Vonoprazan: First global approval

Drugs

Volumn 75, Issue 4, 2015, Pages 439-443

  Garnock Jones, Karly P ^a  

^a Springer ^*  (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

VONOPRAZAN; 1-(5-(2-FLUOROPHENYL)-1-(PYRIDIN-3-YLSULFONYL)-1H-PYRROL-3-YL)-N-METHYLMETHANAMINE; PYRROLE DERIVATIVE; SULFONAMIDE;

AREA UNDER THE CURVE; ARTICLE; DRUG ABSORPTION; DRUG APPROVAL; DRUG ELIMINATION; DRUG HALF LIFE; DUODENUM ULCER; HELICOBACTER INFECTION; HUMAN; IC50; MULTICENTER STUDY (TOPIC); NONHUMAN; PH; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; REFLUX ESOPHAGITIS; RHINOPHARYNGITIS; STOMACH ULCER; ANIMAL; CHEMISTRY; COMPLICATION; DRUG EFFECTS; DUODENAL ULCER; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; LEGISLATION AND JURISPRUDENCE; METABOLISM; PROCEDURES;

ANIMALS; DRUG APPROVAL; DUODENAL ULCER; HELICOBACTER INFECTIONS; HELICOBACTER PYLORI; HUMANS; PYRROLES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONAMIDES;

EID: 84925507712     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-015-0368-z     Document Type: Article

References (17)

1. Sachs G, Shin JM, Hunt R. Novel approaches to inhibition of gastric acid secretion. Curr Gastroenterol Rep. 2010;12(6):437-47.
2. Luo HJ, Deng WQ, Zou K. Protonated form: the potent form of potassium-competitive acid blockers. PLoS One. 2014;9(5):e97688.
3. Shin JM, Inatomi N, Munson K, et al. Characterization of a novel potassium-competitive acid blocker of the gastric H, K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438). J Pharmacol Exp Ther. 2011;339(2):412-20.
4. Takeda. New drug application approval of TAKECAB® for the treatment of acid-related diseases in Japan (media release). 26 Dec 2014. http://www.takeda.com.
5. Takeda. Takeda submits a new drug application for TAK-438 in Japan for the treatment of acid-related diseases (media release). 28 Feb 2014. http://www.takeda.co.jp.
6. Takeda. ClinicalTrials.gov. 2014. http://www.clinicaltrials.gov/. Accessed 30 Jan 2015.
7. Otsuka Pharmaceutical, Takeda Pharmaceutical Company Limited. Otsuka and Takeda announce a co-promotion agreement in Japan of TAK-438 for the treatment of acid-related diseases in the gastrointestinal therapeutic area (media release). 2014. http://www.otsuka.co.jp. Accessed 27 Mar 2014.
8. Hori Y, Imanishi A, Matsukawa J, et al. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamin e monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. J Pharmacol Exp Ther. 2010;335(1):231-8.
9. Takeda. Takecab® (vonoprazan tablets): Japanese prescribing information. 2014. http://www.takedamed.com/content/medicine/pdf/pre-takecab.pdf. Accessed 5 Feb 2015.
10. Arikawa Y, Nishida H, Kurasawa O, et al. Discovery of a novel pyrrole derivative 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamin e fumarate (TAK-438) as a potassium-competitive acid blocker (P-CAB). J Med Chem. 2012;55(9):4446-56.
11. Mizokami Y, Ashida K, Soen S, et al. TAK-438 vs. lansoprazole 15 mg for secondary prevention of peptic ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy: results of a phase 3 trial [abstract no. Tu1054]. Gastroenterology. 2014;146(5 Suppl. 1):S-739.
12. Kawai T, Ashida K, Mizokami Y, et al. TAK-438 vs. lansoprazole 15 mg for secondary prevention of peptic ulcers associated with low-dose aspirin therapy: results of a phase 3 trial (abstract no. Tu1055). Gastroenterology. 2014;146(5 Suppl. 1):S-739.
13. Iwakiri K, Umegaki E, Hiramatsu N, et al. A phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of TAK-438 (20 mg once-daily) compared to lansoprazole (30 mg once-daily) in patients with erosive esophagitis (abstract no. Tu1059). Gastroenterology. 2014;146(5 Suppl. 1):S-741.
14. Umegaki E, Iwakiri K, Hiramatsu N, et al. A phase 3, randomized, double-blind, multicenter study to evaluate the efficacy and safety of TAK-438 (10 mg or 20 mg once-daily) compared to lansoprazole (15 mg once-daily) in a 24-week maintenance treatment for healed erosive esophagitis (abstract no. Tu1052). Gastroenterology. 2014;146(5 Suppl. 1):S-738.
15. Chiba T, Sakurai Y, Nishimura A, et al. A phase 2, randomized, double-blind, parallel-group, multicenter, dose-ranging study to evaluate the efficacy and safety of a novel potassium-competitive acid blocker (P-CAB) TAK-438 in patients with erosive esophagitis (abstract no. Mo1053). Gastroenterology. 2013;144(5 Suppl. 1):S-564-5.
16. Murakami K, Sakurai Y, Shiino M, et al. A newly developed potassium-competitive acid blocker, vonoprazan vs. Lansoprazole in first-line triple therapy with amoxicillin, and clarithromycin for H. pylori eradication - phase 3, double-blind study (abstract no. W2.2). Helicobacter. 2014;19(Suppl 1):79.
17. Murakami K, Sakurai Y, Shiino M, et al. A phase 3, double-blind study of a triple therapy with TAK-438, amoxicillin, and clarithromycin as first line eradication of H. pylori and a triple therapy With TAK-438, amoxicillin, and metronidazole as second line eradication of H. pylori (abstract no. Tu1056). Gastroenterology. 2014;146(5 Suppl. 1):S-740.