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Sunitinib | CAS No: 557795-19-4 | GMP-certified suppliers
A medication that treats advanced renal cell carcinoma, gastrointestinal stromal tumors after imatinib failure, and progressive pancreatic neuroendocrine tumors in adults.
Therapeutic categories
Primary indications
- Sunitinib is indicated for the following conditions:
- Treatment of adult patients with gastrointestinal stromal tumor (GIST) following disease progression on (or intolerance to) [imatinib] mesylate
- Treatment of adult patients with advanced renal cell carcinoma (RCC)
- Adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy
Product Snapshot
- Sunitinib is an oral small molecule formulated in gelatin-coated capsules
- It is indicated for the treatment of gastrointestinal stromal tumors (GIST), advanced and recurrent renal cell carcinoma (RCC), and progressive pancreatic neuroendocrine tumors (pNET)
- The product is approved for use in major regulatory markets including the US, EU, and Canada
Clinical Overview
Clinically, sunitinib is indicated for several oncologic conditions. These include adult patients with GIST following progression on or intolerance to imatinib, advanced RCC, adjuvant therapy for high-risk RCC post-nephrectomy, and progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) that are unresectable or metastatic.
The pharmacological activity of sunitinib arises from its inhibition of multiple RTKs involved in tumor growth, angiogenesis, and metastatic progression. Key targets include platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT/CD117), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). This broad kinase inhibition disrupts signaling pathways essential for neoplastic cell proliferation and vascularization. Its primary metabolite demonstrates comparable inhibitory potency.
Regarding absorption, distribution, metabolism, and excretion (ADME), sunitinib is well absorbed orally, extensively metabolized predominantly by cytochrome P450 3A4 (CYP3A4), and exhibits a narrow therapeutic index. Due to its metabolism and substrate status for multiple cytochrome P450 isoforms and P-glycoprotein, sunitinib carries potential for pharmacokinetic interactions. Safety considerations include possible hepatotoxicity, risks of QTc interval prolongation, and other class-associated toxicities. Careful monitoring of hepatic function and cardiac status is advised during treatment.
Sunitinib is marketed under various brand names globally and is specifically formulated as oral capsules for systemic administration.
From an API sourcing perspective, manufacturers and procurement specialists must ensure high purity and stringent control of impurities given the drug's narrow therapeutic window and complex pharmacology. Suppliers should provide detailed characterization of the API, including impurity profiling and adherence to current Good Manufacturing Practice (cGMP) guidelines to support global regulatory requirements.
Identification & chemistry
| Generic name | Sunitinib |
|---|---|
| Molecule type | Small molecule |
| CAS | 557795-19-4 |
| UNII | V99T50803M |
| DrugBank ID | DB01268 |
Pharmacology
| Summary | Sunitinib is a small-molecule inhibitor targeting multiple receptor tyrosine kinases involved in tumor cell proliferation, angiogenesis, and metastatic progression. Its primary targets include PDGFRα/β, VEGFR1-3, KIT, FLT3, CSF-1R, and RET, leading to inhibition of signaling pathways that support tumor growth and vascular development. The drug’s multi-kinase inhibitory profile underlies its therapeutic application in various malignancies characterized by aberrant RTK activity. |
|---|---|
| Mechanism of action | Sunitinib is a small molecule that inhibits multiple RTKs, some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRa and PDGFRb), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). Sunitinib inhibition of the activity of these RTKs has been demonstrated in biochemical and cellular assays, and inhibition of function has been demonstrated in cell proliferation assays. The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays. |
| Pharmacodynamics | Sunitinib is an oral, small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor that was approved by the FDA on January 26, 2006. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Platelet-derived growth factor receptor beta | Humans | inhibitor |
| Vascular endothelial growth factor receptor 1 | Humans | inhibitor |
| Mast/stem cell growth factor receptor Kit | Humans | inhibitor |
ADME / PK
| Absorption | Maximum plasma concentrations (Cmax) of sunitinib are generally observed between 6 and 12 hours (Tmax) following oral administration. Food has no effect on the bioavailability of sunitinib. Sunitinib may be taken with or without food. The pharmacokinetics were similar in healthy volunteers and in the solid tumor patient populations tested, including patients with GIST and RCC. |
|---|---|
| Half-life | Following administration of a single oral dose in healthy volunteers, the terminal half-lives of sunitinib and its primary active metabolite are approximately 40 to 60 hours and 80 to 110 hours, respectively. |
| Protein binding | Binding of sunitinib and its primary metabolite to human plasma protein in vitro was 95% and 90%, respectively. |
| Metabolism | Sunitinib is metabolized primarily by the cytochrome P450 enzyme, CYP3A4, to produce its primary active metabolite, which is further metabolized by CYP3A4. |
| Route of elimination | Sunitinib is metabolized primarily by the cytochrome P450 enzyme, CYP3A4, to produce its primary active metabolite, which is further metabolized by CYP3A4. Elimination is primarily via feces. In a human mass balance study of [14C]sunitinib, 61% of the dose was eliminated in feces, with renal elimination accounting for 16% of the administered dose. |
| Volume of distribution | * 2230 L (apparent volume of distribution, Vd/F) |
| Clearance | * 34 - 62 L/h [Total oral clearance] |
Formulation & handling
- Sunitinib is formulated as an oral small molecule drug primarily delivered in capsule form.
- It exhibits low water solubility and moderate lipophilicity (LogP ~3), relevant for formulation optimization.
- Careful consideration is required to avoid interactions with CYP3A4 modifiers such as grapefruit and St. John's Wort during handling and patient administration.
Regulatory status
| Lifecycle | The API's key patents in Canada and the United States expired between late 2020 and mid-2021, indicating it is in the mature phase of its lifecycle in these markets. The status in the EU suggests similar market maturity given the timing of patent expirations. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Sunitinib manufacturing is primarily associated with originator companies supplying branded products across major markets including Canada, the EU, and the US. Multiple patents expiring between late 2020 and mid-2021 in Canada and the US indicate that generic competition is either imminent or already established in these regions. The presence of various branded versions suggests ongoing market activity post-patent expiry. |
|---|
Safety
| Toxicity | The maximally tolerated dose for rat, mouse, and dog when given orally is greater than 500 mg/kg. The maximally tolerated dose of a non-human primate is greater 1200 mg/kg. |
|---|
- Oral administration in preclinical species showed maximally tolerated doses above 500 mg/kg in rodents and dogs, and above 1200 mg/kg in non-human primates
- Handling should minimize exposure to prevent potential systemic toxicity due to its pharmacological activity
- Use appropriate personal protective equipment and containment measures to avoid dermal and inhalation contact
Sunitinib is a type of Protein kinase inhibitors
Protein kinase inhibitors are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in targeted cancer therapies. These inhibitors specifically target and block the activity of protein kinases, enzymes that regulate various cellular processes, including cell growth, division, and signal transduction.
Protein kinase inhibitors function by binding to the active site of protein kinases, preventing them from phosphorylating specific proteins and disrupting intracellular signaling pathways. This targeted approach inhibits the uncontrolled growth and proliferation of cancer cells, ultimately leading to their death.
The development of protein kinase inhibitors has revolutionized cancer treatment by providing more effective and less toxic alternatives to traditional chemotherapy. These drugs have demonstrated impressive results in the treatment of various cancers, including lung, breast, and leukemia.
The pharmaceutical industry invests heavily in research and development to discover novel protein kinase inhibitors with improved potency, selectivity, and pharmacokinetic properties. High-throughput screening, computational modeling, and structure-activity relationship studies are employed to identify potential lead compounds.
The success of protein kinase inhibitors in treating cancer has spurred significant interest in this subcategory of APIs. Ongoing research aims to expand their applications to other diseases, such as autoimmune disorders and neurological conditions.
In conclusion, protein kinase inhibitors are a valuable class of pharmaceutical APIs with immense potential for targeted cancer therapies. Continued advancements in this field hold promise for improved treatment outcomes and enhanced patient care.
Sunitinib (Protein kinase inhibitors), 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.
Sunitinib API manufacturers & distributors
Compare qualified Sunitinib API suppliers worldwide. We currently have 11 companies offering Sunitinib API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Adley Formulations | Producer | India | India | CoA, GMP | 14 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Labs | Producer | India | India | CoA, GMP, WC | 90 products |
| Hunan Ouya Biological Co.... | Producer | China | China | CoA | 7 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Qilu Antibiotics | Producer | China | China | CoA, WC | 33 products |
| Reliance Life Sciences | Producer | India | India | CoA, USDMF, WC | 11 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
When sending a request, specify which Sunitinib 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 Sunitinib 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.
