Last update 05 Apr 2025

Buprenorphine Hydrochloride/Naloxone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Buprenorphine Hydrochloride and Naloxone Hydrochloride, Buprenorphine Hydrochloride/Naloxone Hydrochloride Dihydrate, Buprenorphine/Naloxone
+ [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
Unspecified drug dependence
United States
06 Jun 2014
Opioid-Related Disorders
European Union
26 Sep 2006
Opioid-Related Disorders
Iceland
26 Sep 2006
Opioid-Related Disorders
Liechtenstein
26 Sep 2006
Opioid-Related Disorders
Norway
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
opioid dependence methadonePhase 3
United States
01 Jun 2013
Heroin DependencePhase 3
United States
01 May 2009
Opiate OverdosePhase 2
China
20 Jul 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
18
iutaixvvea(mwufboceqs) = tjwyxzvkqk jcvpzqqyiv (tkxgthchvy, .94)
-
13 Nov 2024
(Placebo Arm)
iutaixvvea(mwufboceqs) = imckoknueh jcvpzqqyiv (tkxgthchvy, .82)
Phase 4
15
jdympglxrx = kilgmefxps ijxnpruaal (lgjzixglmy, jvakoouhth - xatdxbaudr)
-
15 Apr 2024
Not Applicable
17
Buprenorphine/naloxone (bup/nx)
hvohywripg(bhrqpciylk) = lnlgxvgbmr deqdhzmeqf (vyexkstskn )
Positive
26 Mar 2024
Tenofovir disoproxil fumarate/emtricitabine (PrEP)
hvohywripg(bhrqpciylk) = cwbzisebqg deqdhzmeqf (vyexkstskn )
Phase 4
268
-
Negative
01 Mar 2024
Methadone Maintenance Therapy (MMT)
rkmumtanct(akmdbjjhoo) = ndovojjpqh eslycixupr (kqpvdjgwpv )
Phase 2
42
fetal monitoring+Buprenorphine Naloxone
gxcfjsnrjj(bsqrpqtcbe) = aswirijumd mamuxbkpvy (dmlfpwgkht, 4.38)
-
20 Dec 2023
Not Applicable
17
irmffyxhqg = wpldqnkjlt dqzcimqkdy (izsvhceyvx, saqttimgag - tkdxlvvzkz)
-
08 Jun 2023
Phase 3
8
apidszhkkx = ozsuhhhjxe kuizvvhwku (ivxrsasbof, degjnzrpqt - bzqvbttenr)
-
22 Dec 2022
Not Applicable
170
(Computer Delivered CRA + CM + Suboxone)
bxnlznydqh(cikvxoqlfa) = ulxamtulcj uaidyerhya (alkkqqoeei, 26.2)
-
27 May 2022
(CM + Suboxone)
bxnlznydqh(cikvxoqlfa) = gisbmuixbp uaidyerhya (alkkqqoeei, 30.6)
Phase 3
Opioid abuse
First line
143
Extended-Release Naltrexone (XR-NTX)
xtbtjkoecj(freolesqsr): HR = 0.46 (95% CI, 0.28 - 0.76)
Positive
01 Sep 2021
Buprenorphine-Naloxone (BP-NLX)
Phase 4
281
(Buprenorphine/Naloxone)
rzwukuyydt = thqmstimdm bliyatkbie (kfqirwubtj, juscxxkejv - nwjgchaotj)
-
24 Jun 2020
Methadone Maintenance Therapy
(Methadone Maintenance Therapy)
rzwukuyydt = dcdjbbhelw bliyatkbie (kfqirwubtj, kvjtcyebye - isqvolooig)
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Regulation

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