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Product name
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Vonoprazan Fumarate
|
|
Molecular Formula
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C21H20FN3O6S
|
|
Molecular Weight
|
461.46
|
|
CAS No.
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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
|
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%.
