Drugs / Divalproex Sodium
last change Dec 2024 re-read 9 days ago

Divalproex Sodium

Small molecule targets BDNF via activation

Developed for
bipolar disorder · epilepsy · schizophrenia · autism · bipolar depression · manic bipolar affective disorder · migraine disorder · mood disorder
+23 more · substance abuse · alcohol dependence · Alzheimer disease · bipolar I disorder · focal epilepsy · intermittent explosive disorder · post-traumatic stress disorder · attention deficit-hyperactivity disorder · autism spectrum disorder · cancer · childhood-onset epilepsy syndrome · conduct disorder · dementia · disruptive behavior disorder · high grade malignant neoplasm · Huntington disease · oppositional defiant disorder · systemic sclerosis · traumatic brain injury · bipolar II disorder · depressive disorder · generalized anxiety disorder · panic disorder
Investigated by
Abbott · National Institute of Mental Health (NIMH) · National Institute of Neurological Disorders and Stroke (NINDS) · Teva Pharmaceuticals USA · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Montefiore Medical Center
+39 more · Mylan Pharmaceuticals Inc · National Institute on Drug Abuse (NIDA) · New York State Psychiatric Institute · Sandoz · Tuscaloosa Research & Education Advancement Corporation · University Hospitals Cleveland Medical Center · Virginia Commonwealth University · Weill Medical College of Cornell University · Boston Children's Hospital · Children's Hospital Medical Center, Cincinnati · Creighton University · Eli Lilly and Company · Emalex Biosciences Inc. · Emory University · Hearthstone Alzheimer Care · Janssen, LP · Lawson, William B., M.D., PhD, DFAPA · Lindner Center of HOPE · Massachusetts General Hospital · Mayo Clinic · Medical College of Wisconsin · Nathan Kline Institute for Psychiatric Research · National Alliance for Research on Schizophrenia and Depression · Nuventra, Inc. · Paul Saenger · Pennington Biomedical Research Center · Puma Biotechnology, Inc. · Research Foundation for Mental Hygiene, Inc. · Seattle Institute for Biomedical and Clinical Research · Stanford University · Stony Brook University · Syneos Health · The University of Texas Medical Branch, Galveston · University of California, Los Angeles · University of Chicago · University of Cincinnati · University of Louisville · VA Office of Research and Development · Yale University

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 112 trials · 1 met primary
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 NCT00913848 Oct 2005 bipolar disorder, epilepsy Sandoz Completed No outcome recorded
Phase 1 NCT00913874 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 NCT00834990 Sep 2003 — Teva Pharmaceuticals USA Completed 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 Stop: Enrollment
Phase 210 trials · 1 missed
Phase 2 NCT02094651 Apr 2014 → Oct 2016 autism spectrum disorder Boston Children's Hospital Withdrawn No outcome recorded Stop: Enrollment
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 Missed primary
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 · 2 met primary · 4 missed
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 Met primary
Phase 3 NCT00195767 Jul 2004 → ? bipolar I disorder Abbott Completed Missed primary
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 Missed primary
Phase 3 NCT00278772 Aug 2003 → Dec 2007 bipolar disorder Lindner Center of HOPE Completed Met primary
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 417 trials · 2 met primary
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 Met primary
Phase 4 NCT00208195 Mar 2004 → Nov 2007 manic bipolar affective disorder, substance abuse, substance dependence Creighton University Completed No outcome recorded
Phase 4 NCT00186186 Jan 2004 → Jan 2009 bipolar depression Stanford 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 Met primary
Phase 4 NCT00181727 Jan 2004 → Nov 2006 manic bipolar affective disorder Massachusetts General Hospital Completed 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
Comparator or background therapy22 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 3 NCT00868452 Comparator Apr 2009 → Dec 2011 bipolar depression Sumitomo Pharma America, Inc. Completed Met primary
Phase 3 NCT00114686 Background Jan 2006 → Apr 2007 alcohol dependence, bipolar I disorder AstraZeneca Completed No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2024-12-01 Alembic Pharmaceuticals Ltd. Regulatory 20th December, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Divalproex Sodium Delayed-Release Capsules USP, 125 mg.
2019-10-22 Lupin Limited Regulatory Lupin receives U.S. FDA approval for Divalproex Sodium ER Tablets USP lupin.com ↗
Lupin Limited (Lupin) announced that it has received approval for its Divalproex Sodium Extended-Release (ER) Tablets USP,250 mg and 500 mg, from the United States Food and Drug Administration (U.S. FDA)
2009-08-05 Impax Laboratories, LLC Regulatory Impax Laboratories Receives Final FDA Approval for Generic Depakote(R) Extended-Release 500mg Tablets amneal.com ↗
Impax Laboratories, Inc. (NASDAQ:IPXL) today confirmed that the U.S. Food and Drug Administration ( FDA ) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 500mg Extended-release Tablets.
2009-05-06 Impax Laboratories, LLC Regulatory Impax Receives Final FDA Approval for Generic Depakote(R) Extended-Release 250mg Tablets amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration ( FDA ) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for generic version of Depakote® (divalproex ER) 250mg Extended-release Tablets.
2009-02-11 Wockhardt Regulatory Wockhardt to launch Divalproex ER in the US market wockhardt.com ↗
Wockhardt received the final approval from the United States Food & Drug Administration (US FDA) for marketing the ER tablets containing 250mg Divalproex sodium and tentative approval for the ER tablets containing 500mg Divalproex sodium.
2008-02-14 Sun Pharmaceutical Industries, Inc. Regulatory Sun Pharma gets USFDA tentative approval for generic Depakote ® delayed release tablets sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application (ANDA) for generic Depakote ®, d ivalproex sodium delayed release tablets.
2006-01-01 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval of Divalproex Sodium Delayed-Release Tablets tevapharm.com ↗
Jerusalem, Israel, January 1, 2006 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg.

Evidence & citations 21 cited values

Every value below carries the sentence it was read from. 83 sources stand behind the page.

FieldValueCited 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 ↗

NCT02166229 ↗

Show 36 more sources

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 ↗

“lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications” NCT00048802 ↗

“Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex.” NCT00318929 ↗

“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 ↗

“Divalproex Sodium (Depakote)” NCT00217932 ↗

“Depakote (divalproex sodium)” NCT02078596 ↗

“500 mg Depakote® Tablets” NCT00834990 ↗

NCT00974012 ↗

Show 4 more sources

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 2009
36

“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 ↗

NCT00221481 ↗

NCT02707965 ↗

NCT00078754 ↗

NCT00048802 ↗

NCT00183469 ↗

NCT00102713 ↗

NCT00579280 ↗

NCT00071253 ↗

Show 26 more sources

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 2009
2

“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 2009
1

“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 ↗