naloxegol

Trade name: movantik

Small moleculeapproved

Approved

Sep 16, 2014

MOVANTIK (naloxegol) is a peripherally-acting mu-opioid receptor antagonist indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic noncancer pain. It is being investigated for the treatment of constipation as a side effect of prescription opioid pain medicines. — NCATS

Clinical trial activity

35 trials · 22 clinical orgs · 5 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 2007 (NCT00600119)

Timeline

2000s

Jan 1, 2007
AstraZeneca — Earliest Phase 2 Sponsor(trial)

2010s

Jan 1, 2011
AstraZeneca — Earliest Phase 1 Sponsor(trial)
Jan 1, 2011
AstraZeneca — Earliest Phase 3 Sponsor(trial)
Sep 16, 2014
AstraZeneca — Earliest FDA Approval
Sep 16, 2014
AstraZeneca — NDA Organization
Sep 16, 2014
AstraZeneca — NDA Secondary Org
Sep 16, 2014
RedHill Biopharma — Marketing Organization
Sep 16, 2014
VALINOR — Marketing Organization
Sep 16, 2014
VALINOR — NDA Secondary Org
Sep 16, 2014
Averitas Pharma — Marketing Organization

2020s

Feb 24, 2021
MSN Laboratories — Marketing Organization

Mechanism of action

Mu opioid receptorANTAGONIST
OPRM antagonist
- Mu-type opioid receptor (OPRM) ↗

Approval history

approvedSep 16, 2014

Chemistry & pharmacology

Loading structure…

SMILES

C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2[C@@H](OCCOCCOCCOCCOCCOCCOCCOC)CC[C@@]3(O)[C@H]1C5

Mol. weight: 651.79 g/mol
Lipinski Ro5: 2 violation(s)
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Sources

Also known as

(5α,6α)-17-allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol
(5α,6α)-17-allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol
az-13337019 oxalate
az-13337019 oxalate
movantik
movantik
movantik
movantik
movantik
moventig
moventig
moventig
moventig
moventig
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol
naloxegol oxalate
naloxegol oxalate
naloxegol oxalate
naloxegol oxalate
naloxegol oxalate
nktr-118
nktr-118
nktr-118
nktr-118
nktr-118
nktr-118-oxalate
nktr-118-oxalate

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT05008926	Phase 3	Oct 31, 2021	University of Western Brittany
NCT04433390	Phase 3	Jul 1, 2020	CHU AMBROISE PARE
NCT04219046	Phase 2	Apr 30, 2020	Institut Paoli-Calmettes
NCT03523520	Phase 4	Jul 1, 2018	University of Missouri
NCT05770960	Phase 4	Jun 27, 2018	Katholieke Universiteit Leuven
NCT03316859	Phase 2/Phase 3 (Phase 3)	Nov 6, 2017	TriHealth
NCT03235739	Phase 4	Oct 1, 2017	The Cleveland Clinic
NCT03087708	Phase 3	Jun 1, 2017	Department of Veteran Affairs, National Cancer Institute (NCI)
NCT02705378	Phase 3	May 1, 2017	AstraZeneca, Harvard University
NCT03060512	Phase 4	Mar 2, 2017	AstraZeneca, IQVIA
NCT03036891	Phase 2	Mar 1, 2017	AstraZeneca, Temple University
NCT02946580	Phase 4	Jan 1, 2017	AstraZeneca, Harvard University
NCT02998606	Phase 2	Jan 1, 2017	AstraZeneca, Temple University
NCT02977286	Phase 4	Nov 1, 2016	Tufts University
NCT02839889	Phase 4	Sep 1, 2016	AstraZeneca, Hospice of Henderson County, Inc.
NCT02745353	Phase 2	May 1, 2016	AstraZeneca, University of California, San Diego
NCT02737059	Phase 1	May 1, 2016	AstraZeneca, Mayo Clinic
NCT02446171	Phase 1	May 1, 2015	AstraZeneca, Parexel
NCT02099591	Phase 1	Nov 1, 2014	Kyowa Hakko Kirin
NCT01623609	Phase 1	Jul 1, 2012	AstraZeneca, IQVIA

Showing 20 of 35 trials

Page 1 / 2

Organizations

Research & Development (22)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
AstraZeneca	For profit	25	18	4	2007
IQVIA	For profit	8	0	2	2011
Harvard University	Academic/Hospital	2	2	2	2017
Orlando Clinical Research Center	For profit	2	0	1	2011
Temple University	Academic/Hospital	2	2	1	2017
CHU AMBROISE PARE	Academic/Hospital	1	1	1	2020
Department of Veteran Affairs	Government	1	0	1	2017
Hospice of Henderson County, Inc.	Academic/Hospital	1	1	1	2016
Institut Paoli-Calmettes	Academic/Hospital	1	1	1	2020
Katholieke Universiteit Leuven	Academic/Hospital	1	1	1	2018
Kyowa Hakko Kirin	For profit	1	1	1	2014
Kyushu Clinical Pharmacolgy Reasearch Clinic	Academic/Hospital	1	0	1	2011
Mayo Clinic	Academic/Hospital	1	1	1	2016
National Cancer Institute (NCI)	Government	1	1	1	2017
Nektar Therapeutics	For profit	1	0	1	2007
Parexel	For profit	1	0	1	2015
The Cleveland Clinic	Academic/Hospital	1	1	1	2017
TriHealth	Academic/Hospital	1	1	1	2017
Tufts University	Academic/Hospital	1	1	1	2016
University of California, San Diego	Academic/Hospital	1	1	1	2016

22 organizations