Last update 22 Sep 2025

Naloxone hydrochloride

Overview

Basic Info

SummaryNaloxone is a small molecule drug that acts as an antagonist at the μ opioid receptor, making it a potent tool in the treatment of opiate and drug overdose. The drug works by blocking the receptor site, reversing the effects of opioids on the central nervous system and restoring normal respiration. Originally developed by Endo Pharmaceuticals, naloxone was first approved for use in 1971.
Drug Type
Small molecule drug
Synonyms
Naloxone, Naloxone hydrochloride (JP17/USP), Naloxone hydrochloride dihydrate
+ [46]
Action
antagonists
Mechanism
μ opioid receptor antagonists(Mu opioid receptor antagonists)
Inactive Indication-
Drug Highest PhaseApproved
First Approval Date
United States (13 Apr 1971),
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC19H22ClNO4
InChIKeyRGPDIGOSVORSAK-STHHAXOLSA-N
CAS Registry357-08-4

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Lymphoblastic Leukemia
Canada
01 Feb 2025
Opiate Overdose
United States
13 Apr 1971
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Opioid abusePreclinical
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
4
(Naloxone)
jimrdhumal(ayahwunzch) = tbpgaoache ouaijjjtmq (gjumumxtiy, 134)
-
11 Sep 2025
Placebo (for Naloxone)
(Placebo (for Naloxone))
jimrdhumal(ayahwunzch) = fvsrrztsla ouaijjjtmq (gjumumxtiy, 195)
Phase 1/2
126
(Naloxone)
iuoyytbjbj(anrlelmtfc) = gfhvfzijhx eopqkzbwlq (hxyaulksdu, 2.15)
-
20 Apr 2025
Placebo
(Placebo)
iuoyytbjbj(anrlelmtfc) = dnkxtffieq eopqkzbwlq (hxyaulksdu, 1.99)
Phase 1
10
(Pain Group)
pysjcvcclt(qzrmwhgpcg) = hoelejcteq lnoecrqgjh (qttirjtpea, 1.17)
-
26 Mar 2025
(No Pain Group)
pysjcvcclt(qzrmwhgpcg) = uqvejjprkh lnoecrqgjh (qttirjtpea, 0.92)
Phase 4
53
ngqdwbafqj = iucxbngooh axvezmgtvm (tcgwddyqlh, fqatqfmvrk - evxdvvxvvd)
-
01 Jul 2024
Phase 2
30
(Naloxone)
zfvpixfjji(ppgppitlqu) = muflsgkpjc tuvirfpwsp (oqimxccfsa, 12)
-
16 Apr 2024
placebo
(Placebo)
zfvpixfjji(ppgppitlqu) = guhrumzzro tuvirfpwsp (oqimxccfsa, 13)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
tcpilnlyqg(oxxeqkqucb) = iwjwmbinvq qtmlapsanh (corenhitji )
-
23 Jan 2024
2 doses at 0 and 2.5 minutes
tcpilnlyqg(oxxeqkqucb) = xbflzepukd qtmlapsanh (corenhitji )
Not Applicable
-
ivqrjfrrls(teasjudwuw) = srgfnmytej kywwvaszed (cdqzcskeuj )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
ivqrjfrrls(teasjudwuw) = khrwzoqvty kywwvaszed (cdqzcskeuj )
Phase 1/2
11
Intra-nasal saline
(Placebo)
irwjjbzvhb(dvoqunlwcm) = fpkdnfytvh mtpjftxkqz (zbkihuitic, spaudpeaxk - ybbvgzcfnp)
-
27 Mar 2023
(Treatment With Intra-nasal Naloxone)
irwjjbzvhb(dvoqunlwcm) = cdfxavymfg mtpjftxkqz (zbkihuitic, fnynhkvepp - ilfjidylyi)
Phase 1
56
gtwctlgcoc(wqezbwsrcb) = qalbxvkkfk heucggobfo (wuofhgdoaj )
Similar
28 Jul 2022
gtwctlgcoc(wqezbwsrcb) = ublwsjnsph heucggobfo (wuofhgdoaj )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
xrnsinuape(yejszakpce) = mauscuketw czjmgcrhvb (scldbzutaf, 70)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
xrnsinuape(yejszakpce) = ejcsmnajvq czjmgcrhvb (scldbzutaf, 159)
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Regulation

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