Naloxegol
- Generic Name
- Naloxegol
- Brand Names
- Movantik, Moventig
- Drug Type
- Small Molecule
- Chemical Formula
- C34H53NO11
- 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)
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
- Conditions
- Renal Impairment
- Interventions
- First Posted Date
- 2011-06-14
- Last Posted Date
- 2014-10-15
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 32
- Registration Number
- NCT01372826
- Locations
- 🇺🇸
Research Site, Overland Park, Kansas, United States
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
- Conditions
- Opioid-Induced Constipation (OIC)
- Interventions
- Drug: Usual care
- First Posted Date
- 2011-04-15
- Last Posted Date
- 2014-10-20
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 844
- Registration Number
- NCT01336205
- Locations
- 🇺🇸
Research Site, Middleton, Wisconsin, United States
A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects
- Conditions
- Amount of NKTR-118 in BloodVariation in the Heart's Electrical Cycle
- Interventions
- First Posted Date
- 2011-03-29
- Last Posted Date
- 2014-10-15
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 45
- Registration Number
- NCT01325415
- Locations
- 🇺🇸
Research Site, Overland Park, Kansas, United States
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
- First Posted Date
- 2011-03-28
- Last Posted Date
- 2015-06-02
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 700
- Registration Number
- NCT01323790
- Locations
- 🇬🇧
Research Site, Derby, United Kingdom
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
- First Posted Date
- 2011-03-18
- Last Posted Date
- 2011-08-25
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 50
- Registration Number
- NCT01318655
- Locations
- 🇯🇵
Research Site, "Chuo-ku", "Fukuoka", Japan
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
- First Posted Date
- 2011-03-07
- Last Posted Date
- 2015-06-01
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 652
- Registration Number
- NCT01309841
- Locations
- 🇸🇰
Research Site, Presov, Slovakia
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)
- First Posted Date
- 2008-01-24
- Last Posted Date
- 2015-06-12
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 207
- Registration Number
- NCT00600119
- Locations
- 🇺🇸
Northwest Clinical Trials, Boise, Idaho, United States
🇺🇸Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States
🇺🇸Pain & Rehabilitation Clinic of Chicago, Chicago, Illinois, United States
Drug Development Updates
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