Daewoong Pharmaceutical obtains phase-1 clinical trial approval for P-CAB injection Fexuprazan for the first time in Korea

Daewoong Pharmaceutical obtains phase-1 clinical trial approval for P-CAB injection Fexuprazan for the first time in Korea, taking the lead in dosage form diversification following its oral tablet - Started to develop an injection for patients who found it difficult to take oral tablets, and obtained approval for a phase-1 clinical trial - Set the clinical trial on the right track for maintenance therapy after treating with oral tablets for gastritis and erosive gastroesophageal reflux disease to ensure various indications Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced that the company obtained approval from the Ministry of Food and Drug Safety (MFDS) for a phase-1 clinical trial to develop the gastroesophageal reflux disease injection Fexuprazan. Daewoong is diversifying its dosage form with this injection, following its current oral tablet. While injections are less preferred by patients than oral tablets, this injection is developed for patients who find it difficult to take oral tablets or need to suppress acid secretion. Meanwhile, as the injection market has been established to a similar size to the tablet market in some countries, this injection is expected to further accelerate the company’s advances in overseas markets. This phase-1 clinical trial will evaluate the safety, tolerability, and pharmacokinetics of Fexuprazan in 36 healthy adults after intravenously injecting the drug. Fexuprazan and placebo will be randomized to the subjects under a double-blinded, placebo-controlled, single-dose, and dose escalation design. Daewoong will start treatment this year and obtain phase-1 clinical results next year. In addition, Daewoong is also conducting a clinical trial to add indications to the tablet Fexuprazan. Along with the only on-going phase-3 clinical trial for gastritis among the same drug class and another phase-3 clinical trial on maintenance therapy after treating gastroesophageal reflux disease, Daewoong is conducting a phase-1 clinical trial on drug-drug interactions between Fexuprazan and nonsteroidal anti-inflammatory drugs (NSAIDs) when used concomitantly. CEO Sengho Jeon at Daewoong said, “By diversifying the dosage form of Fexuprazan, which we develop as a best-in-class drug, we hope it helps to treat patients, who are difficult to treat with oral tablets. Daewoong will focus on strengthening the product value of Fexuprazan by expanding its indications and developing its various dosage forms.” Meanwhile, Daewoong will expand its market around the world as it is preparing to start clinical trials for Fexuprazan overseas as well in the US and China, and signed an export agreement in August with Brazil, the largest market in Latin America. #  #  #

The release as fetched from its publisher. daewoong.co.kr ↗