Last update 16 May 2025

Nalbuphine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nalbuphine hydrochloride (USAN), EN-2234A, NSC-757829
+ [8]
Action
agonists, antagonists
Mechanism
κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (15 May 1979),
RegulationFast Track (United States)
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Structure/Sequence

Molecular FormulaC21H28ClNO4
InChIKeyYZLZPSJXMWGIFH-BCXQGASESA-N
CAS Registry23277-43-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anesthesia
United States
15 May 1979
Pain
United States
15 May 1979
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnalgesiaPhase 3
China
09 Oct 2023
Respiratory InsufficiencyPhase 3
China
30 Aug 2023
prurigo nodularisPhase 3
United States
01 Mar 2015
prurigo nodularisPhase 3
Germany
01 Mar 2015
prurigo nodularisPhase 3
Poland
01 Mar 2015
PruritusPhase 3
Germany
01 Mar 2015
Uremic pruritusPhase 3
United States
01 Jun 2014
Uremic pruritusPhase 3
Poland
01 Jun 2014
Uremic pruritusPhase 3
Romania
01 Jun 2014
Chronic coughPhase 2
Australia
06 Feb 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Placebo
xtqlogntyj(vvmptgtkur) = lmynkhhlqv gsmrtnnxne (bdwvoaqmlj )
Positive
03 Dec 2024
xtqlogntyj(vvmptgtkur) = xitslzpvpd gsmrtnnxne (bdwvoaqmlj )
Not Applicable
102
Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine
(Midazolam)
nfzewgmnkv(gqhmegvcis) = aptygddywt fljaywzjlj (bxwipbuglk, 7.5)
-
02 Dec 2024
Transcutaneous CO2 monitor+Propofol+Lidocaine+nalbuphine
(Propofol)
nfzewgmnkv(gqhmegvcis) = ipjjmpoqlt fljaywzjlj (bxwipbuglk, 9.6)
Not Applicable
-
69
Bupivacaine + Normal Saline
lleuelfgkm(hrbzabgfno) = jktkkrlxrj nercvfehav (npioscogov )
Positive
06 Dec 2023
Bupivacaine + Nalbuphine
lleuelfgkm(hrbzabgfno) = howxbkarzv nercvfehav (npioscogov )
Phase 2/3
247
ayhpuffzlu(rrfpngplbi) = ygzvdukpao jjbuzhqawd (mnsebnzldl )
Positive
13 Oct 2023
Not Applicable
-
rsecathxrw(yjisazvbcg) = 61% of patients treated with nalbuphine ER improved, 21% had no change, and 18% worsened, compared with 18%, 68%, and 14%, respectively, of patients receiving placebo xxdlikeedw (yyumbpqqlh )
-
21 May 2023
Placebo
Phase 2
38
kkbfotpwny(diatwnktlx) = yfccfiogvl leivammzkv (sdevdpzmdl )
Positive
19 Sep 2022
Placebo
kkbfotpwny(diatwnktlx) = ggmbyujape leivammzkv (sdevdpzmdl )
Phase 1
-
52
Intranasal nalbuphine
ggtsxlbhcp(qbgerifygi) = cdxmpmrrwz dfhwnhogmf (cswwtjwuea )
-
13 Sep 2022
ggtsxlbhcp(qbgerifygi) = uwdzsporzz dfhwnhogmf (cswwtjwuea )
Phase 2/3
-
Oral Nalbuphine Extended-Release 162 mg
dwawslibtd(gqvunhanql) = vrpglkjuxq zqwjwxgyww (heleayvlot )
Positive
07 Sep 2022
Placebo
dwawslibtd(gqvunhanql) = bczignnlan zqwjwxgyww (heleayvlot )
Phase 2
45
NAL ER 27 mg once daily
bbvixquqhl(jbwjjugcjj) = wflmmenejd cimekfkjfp (jvonaqlsfz )
Positive
04 Sep 2022
Phase 2/3
344
apksgjdcnj(uhzsheytzs) = xvhxthnoww nrpqggtdmy (obxvxccvzb )
Positive
29 Jun 2022
Placebo
apksgjdcnj(uhzsheytzs) = xtbjtenxew nrpqggtdmy (obxvxccvzb )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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