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VONOPRAZAN FUMARATE 1260141-27-2

VONOPRAZAN FUMARATE 1260141-27-2

99% up
  • Product Details

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%.

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