Naloxegol

Generic Name: Naloxegol

Brand Names: Movantik, Moventig

Drug Type: Small Molecule

Chemical Formula: C_₃₄H_₅₃NO_₁₁

CAS Number: 854601-70-0

Unique Ingredient Identifier: 44T7335BKE

Background: Naloxegol, for "PEGylated naloxol" is a peripherally-selective opioid antagonist developed by AstraZeneca. It was approved by the FDA in September 2014 and is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non‑cancer pain. The advantage of naloxegol over the opioid antagonist naloxone is that its PEGylated structure allows for high selectivity for peripheral opioid receptors and lack of entry into the central nervous system through the blood-brain barrier.

Indication: 适用于治疗患有慢性非癌性疼痛的成年患者的阿片类药物引起的便秘（OIC），包括不需要频繁（如每周）增加阿片类剂量的既往癌症或其治疗相关的慢性疼痛患者。

Associated Conditions: Opioid Induced Constipation (OIC)

Clinical Trials

Colonic Motor Patterns in Healthy Volunteers

Phase 4

Completed

Conditions: Opioid-Induced Constipation

Interventions: Drug: Naloxegol
Other: Placebo
Drug: codeine phosphate

First Posted Date: 2023-03-16

Last Posted Date: 2023-03-16

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 15

Registration Number: NCT05770960

Locations: 🇧🇪
UZ Leuven, Leuven, Vlaams-Brabant, Belgium

The NIPA Study Naloxegol Administration to Prevent Opioids Induced Gastrointestinal Motility Disturbance in Brain Injured PAtients

Phase 3

Recruiting

Conditions: Brain Injuries

Interventions: Drug: Placebo
Drug: Naloxegol

First Posted Date: 2021-08-17

Last Posted Date: 2024-12-16

Lead Sponsor: University Hospital, Brest

Target Recruit Count: 370

Registration Number: NCT05008926

Locations: 🇫🇷
CHU Bordeaux, Bordeaux, France
🇫🇷
CHU de Bordeaux - Réanimation chirurgicale, Bordeaux, France
🇫🇷
CHU Brest, Brest, France

and more 8 locations

Effect of Naloxegol on Postoperative Ileus in Patients Undergoing Cardiac Surgery

Phase 3

Completed

Conditions: Postoperative Ileus (Post Cardiac Surgery Constipation)

Interventions: Drug: inert tablet
Drug: Naloxegol

First Posted Date: 2020-06-16

Last Posted Date: 2022-03-08

Lead Sponsor: CMC Ambroise Paré

Target Recruit Count: 305

Registration Number: NCT04433390

Locations: 🇫🇷
CMC Ambroise Paré, Neuilly-sur-Seine, Neuilly Sur Seine, France

Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol

Completed

Conditions: Opioid-induced Constipation

Interventions: Drug: Naloxegol

First Posted Date: 2019-11-22

Last Posted Date: 2019-11-22

Lead Sponsor: Kyowa Kirin Farmacéutica S.L.U.

Target Recruit Count: 126

Registration Number: NCT04173858

Locations: 🇪🇸
Hospital Universitario de Torrejon, Torrejón De Ardoz, Madrid, Spain

Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

Recruiting

Conditions: Opioid-induced Constipation

Interventions: Drug: Naldemedine
Drug: Lubiprostone
Drug: Naloxegol

First Posted Date: 2018-10-25

Last Posted Date: 2025-02-12

Lead Sponsor: BioDelivery Sciences International

Target Recruit Count: 34532

Registration Number: NCT03720613

Locations: 🇺🇸
Research Site, Wilmington, Delaware, United States

Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

Completed

Conditions: Opioid Induced Constipation

First Posted Date: 2018-08-20

Last Posted Date: 2024-06-17

Lead Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Target Recruit Count: 183

Registration Number: NCT03638440

Locations: 🇳🇱
Rijnstate hospital, Arnhem, Netherlands
🇸🇪
Skane University Hospital, Lund, Sweden
🇮🇹
AORN dei Colli, Napoli, Italy

and more 7 locations

Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

Phase 4

Completed

Conditions: Constipation Drug Induced

Interventions: Drug: Methylnaltrexone Bromide 150 mg Oral Tablet
Drug: Naloxegol 25 MG Oral Tablet
Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1

First Posted Date: 2018-05-14

Last Posted Date: 2023-04-11

Lead Sponsor: University of Missouri-Columbia

Target Recruit Count: 15

Registration Number: NCT03523520

Locations: 🇺🇸
Kara B. Goddard, Columbia, Missouri, United States

Naloxegol and Opioid-induced Constipation

Phase 2

Conditions: Constipation
Constipation Drug Induced

Interventions: Other: Placebo pill
Drug: Naloxegol 25 MG

First Posted Date: 2017-10-20

Last Posted Date: 2022-05-05

Lead Sponsor: TriHealth Inc.

Target Recruit Count: 280

Registration Number: NCT03316859

Locations: 🇺🇸
Bethesda North TriHealth Hospital, Cincinnati, Ohio, United States

Ancillary Effects of Oral Naloxegol (Movantik)

Phase 4

Completed

Conditions: Pain, Postoperative

Interventions: Drug: Naloxegol 25 MG
Drug: Placebo

First Posted Date: 2017-08-01

Last Posted Date: 2023-09-05

Lead Sponsor: The Cleveland Clinic

Target Recruit Count: 136

Registration Number: NCT03235739

Locations: 🇺🇸
The Cleveland Clinic Foundation, Cleveland, Ohio, United States

Naloxegol in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

Phase 2

Terminated

Conditions: Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Interventions: Drug: Naloxegol
Other: Placebo
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment

First Posted Date: 2017-03-22

Last Posted Date: 2025-02-03

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 50

Registration Number: NCT03087708

Locations: 🇺🇸
Mount Carmel East Hospital, Columbus, Ohio, United States
🇺🇸
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
🇺🇸
Grant Medical Center, Columbus, Ohio, United States

and more 656 locations

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