Vonoprazan fumarate is under clinical development by Phathom Pharmaceuticals and currently in Pre-Registration for Nonerosive Reflux Disease (NERD). According to GlobalData, Pre-Registration drugs for Nonerosive Reflux Disease (NERD) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Vonoprazan fumarate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Vonoprazan fumarate overview

Vonoprazan fumarate (Takecab, Inzelm, Vocinti, Denziza) is a novel anti-secretory drug, acts as gastrointestinal protective agent. It is formulated as film-coated tablets and tablets for the oral route of administration. It is indicated in gastric ulcer, duodenal ulcer, reflux esophagitis, erosive esophagitis, prevention of recurrence of gastric or duodenal ulcer during low-dose aspirin administration, prevention of recurrence of gastric or duodenal ulcer during non-steroidal anti-inflammatory drug (NSAID) administration, as an adjunct to Helicobacter pylori eradication in the gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphatic tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, the stomach after endoscopic resection of early-stage gastric cancer, or Helicobacter pylori gastritis.

Vonoprazan is under development for the treatment of Helicobacter pylori infections, gastro-esophageal reflux disease in patients who have a partial response following treatment with a proton pump inhibitor and erosive esophagitis, gastric cancer, eosinophilic esophagitis (EoE) and nonerosive reflux disease (NERD). The drug candidate is a potassium-competitive acid blocker (P-CAB). It is formulated as a capsule and tablet for oral route of administration. It was also under development for nonerosive reflux disease (NERD) and duodenal ulcer adjunct to Helicobacter pylori eradication.

Phathom Pharmaceuticals overview

Phathom Pharmaceuticals develops and commercializes medicines for the treatment of gastrointestinal (GI) diseases. The company’s pipeline products include vonoprazan, an oral small-molecule potassium-competitive acid blocker (P-CAB). It also evaluates its vonoprazan in combination with antibiotics for the treatment of Helicobacter pylori infection. It also has a research and development center to develop GI therapeutics, including anti-secretory agents in the pharmaceutical industry market. The company operates in the US and Canada. Phathom Pharmaceuticals is headquartered in Buffalo Grove, Illinois, the US.

For a complete picture of Vonoprazan fumarate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 18 March 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.