Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication VOQUEZNA is indicated: for healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. to maintain healing of all grades of erosive esophagitis and relief of heartburn associated with erosive esophagitis in adults. for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults. FDA label
Also known as Vonoprazan (Reference)
Vonoprazan · 9 trials · 9 indications
Participants were assigned an electronic diary to complete twice daily, in the morning and evening. Diary day was considered heartburn-free if both morning and evening diary entries were heartburn-free and there was no reported use of rescue antacid, H2RAs, or PPIs.
H pylori eradication was determined by the \^13C-UBT test.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
A participant was considered to have complete healing of EE if healing was demonstrated during endoscopy.
An evaluable heartburn episode was an episode for which study drug was taken and for which the participant completed at least one entry in the heartburn episode diary. For a heartburn episode to be considered completely relieved, a participant must not have taken rescue antacid within 3 hours of taking study drug. For sustained relief, complete relief must have been accompanied by 24 hours without another heartburn episode after taking study drug.
AUC from time 0 to 24 hours post-dose, calculated as: the sum of the product of the concentration of the interval and the width of the interval.
Maximum observed concentration after dosing.
Minimum observed concentration after dosing.
Average concentration, calculated as: AUC0-24/tau (tau=the difference between the end time of the last interval and dosing time).
Time to maximum observed concentration (actual midpoint of the interval in which Cmax was observed).
Plasma pharmacokinetic (PK) parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Oral PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Plasma PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time. Data presented based on collections on both Day 7 and Day 14.
Plasma pharmacokinetic (PK) parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time.
PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time.
PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time.
PK parameters were estimated using a non-linear mixed effects model and were determined from the concentration-time data for all evaluable participants. Actual sampling times, rather than scheduled or nominal sampling times, were used in all computations using sampling time.
| Arm | Type | Description |
|---|---|---|
| Vonoprazan 10 mg | EXPERIMENTAL | Participants will be administered open-label vonoprazan 10 mg once daily (QD) to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered vonoprazan 10 mg to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered open-label vonoprazan 10 mg QD to be taken orally for 4 weeks during the 4-week run-in period. Participants will be administered placebo to be taken orally as needed at the onset of each heartburn episode (maximum of once in a 24-hour period) during the 12-week placebo-controlled timed assessment period and the subsequent 12-week placebo-controlled extension period. |
| Vonoprazan 20 mg | EXPERIMENTAL | Participants will be administered vonoprazan at a dose of 20 mg QD in the 4 week Placebo-controlled Treatment Period. Participants randomized to vonoprazan 20 mg in the Placebo-controlled Treatment Period will continue to take the same dose in the 20 week Extension Period. |
| Vonoprazan dual therapy | EXPERIMENTAL | Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days. |
| Vonoprazan triple therapy | EXPERIMENTAL | Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days. |
| Lansoprazole triple therapy | ACTIVE_COMPARATOR | Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days. |
| Healing Phase: Vonoprazan 20 mg | EXPERIMENTAL | Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 8 weeks. |
| Healing Phase: Lansoprazole 30 mg | ACTIVE_COMPARATOR | Participants will receive oral lansoprazole 30 mg once per day (QD) for a maximum of 8 weeks. |
| Maintenance Phase: Vonoprazan 10 mg | EXPERIMENTAL | Participants will receive oral vonoprazan 10 mg once per day (QD) for a maximum of 24 weeks. |
| Maintenance Phase: Vonoprazan 20 mg | EXPERIMENTAL | Participants will receive oral vonoprazan 20 mg once per day (QD) for a maximum of 24 weeks. |
| Maintenance Phase: Lansoprazole 15 mg | ACTIVE_COMPARATOR | Participants will receive oral lansoprazole 15 mg once per day (QD) for a maximum of 24 weeks. |
| Run-In Period | EXPERIMENTAL | Participants will receive vonoprazan 20 mg once daily for up to 4 weeks. |
| Vonoprazan 10 mg: On-Demand Treatment Period | EXPERIMENTAL | Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 10 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. |
| Vonoprazan 20 mg: On-Demand Treatment Period | EXPERIMENTAL | Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 20 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. |
| Vonoprazan 40 mg: On-Demand Treatment Period | EXPERIMENTAL | Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take vonoprazan 40 mg when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. |
| Placebo: On-Demand Treatment Period | PLACEBO_COMPARATOR | Participants who have stable disease (no heartburn on the last 7 days of the Run-In Period) will take a placebo when heartburn occurs during the 6 week On-Demand Treatment Period. Participants can take no more than one dose in a 24 hour period. |
| Vonoprazan 20 mg Once Daily | EXPERIMENTAL | Participants will be administered once-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). |
| Vonoprazan 20 mg Twice Daily | EXPERIMENTAL | Participants will be administered twice-daily doses of vonoprazan 20 mg for 4 consecutive days (Days 1 through 4). |
| Vonoprazan 10mg | EXPERIMENTAL | Participants will receive vonoprazan 10mg QD for 14 days. |
| Vonoprazan 20mg | EXPERIMENTAL | Participants will receive vonoprazan 20mg QD for 14 days. |
| Name | Type | Description |
|---|---|---|
| Vonoprazan | DRUG | Oral tablet. |
| Placebo | DRUG | Oral tablet. |
| Amoxicillin | DRUG | Capsules administered orally. |
| Clarithromycin | DRUG | Tablets administered orally. |
| Lansoprazole | DRUG | Over-encapsulated capsules administered orally. |
Inclusion Criteria for Run-in Period: * The participant is ≥18 years of age at the time of informed consent signing. * In the opinion of the Investigator or Sub-investigators, the participant is capable of understanding and complying with protocol requirements, including compliance with the electro...
Vonoprazan is a small molecule drug being developed by Phathom Pharmaceuticals, Inc. (ticker PHAT) for gastrointestinal conditions. Its development spans eosinophilic esophagitis, erosive esophagitis, gastroesophageal reflux disease, non-erosive gastro-esophageal reflux disease, and Helicobacter pylori infection. It is an investigational therapy rather than an approved product.
Vonoprazan targets ATP4A and ATP4B and acts as an inhibitor of these targets. This mechanism underlies its development across acid-related gastrointestinal conditions such as gastroesophageal reflux disease, erosive esophagitis, and Helicobacter pylori infection.
Vonoprazan is developed by Phathom Pharmaceuticals, Inc., which trades under the ticker PHAT. The company is running clinical studies of the drug in gastrointestinal indications including eosinophilic esophagitis and symptomatic non-erosive gastroesophageal reflux disease.
Vonoprazan is in clinical development and is not an approved therapy. Its recorded development stage is Phase 2, and its clinical program includes Phase 1, Phase 2, and Phase 3 studies. The Phase 3 study NCT07752407 is currently recruiting participants.
Vonoprazan trials include NCT07752407, a recruiting Phase 3 study in symptomatic non-erosive gastroesophageal reflux disease, and NCT06851559, an active Phase 2 study in eosinophilic esophagitis. Completed studies include NCT06391177 in lactating women and NCT06106022 in children with gastroesophageal reflux disease.
Yes, Vonoprazan (Reference) is an alternative name for Vonoprazan. Both names refer to the same small molecule drug candidate developed by Phathom Pharmaceuticals, Inc. (ticker PHAT) for gastrointestinal indications.