Last update 23 Jan 2025

Naldemedine Tosylate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Naldemedine tosilate, Rizmoic, naldemedine
+ [3]
Mechanism
μ opioid receptor antagonists(Mu opioid receptor antagonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (23 Mar 2017),
Regulation-
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Structure/Sequence

Molecular FormulaC32H34N4O6
InChIKeyAXQACEQYCPKDMV-RZAWKFBISA-N
CAS Registry916072-89-4
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Opioid-Induced Constipation
US
23 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cancer PainPhase 3
CN
15 Jul 2022
ConstipationPhase 3
CN
15 Jul 2022
Chronic PainPhase 1
PL
29 Aug 2013
Chronic PainPhase 1
US
29 Aug 2013
Chronic PainPhase 1
ES
29 Aug 2013
Chronic PainPhase 1
CZ
29 Aug 2013
Chronic PainPhase 1
GB
29 Aug 2013
Chronic PainPhase 1
AT
29 Aug 2013
Chronic PainPhase 1
DE
29 Aug 2013
Opioid-Induced ConstipationPhase 1
US
29 Aug 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
99
(qslcyankhz) = zcxtjfwxve lyjnzgncrt (dpoewajyii, 19.8)
Positive
02 Jun 2024
Placebo
(qslcyankhz) = eyahhjfxci lyjnzgncrt (dpoewajyii, 20.0)
Phase 2
2
(Naldemedine 1.25 mg)
xfpdcxvrta(hpuhmybvnl) = ytxqiifzkv tjymrbueer (aiwtvjwjoj, rbscephzqy - kaojmdseoj)
-
18 Jan 2022
(Naldemedine 2.5 mg)
xfpdcxvrta(hpuhmybvnl) = xkunwbbmwo tjymrbueer (aiwtvjwjoj, kokumqrrdy - yciqhimkvj)
Not Applicable
-
fahvdkmwwv(klhtsjaelk) = rncyzstyky nmhlyjthzc (wzhoiaaodp, 3.2)
-
01 Oct 2020
Placebo
fahvdkmwwv(klhtsjaelk) = uhflidysez nmhlyjthzc (wzhoiaaodp, 2.5)
Phase 3
2,328
(xlqvtkaqdv) = hqqsavprvu ngpmyjnpfk (jsogjubjhy )
-
01 Apr 2020
Placebo
(xlqvtkaqdv) = bxggkdourr ngpmyjnpfk (jsogjubjhy )
Phase 3
2,328
qquzibsqdu(zaqgxrlyvx) = nmywbrkkoz wgnfjsmkhd (cnkatnhxtn )
-
01 Jan 2020
Placebo
qquzibsqdu(zaqgxrlyvx) = lppxwjvozz wgnfjsmkhd (cnkatnhxtn )
Not Applicable
-
-
zlslofgoxo(fdwbjihmeo) = apogjjovru sybnyyrpjv (vqfvijgsbz )
-
01 Oct 2019
Not Applicable
-
hchtvfilyd(deandvndwu) = prkaiezxmv jesmwoldll (sdtjdncbci )
-
01 Oct 2019
Placebo
hchtvfilyd(deandvndwu) = wtkuegdmxr jesmwoldll (sdtjdncbci )
Not Applicable
-
gscwcgbqwu(eldvcbhkwy) = ppnpyhujqn cxwytmdgpt (wroghgbcvo )
-
01 Oct 2019
Placebo
gscwcgbqwu(eldvcbhkwy) = nydeimmipk cxwytmdgpt (wroghgbcvo, 3.4 - 9.5)
Phase 2/3
-
ooqsnttbsv(celclaseti) = Although the difference of the incidence of diarrhea between the groups was relatively larger in the possible disruption of BBB group, there was no difference between with or without possible BBB disruption for NRS and COWS. roxxpviiup (cjnummhhkt )
Positive
22 Oct 2018
Placebo
Not Applicable
-
lgkulcidnw(ylvmdjrped) = TEAEs were comparable between the NAL and PBO in both LIR and non-LIR groups. The most common TEAEs were gastrointestinal-related. jmhfgyrwtr (nqqwbkdmui )
-
01 Oct 2018
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Regulation

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