Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Drugs
Published in: Drugs 4/2015

01-03-2015 | R&D Insight Report

Vonoprazan: First Global Approval

Author: Karly P. Garnock-Jones

Published in: Drugs | Issue 4/2015

Login to get access

Abstract

Vonoprazan (Takecab®) is an orally bioavailable potassium-competitive acid blocker (P-CAB) being developed by Takeda for the treatment and prevention of acid-related diseases. The drug is approved in Japan for the treatment of acid-related diseases, including erosive oesophagitis, gastric ulcer, duodenal ulcer, peptic ulcer, gastro-oesophageal reflux, reflux oesophagitis and Helicobacter pylori eradication. Phase III development is underway for the prevention of recurrence of duodenal and gastric ulcer in patients receiving aspirin or NSAID therapy. Phase I development was conducted in the UK for gastro-oesophageal reflux; however, no further development has been reported. This article summarizes the milestones in the development of vonoprazan leading to this first approval for acid-related diseases.
Literature
1.
2.
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.CrossRefPubMedCentralPubMed
4.
5.
6.
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.CrossRefPubMed
9.
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.CrossRefPubMed
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.
Metadata
Title
Vonoprazan: First Global Approval
Author
Karly P. Garnock-Jones
Publication date
01-03-2015
Publisher
Springer International Publishing
Published in
Drugs / Issue 4/2015
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-015-0368-z

Other articles of this Issue 4/2015

Drugs 4/2015 Go to the issue

Review Article

The Role of Pre-Transplant Induction Regimens and Autologous Stem Cell Transplantation in the Era of Novel Targeted Agents

Adis Drug Evaluation

Posaconazole: A Review of the Gastro-Resistant Tablet and Intravenous Solution in Invasive Fungal Infections

Adis Drug Evaluation

Naloxegol: A Review of Its Use in Patients with Opioid-Induced Constipation

Therapy in Practice

Identification and Management of Alcohol Withdrawal Syndrome

Review Article

Clinical Efficacy and Safety of Cilostazol: A Critical Review of the Literature

Adis Drug Evaluation

Fluticasone Furoate/Vilanterol: a Review of Its Use in Patients with Asthma