Language
Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Sample Provided: yes
Payment Terms: L/L
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Product Information |
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Product name |
Vonoprazan Fumarate |
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Molecular Formula |
C21H20FN3O6S |
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Molecular Weight |
461.46 |
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CAS No. |
1260141-27-2 |
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Quality Standard |
99% up |
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Appearance |
White crystalline powder |
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COA of Vonoprazan Fumarate |
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Test items |
Specifications |
Result |
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Appearance |
White or almost white crystalline powder |
White crystalline powder |
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Solubility |
Soluble in DMSO, slightly soluble in methanol and water, very slightly soluble in ethanol |
Complied |
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Identification (HPLC) |
Must comply with enterprise standard |
Complied |
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Test: |
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Loss on drying |
≤0.5% |
0.02% |
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Residue on ignition |
≤0.1% |
0.08% |
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Heavy metals |
≤20ppm |
Complied |
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Related Substances: |
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Individual impurity |
≤0.5% |
0.10% |
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Total impurities |
≤1.0% |
0.15% |
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Conclusion |
The product complies the enterprise standard |
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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%.
