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. Furthe...
- 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
- 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
- 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
- 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
- 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
- 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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