1260141-27-2,Vonoprazan fumarate,The latest news,ANQING CHICO PHARMACEUTICAL CO., LTD.

Abstract:
Vonoprazan fumarate, known by its chemical identifier CAS 1260141-27-2, is a novel potassium-competitive acid blocker (PCAB) developed by Takeda Pharmaceutical Company. It represents a significant advancement in the treatment of acid-related gastrointestinal disorders, offering rapid and sustained acid suppression. Since its initial approval in Japan in 2014, vonoprazan has expanded its global presence, with approvals in multiple countries, including the United States in 2023.

Keywords:
Vonoprazan fumarate, CAS 1260141-27-2, TAK-438, PCAB, acid-related disorders, market analysis, generics, global sales

Introduction:
Acid-related gastrointestinal disorders, such as gastroesophageal reflux disease (GERD) and peptic ulcers, affect millions worldwide. Traditional treatments, primarily proton pump inhibitors (PPIs), have limitations, including delayed onset of action and variable efficacy. Vonoprazan fumarate, a first-in-class PCAB, offers a promising alternative with its rapid and sustained acid suppression. This paper explores vonoprazan's journey from development to its current market status, highlighting its chemical characteristics, clinical efficacy, and commercial performance.

Chemical Properties:

• Chemical Name: 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine fumarate

• Synonyms: TAK-438

• CAS Number: 1260141-27-2

• Molecular Formula: C21H20FN3O6S

• Molecular Weight: 461.46 g/mol

• Solubility: Insoluble in water and ethanol; soluble in DMSO (≥18.9 mg/mL)

• Storage Conditions: Store at -20°C

Development and Approvals:
Vonoprazan was developed by Takeda Pharmaceutical Company and Otsuka. It received its first approval in Japan in December 2014 for the treatment of gastric and duodenal ulcers and reflux esophagitis. Subsequent approvals include:

• Russia: April 2021

• United States: November 2023, approved for erosive esophagitis and later for non-erosive GERD in July 2024

Market Performance:
Since its launch, vonoprazan has shown significant market growth:

• 2020: $350 million

• 2021: $420 million

• 2022: $500 million

• 2023: $580 million

• 2024: $700 million

In the U.S., Phathom Pharmaceuticals reported a revenue of $7.3 million in Q2 2024, marking a 280% increase from the previous quarter. Over 122,000 prescriptions for VOQUEZNA® products were written by healthcare providers since launch, indicating strong market uptake .

Market Competition and Generics:
Vonoprazan faces competition from established PPIs. However, its rapid action and sustained efficacy provide a competitive edge. In India, companies like Sun Pharma and Cipla have entered licensing agreements with Takeda to market vonoprazan, indicating the drug's expanding global footprint . As of now, generic versions are limited, but with patent expirations approaching, increased generic competition is anticipated.

Recent Developments:

• FDA approval for the treatment of non-erosive GERD in July 2024 .

• Addition of VOQUEZNA® to CVS Caremark formularies, expanding access to over 116 million commercially insured patients in the U.S. .

• FDA approval of reformulated vonoprazan tablets for H. pylori treatment in October 2023 .

Conclusion:
Vonoprazan fumarate represents a significant advancement in the treatment of acid-related gastrointestinal disorders. Its rapid onset, sustained efficacy, and expanding global approvals position it as a strong competitor in the market. With ongoing developments and potential generic entries, vonoprazan's market dynamics will continue to evolve, offering new opportunities and challenges in the gastrointestinal therapeutics landscape.

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