Delving into the Latest Updates on Renzapride hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Renzapride

+ [2]

Target

5-HT3 receptor x 5-HT4 receptor

Mechanism

5-HT3 receptor agonists(Serotonin 3 (5-HT3) receptor agonists), 5-HT4 receptor agonists(Serotonin 4 (5-HT4) receptor agonists)

Therapeutic Areas

Digestive System DisordersNervous System DiseasesEndocrinology and Metabolic Disease+ [6]

Active Indication-

Inactive Indication

Cystic FibrosisDiabetic GastroparesisGastroesophageal Reflux+ [4]

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

Atlantic Healthcare Plc

Alizyme Plc

GSK Plc

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure

Molecular FormulaC16H23Cl2N3O2

InChIKeyWYONTPMGUQWRKN-BCFCJEPWSA-N

CAS Registry109872-41-5

View All Structures (2)

Cancer cachexia (CC) is one of the most distressing syndromes for both patients and their families. CC can have an impact on patient reported quality of life and overall survival. It is often associated with symptoms such as fatigue, depressed mood, early satiety, and anorexia. Prokinetic agents have been found to improve chronic nausea and early satiety associated with CC. Among the prokinetic agents, metoclopramide is one of the best studied medications. The role of the other prokinetic agents, such as domperidone, erythromycin, haloperidol, levosulpiride, tegaserod, cisapride, mosapride, renzapride, and prucalopride is unclear for use in cachectic cancer patients due to their side effect profile and limited efficacy studies in cancer patients. There has been an increased interest in the use of ghrelin-receptor agonists for the treatment of CC. Anamorelin HCl is a highly selective, novel ghrelin receptor agonist. A meta-analysis was conducted of the recent randomized trials using anamorelin (daily dose of 50 and 100 mg daily). Results show that both total body weight and lean body mass were significantly increased from baseline in the anamorelin group. Anamorelin did not improve overall survival or hand grip strength, and there were no significant differences between groups for frequency or severity of any adverse events. In this review, the authors discuss the available evidence for the use of prokinetics such as metoclopramide and ghrelin receptor agonists for the treatment of CC.

01 Nov 2018·Clinical Gastroenterology and HepatologyQ1 · MEDICINE

Factors Associated With Response to Placebo in Patients With Irritable Bowel Syndrome and Constipation

Q1 · MEDICINE

Article

Author: Iturrino, Johanna ; Kaptchuk, Ted J ; Singh, Prashant ; Sommers, Thomas ; Hirsch, William ; Rangan, Vikram ; Beath, Alissa ; Jones, Mike ; Lembo, Anthony ; Ballou, Sarah ; Nee, Judy

BACKGROUND & AIMSA high proportion of patients with irritable bowel syndrome (IBS) respond to placebo in clinical trials (estimated at about 40%). We aimed to identify factors that contribute to the high placebo response rate using data from a placebo-controlled trial of patients with IBS.METHODSWe performed a retrospective analysis of 599 women with IBS with constipation who were in the placebo group of a 12-week, randomized, double-blind, phase 3 trial of the experimental medication renzapride. Primary analyses evaluated frequency of abdominal pain in patients who received placebo, defined as ≥30% pain improvement from baseline for ≥6 of the 12 study weeks. We performed backward elimination regression with bootstrapping to identify factors associated with response to placebo.RESULTSIn the placebo group, 29.0% of the patients had an abdominal pain response. Factors associated with a response to placebo were baseline variation in abdominal pain (odds ratio [OR], 1.71), maximum baseline pain severity (OR, 1.34), and placebo response in study week 2 (OR, 2.23) or week 3 (OR, 3.69). Factors associated with lack of response to placebo were number of baseline complete spontaneous bowel movements (OR, 0.73; P = .019) and final baseline pain ratings (OR, 0.73; P < .001).CONCLUSIONSWe identified factors associated with a response in abdominal pain to placebo using original data from an IBS clinical trial. Baseline factors associated with the placebo response in women with IBS and constipation included variation in baseline pain symptoms, severity of baseline symptoms, and early improvement of abdominal pain. These findings have significant implications for clinical trial design.

01 May 2014·Expert Opinion on Drug SafetyQ3 · MEDICINE

The safety of novel drugs used to treat irritable bowel syndrome

Q3 · MEDICINE

Review

Author: Mozaffari, Shilan ; Abdollahi, Mohammad ; Nikfar, Shekoufeh

INTRODUCTIONIrritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder with a high prevalence. Besides efficacy, the safety of each drugs used to treat GI disorders is an important issue in the drug development process.AREAS COVEREDThis article reviews all Phase I to IV clinical trials or case reports with results related to the safety of novel GI drugs. The drugs are currently approved or under evaluation for approval.EXPERT OPINIONMost of the reported adverse events were related to the GI tract with mild-to-moderate severity. Diarrhea was significantly higher versus placebo following use of linaclotide and renzapride, similar to that of constipation with ramosetron. Lubiprostone, linaclotide and rifaximin with low systemic bioavailability have less adverse events and exert more advantageous results. Asimadoline acts peripherally on κ-opioid receptors and is not associated with CNS side effects. As lubiprostone and linaclotide cause dose-dependent adverse events, starting the treatment with the lowest effective doses is advised. Ramosetron is under evaluation for diarrhea-predominant IBS due to its acceptable safety and tolerability, besides its efficacy. Rifaximin, asimadoline and renzapride are still in need of more long-term studies regarding their safety.

100 Deals associated with Renzapride hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Renzapride hydrochloride	-	DB04917

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastroparesis	Phase 3	GB	Atlantic Healthcare Plc	09 Aug 2021
Irritable Bowel Syndrome	Phase 3	GB	Alizyme Plc	01 Dec 2005
Irritable Bowel Syndrome	Phase 3	GB	Alizyme Plc	01 Dec 2005
Diabetic Gastroparesis	Phase 3	GB	Alizyme Plc	-
Gastroesophageal Reflux	Phase 3	GB	GSK Plc	-
Parkinson Disease	Discovery	GB	Atlantic Healthcare Plc	27 Jan 2021
Cystic Fibrosis	Discovery	GB	Atlantic Healthcare Plc	23 Jan 2020
Scleroderma, Systemic	Discovery	GB	Atlantic Healthcare Plc	15 Jan 2020