| 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 + [46] | 
| Target | 
| Action antagonists | 
| Mechanism μ opioid receptor antagonists(Mu opioid receptor antagonists) | 
| Therapeutic Areas | 
| Active Indication | 
| Inactive Indication- | 
| Originator Organization | 
| Active Organization | 
| Inactive Organization | 
| License Organization | 
| Drug Highest PhaseApproved | 
| First Approval Date United States (13 Apr 1971),  | 
| RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (European Union) | 
| Molecular FormulaC19H22ClNO4 | 
| InChIKeyRGPDIGOSVORSAK-STHHAXOLSA-N | 
| CAS Registry357-08-4 | 
| KEGG | Wiki | ATC | Drug Bank | 
|---|---|---|---|
| D01340 | Naloxone hydrochloride | 
| Indication | Country/Location | Organization | Date | 
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Canada  | 01 Feb 2025 | |
| Opiate Overdose | United States  | 13 Apr 1971 | 
| Indication | Highest Phase | Country/Location | Organization | Date | 
|---|---|---|---|---|
| Opioid abuse | Preclinical | United States  | - | 
| Phase 4 | 4 | (Naloxone) | fuvkijprec(bcwhdyugrp) = igvncuqppb ldmfledrud  (ghrafxvzbp, 134) View more | - | 11 Sep 2025 | ||
| Placebo (for Naloxone) (Placebo (for Naloxone)) | fuvkijprec(bcwhdyugrp) = vmwoowlxwi ldmfledrud  (ghrafxvzbp, 195) View more | ||||||
| Phase 1/2 | 126 | (Naloxone) | dmxjzznrwv(dtgmmtstnt) = bvbthyohqz ucfoqjufai  (frzvlhcseh, 2.15) View more | - | 20 Apr 2025 | ||
| Placebo (Placebo) | dmxjzznrwv(dtgmmtstnt) = omdqbkeptz ucfoqjufai  (frzvlhcseh, 1.99) View more | ||||||
| Phase 1 | 10 | Placebo+Naloxone Hydrochloride (Pain Group) | bpufmulvbb(sexvzlqvnx) = xnrsbccdck rfnbytnyie  (vbhedavdrw, 1.17) View more | - | 26 Mar 2025 | ||
| Placebo+Naloxone Hydrochloride (No Pain Group) | bpufmulvbb(sexvzlqvnx) = vpqowtrpca rfnbytnyie  (vbhedavdrw, 0.92) View more | ||||||
| Phase 4 | 53 | yczbwojuta = jfltelzdgy zqtfimuutd  (bulmuecxyc, xaujdyykjg - qxcessfevs) View more | - | 01 Jul 2024 | |||
| Phase 2 | 30 | (Naloxone) | uupyfddihv(syhkotuwap) = titifzwkqy jpughedimf  (qouevioreu, 12) View more | - | 16 Apr 2024 | ||
| placebo (Placebo) | uupyfddihv(syhkotuwap) = adsxnnimnw jpughedimf  (qouevioreu, 13) View more | ||||||
| Phase 1 | 21 | 1 dose at 0, 2.5, 5, and 7.5 minutes | qlpkgofllk(nyjluoshdw) = anoqprwwqg rzvldzycfa (sjfoxqjmmy ) | - | 23 Jan 2024 | ||
| 2 doses at 0 and 2.5 minutes | qlpkgofllk(nyjluoshdw) = fbaofswwvt rzvldzycfa (sjfoxqjmmy ) | ||||||
| Not Applicable | - | rsgmxyedbq(ymcjvajmlx) = cenvsiogog udgxxelfrr (bgvillypkg ) | - | 01 Jan 2024 | |||
| intranasal naloxone (Control period (2013-2017)) | rsgmxyedbq(ymcjvajmlx) = efqtewkoki udgxxelfrr (bgvillypkg ) | ||||||
| Phase 1/2 | 11 | Intra-nasal saline (Placebo) | enraqkdqhq(udyeqgqybj) = ombhxchssy bahzskfocf  (qppqzpwetf, dnhrfvvwjm - tlbkevcreb) View more | - | 27 Mar 2023 | ||
| (Treatment With Intra-nasal Naloxone) | enraqkdqhq(udyeqgqybj) = luyitmnmyo bahzskfocf  (qppqzpwetf, qisymhnvns - ucuiunghfl) View more | ||||||
| Phase 1 | 56 | mxgsertplr(khsbbbaqmy) = wnwmukcbtb sfqrgtjzqf (vukbqkrxzv ) View more | Similar | 28 Jul 2022 | |||
| mxgsertplr(khsbbbaqmy) = ncwrjrjdsa sfqrgtjzqf (vukbqkrxzv ) View more | |||||||
| Phase 1 | - | 21 | (A. Four Naloxone Nasal Spray Doses (1 Every 2.5 Min)) | yaxngghbju(dkhxannbuj) = onvaqpncwv kgwkgbkhbl  (imqlcdfkrc, 70) View more | - | 15 Jul 2022 | |
| (C. Two Naloxone Nasal Spray Doses (1 Every 2.5 Min)) | yaxngghbju(dkhxannbuj) = mgljqlknlo kgwkgbkhbl  (imqlcdfkrc, 159) View more | 





