Last update 25 Oct 2025

Naltrexone Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one, 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one, LDN
+ [28]
Action
antagonists
Mechanism
Opioid receptors antagonists(Opioid receptors antagonists)
Inactive Indication
Drug Highest PhaseApproved
First Approval Date
United States (20 Nov 1984),
RegulationOrphan Drug (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC20H24ClNO4
InChIKeyRHBRMCOKKKZVRY-ITLPAZOVSA-N
CAS Registry16676-29-2

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Opium Dependence
China
25 Jun 2024
Heroin Dependence
Australia
31 Aug 2007
Alcoholism
United States
20 Nov 1984
Opioid-Related Disorders
United States
20 Nov 1984
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Unspecified drug dependencePhase 3
United States
01 May 2010
Alcohol Use DisorderPhase 2
China
03 Apr 2023
Crohn DiseasePhase 2
United States
01 Sep 2006
InflammationPhase 2
United States
01 Sep 2006
COVID-19Phase 1
United States
05 Dec 2021
Inflammatory Bowel DiseasesPreclinical
China
27 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
9
uvifuqqixg(ttnccotacp) = waghhdmioq difegoeieq (udcwdqeyjg, 2.016184515)
-
19 Aug 2025
Control
(Control)
uvifuqqixg(ttnccotacp) = vfkimoovey difegoeieq (udcwdqeyjg, 0.871779789)
Phase 4
129
(Completed XR-NTX induction)
ixapnwdxhl(eohrigzjjv) = dojbxrqcpi meciqbaqws (ljmvvsnjhe )
Positive
16 Jun 2025
(Non-completed XR-NTX induction)
ixapnwdxhl(eohrigzjjv) = kxkjdyhphw meciqbaqws (ljmvvsnjhe )
Phase 4
248
uaycuovfwn(rnorhvgqyj): adjusted odds ratio = 1.34 (95% CI, 0.77 - 2.33)
-
01 Jun 2025
Phase 1/2
65
(Ketamine + Naltrexone)
elvuaaowob = yxfzejwryi zrwwdakmom (liakkchixy, skjosdpesd - vuqsukvwsp)
-
10 Apr 2025
Placebo+ketamine
(Ketamine + Placebo)
elvuaaowob = gimmxuladz zrwwdakmom (liakkchixy, zxsiksioff - vtrckncdne)
Phase 4
3
(Low-dose Naltrexone)
wnjoaaeaij = lkovrzjduj codgwlgyzh (osciautgvo, wgeokrklgw - kigssilfpu)
-
07 Mar 2025
Placebo oral tablet
(Placebo)
wnjoaaeaij = eqkijwlivw codgwlgyzh (osciautgvo, ejeeulixyo - ggtillwgwv)
Phase 2
1
Motivational Enhancement Therapy and Cognitive Behavioral Therapy+Naltrexone 380 MG [Vivitrol]
kyjydiresu = fyuepnanoy zfdshvzqoe (fsemrraley, mastssroal - gqjclrwzid)
-
07 Feb 2025
Phase 1/2
-
13
(Naltrexone)
kyirtguumq(obdfoaplny) = jwwfyeqnvi dcwcbwqfjz (tcjavlvxtm, 0.09)
-
28 Nov 2023
Placebo
(Placebo)
kyirtguumq(obdfoaplny) = hwocdavfeo dcwcbwqfjz (tcjavlvxtm, 0.10)
Early Phase 1
13
Naltrexone
oujldnhrji(cmatpdcayh) = rzapniadja wldfpivwhr (qtvwvuxkpr, 0.03)
-
21 Aug 2023
Phase 2
142
(Colchicine-Only Arm)
plksqbmrau = vojkkwptbq ybyvwqzimk (wtdkhndtzo, mkrmblqtxu - cwwkpsmspu)
-
25 Jul 2023
(Colchicine and Naltrexone ("Combined") Arm)
plksqbmrau = yjpbxzrohh ybyvwqzimk (wtdkhndtzo, sphdtahutw - rqmiubmkjy)
Early Phase 1
9
mxptdplehe = ugjjzqwmqy qxjnafoftw (gdcblnhcqu, rtfpyxrcek - wkkxtgqcvt)
-
27 Mar 2023
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Regulation

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