the treatment of breast, lung, ovarian, and other types of cancers. Another taxane, docetaxel, shares similar mechanisms of action and is commonly used in the management of breast, prostate, and lung cancers.
The isolation and purification of taxanes from natural sources present significant challenges due to their low abundance. Consequently, pharmaceutical companies have developed synthetic methods to produce taxanes, ensuring a stable supply for medical purposes. These synthetic taxanes have shown comparable efficacy to their natural counterparts.
Taxanes are typically administered intravenously, allowing for optimal distribution throughout the body. They are formulated as injectable solutions containing taxane APIs along with other excipients to enhance solubility and stability. The dosage and administration of taxanes are carefully determined by healthcare professionals, taking into account factors such as the patient's condition and the specific cancer being treated.
In conclusion, taxanes are a crucial subcategory of pharmaceutical APIs used in cancer treatment. Their remarkable anticancer properties, derived from natural or synthetic sources, have revolutionized the management of various types of cancers, providing patients with improved therapeutic options.
Cabazitaxel (Taxanes), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Cabazitaxel API manufacturers & distributors
Compare qualified Cabazitaxel API suppliers worldwide. We currently have 14 companies offering Cabazitaxel API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Chongqing Sintaho Pharmac... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 42 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Hetero Labs | Producer | India | India | CoA, GMP, USDMF, WC | 90 products |
| Indena | Producer | Italy | France | CoA, GMP | 15 products |
| Intas Pharma | Producer | United Kingdom | Unknown | CoA, USDMF | 30 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| Laurus Labs | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Polymed Therapeutics | Producer | United States | United States | CoA, USDMF | 11 products |
| Sanofi | Producer | France | Unknown | CoA, GMP, USDMF | 93 products |
| Shanghai Jinhe Bio-Pharma | Producer | China | China | CoA | 12 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001 | 757 products |
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
When sending a request, specify which Cabazitaxel API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Cabazitaxel API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Cabazitaxel API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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