Drugs / Divalproex Sodium
Divalproex Sodium
also known as
divalproex · Depakote · Depakote ER · divalproex ER · Depakote Sprinkle Capsules · divalproex extended-release · Divalproex Sodium ER · Divalproex sodium extended release · +8 more
Small molecule targets BDNF via activation
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | DEPAKOTE ER | — | 2003-08-14 – 2009-10-15 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | DEPAKOTE | — | 1996-03-18 – 1996-06-20 | fda.gov ↗ |
| Approved | US (FDA) | DEPAKOTE | — | 1983-03-10 | fda.gov ↗ |
Trials 59 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 112 trials | ||||||
| Phase 1 | NCT04902105 | May → Jul 2021 | — | Emalex Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01094249 | Feb → Apr 2009 | bipolar disorder, schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01060228 | Jan → Feb 2009 | epilepsy, schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00974441 | Aug → Sep 2006 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00913874 | Oct 2005 | bipolar disorder, epilepsy | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00913848 | Oct 2005 | bipolar disorder, epilepsy | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00648076 | Dec 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00647712 | Dec 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00197834 | Mar 2004 → ? | dementia | Hearthstone Alzheimer Care | Unknown | No outcome recorded |
| Phase 1 | NCT00834639 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00834990 | Sep 2003 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00195156 | Jul 2003 → ? | high grade malignant neoplasm | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT03919292 | May 2019 → Dec 2029 | cancer | Virginia Commonwealth University | Suspended | No outcome recorded |
| Phase 1/2 | NCT02166229 | Jun → Aug 2014 | systemic sclerosis | Yale University | Withdrawn | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT02094651 | Apr 2014 → Oct 2016 | autism spectrum disorder | Boston Children's Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT01170325 | Jun 2010 → Jan 2011 | autism | National Institute of Mental Health (NIMH) | Withdrawn | No outcome recorded |
| Phase 2 | NCT00095355 | Oct 2004 → Mar 2005 | Huntington disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00088387 | Jul 2004 → Mar 2005 | Alzheimer disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00073164 | Jul 2003 → ? | schizophrenia | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT00204503 | Jun 2003 → May 2005 | bipolar depression | The University of Texas Medical Branch, Galveston | Withdrawn | No outcome recorded |
| Phase 2 | NCT00078754 | May 2003 → Oct 2008 | intermittent explosive disorder | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT00646711 | Feb → Dec 2003 | childhood-onset epilepsy syndrome | Abbott | Completed | No outcome recorded |
| Phase 2 | NCT00211757 | Sep 2002 → Jul 2008 | autism | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00217932 | Sep 2000 → Aug 2005 | mood disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00202514 | Sep 2004 → Jul 2006 | alcohol dependence, mood disorder | Seattle Institute for Biomedical and Clinical Research | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT00102713 | Feb 2005 → ? | focal epilepsy | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00195806 | Feb 2005 → ? | migraine disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00195780 | Feb 2005 → ? | bipolar I disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00194116 | Sep 2004 → Oct 2007 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00195767 | Jul 2004 → ? | bipolar I disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00195754 | Jul 2004 → ? | migraine disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00108576 | Oct 2003 → Aug 2005 | post-traumatic stress disorder | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT00278772 | Aug 2003 → Dec 2007 | bipolar disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 3 | NCT00067431 | Jul 2003 → ? | focal epilepsy | Abbott | Terminated | No outcome recorded |
| Phase 3 | NCT00195741 | May 2003 → ? | migraine disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00067262 | Mar 2003 → ? | bipolar disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00060905 | Jan 2003 → ? | bipolar disorder | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00221429 | Mar 2001 → Aug 2006 | bipolar disorder | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 3 | NCT00218114 | Feb 2000 → Feb 2005 | disruptive behavior disorder, substance abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 3 | NCT00194129 | Nov 1997 → Sep 2006 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT01075126 | Dec 2006 | bipolar disorder | Lawson, William B., M.D., PhD, DFAPA | Withdrawn | No outcome recorded |
| Phase 4 | NCT00287053 | Feb → Sep 2006 | — | Pennington Biomedical Research Center | Completed | No outcome recorded |
| Phase 4 | NCT00254488 | Nov 2005 → Aug 2011 | manic bipolar affective disorder | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 4 | NCT00211796 | Apr 2005 → Apr 2007 | autism | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00094549 | Oct 2004 → Dec 2006 | bipolar disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00208195 | Mar 2004 → Nov 2007 | manic bipolar affective disorder, substance abuse, substance dependence | Creighton University | Completed | No outcome recorded |
| Phase 4 | NCT00203528 | Jan 2004 → Feb 2007 | bipolar depression, substance abuse | Tuscaloosa Research & Education Advancement Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00228046 | Jan 2004 → Jul 2007 | attention deficit-hyperactivity disorder, conduct disorder, oppositional defiant disorder | Stony Brook University | Completed | No outcome recorded |
| Phase 4 | NCT00186186 | Jan 2004 → Jan 2009 | bipolar depression | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT00181727 | Jan 2004 → Nov 2006 | manic bipolar affective disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00199966 | Dec 2003 → Nov 2005 | bipolar disorder | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 4 | NCT00208819 | Sep 2003 → Jul 2007 | Alzheimer disease | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT00071253 | Jul 2003 → ? | bipolar disorder | Abbott | Terminated | No outcome recorded |
| Phase 4 | NCT00203385 | May 2003 → Mar 2005 | post-traumatic stress disorder | Tuscaloosa Research & Education Advancement Corporation | Terminated | No outcome recorded |
| Phase 4 | NCT00308360 | Sep 1999 → Apr 2004 | schizophrenia | Nathan Kline Institute for Psychiatric Research | Completed | No outcome recorded |
| Phase 4 | NCT02078596 | Mar 1997 → Mar 2004 | intermittent explosive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT00221481 | ? → Mar 2006 | bipolar disorder | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01326663 | Oct 2009 → May 2013 | alcohol dependence, mood disorder, traumatic brain injury | Paul Saenger | Unknown | No outcome recorded |
| — | NCT00318929 | Apr 2006 → Jan 2008 | epilepsy | Virginia Commonwealth University | Completed | No outcome recorded |
Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02707965 Comparator | Jun 2017 → Aug 2018 | epilepsy | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01898676 Comparator | Jul → Aug 2013 | epilepsy | Vince & Associates Clinical Research, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT00974012 Comparator | Oct 2006 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT00868452 Comparator | Apr 2009 → Dec 2011 | bipolar depression | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00114686 Background | Jan 2006 → Apr 2007 | alcohol dependence, bipolar I disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00107731 Background | Apr 2004 → Oct 2006 | bipolar I disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00081380 Background | Mar 2004 → Sep 2006 | bipolar disorder | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00176202 Comparator | Apr 2003 → Jan 2008 | bipolar disorder | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 3 | NCT00221975 Comparator | Jul 2002 → Jun 2007 | bipolar disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00063362 Background | Feb 2002 → Jul 2007 | bipolar disorder | University Hospitals Cleveland Medical Center | Terminated | No outcome recorded |
| Phase 49 trials | ||||||
| Phase 4 | NCT03012815 Background | Feb 2017 → Mar 2021 | alcohol withdrawal | Mayo Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01588457 Comparator | Jun 2011 → Dec 2016 | bipolar I disorder, bipolar II disorder | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT01587066 Comparator | Aug 2010 → Aug 2011 | bipolar depression | Bo-Hyun Yoon | Withdrawn | No outcome recorded |
| Phase 4 | NCT00545675 Comparator | Dec 2007 → Jul 2010 | bipolar disorder | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00579280 Comparator | Jul 2007 → Dec 2010 | bipolar disorder, generalized anxiety disorder, panic disorder | University of South Florida | Completed | No outcome recorded |
| Phase 4 | NCT00402324 Background | Dec 2006 → Feb 2008 | bipolar I disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT00334347 Comparator | Jun 2006 → Sep 2007 | manic bipolar affective disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00183469 Comparator | Dec 2004 → Feb 2009 | bipolar disorder, depressive disorder | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT00048802 Background | Aug 2002 → Aug 2006 | bipolar disorder | Northwell Health | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02300051 Background | Feb 2011 → Apr 2015 | sexual disorder | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| — | NCT01760785 Comparator | Sep 2008 → Aug 2014 | alcohol dependence, traumatic brain injury | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00347152 Comparator | Nov 2006 → Dec 2007 | epilepsy | University of Kansas | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2006-01-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Divalproex Sodium Delayed-Release Tablets tevapharm.com ↗ |
Evidence & citations 21 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | divalproex sodium | “mood stabilizers (topiramate 25 - 200 mg/day, divalproex sodium (500 - 1500 mg/day, oxcarbazepine (300 - 1200 mg/day, and lamotrigine 50 - 200 mg/day).” NCT02300051 ↗46“The primary objective is to evaluate the long-term efficacy of divalproex sodium (Depakote) in the continuation treatment of PTSD.” NCT00203385 ↗ “This study utilizes the extended release formulation of divalproex sodium, with demonstrated increased tolerability.” NCT00186186 ↗ “500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets” NCT00974441 ↗ “Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.” NCT01326663 ↗ “Divalproex Sodium ER (Divalproex Sodium Extended Release)” NCT00579280 ↗ “Divalproex Sodium (Depakote Sprinkle Capsules)” NCT00102713 ↗ “Divalproex Sodium (Delayed-Release Tablets)” NCT00071253 ↗ “Depakote (divalproex sodium)” NCT02078596 ↗ “divalproex sodium” NCT00646711 ↗ |
| Known as | Depakote | “This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive...” NCT00078754 ↗14“Divalproex sodium (Depakote) is a drug that has been used for many years to treat epilepsy and other brain disorders in children and adults.” NCT01170325 ↗ “Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex.” NCT00318929 ↗ “lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications” NCT00048802 ↗ “the drugs lithium and divalproex (Depakote) on tau proteins” NCT00088387 ↗ “Depakote 500 mg DR Tablets (Abbott Laboratories, USA)” NCT00913874 ↗ “with that of 500 mg Depakote® Tablets” NCT00834639 ↗ “Depakote (divalproex sodium)” NCT02078596 ↗ “Divalproex Sodium (Depakote)” NCT00217932 ↗ “500 mg Depakote® Tablets” NCT00834990 ↗ |
| Known as | Depakote ER | “The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of...” NCT00067262 ↗7“The purpose of this study is to test the safety and effectiveness of an extended release form of a medication called divalproex sodium (Depakote ER) for the treatment of people...” NCT00202514 ↗ “An Open Label Pilot Study Evaluating Safety and Efficacy of Divalproex Sodium (Depakote ER) in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence.” NCT00204503 ↗ “A new formulation, divalproex, Depakote ER, was recently FDA approved for the treatment of epilepsy and prophylaxis of migraine headaches.” NCT00334347 ↗ “Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex.” NCT00318929 ↗ “Divalproex Sodium (Depakote ER)” NCT00060905 ↗ “Divalproex Sodium (Depakote ER)” NCT00195780 ↗ “Depakote ER (Divalproex ER)” NCT00208195 ↗ |
| Known as | Depakote Sprinkle Capsules | “Divalproex Sodium (Depakote® Sprinkle Capsules)” NCT00067431 ↗1“Divalproex Sodium (Depakote Sprinkle Capsules)” NCT00102713 ↗ |
| Known as | DIV | “Divalproex (DIV) ER” NCT00183469 ↗ |
| Known as | divalproate | “Depakote (divalproate)” NCT00545675 ↗ |
| Known as | divalproex | “OBJECTIVE: To compare the efficacy and safety of divalproex extended-release (ER) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and...” PMID 19325497 ↗ May 200936“An Open Label Pilot Study Evaluating Safety and Efficacy of Divalproex Sodium (Depakote ER) in Patients With Bipolar I or II Depression and Alcohol Abuse or Dependence.” NCT00204503 ↗ “There are several studies demonstrating the efficacy of divalproex in the acute treatment of mania and mixed mania.” NCT00334347 ↗ |
| Known as | divalproex ER | “OBJECTIVE: To compare the efficacy and safety of divalproex extended-release (ER) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and...” PMID 19325497 ↗ May 20092“The efficacy and safety of divalproex sodium extended release (divalproex ER) were evaluated in patients hospitalized for acute mania associated with bipolar I disorder, manic...” PMID 17107240 ↗ Oct 2006 “Depakote ER (Divalproex ER)” NCT00208195 ↗ |
| Known as | divalproex extended-release | “OBJECTIVE: To compare the efficacy and safety of divalproex extended-release (ER) to placebo in a 28-day double-blind study of bipolar disorder in children and adolescents and...” PMID 19325497 ↗ May 20091“divalproex extended release (DPX-ER) monotherapy” NCT00278772 ↗ |
| Known as | Divalproex Sodium ER | “Divalproex Sodium ER (Divalproex Sodium Extended Release)” NCT00579280 ↗1“Drug: Divalproex Sodium ER” NCT04902105 ↗ |
| Known as | Divalproex sodium extended release | “subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).” NCT00199966 ↗1“Divalproex Sodium ER (Divalproex Sodium Extended Release)” NCT00579280 ↗ |
| Known as | DPX-ER | “divalproex extended release (DPX-ER) monotherapy” NCT00278772 ↗ |
| Known as | DVP | “Anticonvulsants, including the divalproex sodium (DVP) formulation of valproate, have established effectiveness for mood disorders, and therapeutic response of mood and anxiety...” NCT00202514 ↗1“subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).” NCT00199966 ↗ |
| Known as | DVP ER | “subjects will be switched in one night from twice-a-day divalproex sodium (DVP) to divalproex sodium extended release (DVP ER).” NCT00199966 ↗ |
| Known as | sodium divalproex | “Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex.” NCT00318929 ↗ |
| Known as | valproic acid | “divalproex sodium (an epilepsy medication also referred to as valproic acid [VPA])” NCT01060228 ↗ |
| Known as | VPA | “divalproex sodium (an epilepsy medication also referred to as valproic acid [VPA])” NCT01060228 ↗ |
| Action | Activate | “It is hypothesized that at safe and tolerable doses these drugs will enhance depleted levels of brain-derived neurotrophic factor (BDNF)” NCT00095355 ↗ |
| Modality | Small molecule | “Divalproex sodium is a co-ordination compound consisting of sodium valproate and valproic acid.” NCT00287053 ↗ |
| Route | Oral | “Divalproex ER capsules by mouth” NCT00078754 ↗ |
| Target | BDNF | “Lithium carbonate, a drug used to treat bipolar disorder, and divalproex, a drug used to treat mood disorders and seizure disorders, have both been shown to increase the amount...” NCT00095355 ↗ |