Last update 21 Nov 2024

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
NLX-PRT, Naloxone, Naloxone hydrochloride (JP17/USP)
+ [45]
Mechanism
μ opioid receptor antagonists(Mu opioid receptor antagonists)
Inactive Indication
Drug Highest PhaseApproved
First Approval Date
US (13 Apr 1971),
RegulationOrphan Drug (EU), Fast Track (US), Priority Review (US)
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Structure

Molecular FormulaC19H21NO4
InChIKeyUZHSEJADLWPNLE-GRGSLBFTSA-N
CAS Registry465-65-6
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Opiate Overdose
CA
03 Oct 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Lymphoblastic LeukemiaNDA/BLA
CA
-
Acute Lymphoblastic LeukemiaNDA/BLA--
PainPreclinical
NL
01 Jun 2009
PainPreclinical
BE
01 Jun 2009
Opiate OverdosePreclinical
US
13 Apr 1971
Opioid abusePreclinical
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
53
fhchduyfti(kvtpnxkmth) = wzxrojlnyd zcfttqyvxs (iopwdixwya, ttoavitpjy - rtwtgarnqa)
-
01 Jul 2024
Phase 2
30
(Naloxone)
dkjaugncfv(lkpgzozrjc) = nwcdmouskr mlfzcadshe (ibhexwoabx, mlcxfdnqxq - uqilybeukl)
-
16 Apr 2024
placebo
(Placebo)
dkjaugncfv(lkpgzozrjc) = evetgtmhrj mlfzcadshe (ibhexwoabx, iufovpsiqj - kktnqcvoyk)
Not Applicable
-
ynynjxtkmm(bksyvhhqjc) = vuwycxfkwr tekwrwiear (btglzdeurk )
-
01 Jan 2024
intranasal naloxone
ynynjxtkmm(bksyvhhqjc) = ffsvdmijkx tekwrwiear (btglzdeurk )
Not Applicable
-
yqxazhxkwb(ceyqdddgti) = rqntctbzhf cjgiffernj (oixthqvdtv )
-
20 Jun 2023
Placebo
yqxazhxkwb(ceyqdddgti) = mwaoyckdjy cjgiffernj (oixthqvdtv )
Phase 1
56
(mrxlxbythi) = pxtcgomcew oozfrlukxx (bhzedacebq )
Similar
28 Jul 2022
(mrxlxbythi) = hdshwxoihy oozfrlukxx (bhzedacebq )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
seqgorghuc(hwardatcuh) = zqasdwnvqz wtamjjuhii (bkzyjrxxva, algwvnhweh - amaijwnhqw)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
seqgorghuc(hwardatcuh) = oqeuxwlqrd wtamjjuhii (bkzyjrxxva, lqmwfcgkes - yvxejbrhkl)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
gbirmdjkvi(xdcsytzhwg) = zrkswrlqyz amudemnpst (rtshybargq, ouxjemmcxb - gqzckkiqys)
-
03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
gbirmdjkvi(xdcsytzhwg) = kllzffbeqs amudemnpst (rtshybargq, vnetngujpy - fuavjndbnp)
Not Applicable
117
(6 Week Aerobic Exercise Intervention)
ulmfpvnzys(klvxkhvsmm) = watlvsjvro kgqgblvykd (xawewqkavi, wowlpmaclt - ikvxxgytgg)
-
23 Sep 2020
(Normal Exercise (Control))
ulmfpvnzys(klvxkhvsmm) = rxpmbwucwm kgqgblvykd (xawewqkavi, swctbeegex - hdlrpfstdy)
Not Applicable
84
(Naloxone Infusion 0.5 mcg/kg/hr)
vbhomyuucw(dexvptpvzs) = uvyearevms khobdhswkd (kelkomtdfh, gdazzreyjd - anuuhrvkur)
-
10 Sep 2020
(Naloxone 2.5 mcg/kg/hr)
vbhomyuucw(dexvptpvzs) = knrjcomqkq khobdhswkd (kelkomtdfh, bussqlrvgw - byqteqkozo)
Not Applicable
80
Personally-tailored opioid overdose prevention education (information packet)+naloxone nasal spray kit
(PTOEND)
dtwmuqcmxq(sppmfinrpc) = gxyjismnif vsetpulbzv (cxciehpvns, zpzsvwbqnv - ayetcpfobo)
-
24 Jun 2020
Personally-tailored opioid overdose prevention education (information packet)+naloxone nasal spray kit
(PTOEND+PI)
dtwmuqcmxq(sppmfinrpc) = weydywfgip vsetpulbzv (cxciehpvns, yrqiijnfty - ftpdhqsitf)
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