Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vonoprazan · 5 trials · 4 indications
HP infection status was determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The percentages are rounded off to report the nearest ten.
Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles \[LA\] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: \>/=1 mucosal breaks \</=5 mm, none of which extends between the tops of the mucosal folds; Grade B: \>/=1 mucosal breaks \>5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve \<75% of esophageal circumference; Grade D: mucosal breaks which involve \>/=75% of esophageal circumference.
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.
Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.
Participants used the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD) every morning upon waking and every evening before going to sleep to document the presence of daytime and nighttime heartburn and regurgitation. The percentage of heartburn-free (HBF) 24-hour periods was calculated for each participant using the following formula: (total 24-hour periods that are heartburn free / total 24-hour periods for which both a daytime and nighttime result is marked) x 100%.
| Arm | Type | Description |
|---|---|---|
| Vonoprazan 20 mg | EXPERIMENTAL | Vonoprazan 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks. |
| Esomeprazole 20 mg | ACTIVE_COMPARATOR | Esomeprazole 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks. |
| Vonoprazan 10 mg | EXPERIMENTAL | Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Vonoprazan 10 mg, tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, and Lansoprazole 15 mg placebo-matching, capsules, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing. |
| Lansoprazole 15 mg | ACTIVE_COMPARATOR | Lansoprazole 30 mg, capsules or tablets, orally, once, daily, for up to 4 or 8 weeks or until confirmed healing of erosive esophagitis (EE) in healing phase for participants with ongoing EE. Lansoprazole 15 mg, capsules, orally, once, daily, and Vonoprazan 10 mg, placebo-matching tablets, orally, once, daily, and Vonoprazan 20 mg, placebo-matching tablets, orally, once, daily, for up to 24 weeks in maintenance phase for participants with confirmed EE healing. |
| Lansoprazole 30 mg | ACTIVE_COMPARATOR | Lansoprazole 30 mg, capsule, orally, once daily and vonoprazan placebo-matching tablet, orally, once daily for up to 8 weeks. |
| Sequence A (Cohort 1): Vonoprazan + Esomeprazole | EXPERIMENTAL | Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then esomeprazole 20 mg, orally, once daily for 7 days. |
| Sequence B (Cohort 1): Esomeprazole + Vonoprazan | EXPERIMENTAL | Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days. |
| Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium | EXPERIMENTAL | Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then Rabeprazole sodium 10 mg, orally, once daily for 7 days. |
| Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan | EXPERIMENTAL | Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days; then vonoprazan 20 mg, orally, once daily for 7 days. |
| Esomeprazole 40 mg | ACTIVE_COMPARATOR | Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by esomeprazole 40 mg, over encapsulated tablets, orally, once daily for 4 weeks during the active treatment period. |
| Vonoprazan 40 mg | EXPERIMENTAL | Esomeprazole 40 mg over-encapsulated tablets, orally, once daily for 4 weeks then esomeprazole placebo-matching capsules, orally, once daily for 2 weeks during the run-in period, followed by vonoprazan 40 mg, over-encapsulated capsules, orally, once daily for 4 weeks during the active treatment period. |
| Name | Type | Description |
|---|---|---|
| Vonoprazan | DRUG | Vonoprazan Tablets |
| Amoxicillin | DRUG | Amoxicillin Capsules |
| Clarithromycin | DRUG | Clarithromycin Tablets |
| Bismuth Potassium citrate | DRUG | Bismuth Potassium citrate |
| Esomeprazole | DRUG | Esomeprazole Tablets |
| Lansoprazole | DRUG | Lansoprazole capsules or tablets |
| Vonoprazan Placebo | DRUG | Vonoprazan placebo-matching tablets |
| Lansoprazole Placebo | DRUG | Lansoprazole placebo-matching capsules |
| Rabeprazole sodium | DRUG | Rabeprazole sodium tablets |
| Esomeprazole Placebo | DRUG | Esomeprazole placebo-matching capsules |
Inclusion Criteria: 1\. Helicobacter pylori (HP)-positive participants as determined by \^13C-urea breath test (\^13C-UBT) at the start of the study (Visit 1 \[screening\]) and who require HP eradication in Physician judgment. Exclusion Criteria: 1. Participant had any of the following conditions...
Vonoprazan is an investigational small molecule being studied for gastrointestinal conditions including erosive esophagitis, gastroesophageal reflux, and Helicobacter pylori infection. It has also been evaluated in healthy volunteers. The drug is in Phase 3 clinical development and is not yet approved by the FDA.
Vonoprazan is a potassium-competitive acid blocker that suppresses gastric acid secretion. It works by competitively inhibiting the gastric proton pump, reducing acid production in the stomach. This mechanism is being studied for the treatment of acid-related gastrointestinal disorders.
Vonoprazan is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 3 clinical trials for gastrointestinal indications.
Vonoprazan is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Clinical trials have been completed for erosive esophagitis and other gastrointestinal conditions.
Vonoprazan has completed several clinical trials, including NCT02388724 and NCT02388737 for erosive esophagitis, NCT02037477 in healthy volunteers, and NCT02743949 for gastroesophageal reflux. These trials were Phase 2 and Phase 3 studies with active controls.
Yes, Vonoprazan is also known as TAK-438. Clinical trial records refer to the drug by both names, such as in the Phase 3 study NCT02037477, which evaluates multiple oral doses of Vonoprazan (TAK-438).