Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Alectinib API Manufacturers & Suppliers
3 verified results
Commercial-scale Suppliers
Employees: 25+
All certificates
Employees: 21,650
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Alectinib | CAS No: 1256580-46-7 | GMP-certified suppliers
A medication that supports treatment of ALK‑positive metastatic non‑small cell lung cancer in patients requiring targeted therapy after intolerance or progression on prior options.
Therapeutic categories
Primary indications
- Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
- This indication is approved under accelerated approval based on tumor response rate and duration of response
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials
Product Snapshot
- Alectinib is an oral small‑molecule kinase inhibitor supplied as capsules
- It is used for ALK‑positive metastatic non‑small cell lung cancer after crizotinib progression or intolerance
- It is approved in the US, EU, and Canada, with some uses still holding investigational or accelerated‑approval status
Clinical Overview
Alectinib selectively inhibits ALK tyrosine kinase activity in tumours expressing ALK fusion proteins such as ALK‑EML4. Inhibition of ALK signaling blocks phosphorylation of downstream effectors including STAT3 and AKT, reducing proliferative and survival signalling in ALK‑driven tumour cells. Both the parent drug and its active metabolite M4 exhibit similar inhibitory activity across multiple ALK mutant variants associated with acquired resistance to earlier-generation inhibitors.
Absorption and disposition are influenced by metabolism through cytochrome P450 3A pathways. Alectinib and M4 function as substrates and inhibitors of several transporters, including P‑glycoprotein and BCRP, which may contribute to variability in exposure and potential drug–drug interactions. The compound is classified among kinase inhibitors with a narrow therapeutic index, requiring attention to factors that may alter systemic concentrations.
Safety considerations include hepatic effects, gastrointestinal disturbances, myalgia, and laboratory abnormalities. The potential for hepatotoxicity and interstitial lung disease necessitates periodic monitoring. Because CYP3A contributes to metabolism, coadministration with strong inducers or inhibitors can affect systemic levels. Alectinib’s ability to inhibit efflux transporters may influence exposure to concomitant substrates.
Alectinib is marketed in several regions under the brand name Alecensa and is used within treatment algorithms for ALK‑positive metastatic NSCLC where resistance to first‑generation agents is common.
For API procurement, sourcing should prioritise manufacturers with demonstrated control of stereochemistry, impurity profiles, and particle size distribution, alongside full documentation supporting regulatory submissions and compliance with regional GMP standards.
Identification & chemistry
| Generic name | Alectinib |
|---|---|
| Molecule type | Small molecule |
| CAS | 1256580-46-7 |
| UNII | LIJ4CT1Z3Y |
| DrugBank ID | DB11363 |
Pharmacology
| Summary | Alectinib is a selective second‑generation inhibitor of the anaplastic lymphoma kinase (ALK) tyrosine kinase, targeting tumors that express ALK fusion proteins such as ALK‑EML4. By blocking ALK‑dependent phosphorylation and downstream signaling through pathways including STAT3 and AKT, it reduces viability of ALK‑driven cancer cells. The parent drug and its active metabolite M4 show comparable activity across multiple ALK mutant forms. |
|---|---|
| Mechanism of action | Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability. Both alectinib and its major active metabolite M4 demonstrate similar in vivo and in vitro activity against multiple mutant forms of ALK. |
Targets
| Target | Organism | Actions |
|---|---|---|
| ALK tyrosine kinase receptor | Humans | inhibitor |
ADME / PK
| Absorption | Alectinib reached maximal concentrations at 4 hours following administration of 600 mg twice daily under fed conditions in patients with ALK-positive NSCLC. The absolute bioavailability was 37% in the fed state. A high-fat, high-calorie meal increased the combined exposure of alectinib and its major metabolite M4 by 3.1-fold following oral administration of a single 600 mg dose. |
|---|---|
| Half-life | The mean elimination half life is 33 hr for alectinib and 31 hr for M4. |
| Protein binding | Alectinib and its major metabolite M4 are >99% bound to human plasma proteins. |
| Metabolism | Alectinib is metabolized by CYP3A4 to its major active metabolite M4. M4 is then further metabolized by CYP3A4. Both alectinib and M4 demonstrate similar in vivo and in vitro activity. In vitro studies suggest that alectinib is not a substrate for P-gp while M4 is. |
| Route of elimination | When radioactively labeled, 98% of radioactivity was found in feces with 84% of that amount excreted as unchanged alectinib and 6% as M4. Less than 0.5% was found to be recovered in urine. |
| Volume of distribution | 4016 L |
| Clearance | The apparent clearance is 81.9L/hr for alectinib and 217 L/hr for M4. |
Formulation & handling
- Oral small‑molecule API formulated as capsules; very low aqueous solubility may require enabling excipients to support dissolution.
- Lipophilic character (high LogP) favors lipid‑based or solid dispersion approaches to improve absorption consistency.
- Administration with food improves exposure; avoid co‑formulation claims but note potential sensitivity to CYP3A‑modulating dietary components during use.
Regulatory status
| Lifecycle | Patent coverage in the United States extends into 2035, indicating the API remains in a protected phase with limited generic competition expected in the near term. With presence in the US, EU, and Canada, the product is marketed across mature regulatory regions but is still early‑ to mid‑lifecycle from a patent‑expiry standpoint. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Alectinib is supplied globally by a single originator manufacturer, with branded products available in the US, EU, and Canada. Market presence is exclusively through the originator’s formulations, indicating centralized control of API and finished‑dose production. Long‑dated US patents extending into 2035 suggest that generic competition is not yet present and is unlikely in the near term. |
|---|
Safety
| Toxicity | The most common adverse reactions (>5%) associated with alectinib use were fatigue, constipation, edema, and myalgia. Less common effects associated with use were hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, bradycardia, severe myalgia and creatine phosphokinase (CPK) elevation, and embryo-fetal toxicity. Females of reproductive potential are advised to use effective contraception during treatment with alectinib and for 1 week following the final dose. |
|---|
- Reported toxicities include frequent fatigue, constipation, peripheral edema, and myalgia, with less common but clinically significant events such as hepatotoxicity, ILD/pneumonitis, bradycardia, and marked CPK elevations
- Handling considerations should account for embryo‑fetal toxicity potential and the need to prevent occupational exposure to materials associated with hepatic and pulmonary adverse effects
- Monitoring during development or manufacturing may focus on parameters relevant to muscle injury and liver function due to the compound’s association with severe myalgia and hepatotoxic events
Alectinib 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.
Alectinib (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.
Alectinib API manufacturers & distributors
Compare qualified Alectinib API suppliers worldwide. We currently have 3 companies offering Alectinib 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 |
|---|---|---|---|---|---|
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, GMP, MSDS, WC | 170 products |
| Hunan Ouya Biological Co.... | Producer | China | China | CoA | 7 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
When sending a request, specify which Alectinib 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 Alectinib 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 Alectinib API
Sourcing
What matters most when sourcing GMP-grade Alectinib?
Which documents are typically required when sourcing Alectinib API?
Which manufacturers are known to produce Alectinib API?
How can I request quotes for Alectinib API from GMP suppliers?
Is a GMP audit report available for Alectinib manufacturers?
How many suppliers offer Alectinib API on Pharmaoffer?
Which countries are known to manufacture Alectinib API?
Which certifications do suppliers of Alectinib usually hold?
Technical
What is Alectinib (CAS 1256580-46-7) used for?
Which therapeutic class does Alectinib fall into?
What conditions is Alectinib mainly prescribed for?
How does Alectinib work?
What should someone know about the safety or toxicity profile of Alectinib?
What are important formulation and handling considerations for Alectinib as an API?
Is Alectinib a small molecule?
Are there special stability concerns for oral Alectinib?
Regulatory
Where is Alectinib approved or in use globally?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Alectinib procurement?
Is Alectinib included in the PRO Data Insights coverage?
Where can I access the API market report for Alectinib?
