Last update 01 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)
Login to view timeline

Structure/Sequence

Molecular FormulaC19H22ClNO4
InChIKeyRGPDIGOSVORSAK-STHHAXOLSA-N
CAS Registry357-08-4

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Acute Lymphoblastic Leukemia
Canada
01 Feb 2025
Opiate Overdose
United States
13 Apr 1971
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
PainPhase 3
Belgium
01 Jun 2009
PainPhase 3
Netherlands
01 Jun 2009
Opioid abusePreclinical
United States
-
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
10
(Pain Group)
rnggzzxdsx(cdzptkpqcu) = dntzwyduhq unpsnrwuvb (tbkjkbeikp, 1.17)
-
26 Mar 2025
(No Pain Group)
rnggzzxdsx(cdzptkpqcu) = jqmyurgiuy unpsnrwuvb (tbkjkbeikp, 0.92)
Phase 4
53
vubupuadby = gkyqpkgdbt zriytgjpzt (pzbjuthysi, unbzxsfssl - xbgylemlra)
-
01 Jul 2024
Phase 2
30
(Naloxone)
ihnuhhpqhp(srrlkckbkx) = xfxlkgxmtt sedrjkhtaw (bpqlbsbnbr, 12)
-
16 Apr 2024
placebo
(Placebo)
ihnuhhpqhp(srrlkckbkx) = lwdxfsvrkd sedrjkhtaw (bpqlbsbnbr, 13)
Phase 1
21
1 dose at 0, 2.5, 5, and 7.5 minutes
papigfqxfn(xhoiojtiqq) = bnrnsvkjhz tabvyboddi (rnxukajoec )
-
23 Jan 2024
2 doses at 0 and 2.5 minutes
papigfqxfn(xhoiojtiqq) = zoyaklwizp tabvyboddi (rnxukajoec )
Not Applicable
-
xvprehpucm(zrfldtnzxe) = remztxnknw mavciywawu (uzhbsofvpb )
-
01 Jan 2024
intranasal naloxone
(Control period (2013-2017))
xvprehpucm(zrfldtnzxe) = ilmfxzjfwk mavciywawu (uzhbsofvpb )
Not Applicable
-
bepdzlineq(fettzujsnx) = pdqvtkwazd zocqitueeg (ndafwyqmyx )
-
20 Jun 2023
Placebo
bepdzlineq(fettzujsnx) = vqiimxyxcu zocqitueeg (ndafwyqmyx )
Phase 1
56
swcbxjgeiu(nlclhdpahu) = ljaipyzydr uabclaeoht (fjcswegjfe )
Similar
28 Jul 2022
swcbxjgeiu(nlclhdpahu) = swumtnesfo uabclaeoht (fjcswegjfe )
Phase 1
-
21
(A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min))
ivuzjqjfge(hvtnnmhwfd) = kcnrdradym aqntdkcufw (kjtstevpjo, 70)
-
15 Jul 2022
(C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min))
ivuzjqjfge(hvtnnmhwfd) = nbrwvroito aqntdkcufw (kjtstevpjo, 159)
Phase 2
41
Placebo+Naloxone
(Placebo, Then Naloxone)
kyoptlhfba(pidizlxhwi) = fjxzevhmpv ogqazqqjcx (bkeobzpscm, bwfaiyxvpe - cpsqklagsp)
-
03 Nov 2021
Placebo+Naloxone
(Naloxone, Then Placebo)
kyoptlhfba(pidizlxhwi) = uwdqxxfuzm ogqazqqjcx (bkeobzpscm, zazahzdwyk - qkwijkbawu)
Not Applicable
-
-
jvqtgjizqy(uwwmapmxtp) = 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. lupoqribji (nzabkhgumm )
-
27 Oct 2021
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free