Drugs / Nalmefene
Nalmefene
also known as
Nalmefene Hydrochloride · Selincro · JF-1 HYDROCHLORIDE · JKB-121 · Nalmefene HCl · NALMEFENE HYDROCHLORIDE DIHYDRATE · Nalmefene hydrochloride hydrate · Nalmefene Hydrochloride Injection · +10 more
Small molecule targets OPRD1, OPRK1, OPRM1 via inhibition / activation
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Selincro | — | 2013-02-24 | europa.eu ↗ |
| Approved | US (FDA) | REVEX | — | 1995-04-17 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02372318 | Apr 2015 → May 2016 | alcohol dependence | Central Institute of Mental Health, Mannheim | Terminated | No outcome recorded Stop: Enrollment |
| Phase 112 trials · 1 met primary | ||||||
| Phase 1 | NCT06198686 | Jan → Feb 2024 | — | Tharimmune Inc | Completed | No outcome recorded |
| Phase 1 | NCT06719986 | Oct → Dec 2022 | acute opioid poisoning | Purdue Pharma LP | Completed | No outcome recorded |
| Phase 1 | NCT05338632 | Jun 2022 → Aug 2026 overdue | respiratory underresponsiveness to hypoxia and hypercapnia, substance-related disorder | Leiden University Medical Center | Recruiting | Mixed |
| Phase 1 | NCT05219669 | Sep → Nov 2021 | acute opioid poisoning | Opiant Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT04828005 | Mar 2021 → Mar 2022 | — | Opiant Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT04759768 | Feb → May 2021 | — | Opiant Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT03279562 | Sep 2017 → Dec 2019 | alcohol abuse, opiate dependence | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT03129347 | Jun 2017 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT02639273 | Jun 2016 → Dec 2023 | — | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase 1 | NCT02679469 | Feb → Mar 2016 | alcohol dependence | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01969617 | Nov 2013 → Oct 2014 | alcohol dependence | H. Lundbeck A/S | Completed | Met primary |
| Phase 1 | NCT01934166 | Jul 2013 → Aug 2014 | impaired renal function disease | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03278886 | Jul → Dec 2018 | HIV infectious disease, alcohol-related disorders | Boston Medical Center | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT06733519 | Jun 2026 → Mar 2027 expected | primary biliary cholangitis | Tharimmune Inc | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02934919 | Dec 2016 → Mar 2018 | Parkinson disease, impulse control disorder | University Hospital, Clermont-Ferrand | Unknown | No outcome recorded |
| Phase 2 | NCT03034408 | Jul 2016 → Dec 2018 | alcohol-related disorders | Prof. Daniele Zullino | Completed | No outcome recorded |
| Phase 2 | NCT00838708 | Jan → Jul 2009 | atopic eczema | Serentis Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00202696 | Sep 2005 → Mar 2006 | — | Somaxon Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00132119 | Aug 2005 → Aug 2006 | pathological gambling | Somaxon Pharmaceuticals | Completed | No outcome recorded |
| Phase 38 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06408714 | Aug → Dec 2024 | acute opioid poisoning | University of New Mexico | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05540288 | Mar 2023 → Jul 2027 expected | — | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT02824354 | Dec 2018 → Dec 2022 | alcohol dependence, cirrhosis of liver | Centre Hospitalier Universitaire, Amiens | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02382276 | Jul 2015 → Jan 2017 | alcohol dependence | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02364947 | Feb 2015 → Jul 2016 | alcohol dependence | Otsuka Pharmaceutical Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT00811941 | Mar 2009 → Nov 2010 | alcohol dependence | H. Lundbeck A/S | Completed | Missed primary |
| Phase 3 | NCT00812461 | Mar 2009 → Mar 2011 | alcohol dependence | H. Lundbeck A/S | Completed | Mixed |
| Phase 3 | NCT00811720 | Dec 2008 → Oct 2010 | alcohol dependence | H. Lundbeck A/S | Completed | Met primary |
| Phase 44 trials · 1 met primary | ||||||
| Phase 4 | NCT05808881 | Jun 2023 → May 2024 | acute opioid poisoning | Purdue Pharma LP | Withdrawn | No outcome recorded |
| Phase 4 | NCT04713358 | Sep 2021 → Dec 2023 | — | RenJi Hospital | Completed | Met primary |
| Phase 4 | NCT02197598 | Sep 2014 → Dec 2015 | alcohol dependence | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 4 | NCT02195817 | Aug 2014 → Feb 2016 | alcohol dependence | H. Lundbeck A/S | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02752503 | Mar 2015 → Jun 2016 | alcohol-related disorders, borderline personality disorder | Sant Pau Research Institute | Unknown | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT07325279 Comparator | Feb → Dec 2026 expected | opioid abuse | ReacX Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07543276 Comparator | Feb → Apr 2026 | acute opioid poisoning | Knoa Pharma LLC | Completed | No outcome recorded |
| Phase 2 | NCT02442687 Comparator | Aug 2015 → Sep 2017 | metabolic dysfunction-associated steatohepatitis | Manal Abdelmalek | Completed | No outcome recorded |
| — | NCT03096730 Comparator | Feb → Dec 2017 | — | Tianjin Medical University General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-05-22 | Indivior Inc. | Regulatory Indivior | Indivior PLC – OPVEE FDA Approval indivior.com ↗
Indivior PLC (LSE: INDV) today announced that the U.S. Food and Drug Administration (FDA) approved OPVEE® (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. |
| 2019-01-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Selincro (nalmefene) Tablets 10mg Receives Regulatory Approval in Japan otsuka.co.jp ↗
Otsuka has received regulatory approval in Japan for the manufacture and sale of Selincro Tablets 10 mg |
| 2017-10-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Submits a Japan NDA for Nalmefene, a Drug to Reduce Alcohol Consumption in Alcohol-Dependent Patients otsuka.co.jp ↗
Otsuka and Lundbeck today announce the submission by Otsuka of a new drug application (NDA) for nalmefene hydrochloride (nalmefene) for patients with alcohol dependency. |
| 2017-06-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Nalmefene, a Drug Candidate to Reduce Alcohol Consumption, Shows Positive Results from Phase III Trial in Japan otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce topline, positive results in Japan from a phase III comparative clinical trial and a follow-on, long-term extension study of nalmefene hydrochloride (nalmefene) in participants with an alcohol dependency. |
All press releases naming this drug 11 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nalmefene | “Immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery” NCT04713358 ↗ |
| Known as | JF-1 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | JKB-121 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02442687 ↗ |
| Known as | Nalmefene HCl | “Nalmefene HCl injection” NCT06719986 ↗ |
| Known as | Nalmefene Hydrochloride | “3 mg IN Nalmefene Hydrochloride dose (one 0.1 mL spray of a 30 mg/mL solution in one nostril)” NCT05219669 ↗3“Nalmefene Hydrochloride (HCl) injection” NCT06719986 ↗ “Drug: Nalmefene hydrochloride” NCT02364947 ↗ “Drug: Nalmefene hydrochloride” NCT02382276 ↗ |
| Known as | NALMEFENE HYDROCHLORIDE DIHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Nalmefene hydrochloride hydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Nalmefene Hydrochloride Injection | “Drug: Nalmefene Hydrochloride Injection” NCT05808881 ↗ |
| Known as | Nalmefeno | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Nalmetrene | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Opvee | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | ORF 1167 | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | ORF 11676 | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Revex | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Selincro | “Drug : 'Nalmefene (Selincro®) 18 mg tablet is a white, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with "S" on one side. It contains 18.06 mg nalmefene (in the...” NCT02824354 ↗ |
| Known as | SRD174 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00838708 ↗ |
| Known as | Th-104 | “Th-104 Nalmefene Mucoadhesive Buccal strip” NCT06733519 ↗ |
| Known as | Zurnai | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Known as | Zurnai (autoinjector) | ChEMBL registry synonym — accepted as the source's own label CHEMBL982 ↗ |
| Action | Activate | “Kappa opioid receptor partial agonist” CHEMBL982 ↗ |
| Action | Inhibit | “Nalmefene is a µ and δ opioid receptor antagonist, κ opioid receptor partial agonist” PMID 28216062 ↗ Jan 2017 |
| Modality | Small molecule | “JKB-121 is a long-acting small molecule” NCT02442687 ↗ |
| Route | Oral | “administered orally” NCT00132119 ↗ |
| Target | OPRD1 | “Delta opioid receptor antagonist” CHEMBL982 ↗ |
| Target | OPRK1 | “Kappa opioid receptor partial agonist” CHEMBL982 ↗ |
| Target | OPRM1 | “Mu opioid receptor antagonist” CHEMBL982 ↗ |