VOQUEZNA vonoprazan

Drug Class

Potassium-competitive acid blocker (P-CAB)

Mechanism

Inhibits gastric acid secretion by acting as a potassium-competitive blocker of hydrogen-potassium ATPase (H+, K+-ATPase) in parietal cells.

Approved Indication

Treatment of H. pylori infection (in combination with antibiotics), healing and maintenance of healing of erosive esophagitis, and relief of heartburn associated with gastroesophageal reflux disease (GERD).

What This Means For Patients

Voquezna (vonoprazan) is a potassium-competitive acid blocker (P-CAB) approved by the FDA and NMPA (under the brand name Vocinti). It provides rapid and long-lasting suppression of gastric acid, used for treating erosive gastroesophageal reflux disease and eradicating H. pylori. Under special regulatory pathways, patients can access this treatment in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2022) — label
• NMPA — approved (2019) — source

Pivotal Clinical Evidence

• PHALCON-EE — Laine et al., Gastroenterology 2023 (NCT04124926) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215650s002lbl.pdf
• https://www.nmpa.gov.cn/