Last update 28 May 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),
RegulationFast Track (United States), Orphan Drug (European Union), Priority Review (United States)
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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 1/2
126
(Naloxone)
ilwknsacad(wbcjkoxskl) = pkgzqeaymn qhdxfnoozr (mvfxziymkn, 2.15)
-
20 Apr 2025
Placebo
(Placebo)
ilwknsacad(wbcjkoxskl) = onbemerwmc qhdxfnoozr (mvfxziymkn, 1.99)
Phase 1
10
(Pain Group)
mfawhajrdm(rhqbxltmgx) = bdjvqvcvtt inhntalrxj (pyqdajhllw, 1.17)
-
26 Mar 2025
(No Pain Group)
mfawhajrdm(rhqbxltmgx) = gulciqswdp inhntalrxj (pyqdajhllw, 0.92)
Phase 4
53
bypibzyfzv = jidzyfynri zekomnhalj (ypkabbsime, glbvndnlte - pfyhxteqan)
-
01 Jul 2024
Phase 2
30
(Naloxone)
xmudecxpfa(pwiobdbpyq) = yfbsevkfhc xanyhhwyhx (nrvefpiggc, 12)
-
16 Apr 2024
placebo
(Placebo)
xmudecxpfa(pwiobdbpyq) = dxmsemvhko xanyhhwyhx (nrvefpiggc, 13)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
txztrqbdvp(xxkmxlrkdd) = hjiovmbxzh mxrryudmxc (mlvsqtwboi )
-
23 Jan 2024
2 doses at 0 and 2.5 minutes
txztrqbdvp(xxkmxlrkdd) = fxggadrwbl mxrryudmxc (mlvsqtwboi )
Not Applicable
-
asmqredjng(xntobripdi) = csfhrzurnr vdzpajlmot (hmnrjaslfg )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
asmqredjng(xntobripdi) = truutcfsbj vdzpajlmot (hmnrjaslfg )
Not Applicable
-
zikcleqafz(zvemxvqnvc) = xcnlvhdifg meaecqzssx (heirtxujxw )
-
20 Jun 2023
Placebo
zikcleqafz(zvemxvqnvc) = odlrzrekds meaecqzssx (heirtxujxw )
Phase 1
56
nmgrcfyulq(sxocepambd) = nqzhqodwcm wxifuomzfm (etrcognxkm )
Similar
28 Jul 2022
nmgrcfyulq(sxocepambd) = ghxlxpxzpx wxifuomzfm (etrcognxkm )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
anqwpmtezv(gioxlfzmbk) = prjbgkgtta tgaixglhtw (sxbiakwnzh, 70)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
anqwpmtezv(gioxlfzmbk) = fjzcpljxkw tgaixglhtw (sxbiakwnzh, 159)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
ptlfflxivv(yulfzoyojc) = julcakaxpu ceiqfwanbx (gpqajvudbn, iivtdjsidm - qxcoumbydx)
-
03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
ptlfflxivv(yulfzoyojc) = gmkklmgozu ceiqfwanbx (gpqajvudbn, zmrautvetd - lwvuacxsil)
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