prucalopride / Generic mfg. - LARVOL DELTA

Enhanced Intestinal Recovery with Prucalopride Succinate After Gastrectomy: Randomized Clinical Trial (IGCC 2025) - "Prucalopride enhances bowel motility and reduces inflammation after gastrectomy, supporting its inclusion in Enhanced Recovery protocols for gastric cancer patients."

Clinical • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor

Bowel Blockage Without a Block: Amyloidosis Presenting as Chronic Intestinal Pseudo-Obstruction. (PubMed, Cureus) - "His symptoms showed partial improvement with prucalopride, but he continues to require total parenteral nutrition and a venting gastrostomy tube for symptom management. Amyloid subtyping and a bone marrow biopsy are pending to determine the underlying etiology."

Journal • Amyloidosis • Cardiomyopathy • Cardiovascular • CNS Disorders • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Pain • Psychiatry • Schizophrenia

EFFICACY OF PHARMACOLOGICAL TREATMENT IN PEDIATRIC INTESTINAL PSEUDO-OBSTRUCTION (DDW 2025) - "We identified the first instance each patient was treated with erythromycin, amoxicillin/clavulanic acid, prucalopride, pyridostigmine, or octreotide and recorded symptoms before and 1 month after starting the medication. Response to prokinetic medications was variable in our cohort of children with PIPO. While less than half improved with erythromycin, over half had some degree of improvement with prokinetics with a more generalized effect like prucalopride, pyridostigmine, and octreotide. Prospective studies are needed to further investigate this potential difference in prokinetic efficacy."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain • Pediatrics

Pharmacokinetics and bioequivalence assessment of two prucalopride formulations in healthy Chinese women: a randomized, open-label, two-period, two-sequence, self-crossover study. (PubMed, Front Pharmacol) - "The generic and branded prucalopride tablets were bioequivalent in terms of PK parameters and demonstrated no clinically relevant differences in safety outcomes. http://www.chinadrugtrials.org.cn/clinicaltrials.prosearch.dhtml, identifier CTR20232669."

Journal • PK/PD data

Pharmacologic treatment of irritable bowel syndrome. Position statement of the Asociación Mexicana de Gastroenterología, 2024. (PubMed, Rev Gastroenterol Mex (Engl Ed)) - "Overall, these recommendations provide a solid framework for personalizing treatment, based on the clinical characteristics of the Mexican patient with IBS."

Clinical guideline • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Ten-Year Trends in Pharmacologic Management of Gastroesophageal Reflux Disease and Pediatric Feeding Disorders in Young Children. (PubMed, J Pediatr) - "In this large, single-center study, prescriptions for young children with GERD or PFD declined over this 10-year period. There were substantial declines in PPI prescribing, contrasting with prior studies. These trends may indicate growing alignment of practice with consensus recommendations that advise against acid suppression as first-line management in this population."

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Pediatrics

Pharmacologic Treatment of Irritable Bowel Syndrome with Predominant Constipation (PubMed, Korean J Gastroenterol) - "Guanylate cyclase-C agonists (linaclotide and plecanatide) enhance intestinal fluid secretion and motility, normalize bowel movements, and reduce abdominal pain. Na+/H+ exchanger inhibitors (e.g., tenapanor) decrease sodium absorption, increase fluid secretion, and alleviate visceral pain. Lubiprostone activates the chloride channels to facilitate bowel movements, while polyethylene glycol laxatives regulate osmotic pressure to improve stool consistency and ease defecation. Highly selective 5-HT4 agonists, such as prucalopride, accelerate gastrointestinal and colonic transit and improve stool frequency and consistency without increasing the cardiovascular risks raised in earlier agents such as tegaserod...These pharmacology agents have shown efficacy and safety in clinical studies, but drug availability, adverse effects, and variable patient responses are still challenging. Effective strategies to manage IBS-C require a personalized approach, considering the..."

Journal • Review • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain

Chronic, combinatorial targeting of NMDARs and 5-HT4Rs exerts extended behavioral effects against stress-induced perseverative behavior and hyponeophagia. (PubMed, Neuropsychopharmacology) - "Here, we evaluated whether administration of combinatorial (R,S)-ketamine, an NMDAR antagonist and Food and Drug Administration (FDA)-approved anesthetic, and prucalopride, a 5-HT type IV receptor (5-HT4R) agonist and FDA-approved drug for chronic idiopathic constipation (CIC), would have additional effects when administered after stress...Our results indicate that chronic administration of K + P has extended benefits for combating stress-induced pathophysiology. Our findings provide strong evidence that future clinical studies using this chronic treatment strategy may prove advantageous in decreasing a broad range of stress-induced psychiatric disorders."

Journal • Anesthesia • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Mental Retardation • Psychiatry

Non-Invasive Auricular Acupoint Stimulation Improves Slow-Transit Constipation: Evidence From a Randomized Controlled Trial. (PubMed, Med Sci Monit) - "The study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucalopride, while the control group, also consisting of 30 patients, was administered prucalopride as a monotherapy...Notably, the study cohort demonstrated a more pronounced decrease in neuropeptide Y and nitric oxide concentrations and a more substantial increase in colonic transit capacity and fecal water content compared to the control cohort (P<0.05). CONCLUSIONS Non-invasive auricular acupoint stimulation significantly enhances symptom relief in patients with slow-transit constipation, suggesting its potential as a complementary therapy for constipation management."

Clinical • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Psychiatric Adverse Effects From Prucalopride in a Medically Complex Adolescent. (PubMed, Case Rep Pediatr) - "Clinicians should be aware of this possible side effect, particularly if considering administering prucalopride in patients with neurodevelopmental and psychiatric comorbid histories. Increased supervision and monitoring is recommended in these patients if prucalopride is administrated."

Adverse events • Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Immunology • Pain • Pediatrics • Psychiatry • Suicidal Ideation

Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Future University in Egypt | Not yet recruiting ➔ Recruiting

Enrollment open

Evolution of the Chicago Classification: Bridging Physiology and Mechanics (clinicaltrials.gov) - P=N/A | N=575 | Recruiting | Sponsor: Northwestern University

New trial • Gastrointestinal Disorder • Rare Diseases

Prucalopride for Cognitive Functioning in Schizophrenia (clinicaltrials.gov) - P=N/A | N=34 | Not yet recruiting | Sponsor: University of Pittsburgh | Trial completion date: Feb 2026 ➔ Aug 2026 | Initiation date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Magnetic particle imaging angiography of the femoral artery in a human cadaveric perfusion model. (PubMed, Commun Med (Lond)) - "This study demonstrates, that the recently developed human-sized MPI scanner facilitates reliable radiation-free image guidance for peripheral vascular interventions in the superficial femoral artery with a tracer approved for use in humans."

Journal

Novel gut-restricted bivalent agonists targeting mucosal 5-HT4R: Design, synthesis, and biological evaluation. (PubMed, Eur J Med Chem) - "Herein, we report for the first time the rational design and synthesis of gut-restricted bivalent agonists targeting mucosal 5-HT4R by integrating pharmacophores of prucalopride and tenapanor. Preclinical studies demonstrated that compound 4 significantly enhanced whole-gut and colonic transit, increased fecal output and water content, while maintaining minimal systemic absorption, confirming its gut-restricted nature. These findings underscore the feasibility of gut-restricted 5-HT4R agonists as a novel therapeutic strategy for CIC and provide valuable insights into the development of safer, more effective treatments for gastrointestinal disorders."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

INTRATHECAL MORPHINE DELIVERED BY BACLOFEN PUMP FOR STATUS DYSTONICUS IN LESCH-NYHAN SYNDROME (SCCM 2025) - "Throughout the 42 hospitalization days (HD), he received intermittent benzodiazepines (HD 2-33), ketorolac (HD 1-23; 22 total doses), both intermittent (HD 3-24) and continuous infusions (HD 24-32) of ketamine, dantrolene (HD 3-41), prucalopride (HD 7-41), hydromorphone (HD 7-40), methadone (HD 15-20), cyclobenzaprine (HD 7-37), hyoscyamine (HD 13-39), amitriptyline (HD 19-41), and dexmedetomidine infusion (HD 20-35)...Gabapentin, previously avoided for history of allergic reaction, was started on HD 28...When the spine is inaccessible, utilization of preexisting intrathecal baclofen pump should be considered for delivery of opiates. More research is needed regarding long term safety, efficacy, and timing to optimize therapy and avoid polypharmacy."

Anesthesia • CNS Disorders • Dystonia • Immunology • Inflammatory Arthritis • Movement Disorders • Nephrology • Renal Calculi • Rheumatology

Application of in-silico docking for green electrochemical quantification of prucalopride succinate in pharmaceutical, urine, and milk matrices. (PubMed, Sci Rep) - "Concerning the statistical assessment, there weren't palpable disparities in functioning between the suggested technique and the published one. Concerning green assessment, the proposed technique surpassed the published techniques in both GAPI and analytical eco-scale metrics."

Journal

Expanding the Gastrointestinal Phenotype of 10p15.3 Microdeletion Syndrome: Refractory Atypical Gastroparesis in an Adult. (PubMed, Cureus) - "This case expands the GI phenotype associated with this rare syndrome and highlights the importance of recognizing motility disorders in patients with neurodevelopmental delays. Further studies are needed to explore the prevalence and underlying mechanisms of atypical gastroparesis in 10p15.3 microdeletion syndrome."

Journal • Developmental Disorders • Eosinophilic Esophagitis • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Genetic Disorders • Immunology • Pediatrics • SMYD3

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database. (PubMed, Expert Opin Drug Saf) - "We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone."

Adverse events • Journal • P4 data • Real-world evidence • Cardiovascular • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery (clinicaltrials.gov) - P3 | N=180 | Not yet recruiting | Sponsor: Future University in Egypt

New P3 trial

The role of prokinetics in managing gastrointestinal involvement in systemic sclerosis: a systematic literature review. (PubMed, Rheumatology (Oxford)) - "Prokinetic drugs may improve GI motility and symptoms in patients with SSc. There is an unmet need for future well-designed studies to refine patient stratification and optimize treatment outcomes."

Journal • Gastrointestinal Disorder • Immunology • Scleroderma • Systemic Sclerosis

A Study of Prucalopride in Breastfeeding Women With Constipation (clinicaltrials.gov) - P=N/A | N=12 | Recruiting | Sponsor: Takeda | Trial completion date: Dec 2026 ➔ Oct 2027 | Trial primary completion date: Dec 2026 ➔ Oct 2027

Trial completion date • Trial primary completion date • Constipation • Gastroenterology • Gastrointestinal Disorder

ANI Pharmaceuticals Announces the FDA Approval and Launch of Prucalopride Tablets with 180-Day CGT Exclusivity (GlobeNewswire) - "ANI Pharmaceuticals, Inc...today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity...The FDA has granted our Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity."

ANDA • Generic launch • Constipation

Single-Center Experience with Concomitant Use of Novel and Off-Label Prescriptions for Chronic Constipation (ACG 2024) - "Charts were reviewed for prescriptions of at least 1 of 8 pharmacotherapies: linaclotide, lubiprostone , plecanatide , prucalopride, tenapanor , tegaserod, pyridostigmine, and colchicine. 405 patients were evaluated for chronic constipation, of which 138 (34%) received one or more prescription-based therapies. The most common diagnoses supporting these prescriptions are listed in Table 1. 110 patients (79.7%) were prescribed monotherapy, 23 (16.67%) given dual therapy simultaneously, 4 (2.8%) given three agents simultaneously, and only 1 (0.7%) given four agents simultaneously."

Clinical • Constipation • Gastroenterology • Gastrointestinal Disorder

Whole Gut Motility Patterns in Patients with Chronic Nausea and Vomiting. (PubMed, J Clin Med) - "In the patient group, our secondary aim was to explore how symptoms and motility patterns were affected by a serotonin HT4 receptor agonist (Prucalopride)... Patients with chronic N/V syndrome have significantly lower gastric contraction amplitude than HVs and may symptomatically benefit from prokinetics. They do not, however, have evidence of panenteric dysmotility."

Journal • Gastrointestinal Disorder