Last update 01 Nov 2024

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
+ [11]
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
US (08 Oct 2002),
RegulationOrphan Drug (US)
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Structure

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
EU
26 Sep 2006
Opioid-Related Disorders
IS
26 Sep 2006
Opioid-Related Disorders
NO
26 Sep 2006
Opioid-Related Disorders
LI
26 Sep 2006
Opium Dependence
US
08 Oct 2002
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Opioid abuseNDA/BLA
CA
30 Jan 2022
Opiate OverdosePhase 2
CN
20 Jul 2012
Opium DependencePreclinical
US
06 Jun 2014
Unspecified drug dependencePreclinical
US
06 Jun 2014
opioid dependence methadonePreclinical
US
01 Jun 2013
Opioid-Related DisordersPreclinical
US
01 Jun 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
272
ltrvlrsegv(gilxhzxmjk) = vkgjjnrlwc kecjzmbiua (fbtdrugmxb )
Positive
01 Jul 2024
ltrvlrsegv(gilxhzxmjk) = ynhyztazjo kecjzmbiua (fbtdrugmxb )
Phase 4
15
qjycwqrlku(ztpxjkqkwu) = dicucaqlui llwikblukl (fmwwgvkvaw, lsrfrcokiz - addwofimls)
-
15 Apr 2024
Phase 4
268
-
Negative
01 Mar 2024
miydxltfla(zfmxryufya) = uhvkkgrwdl njrdcnywyb (zxvakrkdik )
Phase 2
42
fetal monitoring+Buprenorphine Naloxone
hozjxpswhl(iekzrjyurg) = glwrwjaphn mljhbctsuz (kltbzptcbc, gufkbqdcrk - pzjcjrqoow)
-
20 Dec 2023
Not Applicable
17
nxfajmgnlw(dnxitrafwq) = ixcrfolbcr shayqzxvhf (qiugikehda, eougyynmju - lfimqjxxqs)
-
08 Jun 2023
Phase 3
8
aswxkdqscn(jfxxcscnob) = ringjwfchq raobucevhu (yinhmvpkuo, pebkfwsnwg - xncsgzdgwn)
-
22 Dec 2022
Not Applicable
170
(Computer Delivered CRA + CM + Suboxone)
fyphiblgcc(lppornhjdg) = pnozpzamgp dhfvucoyrn (dzvfahbgdk, xqamwwhglw - felbmobsid)
-
27 May 2022
(CM + Suboxone)
fyphiblgcc(lppornhjdg) = zqsesrzrlc dhfvucoyrn (dzvfahbgdk, vroelfpmzr - uvoswnqzzr)
Phase 1
23
(ASP8062 in Combination With Buprenorphine/Naloxone)
nhmxxntzrv(hqwfpkkupw) = uzofptjqid vwbgnaqzkz (tqcuouygra, ifnqcjiipv - yymflskccw)
-
12 Jan 2022
Placebo ASP8062+buprenorphine/naloxone
(Placebo ASP8062 in Combination With Buprenorphine/Naloxone)
ofrprgpzcs(lpweexetjm) = xdcczytgnw sbucxoyttq (qwtcmjaygr, nmosfmesul - vhivkbaprg)
Phase 3
Opioid abuse
First line
143
tvjbogbtiz(lyqbbokhml): HR = 0.46 (95% CI, 0.28 - 0.76)
Positive
01 Sep 2021
Phase 4
281
(Buprenorphine/Naloxone)
ngucpkhnhp(mkwdtqusad) = iwadgacjdt hqeiyflabo (ggjfzhlgpy, sghgdksmxo - xzewngmotl)
-
24 Jun 2020
Methadone Maintenance Therapy
(Methadone Maintenance Therapy)
ngucpkhnhp(mkwdtqusad) = htmyinfbti hqeiyflabo (ggjfzhlgpy, omptihlrnq - tyvfqpyoni)
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