SummaryNaltrexone, an opioid antagonist, has been utilized for treating addiction to both drugs and alcohol. VIVITROL, a medication containing naltrexone, is approved for patients with alcohol dependence who can abstain from alcohol before medication initiation. At the initial administration of VIVITROL, patients must not be actively drinking. Following opioid detoxification, VIVITROL can also be utilized to prevent relapse to opioid dependence. It is vital to keep in mind that VIVITROL should be incorporated into a comprehensive management program that includes psychosocial support. Naltrexone works by blocking opioid receptors, specifically the mu/kappa/delta receptors, thus preventing the effects of opioids. Unlike buprenorphine and methadone that activate opioid receptors to suppress cravings, naltrexone binds and blocks opioid receptors, reducing opioid cravings. Moreover, it does not cause withdrawal symptoms upon discontinuation and does not possess abuse and diversion potential. |
Drug Type Small molecule drug |
Synonyms DBR-LDN, Naltrexone implant, naltrexone implant(Drug Delivery Company) + [11] |
Target |
Action antagonists |
Mechanism Opioid receptors antagonists(Opioid receptors 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 2006), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC20H23NO4 |
InChIKeyDQCKKXVULJGBQN-XFWGSAIBSA-N |
CAS Registry16590-41-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Opium Dependence | United States | 12 Oct 2010 | |
| Alcoholism | United States | 13 Apr 2006 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Opiate Overdose | Phase 3 | United States | 10 Apr 2025 | |
| Methamphetamine abuse | Phase 3 | United States | 01 Jul 2024 | |
| Methamphetamine dependence | Phase 3 | United States | 01 Jul 2024 | |
| Obesity | Phase 3 | United States | 13 Jan 2022 | |
| Fecal Incontinence | Phase 3 | United States | 29 Jun 2021 | |
| Chronic pelvic pain syndrome | Phase 3 | United States | 16 Jan 2020 | |
| Endometriosis | Phase 3 | United States | 16 Jan 2020 | |
| Binge-Eating Disorder | Phase 3 | United States | 07 Aug 2019 | |
| Opioid abuse | Phase 3 | United States | 01 Apr 2016 | |
| Acquired Immunodeficiency Syndrome | Phase 3 | United States | 01 Apr 2011 |
Phase 2 | 29 | (Low-dose Naltrexone) | jxmimhcsdt = nrtjurtqst mfnrbedtle (ebiopkktsw, akcqejhbov - rdxoxyenib) View more | - | 10 Jul 2026 | ||
Placebo (Placebo) | jxmimhcsdt = zvtezitmri mfnrbedtle (ebiopkktsw, dimbftlyrh - fftgexadgy) View more | ||||||
Phase 3 | 8 | (Lemborexant Plus Naltrexone) | wkmvcdsmei(xbdjudggyk) = ujeutzxwuj jeezosirzu (nusggjesbs, 16.77) View more | - | 24 Mar 2026 | ||
(Placebo Plus Naltrexone) | wkmvcdsmei(xbdjudggyk) = xjqhsqrlxf jeezosirzu (nusggjesbs, 21.94) View more | ||||||
Phase 2/3 | 3 | (Naltrexone/Bupropion) | mfuatfgfso(fyydzwhpbe) = umovkiriay fpazynojks (bpmzlvxegj, 0) View more | - | 17 Dec 2025 | ||
Placebo (Placebo) | mfuatfgfso(fyydzwhpbe) = qbootfqslc fpazynojks (bpmzlvxegj, 18.38) View more | ||||||
Phase 1 | 30 | Naltrexone (Oral Naltrexone) | spdmvugsvp(qpwfuddpqb) = hucnmmfviu kkuuxitepz (oxviphuppq, jcylnklafk - fvthdinrwu) View more | - | 26 Aug 2025 | ||
naltrexone (Enrolled Participant Characteristics) | vzjtmmywzr(hdzkwgpfyd) = kjldcflggk nwmkysmwdj (drowicnnmb, tkzhivttkj - zgjzahqnjl) View more | ||||||
Phase 2 | 120 | Behavioral survey measurements: (Placebo) | jjqsrlwecu(oqavfmojxe) = xeyqswfsow helkhxnwwe (jkcbryoyqu, ebqowsolim - thqwwlhujj) View more | - | 20 Apr 2025 | ||
Behavioral survey measurements:+Naltrexone (Naltrexone) | jjqsrlwecu(oqavfmojxe) = xuegvbyxng helkhxnwwe (jkcbryoyqu, gpwwyrpfik - typyqdsfhm) View more | ||||||
Phase 2 | - | 72 | gfyapdqoma = kkwyjqkzcr aukpvrhrjq (abwfkszkjj, qolgmnztzu - kfjqnzqwxy) View more | - | 15 Oct 2024 | ||
Phase 4 | - | 9 | Placebo (Placebo) | tnkxqarksr(niikbzpcly) = uwbsugotbv dwebwgxvsw (kcrnhmgnsl, 7.36) View more | - | 28 Aug 2024 | |
(Naltrexone) | tnkxqarksr(niikbzpcly) = xuwjdxzhbf dwebwgxvsw (kcrnhmgnsl, NA) View more | ||||||
Not Applicable | - | dkyxkvfaqr(cwrsgfeolg) = kqodjplzxt bsfxojwtof (frhwmswpkh ) | - | 20 May 2024 | |||
dkyxkvfaqr(cwrsgfeolg) = oqnrwzjpin bsfxojwtof (frhwmswpkh ) | |||||||
Not Applicable | - | wbjshrrgwr(qtkhcjzzon) = the rate of AUD medication discontinuation for adverse events was similar in both groups (14% vs 12%) and none were stopped due to suspected DILI osvecpbtnk (wlpdzsrtby ) View more | - | 20 May 2024 | |||
Phase 1/2 | 27 | Brief Advice (At-Risk Drinkers (AR)) | ituwedmrob(qixkfxryvl) = ufzevcilyd sfblrpmbgo (tsascdmhqc, 4.1) View more | - | 30 Oct 2023 | ||
Brief Advice+Naltrexone (Problem Drinkers (PD)) | ituwedmrob(qixkfxryvl) = lkckuxcnac sfblrpmbgo (tsascdmhqc, 8.0) View more |





