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 · a red edge is where a trial was stopped
| 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 |
| Phase 112 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| Phase 3 | NCT06408714 | Aug → Dec 2024 | acute opioid poisoning | University of New Mexico | Withdrawn | No outcome recorded |
| 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 |
| 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 | No outcome recorded |
| Phase 3 | NCT00812461 | Mar 2009 → Mar 2011 | alcohol dependence | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00811941 | Mar 2009 → Nov 2010 | alcohol dependence | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT00811720 | Dec 2008 → Oct 2010 | alcohol dependence | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 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 21 trial | ||||||
| Phase 2 | NCT02442687 Comparator | Aug 2015 → Sep 2017 | metabolic dysfunction-associated steatohepatitis | Manal Abdelmalek | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03096730 Comparator | Feb → Dec 2017 | — | Tianjin Medical University General Hospital | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-05 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Selincro Tablets 10mg Launched in Japan otsuka.co.jp ↗ |
| 2019-01-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Selincro (nalmefene) Tablets 10mg Receives Regulatory Approval in Japan otsuka.co.jp ↗ |
| 2017-10-17 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Submits a Japan NDA for Nalmefene, a Drug to Reduce Alcohol Consumption in Alcohol-Dependent Patients otsuka.co.jp ↗ |
| 2017-06-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Nalmefene, a Drug Candidate to Reduce Alcohol Consumption, Shows Positive Results from Phase III Trial in Japan otsuka.co.jp ↗ |
| 2013-10-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Named as Lundbeck's Partner in Japan on Nalmefene for the Reduction of Alcohol Consumption otsuka.co.jp ↗ |
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 ↗33 |
| 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” NCT02382276 ↗ “Drug: Nalmefene hydrochloride” NCT02364947 ↗ |
| 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 ↗ |