Vonoprazan

Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H + , K + -ATPase enzyme system in a potassium-competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production.

• 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.ICD-10: K21.00

• VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA. Reactions have included anaphylactic shock [see Adverse Reactions (6.2) and Description (11) ] .contraindicated

Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks. ( 2.1 ) Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6 months. ( 2.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease: 10 mg once daily for 4 weeks. ( 2.1 ) Treatment of H. pylori Infection: see full prescribing information. ( 2.1 ) See also full prescribing information for the recommended dosage by indication for patients with renal or hepatic impairment. ( 2.2 , 2.3 ) Administration Instructions : Take with or without food. ( 2.4 ) Swallow whole; do not chew or crush. ( 2.4 ) 2.1 Recommended Dosage Healing of Erosive Esophagitis The recommended adult oral dosage is VOQUEZNA 20 mg once daily for 8 weeks for the treatment of healing of erosive esophagitis and relief of associated heartburn. Maintenance of Healed Erosive Esophagitis The recommended adult oral dosage is VOQUEZNA 10 mg once daily for up to 6 months for the maintenance of healed erosive esophagitis and relief of associated heartburn. Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease The recommended adult oral dosage is VOQUEZNA 10 mg once daily for 4 weeks. Treatment of H. pylori Infection Triple Therapy: The recommended adult oral dosage is VOQUEZNA 20 mg plus amoxicillin 1,000 mg plus clarithromycin 500 mg, each given twice daily (in the morning and evening, 12 hours apart) for 14 days.

Gastric Malignancy : Symptomatic response to treatment does not preclude the presence of gastric malignancy; consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. ( 5.2 ) Clostridioides difficile -Associated Diarrhea (CDAD) : May be associated with an increased risk; use the shortest duration of treatment appropriate to the condition. ( 5.3 ) Bone Fracture, including Osteoporosis-related Fracture : Use the shortest duration of treatment appropriate to the condition. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. ( 5.5 ) Vitamin B12 (Cobalamin) Deficiency : Long-term use may lead to malabsorption or deficiency; consider further workup if clinical symptoms are present. ( 5.6 ) Hypomagnesemia and Mineral Metabolism : Hypomagnesemia may lead to hypocalcemia and/or hypokalemia. Consider monitoring magnesium and calcium levels in at-risk patients, or if there is concomitant use of digoxin or other drugs that cause hypomagnesemia. ( 5.7 ) Interactions with Investigations for Neuroendocrine Tumors : Increased chromogranin A (CgA) levels may interfere with diagnostic investigations; temporarily stop VOQUEZNA at least 4 weeks before assessing CgA levels. ( 5.8 , 7 ) Fundic Gland Polyps : Risk increases with long-term use; use the shortest duration of treatment appropriate to the condition.

The following serious adverse reactions are described elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Vitamin B12 (Cobalamin) Deficiency [see Warnings and Precautions (5.6) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.7) ] Fundic Gland Polyps [see Warnings and Precautions (5.9) ] Most common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal distension, abdominal pain, and nausea. ( 6.1 ) Maintenance of Healed Erosive Esophagitis (≥3%): gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection. ( 6.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease (≥2%): abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. ( 6.1 ) Treatment of H. pylori Infection (≥2%): diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Phathom Pharmaceuticals, Inc. at toll-free phone 1-888-775-7428 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VOQUEZNA during pregnancy. Healthcare providers are encouraged to register patients by calling 1-866-609-1612 or visiting https://voqueznapregnancyregistry.com/ . Risk Summary There are no adequate and well-controlled studies of vonoprazan in pregnant women. Available data from pharmacovigilance reports with vonoprazan-containing products used in pregnant women are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In pregnant rats, no adverse effects were noted after oral administration of vonoprazan during organogenesis at approximately 27-times the maximum recommended human dose (MRHD), based on AUC exposure comparisons. In a pre- and postnatal development (PPND) study, pups from dams orally administered vonoprazan during organogenesis and through lactation exhibited liver discoloration, which, in follow-up mechanistic animal studies, was associated with necrosis, fibrosis, and hemorrhage at a dose approximately 22-times the MRHD, based on AUC comparisons that were likely attributable to exposure during lactation [see Use in Specific Populations (8.2) ] .

Metabolism

Steady state pharmacokinetic (PK) parameters for vonoprazan 10 mg or 20 mg following once daily administration and vonoprazan 20 mg following twice daily administration from data collected across multiple studies are summarized in Table 12 .

• May 3, 2022NDANDA215152Phathom
• May 3, 2022NDANDA215153Phathom
• Nov 1, 2023NDANDA215151Phathom

1. 1Off Label Use4496.7%
2. 2Diarrhoea4296.4%
3. 3Drug Ineffective3955.9%
4. 4Nausea3895.8%
5. 5Malaise2583.8%
6. 6Decreased Appetite2483.7%
7. 7Gastrooesophageal Reflux Disease2393.5%
8. 8Pyrexia2303.4%
9. 9Headache2193.2%
10. 10Abdominal Pain Upper1892.8%
11. 11Interstitial Lung Disease1882.8%
12. 12Pneumonia1812.7%
13. 13Vomiting1812.7%
14. 14Anaemia1742.6%
15. 15Dyspnoea1742.6%

The 10 most recently updated of 144 ClinicalTrials.gov registrations naming Vonoprazan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Vonoprazan High-Dose Dual VS Levofloxacin Concomitant
  Not yet recruiting · Phase 4 · Interventional · 150 enrolled · Damascus Hospital
  NCT07624422updated 2026-06-03
• Comparison of Rabeprazole and Vonoprazan in the Prevention of Post-endoscopic Variceal Ligation Ulcer in Patients With Cirrhosis
  Not yet recruiting · Phase 3 · Interventional · 300 enrolled · King George's Medical University
  NCT07608536updated 2026-05-27
• Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
  Recruiting · Phase 3 · Interventional · 990 enrolled · National Taiwan University Hospital
  NCT07576959updated 2026-05-08
• Comparison of Esomeprazole Versus Vonoprazan in Gastroesophageal Reflux Disease
  Completed · Interventional · 824 enrolled · Muhammad Aamir Latif
  NCT07563491updated 2026-05-04
• Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
  Recruiting · Interventional · 70 enrolled · Peking University First Hospital
  NCT07439445updated 2026-04-30
• A Study in Adult Participants With EoE to Evaluate Vonoprazan 20 mg Compared to Placebo After 12 Weeks and to Evaluate Vonoprazan 20 mg Up to 24 Weeks
  Recruiting · Phase 2 · Interventional · 80 enrolled · Phathom Pharmaceuticals, Inc.
  NCT06851559updated 2026-04-28
• Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
  Recruiting · Interventional · 300 enrolled · Asian Institute of Gastroenterology, India
  NCT06955520updated 2026-04-27
• Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
  Recruiting · Phase 4 · Interventional · 80 enrolled · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
  NCT07537634updated 2026-04-22
• Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
  Not yet recruiting · Interventional · 531 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07533422updated 2026-04-16
• Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
  Recruiting · Interventional · 372 enrolled · Yanqing Li
  NCT07179159updated 2026-04-15

Frequently asked questions

How does Vonoprazan work?

Vonoprazan suppresses basal and stimulated gastric acid secretion at the secretory surface of the gastric parietal cell through inhibition of the H + , K + -ATPase enzyme system in a potassium-competitive manner. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, vonoprazan has been characterized as a type of gastric proton-pump inhibitor, in that it blocks the final step of acid production.

What is Vonoprazan used for?

According to FDA labeling, Vonoprazan carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vonoprazan?

Vonoprazan is classified as Proton pump inhibitors, Proton Pump Inhibitors, Inhibition Gastric Acid Secretion.

What are the brand names for Vonoprazan?

Vonoprazan is marketed under brand names including Voquezna.

What are the contraindications for Vonoprazan?

Vonoprazan labeling lists contraindications including: VOQUEZNA is contraindicated in patients with a known hypersensitivity to vonoprazan or any component of VOQUEZNA. Reactions have included anaphylactic shock [see Adverse Reactions (6.2) and Description (11) ] .. Always consult the full prescribing information and a clinician.