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

To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

Phase 4

Completed

Conditions: Opioid Induced Constipation

Interventions: Drug: Polyethylene Glycol 3350
Drug: Movantik

First Posted Date: 2017-02-23

Last Posted Date: 2018-07-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 276

Registration Number: NCT03060512

Locations: 🇺🇸
Research Site, West Jordan, Utah, United States

Naloxegol for Opioid-Related Gastroparesis

Phase 2

Withdrawn

Conditions: Gastroparesis
Opioid Use

Interventions: Drug: Naloxegol 25 MG Oral Tablet [Movantik]
Drug: Placebo Oral Tablet

First Posted Date: 2017-01-30

Last Posted Date: 2020-08-27

Lead Sponsor: Temple University

Registration Number: NCT03036891

Locations: 🇺🇸
Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania, United States

Movantik for Opioid-Related Esophageal Disorders

Phase 2

Terminated

Conditions: Opioid-Induced Disorders
Esophagus Disorder

Interventions: Drug: Placebo Oral Capsule
Drug: Naloxegol

First Posted Date: 2016-12-20

Last Posted Date: 2018-12-24

Lead Sponsor: Temple University

Target Recruit Count: 2

Registration Number: NCT02998606

Locations: 🇺🇸
Temple University, Philadelphia, Pennsylvania, United States

Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

Phase 4

Terminated

Conditions: Constipation

Interventions: Drug: Placebo Oral Tablet
Drug: Naloxegol Oral Tablet
Drug: Docusate Sodium 100 Mg oral capsule [Colace]
Drug: Senna 217 Mg Oral Tablet
Drug: Polyethylene Glycols
Drug: Bisacodyl 10 mg Suppository
Drug: Magnesium Citrate Oral Liquid Product
Drug: Methylnaltrexone

First Posted Date: 2016-11-30

Last Posted Date: 2023-02-16

Lead Sponsor: Tufts Medical Center

Target Recruit Count: 12

Registration Number: NCT02977286

Locations: 🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)

Phase 4

Terminated

Conditions: Constipation
Pain
Cancer

Interventions: Drug: Naloxegol
Drug: Placebo

First Posted Date: 2016-07-21

Last Posted Date: 2019-03-05

Lead Sponsor: Hospice of Henderson County, Inc.

Target Recruit Count: 12

Registration Number: NCT02839889

Locations: 🇺🇸
Hospice of Henderson County, Inc, Flat Rock, North Carolina, United States
🇺🇸
Hospice of the Western Reserve, Inc., Cleveland, Ohio, United States
🇺🇸
MJHS Institute for Innovation in Palliative Care, New York, New York, United States