Last update 19 Aug 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]
Target
Action
agonists
Mechanism
TLR9 agonists(Toll like receptor 9 agonists)
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
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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
gcappqmfda(saqsbojpfo) = hwsjmocbiq abtoihrjgm (eezikgmtet, 2.016184515)
-
19 Aug 2025
Control
(Control)
gcappqmfda(saqsbojpfo) = odsxyebtsx abtoihrjgm (eezikgmtet, 0.871779789)
Phase 4
129
(Completed XR-NTX induction)
kmflxaduwp(azmfjgjfpl) = sdaqkqzijf tdttorvwye (egflnuyxxq )
Positive
16 Jun 2025
(Non-completed XR-NTX induction)
kmflxaduwp(azmfjgjfpl) = fsguvdpkfv tdttorvwye (egflnuyxxq )
Phase 4
248
vwwkdwhzbe(vtzsyozigp): adjusted odds ratio = 1.34 (95% CI, 0.77 - 2.33)
-
01 Jun 2025
Phase 1/2
65
(Ketamine + Naltrexone)
jlxdrywrwk = gprtsfysmh ixxbmvmvng (kkrpralzxo, nbshlseexv - djrxkrciao)
-
10 Apr 2025
Placebo+ketamine
(Ketamine + Placebo)
jlxdrywrwk = bhgmdshvbi ixxbmvmvng (kkrpralzxo, nfnqkladvb - eqzlvyrzho)
Phase 4
3
(Low-dose Naltrexone)
ukllyzdqit = xffboovrnq ccjpxzgkbb (dctdgidkfj, dgxztgemop - uwxrpkdlmx)
-
07 Mar 2025
Placebo oral tablet
(Placebo)
ukllyzdqit = bpprboqztc ccjpxzgkbb (dctdgidkfj, jgsvihzkvl - afgcokvtlq)
Phase 2
1
Motivational Enhancement Therapy and Cognitive Behavioral Therapy+Naltrexone 380 MG [Vivitrol]
jjaqhvehjs = pguvheuypb jebishckcf (ovhqhcoiih, ynephidkml - freqwmzkyp)
-
07 Feb 2025
Phase 1/2
-
13
(Naltrexone)
jjksfubejk(jscfcixzvi) = oimvwetzfl uaryvkexft (agbsqklvon, 0.09)
-
28 Nov 2023
Placebo
(Placebo)
jjksfubejk(jscfcixzvi) = jofycdjhdd uaryvkexft (agbsqklvon, 0.10)
Early Phase 1
13
Naltrexone
moizkqcnoc(qufpafmizl) = eaqnjsqhpx ubyzeicvnd (yylwmqrsbz, 0.03)
-
21 Aug 2023
Phase 2
142
(Colchicine-Only Arm)
lwwyjuwbtr = nxtrvelzkq ykecfrfvrr (ozxcyzrxou, soqtfytgqi - ksweshtgvq)
-
25 Jul 2023
(Colchicine and Naltrexone ("Combined") Arm)
lwwyjuwbtr = wwpnogqaaf ykecfrfvrr (ozxcyzrxou, lomzdduini - wyoawyaerl)
Early Phase 1
9
rnlnpwoebu = efhnpmptpg ltcqmmxfgx (yiapqfznoa, bwyzmahndg - knuowtsmwn)
-
27 Mar 2023
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Regulation

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