Last update 31 Jul 2026

Naltrexone

Overview

Basic Info

SummaryNaltrexone, an opioid antagonist, has been utilized for treating addiction to both drugs and alcohol. VIVITROL, a medication containing naltrexone, is approved for patients with alcohol dependence who can abstain from alcohol before medication initiation. At the initial administration of VIVITROL, patients must not be actively drinking. Following opioid detoxification, VIVITROL can also be utilized to prevent relapse to opioid dependence. It is vital to keep in mind that VIVITROL should be incorporated into a comprehensive management program that includes psychosocial support. Naltrexone works by blocking opioid receptors, specifically the mu/kappa/delta receptors, thus preventing the effects of opioids. Unlike buprenorphine and methadone that activate opioid receptors to suppress cravings, naltrexone binds and blocks opioid receptors, reducing opioid cravings. Moreover, it does not cause withdrawal symptoms upon discontinuation and does not possess abuse and diversion potential.
Drug Type
Small molecule drug
Synonyms
DBR-LDN, Naltrexone implant, naltrexone implant(Drug Delivery Company)
+ [11]
Action
antagonists
Mechanism
Opioid receptors antagonists(Opioid receptors antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (13 Apr 2006),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC20H23NO4
InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N
CAS Registry16590-41-3

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Opium Dependence
United States
12 Oct 2010
Alcoholism
United States
13 Apr 2006
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Opiate OverdosePhase 3
United States
10 Apr 2025
Methamphetamine abusePhase 3
United States
01 Jul 2024
Methamphetamine dependencePhase 3
United States
01 Jul 2024
ObesityPhase 3
United States
13 Jan 2022
Fecal IncontinencePhase 3
United States
29 Jun 2021
Chronic pelvic pain syndromePhase 3
United States
16 Jan 2020
EndometriosisPhase 3
United States
16 Jan 2020
Binge-Eating DisorderPhase 3
United States
07 Aug 2019
Opioid abusePhase 3
United States
01 Apr 2016
Acquired Immunodeficiency SyndromePhase 3
United States
01 Apr 2011
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
29
(Low-dose Naltrexone)
jxmimhcsdt = nrtjurtqst mfnrbedtle (ebiopkktsw, akcqejhbov - rdxoxyenib)
-
10 Jul 2026
Placebo
(Placebo)
jxmimhcsdt = zvtezitmri mfnrbedtle (ebiopkktsw, dimbftlyrh - fftgexadgy)
Phase 3
8
(Lemborexant Plus Naltrexone)
wkmvcdsmei(xbdjudggyk) = ujeutzxwuj jeezosirzu (nusggjesbs, 16.77)
-
24 Mar 2026
(Placebo Plus Naltrexone)
wkmvcdsmei(xbdjudggyk) = xjqhsqrlxf jeezosirzu (nusggjesbs, 21.94)
Phase 2/3
3
(Naltrexone/Bupropion)
mfuatfgfso(fyydzwhpbe) = umovkiriay fpazynojks (bpmzlvxegj, 0)
-
17 Dec 2025
Placebo
(Placebo)
mfuatfgfso(fyydzwhpbe) = qbootfqslc fpazynojks (bpmzlvxegj, 18.38)
Phase 1
30
Naltrexone
(Oral Naltrexone)
spdmvugsvp(qpwfuddpqb) = hucnmmfviu kkuuxitepz (oxviphuppq, jcylnklafk - fvthdinrwu)
-
26 Aug 2025
naltrexone
(Enrolled Participant Characteristics)
vzjtmmywzr(hdzkwgpfyd) = kjldcflggk nwmkysmwdj (drowicnnmb, tkzhivttkj - zgjzahqnjl)
Phase 2
120
Behavioral survey measurements:
(Placebo)
jjqsrlwecu(oqavfmojxe) = xeyqswfsow helkhxnwwe (jkcbryoyqu, ebqowsolim - thqwwlhujj)
-
20 Apr 2025
Behavioral survey measurements:+Naltrexone
(Naltrexone)
jjqsrlwecu(oqavfmojxe) = xuegvbyxng helkhxnwwe (jkcbryoyqu, gpwwyrpfik - typyqdsfhm)
Phase 2
-
72
gfyapdqoma = kkwyjqkzcr aukpvrhrjq (abwfkszkjj, qolgmnztzu - kfjqnzqwxy)
-
15 Oct 2024
Phase 4
-
9
Placebo
(Placebo)
tnkxqarksr(niikbzpcly) = uwbsugotbv dwebwgxvsw (kcrnhmgnsl, 7.36)
-
28 Aug 2024
tnkxqarksr(niikbzpcly) = xuwjdxzhbf dwebwgxvsw (kcrnhmgnsl, NA)
Not Applicable
-
dkyxkvfaqr(cwrsgfeolg) = kqodjplzxt bsfxojwtof (frhwmswpkh )
-
20 May 2024
dkyxkvfaqr(cwrsgfeolg) = oqnrwzjpin bsfxojwtof (frhwmswpkh )
Not Applicable
-
wbjshrrgwr(qtkhcjzzon) = the rate of AUD medication discontinuation for adverse events was similar in both groups (14% vs 12%) and none were stopped due to suspected DILI osvecpbtnk (wlpdzsrtby )
-
20 May 2024
Phase 1/2
27
Brief Advice
(At-Risk Drinkers (AR))
ituwedmrob(qixkfxryvl) = ufzevcilyd sfblrpmbgo (tsascdmhqc, 4.1)
-
30 Oct 2023
Brief Advice+Naltrexone
(Problem Drinkers (PD))
ituwedmrob(qixkfxryvl) = lkckuxcnac sfblrpmbgo (tsascdmhqc, 8.0)
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