DeepMed Research

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

The Effect of Naloxegol on Refractory Constipation in the Intensive Care Unit

Phase 3

Withdrawn

Conditions: Constipation
Critical Illness

Interventions: Drug: Polyethylene glycol
Drug: naloxegol

First Posted Date: 2016-03-10

Last Posted Date: 2021-05-05

Lead Sponsor: Massachusetts General Hospital

Registration Number: NCT02705378

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

A Bioavailability Study With Alternate Methods of Administration of Naloxegol Tablets, and Solution

Phase 1

Completed

Conditions: Bioavailability
Healthy Subjects

Interventions: Drug: Naloxegol 25 mg tablet, crushed, suspended in water, given orally
Drug: Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube
Drug: Naloxegol 25 mg (10 mL oral solution)
Drug: Naloxegol 25 mg tablet, given orally

First Posted Date: 2015-05-18

Last Posted Date: 2017-03-10

Lead Sponsor: AstraZeneca

Target Recruit Count: 44

Registration Number: NCT02446171

Locations: 🇩🇪
Research Site, Berlin, Germany

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

Phase 1

Completed

Conditions: Constipation, Signs and Symptoms, Digestive

Interventions: Drug: Naloxegol

First Posted Date: 2014-03-31

Last Posted Date: 2024-06-17

Lead Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Target Recruit Count: 61

Registration Number: NCT02099591

Locations: 🇬🇧
Royal Marsden Hospital, London, United Kingdom
🇪🇸
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe, Madrid, Spain
🇳🇴
St. Olavs Hospital, Trondheim, Norway

and more 13 locations

Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

Phase 1

Completed

Conditions: Opioid Induced Constipation

Interventions: Drug: Naloxegol

First Posted Date: 2012-06-20

Last Posted Date: 2014-10-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 42

Registration Number: NCT01623609

Locations: 🇬🇧
Research Site, London, United Kingdom

Study in Healthy Volunteers to Investigate the Effects of Diltiazem on the Pharmacokinetics of Naloxegol

Phase 1

Completed

Conditions: Drug Induced Constipation

Interventions: Drug: Naloxegol
Drug: Diltiazem XR

First Posted Date: 2012-05-09

Last Posted Date: 2014-10-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 44

Registration Number: NCT01594619

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118

Phase 1

Completed

Conditions: Drug Induced Constipation

Interventions: Drug: NKTR-118
Drug: Rifampin

First Posted Date: 2012-02-15

Last Posted Date: 2014-10-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 22

Registration Number: NCT01533870

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

Study in Healthy Volunteers to Investigate the Effects of Ketoconazole on the Pharmacokinetics of NKTR-118

Phase 1

Completed

Conditions: Drug- Drug Interactions
Bioavailability
Healthy Volunteers

Interventions: Drug: NKTR-118
Drug: Ketoconazole

First Posted Date: 2012-01-30

Last Posted Date: 2014-10-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 22

Registration Number: NCT01520896

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation

Phase 3

Completed

Conditions: Opioid-Induced Constipation (OIC)

Interventions: Drug: Placebo
Drug: NKTR-118

First Posted Date: 2011-07-15

Last Posted Date: 2017-02-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 302

Registration Number: NCT01395524

Locations: 🇺🇸
Reserach Site, Indianapolis, Indiana, United States
🇸🇰
Research Site, Presov, Slovakia

Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function

Phase 1

Completed

Conditions: Hepatic; Functional Disturbance

Interventions: Drug: NKTR-118

First Posted Date: 2011-07-13

Last Posted Date: 2014-10-15

Lead Sponsor: AstraZeneca

Target Recruit Count: 24

Registration Number: NCT01392807

Locations: 🇺🇸
Research Site, Overland Park, Kansas, United States

Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

Phase 3

Terminated

Conditions: Opioid-Induced Constipation

Interventions: Drug: Placebo
Drug: NKTR-118

First Posted Date: 2011-06-29

Last Posted Date: 2015-06-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 14

Registration Number: NCT01384292

Locations: 🇬🇧
Research Site, London, United Kingdom

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