VONOPRAZAN FUMARATE 1260141-27-2

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Product Information

Product name	Vonoprazan Fumarate
Molecular Formula	C21H20FN3O6S
Molecular Weight	461.46
CAS No.	1260141-27-2
Quality Standard	99% up
Appearance	White crystalline powder

COA of Vonoprazan Fumarate

Test items	Specifications	Result
Appearance	White or almost white crystalline powder	White crystalline powder
Solubility	Soluble in DMSO, slightly soluble in methanol and water, very slightly soluble in ethanol	Complied
Identification (HPLC)	Must comply with enterprise standard	Complied
Test:
Loss on drying	≤0.5%	0.02%
Residue on ignition	≤0.1%	0.08%
Heavy metals	≤20ppm	Complied
Related Substances:
Individual impurity	≤0.5%	0.10%
Total impurities	≤1.0%	0.15%
Conclusion	The product complies the enterprise standard

Usage

Function of Vonoprazan Fumarate
1) Prevention of duodenal ulcer and gastric ulcer recurrence

A randomized, double-blind, multi-center clinical phase 3 trial comparing the effects of Voronazan fumarate (10mgqd and 20mgqd) and lansoprazole (15mgqd) on nonsteroidal anti-inflammatory drug-related peptic ulcer A total of 642 patients had been diagnosed with endoscopic peptic ulcers and needed to take non-steroidal anti-inflammatory drugs. The treatment period was 24 weeks. The primary endpoint was the proportion of duodenal ulcer and gastric ulcer recurrence at 24 weeks.

2) Corrosive esophagitis (erosiveoesophagitis, EO)

In a randomized, double-blind, multi-center, dose-range clinical phase 2 trial, in patients with EO, compared with lansoprazole, Voronazan fumarate showed non-inferiority and was rated in Los Angeles as C/D grade patients showed excellent effects, and oral administration of 20 mg once daily became the clinically recommended dose for the treatment of EO. A randomized, double-blind, multi-center clinical phase 3 trial comparing the efficacy of this product (20mgqd) and lansoprazole (30mgqd) on EO, a total of 409 patients participated in the study.

3) Helicobacter pylori infection (Helicobacterpylori, Hp)

A randomized, double-blind, multi-center clinical phase 3 trial comparing vonolazan fumarate (20mgbid) and lansoprazole (30mgbid), combined with amoxicillin and clarithromycin, to form a triple therapy, The effect of first-line medicine to eradicate Hp was included in a total of 650 Hp-positive patients who had had gastric ulcer or duodenal ulcer. The Hp eradication rates of this product and lansoprazole in the test group were 92.6% and 75.9%, respectively. For patients with clarithromycin resistance, the Hp eradication rates in the two test groups were 82.0% and 40.0%, respectively. Significantly superior to lansoprazole. In this trial, the first 50 patients who failed first-line treatment received second-line treatment with triple therapy of this product, amoxicillin and metronidazole, and the Hp clearance rate was 98%.

*Products under the patent are only for R&D use