Vonoprazan fumarate is under clinical development by Takeda Pharmaceutical and currently in the Phase III and Pre-Registration in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Vonoprazan fumarate’s likelihood of approval (LoA) and phase transition for Corrosive Esophagitis (Erosive Esophagitis) took place on 08 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Vonoprazan fumarate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Takeda Pharmaceutical overview

Takeda Pharmaceutical (Takeda) is a research-based pharmaceutical company which focuses on the discovery, development, manufacturing, marketing, commercialization, import and export of pharmaceutical drugs. The company offers products in the areas of rare diseases, gastrointestinal, oncology, neuroscience, vaccines, and plasma-derived therapies. Takeda has facilities in Japan, Argentina, Brazil, Mexico, the US, Denmark, Norway, Europe, Poland, Russia, Spain, Switzerland, China and India, Canada among others. It markets products directly and through a network of wholesale distributors, retail chains and other purchasing groups worldwide. Takeda has partnership with academic institutions, small biotech, and large pharmaceutical companies. It has presence in the Americas, Europe, and Asia, among others. Takeda is headquartered in Tokyo, Japan.

Quick View Vonoprazan fumarate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Vonoprazan fumarate
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.