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
- 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
- Associated Therapies
- -
Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"
- Conditions
- Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis
- Interventions
- First Posted Date
- 2017-07-12
- Last Posted Date
- 2019-12-12
- Lead Sponsor
- Takeda
- Target Recruit Count
- 3183
- Registration Number
- NCT03214952
- Locations
- 🇯🇵
Takeda Selected Site, Tokyo, Japan
Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2019-10-23
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1237
- Registration Number
- NCT03214081
- Locations
- 🇯🇵
Takeda Selected Site, Tokyo, Japan
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2023-06-07
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1304
- Registration Number
- NCT03214198
- Locations
- 🇯🇵
Takeda Selected Site, Tokyo, Japan
Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"
- First Posted Date
- 2017-07-11
- Last Posted Date
- 2020-03-11
- Lead Sponsor
- Takeda
- Target Recruit Count
- 1119
- Registration Number
- NCT03214094
- Locations
- 🇯🇵
Takeda Selected Site, Tokyo, Japan
Vonoprazan Study of Investigating the Effect on Sleep Disturbance Associated With Reflux Esophagitis- Exploratory Evaluation
- First Posted Date
- 2017-04-17
- Last Posted Date
- 2019-03-29
- Lead Sponsor
- Takeda
- Target Recruit Count
- 3
- Registration Number
- NCT03116841
- Locations
- 🇯🇵
Tokatsu Tsujinaka Hospital, Abiko, Chiba, Japan
🇯🇵Aoyama Clinic, Kobe, Hyogo, Japan
🇯🇵Saino Clinic, Tokorozawa, Saitama, Japan
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)
- Conditions
- Gastroesophageal Reflux
- Interventions
- First Posted Date
- 2016-04-19
- Last Posted Date
- 2020-02-18
- Lead Sponsor
- Takeda
- Target Recruit Count
- 256
- Registration Number
- NCT02743949
- Locations
- 🇪🇪
OU Innomedica, Tallinn, Estonia
🇵🇱NZOZ Inter-Med, Czestochowa, Poland
🇬🇧Royal Stoke University Hospital, Stoke on Trent, Staffordshire, United Kingdom
Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety
- First Posted Date
- 2016-02-10
- Last Posted Date
- 2023-12-13
- Lead Sponsor
- Takeda
- Target Recruit Count
- 208
- Registration Number
- NCT02679508
- Locations
- 🇯🇵
Tokatsu Tsujinaka Hospital, Abiko, Chiba, Japan
🇯🇵Hakodate Hospital, Hakodate, Hokkaido, Japan
🇯🇵Shiga University Of Medical Science Hospital, Otsu, Shiga, Japan
Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis
- Conditions
- Erosive Esophagitis
- Interventions
- First Posted Date
- 2015-03-17
- Last Posted Date
- 2019-06-03
- Lead Sponsor
- Takeda
- Target Recruit Count
- 481
- Registration Number
- NCT02388724
- Locations
- 🇰🇷
Kangbuk Samsung Hospital, Seoul, Korea, Republic of
🇰🇷Asan Medical Center, Seoul, Korea, Republic of
🇰🇷The Catholic University of Korea, Seoul St. Marys Hospital, Seoul, Korea, Republic of
Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
- Conditions
- Erosive Esophagitis
- Interventions
- First Posted Date
- 2015-03-17
- Last Posted Date
- 2020-02-21
- Lead Sponsor
- Takeda
- Target Recruit Count
- 703
- Registration Number
- NCT02388737
- Locations
- 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Malaysia
🇨🇳Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
🇨🇳Taipei Medical University Hospital, Taipei City, Taiwan
Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2014-01-16
- Last Posted Date
- 2016-10-17
- Lead Sponsor
- Takeda
- Target Recruit Count
- 20
- Registration Number
- NCT02037477
Drug Development Updates
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