Drugs / Acamprosate
Acamprosate
also known as
Campral · Acamprosate calcium · Acamprosate(Campral) · Acamprosato · Aotal · Campral ec · NSC-759186 · SN-102
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CAMPRAL | — | 2004-07-29 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02998151 | Jan 2016 → Nov 2020 | fragile X syndrome | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07204977 | Feb 2026 → Sep 2027 expected | amyotrophic lateral sclerosis | National Institute of Neurological Disorders and Stroke (NINDS) | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00330486 | Apr 2006 → Jun 2007 | alcohol dependence, bipolar disorder | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT06471686 | Dec 2021 → Jul 2023 | alcohol-related disorders | University of Southern California | Completed | No outcome recorded |
| Phase 2 | NCT04287920 | Sep 2020 → Jan 2022 | alcoholic liver disease | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT06312800 | Mar 2016 → Jun 2017 | essential tremor | Henry Ford Health System | Withdrawn | No outcome recorded |
| Phase 2 | NCT02361242 | Jun 2013 → Dec 2015 | Alzheimer disease | Pharnext S.C.A. | Completed | No outcome recorded |
| Phase 2 | NCT02361424 | Feb 2013 → Jun 2015 | Alzheimer disease | Pharnext S.C.A. | Completed | No outcome recorded |
| Phase 2 | NCT00605904 | Jan 2008 → Sep 2010 | alcohol dependence | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase 2 | NCT00385268 | Nov 2006 → May 2008 | cocaine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00360594 | Oct 2006 → Sep 2007 | alcohol dependence | Forest Laboratories | Completed | No outcome recorded |
| Phase 2 | NCT00106106 | Mar 2005 → Jul 2010 | alcohol dependence | National Institutes of Health Clinical Center (CC) | Completed | No outcome recorded |
| Phase 2 | NCT00004552 | ? → Dec 2002 | alcohol dependence | Yale University | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00511940 | Apr 2007 → Jan 2011 | binge eating disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00463346 | Sep 2006 → Jul 2015 | alcohol dependence, schizophrenia | Yale University | Completed | No outcome recorded |
| Phase 3 | NCT00006206 | Aug 1997 → May 2006 | alcohol dependence | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT00855699 | Nov 2009 → Jul 2010 | alcohol dependence | University of Bristol | Completed | No outcome recorded |
| Phase 4 | NCT00688324 | Jun 2008 → Feb 2012 | schizoaffective disorder, schizophrenia | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 4 | NCT00571103 | Oct 2007 → Jul 2009 | pathological gambling | University of Iowa | Completed | No outcome recorded |
| Phase 4 | NCT00466661 | Apr 2007 → Feb 2010 | alcohol dependence, bipolar disorder | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT00452543 | Mar 2007 → May 2010 | alcohol abuse, alcohol dependence, major depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00655967 | Dec 2006 | alcohol dependence | University of New Mexico | Withdrawn | No outcome recorded |
| Phase 4 | NCT00330174 | Apr 2006 → Sep 2010 | alcohol dependence, generalized anxiety disorder, major depressive disorder, social phobia | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT00249379 | Jun 2005 → Aug 2008 | alcohol dependence | Virginia Commonwealth University | Terminated | No outcome recorded |
| Phase 4 | NCT00159107 | May 2003 → Dec 2006 | alcohol dependence | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
| Phase 4 | NCT00120601 | Mar 2003 → Jun 2005 | alcohol dependence | University of Sydney | Unknown | No outcome recorded |
| Phase 4 | NCT00435435 | Sep 2000 → Apr 2005 | alcohol dependence | Finnish Institute for Health and Welfare | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT00425711 | Feb 2007 → Dec 2009 | alcohol dependence | University of Oklahoma | Terminated | No outcome recorded |
| — | NCT00640952 | Aug 2006 → Sep 2008 | Parkinson disease | Baylor College of Medicine | Withdrawn | No outcome recorded |
| — | NCT00591565 | Jun 2006 → Dec 2009 | anxiety | State University of New York - Upstate Medical University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT01911455 Comparator | Aug 2013 → Nov 2018 | fragile X syndrome | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT01813318 Comparator | Jul 2013 → Sep 2017 | autism | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT00596531 Comparator | Jan 2008 → Nov 2013 | tinnitus | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00571922 Comparator | Jul 2007 → Nov 2008 | methamphetamine dependence | NYU Langone Health | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT07060638 Comparator | Jan 2026 → Dec 2029 expected | alcoholic hepatitis | Samer Gawrieh | Recruiting | No outcome recorded |
| Phase 2 | NCT04498897 Comparator | Jan 2019 → Apr 2021 | alcohol dependence, major depressive disorder | Hanyang University Seoul Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01300923 Comparator | Aug 2010 → Sep 2011 | autism spectrum disorder, fragile X syndrome | Indiana University | Completed | No outcome recorded |
| Phase 2 | NCT00656630 Comparator | Dec 2007 → Jan 2010 | alcohol dependence | The Scripps Research Institute | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03634917 Comparator | Aug 2020 → Aug 2023 | alcohol dependence | Technical University Dresden | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT06269627 Comparator | May 2025 → Dec 2026 expected | alcohol-related disorders | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Recruiting | No outcome recorded |
| Phase 4 | NCT03818191 Comparator | Jul 2019 → Nov 2023 | alcohol-related disorders | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00381043 Comparator | Aug 2006 → Jul 2008 | alcohol dependence | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 4 | NCT00317031 Comparator | Nov 2002 → Jun 2008 | alcohol dependence | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2016-03-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of Generic Campral® in the United States tevapharm.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | acamprosate | “Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day.” NCT04287920 ↗43“1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks.” NCT02361242 ↗ “PXT00864 is a fixed-dose combination of baclofen and acamprosate” NCT02361424 ↗ “* Baseline: Vortioxetine 10mg (or placebo) + Acamprosate” NCT04498897 ↗ |
| Known as | Acamprosate calcium | “An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial...” NCT00591565 ↗ |
| Known as | Acamprosate(Campral) | “Acamprosate(Campral)” NCT00655967 ↗ |
| Known as | Acamprosato | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201293 ↗ |
| Known as | Aotal | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201293 ↗ |
| Known as | Campral | “An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial...” NCT00591565 ↗4“The purpose of this study is to determine whether acamprosate (Campral) is safe and effective in treating alcohol dependence in individuals with bipolar disorder.” NCT00330486 ↗ “The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.” NCT00571103 ↗ “acamprosate (Campral)” NCT00004552 ↗ “acamprosate (Campral)” NCT00006206 ↗ |
| Known as | Campral ec | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201293 ↗ |
| Known as | NSC-759186 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201293 ↗ |
| Known as | SN-102 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201293 ↗ |
| Action | Restore | “The mechanism of action involves primarily the restoration of a normal N-methyl- D -aspartate (NMDA) receptor tone in glutamatergic systems” NCT00655967 ↗ |
| Modality | Small molecule | “propane-1 sulfonic acid” NCT07060638 ↗ |
| Route | Oral | “Intervention Four weeks of acamprosate (initial oral loading followed by 1998 mg daily) or matched placebo, initiated at the time of admission.” PMID 20921123 ↗ Oct 2010 |