A pharmaceutical company in South Korea has ambitious plans to “disrupt the global market for gastroesophageal reflux disease (GERD) treatments” with its new drug Fexuclue. But what is it and how does it work?
What is Fexuclue?
Fexuclue – also known as Fexuprazan – is a potassium-competitive acid blocker (P-CAB) drug that inhibits gastric acid secretion without activating gastric acid.
It binds to the proton pump without activating gastric acid and quickly and stably inhibits the secretion of gastric acid.
Currently, the drug is aimed at the treatment of erosive GERD and the improvement of gastric mucosal lesions in acute and chronic gastritis.
Who makes it?
Fexuclue Tablet was officially launched by Daewoong Pharmaceutical in Korea in July last year. Daewoong set up a booth at the Digestive Disease Week 2023 (#DDW2023) held in Chicago, USA and revealed new clinical data through two poster sessions demonstrating the efficacy and safety of Fexuclue on patients with gastroesophageal reflux disease.
Where will it be available?
The company recently completed new drug application submissions for Fexuclue in 11 countries, including Colombia, Vietnam, and Saudi Arabia, just one year after gaining approval in Korea.
It also plans to expand into 30 countries by 2025 and launch in 100 countries by 2030, starting with China.
When will it be available?
Daewoong Pharmaceutical is conducting phase three clinical trials for additional indications for maintenance therapy after treatment of erosive GERD and prevention of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs), and also commenced on clinical trials for eradicating Helicobacter pylori.
In addition, it is preparing to expand its lineup through the development of orally disintegrating tablets and IV formulations (injections).
Is it unique and how does it compare to PPIs?
Fexuclue is similar to Vonoprazan as they are both P-CABs used for treating GERD. However, the specific active ingredients, formulation, and other details of their use may vary.
Proton pump inhibitors (PPIs) have been the main medication for reflux disease for many years. They reduce the amount of acid produced in the stomach, which helps relieve the symptoms of GERD. They do this by blocking the pumps in the stomach that produce acid.
P-CABs, on the other hand, bind to the proton pump without activating it and thus quickly and stably inhibit the secretion of gastric acid. The difference between the two is that PPIs directly suppress the production of acid, while P-CABs block acid production by binding to the proton pump.
In simpler terms, both types of drugs aim to reduce the amount of acid in the stomach to relieve GERD symptoms, but they do so in different ways.
Does it work?
Compared with existing drugs, it has the advantages of rapid onset of drug effect, fast and excellent symptom improvement, night-time symptom improvement, convenience in medication, low drug interaction, and consistency in the efficacy.
The Fexuclue tablet, among the PPIs as well as the P-CABs, has the longest half-life of nine hours. This indicates a remarkably high rate of improvement in chest pain at night.
Professor Sung In-Kyung, who oversaw a clinical trial, said: “In this study, Fexuprazan is the first P-CAB agent to demonstrate equal effectiveness regardless of food intake, enabling convenient administration. At two and four weeks, Fexuprazan has shown the potential to provide a faster and stronger in suppressing the production of gastric acid than PPIs. We anticipate that the investigational use of Fexuprazan will exhibit excellent efficacy in other conditions resulting from excessive gastric acid secretion.”
For more information on medication, it is advisable to consult a healthcare provider.