Daewoong Pharmaceutical Receives Approval for Phase 1 Clinical Trial of 'Pexuprazan' Injection

[Asia Economy Reporter Cho Hyun-ui] Daewoong Pharmaceutical announced on the 14th that it has received approval from the Ministry of Food and Drug Safety to conduct a Phase 1 clinical trial for the injectable form of 'Pexuprazan,' a treatment for gastroesophageal reflux disease.

Following the development of the existing oral formulation, Daewoong Pharmaceutical is diversifying the dosage form by developing an injectable. Although the injectable is less preferred by patients compared to the oral form, it is being developed for patients who have difficulty with oral administration or require rapid suppression of gastric acid secretion. In some countries, the injectable market is formed at a level similar to that of tablets.

In this Phase 1 clinical trial, safety, tolerability, and pharmacokinetic properties will be evaluated in 36 healthy adults after intravenous administration. Pexuprazan and placebo will be randomly assigned in a double-blind, placebo-controlled, single-dose study with stepwise dose escalation. Daewoong Pharmaceutical plans to start dosing this year and secure Phase 1 clinical trial results by next year.

Additionally, Daewoong Pharmaceutical is conducting clinical trials to expand the indications of Pexuprazan tablets. These include a Phase 3 trial for gastritis, the only one among drugs in the same class, a Phase 3 trial for maintenance therapy after treatment of erosive gastroesophageal reflux disease, and a Phase 1 trial on drug interactions when combined with nonsteroidal anti-inflammatory drugs (NSAIDs).

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "We hope that diversifying the dosage forms of Pexuprazan, which is being developed as the most innovative new drug in its class, will help treat patients who had difficulty with oral administration." He added, "Daewoong Pharmaceutical will focus its capabilities on strengthening product competitiveness through expanding indications and developing various formulations of Pexuprazan."

This content was produced with the assistance of AI translation services.