Drugs / Naloxegol
Naloxegol
also known as
NKTR118 · Movantik · AZ-13337019 · AZ-13337019 OXALATE · Moventig · Naloxegol oxalate component of movantik · Naloxégol oxalate · NKTR-118 oxalate · +1 more
Small molecule targets OPRM1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Moventig | — | 2014-12-07 | europa.eu ↗ |
| Approved | US (FDA) | MOVANTIK | — | 2014-09-16 | fda.gov ↗ |
Trials 28 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT02446171 | May → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02099591 | Nov 2014 → Apr 2021 | constipation disorder | Kyowa Kirin Pharmaceutical Development Ltd | Completed | No outcome recorded |
| Phase 1 | NCT01594619 | May → Aug 2012 | constipation disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01533870 | Mar → May 2012 | constipation disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01520896 | Feb → Apr 2012 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01392807 | Jul → Nov 2011 | liver disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01372826 | Jun → Oct 2011 | impaired renal function disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01365000 | Jun → Aug 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01348724 | Jun → Sep 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01325415 | Apr → Jul 2011 | cardiac rhythm disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01318655 | Mar → Jul 2011 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04219046 | Mar 2021 → Sep 2022 | urinary bladder cancer | Institut Paoli-Calmettes | Unknown | No outcome recorded |
| Phase 2 | NCT02998606 | Jan 2017 → Oct 2018 | esophageal disorder, substance-related disorder | Temple University | Terminated | No outcome recorded |
| Phase 2 | NCT03036891 | Dec 2016 → Sep 2019 | gastroparesis, substance-related disorder | Temple University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00600119 | Dec 2007 → Mar 2009 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03316859 | Nov 2017 → Dec 2022 | opioid-induced constipation | TriHealth Inc. | Unknown | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT05008926 | Mar 2022 → Oct 2027 | brain injury | University Hospital, Brest | Suspended | No outcome recorded |
| Phase 3 | NCT04433390 | Oct 2020 → Jan 2022 | paralytic ileus | CMC Ambroise Paré | Completed | No outcome recorded |
| Phase 3 | NCT02705378 | May 2017 → Apr 2019 | constipation disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded |
| Phase 3 | NCT01395524 | Jul 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01384292 | Jun 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT01336205 | Apr 2011 → Dec 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01323790 | Mar 2011 → Sep 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01309841 | Mar 2011 → Aug 2012 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05770960 | Jun 2018 → May 2019 | opioid-induced constipation | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT03235739 | Oct 2017 → May 2021 | neuropathy, painful | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT02977286 | Jan 2017 → Oct 2019 | constipation disorder | Tufts Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT02946580 | Jan 2017 → Feb 2018 | constipation disorder | Massachusetts General Hospital | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02737059 Comparator | Jul 2016 → May 2017 | opioid-induced constipation | Michael Camilleri | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03087708 Comparator | Mar 2018 → Jan 2021 | non-small cell lung carcinoma | Alliance for Clinical Trials in Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT02745353 Comparator | May 2016 → Jun 2017 | constipation disorder | Joseph Ma | Terminated | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03523520 Comparator | Dec 2020 → Mar 2023 | opioid-induced constipation | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT03060512 Comparator | Mar → Aug 2017 | opioid-induced constipation | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02839889 Comparator | Sep 2016 → Jan 2018 | cancer, constipation disorder | Hospice of Henderson County, Inc. | Terminated | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-03-20 | Daiichi Sankyo | Daiichi Sankyo Signs Agreement with AstraZeneca to Co-commercialize MOVANTIK™ in the US daiichisankyo.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Naloxegol | “AIM: To evaluate the long-term safety and tolerability of naloxegol, an oral, peripherally acting μ-opioid receptor antagonist (PAMORA), in patients with noncancer pain and OIC.” PMID 25112584 ↗ Aug 201420“MOVANTIK™ (Naloxegol) is the first oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation.” NCT02998606 ↗ “The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol.” PMID 24946021 ↗ Jul 2014 |
| Known as | AZ-13337019 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219418 ↗ |
| Known as | AZ-13337019 OXALATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219418 ↗ |
| Known as | Movantik | “Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until...” NCT02946580 ↗2“Movantik (Naloxegol) is an opioid agonist specifically designed to work outside of the central nervous system.” NCT03036891 ↗ |
| Known as | Moventig | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219418 ↗ |
| Known as | Naloxegol oxalate component of movantik | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219418 ↗ |
| Known as | Naloxégol oxalate | “Drug: Naloxégol oxalate” NCT04219046 ↗ |
| Known as | NKTR-118 oxalate | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219418 ↗ |
| Known as | NKTR118 | “Assessment of Relative Bioavailability of NKTR-118 in Three Formulations” NCT01365000 ↗ |
| Known as | PEG-naloxol | “A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)” NCT00600119 ↗ |
| Action | Inhibit | “an oral, peripherally acting, μ-opioid receptor antagonist” PMID 24896818 ↗ Jun 20141“Mu opioid receptor antagonist” CHEMBL2219418 ↗ |
| Modality | Small molecule | — CHEMBL2219418 ↗ |
| Route | Oral | “5 mg, 25 mg, 50 mg or 100 mg, oral,once daily (QD)” NCT00600119 ↗ |
| Target | OPRM1 | “Mu opioid receptor antagonist” CHEMBL2219418 ↗ |