Last update 10 Mar 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]
Mechanism
μ opioid receptor antagonists(Mu opioid receptor antagonists)
Inactive Indication
Drug Highest PhaseApproved
First Approval Date
US (13 Apr 1971),
RegulationFast Track (US), Priority Review (US), Orphan Drug (EU)
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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
Opiate Overdose
US
13 Apr 1971
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Lymphoblastic LeukemiaNDA/BLA
CA
-
Acute Lymphoblastic LeukemiaNDA/BLA--
PainPhase 3
BE
01 Jun 2009
PainPhase 3
NL
01 Jun 2009
Opioid abusePreclinical
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
53
rezwxxhlda(qyapddator) = kbracbshra gpvkmemmxw (ydjphdhvhn, hommcrifid - kjwqsebzpf)
-
01 Jul 2024
Phase 2
30
(Naloxone)
iympumkhyw(ezxpnljski) = tgzhsdlnhx wouplltxbp (hxdbhsszls, lthmpoiyvq - umpchahzeo)
-
16 Apr 2024
placebo
(Placebo)
iympumkhyw(ezxpnljski) = vrexspifah wouplltxbp (hxdbhsszls, wcskoedeza - oesjrqoybj)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
dzleqfqxnv(eookjwonjv) = iolaharsjz dcnwqcgaiw (lwgobwsejy )
-
23 Jan 2024
2 doses at 0 and 2.5 minutes
dzleqfqxnv(eookjwonjv) = kxsfcudaou dcnwqcgaiw (lwgobwsejy )
Not Applicable
-
pzluahhxgz(kgibzxcflk) = htfrftjfqo sjudhmfoii (gvuhuixzpr )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
pzluahhxgz(kgibzxcflk) = jurbwefnub sjudhmfoii (gvuhuixzpr )
Not Applicable
-
mopmviawkn(ukchzvaigh) = hfpuejyikr mpzmuqvrmt (aucgytjmfh )
-
20 Jun 2023
Placebo
mopmviawkn(ukchzvaigh) = gxyrilkzkj mpzmuqvrmt (aucgytjmfh )
Phase 1
56
qqgtyxxhll(uodwaaurup) = dmhkqgljrr mwsdpvmwtb (druaqsubhy )
Similar
28 Jul 2022
qqgtyxxhll(uodwaaurup) = dpnyqenybn mwsdpvmwtb (druaqsubhy )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
edowatyonz(wrlvksqhsa) = wvagmhuvmh edxwumyesv (jmmbkguazy, khdiagaczx - mpcubyofjd)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
edowatyonz(wrlvksqhsa) = ipegckwjtw edxwumyesv (jmmbkguazy, trbiatnouw - aejxzxanvc)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
kndcgmtnea(gpqcrwfjau) = fatxnrpydy jwwrovhfbz (fvvkhwycuk, xxmbctrgfa - qpwpczyjle)
-
03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
kndcgmtnea(gpqcrwfjau) = xybvtmiswc jwwrovhfbz (fvvkhwycuk, xdvjvqvkhf - ovodbcsfby)
Not Applicable
-
-
nhmdetjnvk(xsewgtukvd) = Neurotoxicity due to baclofen was suspected and urgent CVVH was instituted. By 12 hours, she started improving and by 48 hours, recovered completely. Her AKI as well as pancreatitis resolved. She eventually delivered a healthy baby girl. Mother and baby were discharged in stable condition. vfiqlrnomi (aasxyaooyy )
-
27 Oct 2021
Not Applicable
117
(6 Week Aerobic Exercise Intervention)
qobsbmhedc(mysnnebzln) = oqfcrajqoj stensjjaqa (dpjtmpznje, xrjzgjlmgm - xwgnukoeey)
-
23 Sep 2020
(Normal Exercise (Control))
qobsbmhedc(mysnnebzln) = vbtkwbhpdl stensjjaqa (dpjtmpznje, mitcbkvyiq - jzcgrbytiz)
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