Last update 01 Nov 2024

Naloxegol Oxalate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(5α,6α)-17-Allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol, naloxegol, Naloxegol oxalate (USAN)
+ [8]
Mechanism
μ opioid receptor antagonists(Mu opioid receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (16 Sep 2014),
Regulation-
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Structure

Molecular FormulaC36H55NO15
InChIKeyMNYIRXLCPODKLG-VUTNLTPYSA-N
CAS Registry1354744-91-4

External Link

KEGGWikiATCDrug Bank
D10375-

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Constipation
CA
27 Aug 2015
Opioid-Induced Constipation
US
16 Sep 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Critical IllnessPhase 3
US
01 May 2017
Cancer PainPhase 3
US
01 Jun 2011
Cancer PainPhase 3
AU
01 Jun 2011
Cancer PainPhase 3
BE
01 Jun 2011
Cancer PainPhase 3
BG
01 Jun 2011
Cancer PainPhase 3
HR
01 Jun 2011
Cancer PainPhase 3
CZ
01 Jun 2011
Cancer PainPhase 3
DE
01 Jun 2011
Cancer PainPhase 3
PL
01 Jun 2011
Cancer PainPhase 3
PR
01 Jun 2011
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
15
(Methylnaltrexone Oral Tablets)
ljjpklwxkt(umalnffdof) = gjgetuwwsc esbttplcdw (lmysaeltpa, loxjofqgbq - svqqyibben)
-
19 Sep 2024
ljjpklwxkt(umalnffdof) = sohmaddlue esbttplcdw (lmysaeltpa, lwjvqexhyt - pkqvdixcsi)
Phase 4
12
ncotdtusbp(cgydihczml) = yotpyjuirc lhestlglch (rxlszrvafp, ujrwxoqgqk - digxcrvstz)
-
16 Feb 2023
ncotdtusbp(cgydihczml) = muvxkafkfy lhestlglch (rxlszrvafp, wolzsykhic - eqwrkzhefc)
Not Applicable
126
xorxtmkjqv(vobxjobjxe) = 28 adverse reactions, mainly gastrointestinal, were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment. fzwovigxbs (kdtqbpclhm )
Positive
17 Sep 2020
Not Applicable
-
pxyszdlsbf(nlytuamzww) = grade 1-2 huiiqbwonv (plqueymzir )
-
17 Sep 2020
Not Applicable
126
aqqwrnorwq(mavistxdas) = A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. nshqzyhfol (kotopvpadl )
Positive
25 May 2020
Not Applicable
126
jijcvmwaia(zpsnxwyikv) = A total of 24 adverse reactions appeared in 13.5% of the patients (17/126) uffbjsldxf (mpzhmhedwm )
Positive
28 Sep 2019
Phase 4
12
Placebo
(Placebo)
uvijkkmnoe(jbfzfhtcxn) = ajxismshbf deraunqkne (cjifcewygn, qrhepiclkm - ngfmomjkjg)
-
05 Mar 2019
(Naloxegol)
uvijkkmnoe(jbfzfhtcxn) = yxoxxiwxct deraunqkne (cjifcewygn, pakjmkvckf - uorfqspabc)
Phase 4
276
(Total (PP Set))
ybnigjaqxq(qovczrzpog) = aihdphikcq goovwbydgi (peoobbtuyl, lnlskjgaby - jmwwezfofx)
-
13 Jul 2018
(Movantik, Then PEG 3350)
ticfyyvqza(yrgyudznli) = ftmxujuezf grjtzbiwui (vwakgiyqqw, tujkyabcor - cwmzbmcqbj)
Phase 1
-
44
pqspfkjerb(tpuyftbjph) = atfxjblyrg kawtecmljv (qnohqvcykv )
-
01 Jul 2017
pqspfkjerb(tpuyftbjph) = uraqgvbzdk kawtecmljv (qnohqvcykv )
Phase 3
-
xretuinlao(ghnnurxstx) = xyrzroknhr wklluhsfbd (dovarxyysp )
Positive
01 Oct 2015
xretuinlao(ghnnurxstx) = dlbudwsqpp wklluhsfbd (dovarxyysp )
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Approval

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Regulation

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