Delving into the Latest Updates on Prucalopride Succinate with Synapse

研究空腹和餐后状态下单次口服受试制剂（琥珀酸普芦卡必利片，规格：1mg，裕松源药业有限公司生产，浙江和泽医药科技股份有限公司提供）与参比制剂（琥珀酸普芦卡必利片，商品名：Resolor®，规格：1 mg，Taked Pharmaceuticals Iternational AG Ireland Branch）在健康成年女性受试者体内的药代动力学，评价两制剂生物等效性，并研究产品在健康受试者体内的安全性。

[Translation]

The pharmacokinetics of the test formulation (prucalopride succinate tablets, specification: 1 mg, produced by Yusongyuan Pharmaceutical Co., Ltd. and provided by Zhejiang Heze Pharmaceutical Technology Co., Ltd.) and the reference formulation (prucalopride succinate tablets, trade name: Resolor®, specification: 1 mg, Taked Pharmaceuticals Iternational AG Ireland Branch) in healthy adult female subjects after a single oral administration in the fasting and fed state were studied, the bioequivalence of the two formulations was evaluated, and the safety of the products in healthy subjects was studied.

Start Date18 Oct 2023

Sponsor / Collaborator

Zhejiang Heze Pharmaceutical Technology Co., Ltd.

TCTR20221216002Phase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Prucalopride 2 mg Film-Coated Tablets and Reference Product (Resolor) in Healthy Thai Volunteers under Fasting Conditions

Start Date01 Mar 2023

Sponsor / Collaborator

International Bio Research

100 Clinical Results associated with Prucalopride Succinate

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100 Translational Medicine associated with Prucalopride Succinate

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100 Patents (Medical) associated with Prucalopride Succinate

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403

Literatures (Medical) associated with Prucalopride Succinate

08 Dec 2023·The Journal of pharmacy and pharmacology

Pharmacomagnetography assessment of the prokinetic effect on metronidazole absorption

Article

Author: de Oliveira, Ricardo Brandt ; Rodrigues, Gustavo Serafim ; Soares, Guilherme Augusto ; de Arruda Miranda, José Ricardo ; Buranello, Lais Pereira

Abstract:

Objectives:

This study aimed to evaluate the effects of prucalopride, a prokinetic agent that acts as a potent serotonin agonist of 5-HT4 receptors, on gastric emptying and small bowel transit and assess its impact on the absorption of metronidazole.

Methods:

Six healthy volunteers, three men and three women, aged between 20 and 27 years, with a body weight ranging from 50 to 80 kg, were enrolled in this study. The pharmacokinetics and gastrointestinal transit parameters were evaluated simultaneously through pharmacomagnetography assessment, combining alternating current biosusceptometry and blood analysis.

Key findings:

The results showed that prucalopride enhances gastric emptying and small bowel transit when administered orally and significantly impacts the rate of metronidazole absorption, leading to enhanced bioavailability and rapid therapeutic response.

Conclusion:

Pharmacomagnetography assessment allows simultaneous tracking of transit by images and is a valuable method for analysing drug absorption using multiple instruments.

01 Dec 2023·Luminescence : the journal of biological and chemical luminescence

Sensitive spectrofluorimetric determination of the prokinetic drug prucalopride succinate based on supramolecular aggregation approach with evaluation of method greenness: application to content uniformity test

Article

Author: Mohammed, Fatma F ; Derayea, Sayed M ; Badr El-Din, Khalid M

Abstract:

The prokinetic drug, prucalopride (PCP) succinate, was determined using a new spectrofluorimetric approach with a highly sensitive, rapid, and simple procedure. The method exploited the enhancement of the inherent native fluorescence of PCP by micellar aggregation with sodium lauryl sulfate (SLS) as an anionic surfactant. Different factors that could affect the fluorescence intensity were carefully studied in order to achieve the maximal fluorescence signal. Measurement of the enhanced fluorescence was done at 354 nm after the excitation at 276 nm. The fluorescence intensity–concentration plot was rectilinear in the concentration range of 50–600 ng/ml with detection and quantitation limits of 13.9 and 42.1 ng/ml, respectively. The method underwent validation according to the International Council for Harmonisation criteria in order to assess its analytical performance, and promising results were achieved that proved the validity and reliability of the method. Furthermore, the method was employed effectively for the analysis of the cited drug in commercial pharmaceutical tablets.

01 Nov 2023·Biological psychiatry. Cognitive neuroscience and neuroimaging

5-HT4 Receptor Agonist Effects on Functional Connectivity in the Human Brain: Implications for Procognitive Action

Article

Author: Murphy, Susannah E ; Gould van Praag, Cassandra D ; Suri, Sana ; Gibson, Daisy ; Harmer, Catherine J ; Martens, Marieke A G ; Wright, Lucy C ; de Cates, Angharad N ; Cowen, Philip J ; Spitz, Gershon

BACKGROUND:

Cognitive deficits are often comorbid with mood disorders and can cause significant functional impairment even after resolution of the primary mood symptoms. We do not currently have pharmacological treatments that adequately address these deficits. 5-HT₄ receptor agonists show promise as potential procognitive agents in animal and early human translational studies. Optimal cognitive performance in humans is directly associated with appropriate functional connectivity between specific resting-state neural networks. However, so far the effect of 5-HT₄ receptor agonism on resting-state functional connectivity (rsFC) in the brain in humans is unknown.

METHODS:

We collected resting-state functional magnetic resonance imaging scans from 50 healthy volunteers, of whom 25 received 6 days × 1 mg prucalopride (a highly selective 5-HT₄ receptor agonist) and 25 received placebo in a randomized double-blind design.

RESULTS:

Network analyses identified that participants in the prucalopride group had enhanced rsFC between the central executive network and the posterior/anterior cingulate cortex. Seed analyses also showed greater rsFC between the left and right rostral anterior cingulate cortex and the left lateral occipital cortex, and reduced rsFC between the hippocampus and other default mode network regions.

CONCLUSIONS:

Similar to other potentially procognitive medications, low-dose prucalopride in healthy volunteers appeared to enhance rsFC between regions involved in cognitive networks and reduce rsFC within the default mode network. This suggests a mechanism for the behavioral cognitive enhancement previously seen with 5-HT₄ receptor agonists in humans and supports the potential for 5-HT₄ receptor agonists to be used in clinical psychiatric populations.

5

News (Medical) associated with Prucalopride Succinate

17 Apr 2024

·www.prnewswire.com

Sanochemia: New contrast agent aims to detect the smallest lymphatic metastases in prostate cancer

NEUFELD, Austria, April 17, 2024 /PRNewswire/ -- Sanochemia Pharmazeutika secures exclusive licensing rights to a new MRI contrast agent based on ferumoxtran, that is in an advanced pivotal trial in clinical phase III and may be used to detect the smallest lymph node metastases in prostate cancer patients. The product is already deployed in the Netherlands within an authorized Named-Patient-Use-Program (Artsenverklaring). Continue Reading Official signing of license deal with Thomas Erkinger and Jürgen Feuerstein The agreement with SPL Medical (Nijmegen, Netherlands) grants Sanochemia exclusive worldwide rights for parts of the manufacture and global distribution of an MRI contrast agent based on ferumoxtran with the exception of the DACH region. The product, which is currently under development in late phase III at several renowned European clinics, shall carry the registered trademark Ferrotran®. Ferrotran® contains iron-based superparamagnetic nanoparticles and is intended to be used to detect even the smallest lymph node metastases in prostate cancer patients. Research is being conducted into the possible use for other types of cancer. Ferrotran® will be the second iron-containing product in Sanochemia's gadolinium-free MRI product range. Only recently, an agreement with b.e.imaging (Baden-Baden, Germany) was announced on the MRI contrast agent Resotran® (ferucarbotran) for the detection of focal liver lesions in adults. "The two agreements mark the start of a new product line," said Sanochemia Managing Director Thomas Erkinger. "We are striving to play a pioneering role in the field of gadolinium-free MRI contrast agents. Innovative specialties optimally complement our classic product line in diagnostic imaging". Both products are based on iron-oxide nanoparticles (USPIO/SPIO: Ultrasmall / Small Superparamagnetic Iron Oxide) and expand the diagnostic options within radiology. Dr. Jürgen Feuerstein, CEO of licensor SPL Medical: "We are gaining access to the worldwide market of medical imaging via the extensive marketing network of Sanochemia. Within an authorized named-patient-use-program, more than 700 prostate cancer patients have already been diagnosed in Nijmegen with ferumoxtran in the Netherlands, enabling them to receive earlier and more specific treatment and a significantly higher chance of recovery. The earlier affected lymph nodes are detected, the better the chances of recovery with targeted, less invasive treatment." Sanochemia Pharmazeutika Sanochemia is a leading supplier of pharmaceuticals for radiological applications in the center of Europe. In addition to classic contrast agents, the company focuses on organ-specific and gadolinium-free specialty products. The company's imaging agents are used by doctors and hospitals in over 50 countries worldwide for diagnostic imaging in MR and CT procedures. At the Austrian production site, more than 200 employees ensure that drug products (FDF) and active pharmaceutical ingredients (APIs) are manufactured to the highest pharmaceutical quality standards. Photo: Logo: SOURCE Sanochemia Pharmazeutika

Phase 3License out/in

14 Sep 2023

·www.fiercebiotech.com

Sanofi slings long-dormant Alzheimer's asset to First Wave for repurposing, secures buy back rights

Sanofi could receive up to $281 million in milestones. Sanofi has handed First Wave BioPharma a chance to reposition a long-dormant molecule. The biotech is paying $500,000 upfront for capeserod as part of a deal that gives Sanofi the right of first refusal to buy the asset back. Investigators stopped phase 2 clinical trials of capeserod in Alzheimer’s disease and urinary incontinence almost 20 years ago. Now, First Wave is exhuming the molecule, which is backed by safety data in more than 600 patients, with a view to repositioning it in gastrointestinal disorders. The biotech plans to move the candidate into clinical trials next year. First Wave said the decision to repurpose capeserod is underpinned by “AI-empowered analyses” that suggest its mechanism of action has potential applications for several gastrointestinal disorders. The possible uses cover “multibillion-dollar markets” with significant unmet clinical needs, according to First Wave. Capeserod is a selective partial agonist of 5-HT4, a target that has been linked to gastrointestinal health for decades. A clinical trial found prucalopride, another agonist of the target, accelerates gastrointestinal and colonic transit in patients with constipation more than 20 years ago and other teams have continued to build on the work. First Wave has landed the chance to assess capeserod in the new indications by paying Sanofi an upfront fee of $500,000 and offering up to $281 million in milestones. Most, $235 million, of the milestones are tied to commercial events, with the rest linked to development and regulatory successes. The biotech ended June with $1.2 million, although it subsequently raised $2.1 million in a public offering. Investor interest in the biotech has collapsed over the past year as doubts about its formulation of adrulipase have intensified, driving its share price down 98% to just 44 cents. First Wave has pitched the asset as a safer alternative to AbbVie’s Creon and other pig-derived pancreatic enzyme replacement therapies but has suffered setbacks in the clinic.

Phase 2Clinical Trial FailureFinancial StatementIPO

25 May 2023

·www.drugs.com

Guidelines Developed for Treating Chronic Idiopathic Constipation

THURSDAY, May 25, 2023 -- In a clinical practice guideline issued by the American Gastroenterological Association and the American College of Gastroenterology, and published online May 19 in the American Journal of Gastroenterology and Gastroenterology , recommendations are presented for the pharmacologic treatment of chronic idiopathic constipation (CIC) in adults. Lin Chang, M.D., from the David Geffen School of Medicine at the University of California in Los Angeles, and colleagues conducted systematic reviews relating to use of fiber, osmotic laxatives, stimulant laxatives, secretagogues, and serotonin type 4 agonists to provide evidence-based practice recommendations for treatment of CIC in adults. The multidisciplinary guideline panel agreed on 10 recommendations for pharmacological management of CIC. These included strong recommendations for use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride, based on moderate certainty of evidence. Conditional recommendations, based on low or very low certainty of evidence, were made for fiber supplementation, lactulose, senna, magnesium oxide, and lubiprostone. "The guidelines are meant to provide a framework for approaching the management of CIC," the authors write. "Clinical providers should engage in shared decision-making based on patient preferences as well as medication cost and availability." Several authors disclosed ties to the pharmaceutical, medical device, and other industries. Several authors hold patents, including for a rectal expulsion device. Abstract/Full Text Posted May 2023

100 Deals associated with Prucalopride Succinate

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KEGG	Wiki	ATC	Drug Bank
D10152	Prucalopride Succinate	A06AX05	DB06480

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic idiopathic constipation	US	Takeda Pharmaceuticals U.S.A., Inc.	14 Dec 2018
Constipation	AU	Amco Ltd	07 Oct 2011
Chronic constipation	EU	Takeda Pharmaceuticals International AG	14 Oct 2009
Chronic constipation	IS	Takeda Pharmaceuticals International AG	14 Oct 2009
Chronic constipation	LI	Takeda Pharmaceuticals International AG	14 Oct 2009
Chronic constipation	NO	Takeda Pharmaceuticals International AG	14 Oct 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 3	CA	Janssen, Inc.	01 Mar 2014
Gastroparesis	Phase 3	CA	Janssen, Inc.	01 Mar 2014
Intestinal preparation	Phase 3	CA	Janssen, Inc.	01 Jun 2013
Colonic Diseases	Phase 3	CA	Queen's University	01 Jul 2012
Colonic Polyps	Phase 3	CA	Queen's University	01 Jul 2012
Constipation - functional	Phase 3	NL	Shire Plc	28 Apr 2011
Intestinal Pseudo-Obstruction	Phase 2	GB	Movetis NV	19 Nov 2008
Liver Diseases	Phase 1	RU	Movetis NV	01 May 2010

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04759833 (CTgov)	Phase 3	Constipation - functional	175	Placebo+Prucalopride	exowtqtzrv(ueptiazmav) = kdphpjcajp xxpownjmnw (rwvioigdtj, qpnzqoupsf - hxricxcyst) View more	-	06 Jun 2024
NCT02947269 (Pubmed)	Phase 3	-	148	Prucalopride 2mg	hvdoialhzj(fqdwzfilez) = rfzrfozmpx orsmkmtulr (xivcrtvqan ) View more	Negative	26 May 2022
				Placebo	hvdoialhzj(fqdwzfilez) = nbqwdidazw orsmkmtulr (xivcrtvqan ) View more
ESMO_GI2017	Not Applicable	Intestinal preparation	-	1-L PEG-Asc plus prucalopride	wvzvlaghnu(jcozijlsvu) = vhqoxyjwhu zerizomaea (wngypoksls, 1.27)	Positive	28 Jun 2017
				2-L PEG-Asc	wvzvlaghnu(jcozijlsvu) = mnijweijlf zerizomaea (wngypoksls, 1.40)
NCT01807000 (Pubmed \| Clin Ther)	Phase 1	-	6	Prucalopride (Healthy Volunteers)	szgvepggpf(wzpsrazqfh) = Prucalopride was well tolerated, with no serious adverse events reported dzzxspoonc (hnqphctedo )	-	01 Sep 2016
NCT01330381 (SPD555-303, Pubmed \| Pharmacol Res Perspect)	Phase 3	Constipation - functional	137	Prucalopride 0.02 mg/kg	pqtxhwrjdt(wqgupeihps) = uavhpktamd gptbzgyxdu (ecoyjnjspf, 40.5 - 82.7)	Negative	01 Aug 2016
				Prucalopride 0.04 mg/kg	pqtxhwrjdt(wqgupeihps) = xlghvauhhr gptbzgyxdu (ecoyjnjspf, 22.7 - 286.0)
NCT02004652 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 2	Postoperative ileus	110	prucalopride	ggixghyvmr(hxtiuqpxxu) = voqzumhaxc fazyyulcji (lznnoxddzz ) View more	Positive	01 Apr 2016
				Placebo	ggixghyvmr(hxtiuqpxxu) = dhahgxcfdm fazyyulcji (lznnoxddzz ) View more
NCT01424228 (Pubmed \| Neurogastroenterol Motil) Manual	Phase 4	Chronic constipation	361	prucalopride	fxzfdaaqnk(hfpzwfnchk) = aowgzexffk yoxjujoito (sodrcihchk )	Negative	01 Jun 2015
				Placebo	fxzfdaaqnk(hfpzwfnchk) = hficfrnrwl yoxjujoito (sodrcihchk )
NCT01147926 (Pubmed) Manual	Phase 3	Chronic constipation	374	prucalopride	ststkonfcc(zaojqhaiht) = uxeglugfak vgzmzhvusu (kiccvesdgq )	Positive	01 May 2015
				Placebo	ststkonfcc(zaojqhaiht) = eqbwlgaeff vgzmzhvusu (kiccvesdgq )
NCT01707667 (CTgov)	Phase 4	Chronic constipation	13	prucalopride (Prucalopride)	khulvxwfvs(craorkvmqx) = moemkjjkdk xyujqvhcum (zndtdvcsob, plellyaegu - rkmiyaqicp) View more	-	22 Oct 2014
				PEG 3350 (PEG 3350)	khulvxwfvs(craorkvmqx) = ycimdqlexy xyujqvhcum (zndtdvcsob, hqxrglhytp - qovyeaulzz) View more
NCT01147926 (CTgov)	Phase 3	Chronic constipation	374	Placebo (PLACEBO)	czeplpzbuz(louzasnqxc) = zpqefjmhsf rvmieeyzyi (xaaudsykur, qmkpzioioa - pypjhkptnx) View more	-	09 Sep 2014
				Prucalopride (PRUCALOPRIDE)	czeplpzbuz(louzasnqxc) = kebsqkwsre rvmieeyzyi (xaaudsykur, xyirunsalc - tycyfwvbke) View more