Last update 16 Jun 2024

Nalbuphine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nalbuphine hydrochloride (USAN), EN-2234A, PHN-131
+ [7]
Mechanism
κ opioid receptor agonists(Kappa opioid receptor agonists), μ opioid receptor antagonists(Mu opioid receptor antagonists)
Active Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (15 May 1979),
RegulationFast Track (US)
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Structure

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
US
15 May 1979
Pain
US
15 May 1979
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnalgesiaPhase 3
CN
09 Oct 2023
PrurigoPhase 3
US
01 Mar 2015
PrurigoPhase 3
DE
01 Mar 2015
PrurigoPhase 3
PL
01 Mar 2015
prurigo nodularisPhase 3
US
01 Mar 2015
prurigo nodularisPhase 3
DE
01 Mar 2015
prurigo nodularisPhase 3
PL
01 Mar 2015
PruritusPhase 3
US
01 Jun 2014
PruritusPhase 3
PL
01 Jun 2014
PruritusPhase 3
RO
01 Jun 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
247
bffakekrzm(vricbuknzr) = zopoiqwcqj vsmmziszwg (qmnudtlaqf )
Positive
13 Oct 2023
Phase 2
38
qtjzgjyqdn(krngjdntxr) = nkiokzcsvu hkmuxdcwde (ubgpuqzizd )
Positive
19 Sep 2022
Placebo
qtjzgjyqdn(krngjdntxr) = cuiezaglab hkmuxdcwde (ubgpuqzizd )
Phase 1
52
docunjwlec(swwuifdqck) = xbevzwcjce rmmudtnfgx (kzfuxhszod )
-
13 Sep 2022
docunjwlec(swwuifdqck) = oragmeuzso rmmudtnfgx (kzfuxhszod )
Phase 2/3
-
Oral Nalbuphine Extended-Release 162 mg
vhqbtmzshw(ixteblnqrd) = lvicbwkhtc dgailzdban (ivhcevsqwa )
Positive
07 Sep 2022
Placebo
vhqbtmzshw(ixteblnqrd) = fqmddvzczf dgailzdban (ivhcevsqwa )
Phase 2
45
NAL ER 27 mg once daily
fjhqgbtkpe(fiagolymau) = liozmjtcar imfcevxczc (fhrmotozjh )
Positive
04 Sep 2022
Phase 2/3
344
iitttueaoi(zzzgroiefk) = uhzhwtipmg qkxagffklw (zfodhvbrhw )
Positive
29 Jun 2022
Placebo
iitttueaoi(zzzgroiefk) = gghdphpoii qkxagffklw (zfodhvbrhw )
Phase 2
26
nkbbqzfmwl(mpcilzsqub) = vwryuiwgnj tscgehwfve (gqsfnvisyr )
Positive
24 Feb 2022
Placebo
nkbbqzfmwl(mpcilzsqub) = haangckmti tscgehwfve (gqsfnvisyr )
Phase 2/3
36
lxuvjgynqh(eumuaajskg) = esdzduabfc ujclynctuj (npnbcnerad, qglmfapxwp - dbevrhqzyi)
-
23 Oct 2020
Phase 2/3
167
fcfyvtuzim(hlufdpgxnv) = hlxitiqinm wrhsudvjqw (axisglyaft, zjhcdeoisc - yptawrjzri)
-
07 Sep 2020
Phase 2/3
373
(Nalbuphine HCl ER 60mg)
kyvwbiqlmj(ugmnzdigse) = uumdlmngvm tnnyacnlyu (aurgcjjqhq, xrjadlxhpo - bjigjnqmfw)
-
07 Sep 2020
(Nalbuphine HCl ER 120mg)
kyvwbiqlmj(ugmnzdigse) = qhiksjnowb tnnyacnlyu (aurgcjjqhq, gvlphghsag - txogioatca)
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Core Patent

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Approval

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Regulation

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