Vonoprazan
- Generic Name
- Vonoprazan
- Brand Names
- Voquezna 14 Day Dualpak 20;500, Voquezna 14 Day Triplepak 20;500;500
- Drug Type
- Small Molecule
- Chemical Formula
- C17H16FN3O2S
- CAS Number
- 881681-00-1
- Unique Ingredient Identifier
- 1R5L3J156G
Overview
Vonoprazan is a potassium-competitive acid blocker (PCAB) that inhibits H, K-ATPase-mediated gastric acid secretion. PCABs represent an alternative to proton-pump inhibitors for the treatment of acid-related disorders. Unlike proton-pump inhibitors, PCABs are not affected by CYP2C19 genetic polymorphisms and do not require acid-resistant formulations. Furthermore, vonoprazan is 350-times more potent than the proton-pump inhibitor lansoprazole, thanks to its ability to accumulate in the gastric corpus mucosa, specifically in the parietal cells. In February 2015, vonoprazan was first marketed in Japan for the treatment of acid-related disorders and as an adjunct to Helicobacter pylori (H. pylori) eradication. In May 2022, the FDA approved the use of vonoprazan in a co-packaged product containing amoxicillin and clarithromycin for the treatment of H. pylori infection. Studies have shown that the concomitant use of vonoprazan, amoxicillin, and clarithromycin leads to an H. pylori eradication rate of approximately 90%.
Background
Vonoprazan is a potassium-competitive acid blocker (PCAB) that inhibits H, K-ATPase-mediated gastric acid secretion. PCABs represent an alternative to proton-pump inhibitors for the treatment of acid-related disorders. Unlike proton-pump inhibitors, PCABs are not affected by CYP2C19 genetic polymorphisms and do not require acid-resistant formulations. Furthermore, vonoprazan is 350-times more potent than the proton-pump inhibitor lansoprazole, thanks to its ability to accumulate in the gastric corpus mucosa, specifically in the parietal cells. In February 2015, vonoprazan was first marketed in Japan for the treatment of acid-related disorders and as an adjunct to Helicobacter pylori (H. pylori) eradication. In May 2022, the FDA approved the use of vonoprazan in a co-packaged product containing amoxicillin and clarithromycin for the treatment of H. pylori infection. Studies have shown that the concomitant use of vonoprazan, amoxicillin, and clarithromycin leads to an H. pylori eradication rate of approximately 90%.
Indication
Vonoprazan, in combination with amoxicillin and clarithromycin in a co-packaged product, is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. Another co-packaged product with only vonoprazan and amoxicillin is also indicated for the treatment of H. pylori infection in adults.
Associated Conditions
- Duodenal Ulcer
- Gastric Ulcer
- Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
- Helicobacter Pylori Infection
- Reflux Esophagitis (RE)
- Develop NSAID-induced gastric ulcers
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/13 | Phase 4 | Recruiting | Yongquan Shi | ||
2023/12/08 | Phase 3 | Completed | |||
2023/12/05 | Phase 4 | Recruiting | |||
2023/10/30 | Phase 1 | Completed | |||
2023/10/26 | Phase 3 | Completed | |||
2023/06/13 | Phase 4 | Completed | Shanghai Jiao Tong University School of Medicine | ||
2023/05/25 | Phase 4 | Recruiting | Shanghai Jiao Tong University School of Medicine | ||
2023/02/14 | Phase 4 | Not yet recruiting | Shanghai East Hospital | ||
2023/02/09 | Phase 3 | Completed | Sixth Affiliated Hospital, Sun Yat-sen University | ||
2022/12/20 | Phase 4 | Not yet recruiting |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
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EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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HSA Approved Products
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NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
H20201005 | 片剂 | 沃克 | 按C17H16FN3O2S计20mg | Chemical Drug | Approved | 2020/02/07 | Import | ||
国药准字H20233736 | 片剂 | N/A | 20mg（按C₁₇H₁₆FN₃O₂S计） | Chemical Drug | Approved | 2023/06/21 | Domestic | ||
国药准字H20244013 | 片剂 | N/A | 10mg（按C₁₇H₁₆FN₃O₂S计） | Chemical Drug | Approved | 2024/06/11 | Domestic | ||
国药准字H20244426 | 片剂 | N/A | 20mg（按C₁₇H₁₆FN₃O₂S计） | Chemical Drug | Approved | 2024/07/09 | Domestic | ||
国药准字HJ20201005 | 片剂 | 沃克 | 按C₁₇H₁₆FN₃O₂S计 20mg | Chemical Drug | Approved | 2024/09/24 | Import | ||
国药准字HJ20201011 | 片剂 | 沃克 | 按C₁₇H₁₆FN₃O₂S计 10mg | Chemical Drug | Approved | 2024/09/24 | Import | ||
国药准字HJ20190064 | 片剂 | 沃克 | 按C₁₇H₁₆FN₃O₂S计 10mg | Chemical Drug | Approved | 2024/09/24 | Import | ||
国药准字HJ20190065 | 片剂 | 沃克 | 按C₁₇H₁₆FN₃O₂S计 20mg | Chemical Drug | Approved | 2024/09/24 | Import | ||
国药准字J20200015 | 片剂 | 沃克 | 按C17H16FN3O2S计 10mg | Chemical Drug | Approved | 2020/07/10 | Import | ||
国药准字H20233737 | 片剂 | N/A | 10mg（按C₁₇H₁₆FN₃O₂S计） | Chemical Drug | Approved | 2023/06/21 | Domestic |
PPB Approved Products
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TGA Approved Products
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