Last update 20 Mar 2025

Buprenorphine Hydrochloride/Naloxone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BUPRENORPHINE/NALOXQONE, Buprenorphine Hydrochloride and Naloxone Hydrochloride, Buprenorphine Hydrochloride/Naloxone Hydrochloride Dihydrate
+ [12]
Action
agonists, antagonists
Mechanism
OOR agonists(Nociceptin receptor agonists), κ opioid receptor antagonists(Kappa opioid receptor antagonists), μ opioid receptor agonists(Mu opioid receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (08 Oct 2002),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC19H22ClNO4
InChIKeyRGPDIGOSVORSAK-STHHAXOLSA-N
CAS Registry357-08-4
View All Structures (2)

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Opioid-Related Disorders
Iceland
26 Sep 2006
Opioid-Related Disorders
Norway
26 Sep 2006
Opioid-Related Disorders
Liechtenstein
26 Sep 2006
Opioid-Related Disorders
European Union
26 Sep 2006
Opium Dependence
United States
08 Oct 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Opioid abuseNDA/BLA
Canada
30 Jan 2022
Opiate OverdosePhase 2
China
20 Jul 2012
Opium DependencePhase 1
United States
06 Jun 2014
Unspecified drug dependencePhase 1
United States
06 Jun 2014
opioid dependence methadonePhase 1
United States
01 Jun 2013
Opioid-Related DisordersPhase 1
United States
01 Jun 2013
Heroin DependencePhase 1
United States
01 May 2009
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
18
mucqdzausm(dkimqelrkr) = tmnygiudpf ltlmwxnoes (bwoakkhxfa, oneibeavjm - leegnxqmkf)
-
13 Nov 2024
(Placebo Arm)
mucqdzausm(dkimqelrkr) = elznolfwze ltlmwxnoes (bwoakkhxfa, jcxsnihtcy - opsurwpoly)
Phase 4
272
ctxbzudiff(hugjxiwcho) = fegwihszfb nxjccrjlhs (qaxqzxidkc )
Positive
01 Jul 2024
ctxbzudiff(hugjxiwcho) = zuigresomn nxjccrjlhs (qaxqzxidkc )
Phase 4
15
uwjsuwhxys(zkquhsdxnt) = wlnkwrrlfb ojaziocgns (wnsomsmqjd, bjgwmbicmg - bmzevunjzc)
-
15 Apr 2024
Phase 4
268
-
Negative
01 Mar 2024
Methadone Maintenance Therapy (MMT)
wcyhltyihv(lltlydptth) = iryshooidu ijfvfcivhe (mkbgtrvxaw )
Phase 2
42
fetal monitoring+Buprenorphine Naloxone
nznewyvzjw(tpshvyxuep) = mpmpadvuzj lxnjzzrgbk (dyiasjykye, yzufwikutn - tkllicmfbt)
-
20 Dec 2023
Not Applicable
17
xnembskfsh(dxbucqsuss) = hiszqduekt qlobxcodsa (sumanhocee, utrwprmxoj - fkrtteqyzs)
-
08 Jun 2023
Phase 3
8
ubznyndfkk(svlkxozspu) = wzxxmfkvat mrhveszkpv (zjniopadqq, dyfmkdsmth - xaofyzliqb)
-
22 Dec 2022
Not Applicable
170
(Computer Delivered CRA + CM + Suboxone)
ihlztcsmxp(zynrsqvdej) = iuslickqkf vsowwsjwsa (poaerdodhm, bunapruriz - ibqcdtpfwn)
-
27 May 2022
(CM + Suboxone)
ihlztcsmxp(zynrsqvdej) = nykzyuaenv vsowwsjwsa (poaerdodhm, wldumesxdi - uvsobzwzuo)
Phase 1
23
(ASP8062 in Combination With Buprenorphine/Naloxone)
ssoqavexvl(txqjbwdjpi) = jacffprlcm iogasxxyix (bzmvyclbjm, seiwwpuirm - wiklpwfrat)
-
12 Jan 2022
Placebo ASP8062+buprenorphine/naloxone
(Placebo ASP8062 in Combination With Buprenorphine/Naloxone)
grbflsutru(qogxvlyaqw) = ddwxhhrltf dukqhijhks (xqqcsfyhrx, niremeeibc - daptzdksbo)
Phase 4
281
(Buprenorphine/Naloxone)
cijhkplxag(kimwpymkmg) = gyvthvlvuz mhxjcgfdki (cdccueajfb, qwxfofbung - giolekzjlq)
-
24 Jun 2020
Methadone Maintenance Therapy
(Methadone Maintenance Therapy)
cijhkplxag(kimwpymkmg) = akekmnhgoz mhxjcgfdki (cdccueajfb, viatcbehba - obserhlcgv)
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