25 completed, 3 terminated, 3 withdrawn, 2 unknown. 14 Phase 1, 9 Phase 3, 6 Phase 2, 4 Phase 4, 2 Not applicable.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis Nalmefene, Placebo - Pruritus, Primary Biliary Cholangitis | Phase 2 | Not yet recruiting | Tharimmune Inc | 40 | 2026-06-01 | 2025-09-09 |
| Pharmacokinetic (PK) Evaluation of Nalmefene Formulations Nalmefene + 0.94% MgCl2, Nalmefene Hydrochloride Injection - Opioid Overdose | Phase 1 | Completed | Knoa Pharma LLC | 13 | 2026-02-06 | 2026-06-05 |
| Nalmefene vs Naloxone for the Treatment of Recurrent Respiratory Depression After Opioid Overdose Nalmefene Injection, Naloxone Injection - Opioid Overdose, Opiate Overdose | Phase 3 | Withdrawn | University of New Mexico | 2024-08-26 | 2025-02-10 | |
| An Evaluation of The Absolute Bioavailability of TH104 Nalmefene - Healthy | Phase 1 | Completed | Tharimmune Inc | 20 | 2024-01-26 | 2025-04-08 |
| Clinical Outcomes From Nalmefene Nalmefene Hydrochloride Injection, Naloxone Hydrochloride Injection - Opioid Overdose | Phase 4 | Withdrawn | Purdue Pharma LP | 2023-06-01 | 2023-07-12 | |
| NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions Nalmefene, Placebo - Behavioural Addiction | Phase 3 | Recruiting | Nantes University Hospital | 266 | 2023-03-31 | 2025-02-12 |
| Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg Nalmefene HCl injection, Naloxone HCl intranasal - Opioid Overdose | Phase 1 | Completed | Purdue Pharma LP | 24 | 2022-10-03 | 2025-07-03 |
| Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists Narcan 40 MG/ML Nasal Spray, Naloxone Hydrochloride, Nalmefene HCl injection - Opioid Induced Respiratory Depression, Chronic Opioid Use | Phase 1 | Terminated | Leiden University Medical Center | 58 | 2022-06-24 | 2026-07-29 |
| Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia Nalmefene, normal Saline - Resuscitation | Phase 4 | Completed | RenJi Hospital | 542 | 2021-09-24 | 2026-02-25 |
| Pharmacokinetic Evaluation of Intranasal Nalmefene Using Three Dosing Regimens Nalmefene Hydrochloride - Opioid Overdose | Phase 1 | Completed | Opiant Pharmaceuticals Inc | 24 | 2021-09-01 | 2024-08-05 |
| Pharmacodynamic Evaluation of Intranasal Nalmefene Nalmefene hydrochloride, Naloxone hydrochloride - Pharmacodynamic | Phase 1 | Completed | Opiant Pharmaceuticals Inc | 84 | 2021-03-30 | 2025-07-14 |
| Pharmacokinetic Evaluation of Intranasal Nalmefene Nalmefene Hydrochloride, Nalmefene - Pharmacokinetics | Phase 1 | Completed | Opiant Pharmaceuticals Inc | 68 | 2021-02-08 | 2024-08-13 |
| Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence. Nalmefene (Selincro®) 18 mg tablet, placebo - Cirrhosis, Alcohol Dependence | Phase 3 | Withdrawn | Centre Hospitalier Universitaire, Amiens | 2018-12-01 | 2023-07-20 | |
| St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene Low dose naltrexone, Nalmefene - HIV Infection, Alcohol Use | Phase 1 / Phase 2 | Completed | Boston Medical Center | 11 | 2018-07-03 | 2020-08-24 |
| Patient Driven Recovery With Nalmefene and Coaching Nalmefene - Opioid-use Disorder, Harmful; Use, Alcohol | Phase 1 | Completed | Yale University | 10 | 2017-09-01 | 2021-01-22 |
| Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers Nalmefene - Opioid-Related Disorders | Phase 1 | Completed | National Institute on Drug Abuse (NIDA) | 14 | 2017-06-01 | 2018-03-26 |
| Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia Normal saline, Remifentanil, Sufentanil - Pain, Anesthesia | Not applicable | Completed | Tianjin Medical University General Hospital | 150 | 2017-02-06 | 2021-08-03 |
| Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study Nalmefene - Impulse Control Disorders, Parkinson Disease | Phase 2 | Unknown | University Hospital, Clermont-Ferrand | 30 | 2016-12-01 | 2016-10-17 |
| Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects Nalmefene, Baclofen, Placebo Oral Capsule - Alcohol Use Disorder | Phase 2 | Completed | Prof. Daniele Zullino | 37 | 2016-07-01 | 2020-10-29 |
| Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation Nalmefene, Placebo - AUD | Phase 1 | Completed | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | 13 | 2016-06-08 | 2026-10-29 |
Showing 20 of 35. Sign in to see all of them.
Alcoholism (14) · Opiate Overdose (5) · Alcohol-Related Disorders (3) · Mental Disorders (3) · Alcohol Drinking (2) · Gambling (2) · Opioid-Related Disorders (2) · Pain (2) · Borderline Personality Disorder (1) · Compulsive Sexual Behavior Disorder (1) · Disruptive, Impulse Control, and Conduct Disorders (1) · Drug Overdose (1) · Fibrosis (1) · Food Addiction (1) · HIV Infections (1)
H. Lundbeck A/S (7) · Opiant Pharmaceuticals Inc (3) · Otsuka Pharmaceutical Co., Ltd. (3) · Purdue Pharma LP (2) · Somaxon Pharmaceuticals (2) · Tharimmune Inc (2) · Boston Medical Center (1) · Central Institute of Mental Health, Mannheim (1) · Centre Hospitalier Universitaire, Amiens (1) · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (1) · Knoa Pharma LLC (1) · Leiden University Medical Center (1) · Nantes University Hospital (1) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) (1) · National Institute on Drug Abuse (NIDA) (1)
United States (11) · France (6) · Germany (5) · Japan (3) · Spain (3) · United Kingdom (3) · China (2) · Czechia (2) · Poland (2) · Russia (2) · Austria (1) · Belgium (1) · Estonia (1) · Finland (1) · Hungary (1)
Philip Jochelson, MD (2) · Caitlin Bonney, MD (1) · Daniele F Zullino, MD (1) · Debra Kelsh, MD (1) · Falk Kiefer, Prof. Dr. (1) · Ingela Danielsson, MD (1) · Jeffrey H. Samet, MD, MA, MPH (1) · Juan C Pascual, MD PhD (1) · Jun-ichi Hashimoto, PhD (1)
PMID 25227627, PMID 23873853, PMID 25832297, PMID 37496452, PMID 23237314, PMID 23562264, PMID 28216062, PMID 33682527, PMID 35426492, PMID 36859316, PMID 37530456, PMID 41642634, PMID 41807006
2014 (1), 2015 (1), 2016 (1), UH2AA026193 (1)