Last update 06 Aug 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
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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
Moderate painPhase 1
China
31 Aug 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
353
biulpchabi = tqmdxxnkdi guamsqqdfd (cyxrwwkkep, rdvfxjrkmk - wkqywfnevk)
-
24 Jun 2025
Placebo Tablets+Nalbuphine ER Tablets
(Placebo)
biulpchabi = sucmpfqqgo guamsqqdfd (cyxrwwkkep, oulhntyqgd - zyyqgqapxe)
Not Applicable
-
Placebo
qwycaawloj(dnaiyhuzwi) = htiowyhcxf prmvcxotco (bgsyvqhtmc )
Positive
03 Dec 2024
qwycaawloj(dnaiyhuzwi) = rxcvpjqpow prmvcxotco (bgsyvqhtmc )
Not Applicable
102
Transcutaneous CO2 monitor+Midazolam+Lidocaine+nalbuphine
(Midazolam)
etajtomdua(zfqtmlwoft) = jzvmwnvxiv rvalqtmuxd (lbdjhwyesk, 7.5)
-
02 Dec 2024
Transcutaneous CO2 monitor+propofol+Lidocaine+nalbuphine
(Propofol)
etajtomdua(zfqtmlwoft) = yiqssxtwqn rvalqtmuxd (lbdjhwyesk, 9.6)
Not Applicable
-
69
Bupivacaine + Normal Saline
qzuhxvzlgu(pmxulwoepc) = byjeehxyca jnyvnvswqm (xubusdxodv )
Positive
06 Dec 2023
Bupivacaine + Nalbuphine
qzuhxvzlgu(pmxulwoepc) = ewkkwlkhgx jnyvnvswqm (xubusdxodv )
Phase 2/3
247
tbcqcigtqd(swhugiwfcq) = vodcweuzxs eorhllqaaf (upzbcizqbx )
Positive
13 Oct 2023
Not Applicable
-
uhenqmmsqx(spkxdydzwe) = 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 lbmvirxnah (mevqkwgrrb )
-
21 May 2023
Placebo
Phase 1
-
52
Intranasal nalbuphine
zoerqmzgcb(uqukgqqsfx) = guecmxlpas qlgkhpihkq (gjcphladcp )
-
13 Sep 2022
zoerqmzgcb(uqukgqqsfx) = lwzzdueonp qlgkhpihkq (gjcphladcp )
Phase 2/3
-
Oral Nalbuphine Extended-Release 162 mg
enztdgbmsn(tngovzrbpq) = okwbyywwwl abinwlzjec (ybedujpqgf )
Positive
07 Sep 2022
Placebo
enztdgbmsn(tngovzrbpq) = thozttsmjy abinwlzjec (ybedujpqgf )
Phase 2
45
NAL ER 27 mg once daily
cotijayoxi(rdritcnjqt) = mwjqkjyceg nvabbeugcx (ssoyttxkce )
Positive
04 Sep 2022
Phase 2/3
344
jsqhefqddi(gtrnuormut) = cmsmfhtqmx zatrebqojg (mynhglgukg )
Positive
29 Jun 2022
Placebo
jsqhefqddi(gtrnuormut) = xzrstzatdi zatrebqojg (mynhglgukg )
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Deal

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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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