Frequently Asked Questions (FAQs)

1. What is the mechanism of action for Fexuclue?

FEXUCLUE® (Fexuprazan), as a Potassium-Competitive Acid Blocker (P-CAB), acts by blocking the potassium exchange channel of the proton pump. This action leads to a rapid, competitive, and reversible inhibition of acid secretion.

Ref.> Hunt RH, et al. Curr Treat Options Gastroenterol. 2018;16(4):570-590

2. What is the approved indication of Fexuclue (Fexuprazan) worldwide?

Erosive Esophagitis (Fexuprazan 40mg : approved in South Korea, Philippines, Ecuador, Chile, and Mexico)

Acute and Chronic Gastritis (Fexuprazan 10mg : approved in South Korea)

3. What is the recommended dosage of Fexuclue (Fexuprazan) for EE (Erosive Esophagitis) patients?

The recommended dosage for EE patients: FEXUCLUE® (Fexuprazan) 40mg, once a day, for 4 weeks (28 days). If the symptoms persists, FEXUCLUE® (Fexuprazan) 40mg may be given for another 4 weeks (28 days).

4. How long is the half-life of Fexuclue (Fexuprazan)?

FEXUCLUE® (Fexuprazan) has the longest half-life among other P-CABs and PPIs. The half-life of FEXUCLUE® (Fexuprazan) 40mg is an average of 8.8 hours.

Ref.> Sunwoo J, et al. Aliment Pharmacol Ther. 2018;48(2):206-218.

5. How long is the half-life of Fexuclue (Fexuprazan)?

FEXUCLUE® (Fexuprazan) has the longest half-life among other P-CABs and PPIs. The half-life of FEXUCLUE® (Fexuprazan) 40mg is an average of 8.8 hours.

Ref.> Sunwoo J, et al. Aliment Pharmacol Ther. 2018;48(2):206-218.

6. Can Fexuclue (Fexuprazan) be taken after meals?

FEXUCLUE® (Fexuprazan) has the longest half-life among other P-CABs and PPIs. The half-life of FEXUCLUE® (Fexuprazan) 40mg is an average of 8.8 hours.

Ref.> Poster Presentation. Digestive Disease Week 2023. Su1311-P.

7. Is Fexuclue (Fexuprazan) a prodrug?

FEXUCLUE® (Fexuprazan) is not a pro-drug; it does not require activation by gastric acid. Therefore, it can be conveniently consumed regardless of meals.

Ref.> 1. Scarpignato C, et al. Ann N Y Acad Sci. 2020;1482(1):193-212; 2. Sunwoo J, et al. Aliment Pharmacol Ther. 2018;48(2):206-218.; 3. Poster Presentation. Digestive Disease Week 2023. Su1311-P.

8. How effective is FEXUCLUE® (Fexuprazan) in relieving atypical symptoms for GERD patients?

One of the atypical syptoms of GERD is chronic cough. In the phase 3 of clinical trial, the proportions of days without chronic cough during Day/Night on day 3,7, and week 8 in the FEXUCLUE® (Fexuprazan) 40mg and esomeprazole 40mg were 81.15% vs. 68.60%(p=0.0061), 77.50% vs. 64.19%(p=0.0030), 80.64% vs. 69.30% (p=0.0024), respectively.

Ref.> Lee KN, et. al. World J Gastroenterol. 2022;28(44):6294-6309

9. What is the impact of minor CYP2C19 metabolism on FEXUCLUE® (Fexuprazan) compared to PPIs?

Most of available PPIs are metabolized primarily by CYP2C19. 1)

CYP2C19 genotype has little influence on the metabolism of P-CABs.2)

Since FEXUCLUE® (Fexuprazan) is metabolized by a non-polymorphic enzyme, FEXUCLUE® is predicted to have little sensitivity to ethnic factors. The extent of gastric acid suppression was similar among ethnicities after multiple doses of FEXUCLUE® 40mg.3)

Ref.> 1) Rouby NE, et al. Expert Opin Drug Metab Toxicol. 2018; 14(4): 447-460; 2) Lee SH. et al. J Neurogastroenterol Motil. 2018;24(suppl 1):S50-S52; 3)

10. What is the difference between P-CAB and PPI in terms of inhibiting acid secretion?

PPIs inhibit acid secretion by binding irreversibly and covalently to the H+/K+-ATPase. However, P-CABs inhibit acid secretion by binding reversibly and competitively to the potassium binding site of the H+/K+-ATPase.

Ref.> 1) Scarpignato C, et al. Ann N Y Acad Sci. 2020;1482(1):193-212; 2) Hunt RH, et al. Clin Transl Gastoenterol. 2015;6(10);e119

11. Is it also indicated in the guidelines that P-CAB can be a highly effective treatment for GERD?

Yes, many guidelines mention recommendations for P-CAB, and among them are: Seoul Consensus on GERD 20201) Statement: The effect of P-CAB is comparable to PPIs for the initial treatment of patients with GERD. Level of evidence: Moderate Strong Recommendation JSGE Guideline 20212) Statement: PPI and P-CAB both achieve esophageal mucosal healing in the initial treatment of mild ERD. Both medications are recommended as first-line treatments. Level of evidence: Moderate Strong Recommendation

Ref.> 1) Jung HK, et al. J Neurogastroenterol Motil. 2021;27(4):453-481; 2) Iwakiri K, et.al. J Gastroenterol. 2022;57(4):267-285

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