319460-85-0,Axitinib,The latest news,ANQING CHICO PHARMACEUTICAL CO., LTD.

Keywords:
Axitinib, Inlyta, VEGFR inhibitor, renal cell carcinoma, tyrosine kinase inhibitor, market analysis, generics, oncology therapeutics

Introduction:
Renal cell carcinoma (RCC) represents a significant portion of kidney cancers, with advanced stages posing therapeutic challenges. The advent of targeted therapies, particularly tyrosine kinase inhibitors (TKIs), has transformed the RCC treatment landscape. Axitinib, a second-generation TKI developed by Pfizer, selectively inhibits VEGFR-1, VEGFR-2, and VEGFR-3, thereby impeding angiogenesis—a critical process in tumor growth and metastasis. Since its FDA approval in 2012, axitinib has been integrated into various treatment regimens, including combinations with immunotherapies, to enhance clinical outcomes in RCC patients.

Chemical Properties:

• Chemical Name: N-methyl-2-[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide

• CAS Number: 319460-85-0

• Molecular Formula: C₂₂H₁₈N₄OS

• Molecular Weight: 386.47 g/mol

• Bioavailability: 58%

• Protein Binding: >99%

• Metabolism: Primarily hepatic via CYP3A4/CYP3A5, with contributions from CYP1A2, CYP2C19, and UGT1A1

• Elimination Half-Life: 2.5–6.1 hours

• Excretion: Feces (41%; 12% as unchanged drug), urine (23%)

Clinical Development and Approval Timeline:

• January 27, 2012: FDA approval for advanced RCC treatment

• June 29, 2012: Approval by Japan's Pharmaceuticals and Medical Devices Agency (PMDA)

• September 3, 2012: European Medicines Agency (EMA) approval

• April 29, 2015: Approval by China's National Medical Products Administration (NMPA)

Axitinib's efficacy was further established through the KEYNOTE-426 trial, leading to FDA approval in April 2019 for its combination with pembrolizumab as a first-line treatment for advanced RCC .

Market Performance and Sales (2020–2024):
Axitinib's market performance has been influenced by its clinical efficacy, competition from other therapies, and the introduction of generics.

The significant increase in 2023 sales is attributed to expanded indications and combination therapy approvals .

Market Competition and Generics:
The expiration of axitinib's primary patents has opened the market to generic versions, intensifying competition:

• December 1, 2020: Glenmark Pharmaceuticals received tentative FDA approval for generic axitinib tablets (1 mg and 5 mg) .

• November 2022: Glenmark and Pfizer reached a settlement agreement regarding axitinib generics .

Generic versions have entered markets like Brazil and Thailand, offering prices up to 70% lower than the branded drug, impacting Pfizer's market share .

Global Market Dynamics:
The global axitinib market was valued at approximately $1.27 billion in 2023 and is projected to reach $2.39 billion by 2031, growing at a CAGR of 8.2% . North America holds the largest market share due to advanced healthcare infrastructure and high adoption rates of targeted therapies. However, the Asia-Pacific region is expected to witness the fastest growth, driven by increasing cancer incidence and improving healthcare access.

Conclusion:
Axitinib has established itself as a vital component in the treatment of advanced RCC, especially in combination with immunotherapies. While the introduction of generics poses challenges to its market dominance, ongoing research into new indications and combination regimens may sustain its relevance in oncology therapeutics.

References:

1. Axitinib. Wikipedia.

2. Axitinib. Pharmacodia.

3. Inlyta FDA Approval History. Drugs.com.

4. Glenmark Pharmaceuticals receives ANDA tentative approval for Axitinib Tablets.

5. Glenmark Pharma reaches settlement agreement with Pfizer for Axitinib tablets.

6. FDA approves pembrolizumab plus axitinib for advanced renal cell carcinoma.

7. Global Axitinib Market. Flair Insights.

8. Axitinib Market. PMarketResearch. (en.wikipedia.org, pharmacodia.com, drugs.com, glenmarkpharma-us.com, health.economictimes.indiatimes.com, fda.gov, flairinsights.com, pmarketresearch.com)

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319460-85-0,Axitinib,(chemical grade, purity ≥99.0%) are currently supplied by our company. [Own compliance factory, fully support factory audit] For details, you can call the bottom line to get the latest price of the product!

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