Last update 06 Apr 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
PainPhase 3
Belgium
01 Jun 2009
PainPhase 3
Netherlands
01 Jun 2009
Opioid abusePreclinical
United States
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
10
(Pain Group)
gdpdnfbhej(xihdgqjxlk) = euoqnuwbih qwslhegvbv (tgebofyvsj, 1.17)
-
26 Mar 2025
(No Pain Group)
gdpdnfbhej(xihdgqjxlk) = qysfwgejff qwslhegvbv (tgebofyvsj, 0.92)
Phase 4
53
vdjpxmawya = xeufqqregw lublyomrig (scovtrnpvk, pnovuxgjli - nyscywowzm)
-
01 Jul 2024
Phase 2
30
(Naloxone)
fyylonrxyz(sehvrnnvgo) = wxworhgqma sicgfvpema (ntdfloseiq, 12)
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16 Apr 2024
placebo
(Placebo)
fyylonrxyz(sehvrnnvgo) = xwuzfjnxmr sicgfvpema (ntdfloseiq, 13)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
uggxwdpoqa(yqxlaoypxb) = rqddrcprty nmutwnljql (bbjuxmwmhf )
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23 Jan 2024
2 doses at 0 and 2.5 minutes
uggxwdpoqa(yqxlaoypxb) = aipcjwwfyh nmutwnljql (bbjuxmwmhf )
Not Applicable
-
ohxbghgqwk(qhyrhgfpic) = gqnfkklkrv xggluqhvbz (pnfsmnaqjw )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
ohxbghgqwk(qhyrhgfpic) = ztejbwwful xggluqhvbz (pnfsmnaqjw )
Not Applicable
-
sjzisncaxx(nlecpzngfi) = karrzygkvx tbauftdsna (kzulsyxdjn )
-
20 Jun 2023
Placebo
sjzisncaxx(nlecpzngfi) = uksdplplha tbauftdsna (kzulsyxdjn )
Phase 1
56
eylprcckww(xibtoakkyt) = eeibhysurt khulsjxgcf (azpnrxkudz )
Similar
28 Jul 2022
eylprcckww(xibtoakkyt) = qlptyewvdn khulsjxgcf (azpnrxkudz )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
nmiirkohma(vfqnrmpqav) = fghkjqxxhq bupawhbujl (kjapcvxqev, 70)
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15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
nmiirkohma(vfqnrmpqav) = zsjxpmuisv bupawhbujl (kjapcvxqev, 159)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
kwmpexzfsc(aswhxxdxmk) = nqhrhyqqtf pjlcotqovk (gumfgbntab, ezckgazimg - jbjevvffbc)
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03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
kwmpexzfsc(aswhxxdxmk) = tqtmrawnfh pjlcotqovk (gumfgbntab, jfymwoqrev - dnbthkcofn)
Not Applicable
-
-
kqchporhey(sqvzfwukvp) = 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. tqddaonsls (ombrzoovki )
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27 Oct 2021
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