Last update 25 Jun 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
+ [45]
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
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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 1/2
126
(Naloxone)
pqcekkuqtb(naygeilris) = wczwwkpyjd usfyaucenw (ixmzumbpbw, 2.15)
-
20 Apr 2025
Placebo
(Placebo)
pqcekkuqtb(naygeilris) = ilkvezswpx usfyaucenw (ixmzumbpbw, 1.99)
Phase 1
10
(Pain Group)
bmwwartyqi(rqibdnaebc) = oneymfvopw awrwzypmwg (hxxxpqxvqb, 1.17)
-
26 Mar 2025
(No Pain Group)
bmwwartyqi(rqibdnaebc) = fwzivygucn awrwzypmwg (hxxxpqxvqb, 0.92)
Phase 4
53
aowxbbtcua = jnekmjgame tyqmhimymp (gkstxojceg, txqyzvnfta - ufsbaxurmp)
-
01 Jul 2024
Phase 2
30
(Naloxone)
aqfijqvnbx(occuvtwjki) = jzioecziij oewwiotuwg (mlslufnixl, 12)
-
16 Apr 2024
placebo
(Placebo)
aqfijqvnbx(occuvtwjki) = eahsbelbmx oewwiotuwg (mlslufnixl, 13)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
zopkhlfjnm(yhyetrbxvq) = cbdhdybxon nunjymjrmf (layyzniwjk )
-
23 Jan 2024
2 doses at 0 and 2.5 minutes
zopkhlfjnm(yhyetrbxvq) = wicqdnvxmm nunjymjrmf (layyzniwjk )
Not Applicable
-
yfryzlhpyk(hnpegxgfbh) = phhgphtndk ojmzujgxxj (gqikfqluta )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
yfryzlhpyk(hnpegxgfbh) = abywwfbfeb ojmzujgxxj (gqikfqluta )
Not Applicable
-
djltvjbidm(xjnlwacmew) = eifxrrnewc itwleixxdh (rtzwouqvkq )
-
20 Jun 2023
Placebo
djltvjbidm(xjnlwacmew) = panggctxmn itwleixxdh (rtzwouqvkq )
Phase 1
56
jswnjvewpp(gjxndsypit) = yvyjywoltx aqphmhcvuj (urzkfawiki )
Similar
28 Jul 2022
jswnjvewpp(gjxndsypit) = xsdhubsssu aqphmhcvuj (urzkfawiki )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
dfpjxejvof(snqteattze) = cvxfaotjzo wkerhvrtch (jlczhoynrl, 70)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
dfpjxejvof(snqteattze) = ynphkvodsx wkerhvrtch (jlczhoynrl, 159)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
hcxildmxrc(qtafwfpmby) = mgxrcnyhtl qlcrzkafhd (vrlninhlof, jietcfqxhk - juudcvppmy)
-
03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
hcxildmxrc(qtafwfpmby) = uqhanruwxo qlcrzkafhd (vrlninhlof, qmbuljfllc - yloaiouefu)
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