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valproic acid

Trade name: depakene

Small moleculeapproved

Approved

Feb 28, 1978

Valproic acid (VPA; valproate; di-n-propylacetic acid, DPA; 2-propylpentanoic acid, or 2-propylvaleric acid) was first synthesized in 1882, by Burton. FDA approved valproic acid for the treatment of manic episodes associated with bipolar disorder, for the monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures and adjunctive therapy in patients with multiple seizure types that include absence seizures and for the prophylaxis of migraine headaches. The mechanisms of VPA which seem to be of clinical importance in the treatment of epilepsy include increased gamma-aminobutyric acid (GABA)-ergic activity, reduction in excitatory neurotransmission, and modification of monoamines. Recently, it was discovered that the VPA is a class I selective histone deacetylase inhibitor. This activity can be distinguished from its therapeutically exploited antiepileptic activity. — NCATS

Clinical trial activity

334 trials · 304 clinical orgs · 50 marketing orgs

Phase 1
93
Phase 2
153
Phase 3
61
Phase 4
78

Earliest trial started Feb 1, 1991 (NCT00004817)

Timeline

1970s

  1. Feb 28, 1978

    AbbVie — Earliest FDA Approval

  2. Feb 28, 1978

    AbbVie — NDA Organization

1980s

  1. Feb 28, 1986

    Par Pharmaceuticals — Marketing Organization

  2. Jul 1, 1986

    Wockhardt — Marketing Organization

  3. Jul 1, 1986

    Xttrium Laboratories — Marketing Organization

  4. Jul 2, 1987

    R.P. Scherer — Marketing Organization

1990s

  1. Jul 11, 1990

    Abbott — Marketing Organization

  2. Jul 11, 1990

    Abbott — NDA Secondary Org

  3. Jan 1, 1991

    Earliest Phase 3 Sponsor(trial)

  4. Oct 29, 1991

    Catalent — Marketing Organization

  5. Aug 25, 1992

    Ani Pharmaceuticals — Marketing Organization

  6. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  7. Jun 29, 1993

    Bionpharma Inc — NDA Secondary Org

  8. Jun 29, 1993

    Bionpharma Inc — Marketing Organization

  9. Jan 13, 1995

    Hi Tech Pharmaceuticals — Marketing Organization

  10. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Dec 15, 2000

    Pharmaceutical Associates — Marketing Organization

  2. Dec 22, 2000

    VistaPharm, Inc. — Marketing Organization

  3. Dec 22, 2000

    Chartwell Pharmaceuticals — Marketing Organization

  4. Nov 14, 2002

    Athenex, Inc. — Marketing Organization

  5. Jun 26, 2003

    Fresenius — Marketing Organization

  6. Jul 29, 2005

    Apotex — Marketing Organization

  7. Jul 29, 2005

    Nostrum Laboratories — Marketing Organization

  8. Jun 9, 2006

    Mylan — Marketing Organization

  9. Oct 13, 2006

    Lannett Company, Inc. — Marketing Organization

  10. Mar 24, 2008

    AbbVie — NDA Secondary Org

  11. Jul 29, 2008

    Lupin — Marketing Organization

  12. Jul 29, 2008

    Sandoz — Marketing Organization

  13. Jul 29, 2008

    Sun Pharmaceuticals — Marketing Organization

  14. Jul 29, 2008

    Upsher-Smith Laboratories — Marketing Organization

  15. Jul 29, 2008

    Invatech — Marketing Organization

  16. Jul 31, 2008

    Celltrion — Marketing Organization

  17. Nov 3, 2008

    Anchen Pharmaceuticals, Inc — Marketing Organization

  18. Nov 25, 2008

    Orbion Pharms — Marketing Organization

  19. Nov 25, 2008

    Orchid Pharma — Marketing Organization

  20. Jan 27, 2009

    Zydus Discovery DMCC — Marketing Organization

  21. May 6, 2009

    Impax Laboratories — Marketing Organization

  22. Aug 3, 2009

    G & W Laboratories Inc. — Marketing Organization

  23. Aug 3, 2009

    Cosette — Marketing Organization

  24. Aug 3, 2009

    ACP Nimble — Marketing Organization

  25. Nov 30, 2009

    Prinston Inc — Marketing Organization

2010s

  1. Feb 17, 2010

    Hikma — Marketing Organization

  2. May 28, 2010

    Pharma Life Sciences LLC — Marketing Organization

  3. May 28, 2010

    TTY Biopharm — Marketing Organization

  4. May 28, 2010

    Eci Pharmaceuticals Llc — Marketing Organization

  5. May 28, 2010

    Quagen Pharma — Marketing Organization

  6. Feb 25, 2011

    Actavis — Marketing Organization

  7. Mar 28, 2011

    Rising Pharmaceuticals — Marketing Organization

  8. Apr 5, 2011

    Unichem — Marketing Organization

  9. Apr 21, 2011

    Aurobindo Pharma — Marketing Organization

  10. Mar 12, 2012

    Dr. Reddy's Laboratories — Marketing Organization

  11. May 29, 2015

    Amneal Pharmaceuticals — Marketing Organization

  12. Aug 5, 2019

    Eywa Pharma — Marketing Organization

  13. Aug 5, 2019

    Novelgenix Therapeutics — Marketing Organization

2020s

  1. Feb 28, 2020

    Ajanta Pharma Ltd — Marketing Organization

  2. Nov 17, 2020

    Teva — Marketing Organization

  3. Mar 15, 2021

    Amta — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFeb 28, 1978

Chemistry & pharmacology

Loading structure…

SMILES

CCCC(CCC)C(O)=O
Mol. weight
144.2114 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 2-n-propyl-n-valeric acid
  • 2-n-propyl-n-valeric acid
  • 2-propyl-pentanoic acid
  • 2-propyl-pentanoic acid
  • 2-propylpentanoic acid
  • 2-propylpentanoic acid
  • 2-propylpentanoic acid
  • 2-propylvaleric acid
  • 2-propylvaleric acid
  • 44089
  • 4-heptanecarboxylic acid
  • 4-heptanecarboxylic acid
  • a-44090
  • a-44090
  • abbott 44090
  • abbott 44090
  • abbott-44090
  • abbott-44090
  • abbott-50711
  • abbott-50711
  • acide valproïque
  • acide valproïque
  • ácido valproico
  • ácido valproico
  • acidum valproicum
  • acidum valproicum
  • convulex
  • convulex
  • delepsine
  • delepsine
  • depacon
  • depacon
  • depacon
  • depakene
  • depakene
  • depakene
  • depakine
  • depakine
  • depakote
  • depakote
  • depakote
  • depakote
  • depakote
  • depakote cp
  • depakote cp
  • depakote er
  • depakote er
  • di-n-propylacetic acid
  • di-n-propylacetic acid
  • di-n-propylessigsäure
  • di-n-propylessigsäure
  • dipropylacetic acid
  • dipropylacetic acid
  • dipropylacetic acid
  • divalproate sodium
  • divalproate sodium
  • divalproex
  • divalproex
  • divalproex
  • divalproex
  • divalproex
  • divalproex disodium
  • divalproex disodium
  • divalproex disodium
  • divalproex disodium
  • divalproex disodium
  • divalproex disodium
  • divalproex sodium
  • divalproex sodium
  • divalproex sodium
  • divalproex sodium
  • divalproex sodium
  • divaproex
  • dpa
  • dpa
  • dp-vpa
  • dp-vpa
  • epilim
  • epilim
  • epilim 200
  • epilim 500
  • epilim chrono 200
  • epilim chrono 300
  • epilim chrono 500
  • epilim chronosphere
  • epilim iv
  • episenta
  • epival
  • kentilim
  • magnesium valproate
  • magnesium valproate
  • magnesium valproate
  • n-dpa
  • n-dpa
  • orfiril
  • orfiril
  • orlept
  • propylisopropylacetic acid
  • semisodium valproate
  • semisodium valproate
  • sodium divalproate
  • sodium divalproate
  • sodium valproate
  • sodium valproate
  • sodium valproate
  • sodium valproate
  • stavzor
  • stavzor
  • valdisoval
  • valproate
  • valproate
  • valproate
  • valproate
  • valproate calcium
  • valproate semisodium
  • valproate semisodium
  • valproate semisodium
  • valproate sodium
  • valproate sodium
  • valproate sodium
  • valproate sodium
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic acid
  • valproic aicd
  • valproinsäure
  • valproinsäure
  • vaproate
  • vpa
  • vpa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07166393Phase 2/Phase 3 (Phase 3)May 31, 2026Department of Defense, Northwestern University
NCT07226141Phase 1/Phase 2 (Phase 2)Jan 1, 2026Harvard University
NCT07140913Phase 3Oct 8, 2025Bristol-Myers Squibb
NCT06929273Phase 3Jul 18, 2025Bristol-Myers Squibb
NCT06729970Phase 1Dec 23, 2024Bristol-Myers Squibb, Karuna Pharmaceuticals
NCT06714357Phase 2Dec 20, 2024Fondazione Giovanni Pascale
NCT07052136N/ANov 1, 2024RESnTEC, Institute of Research
NCT06199557Phase 1/Phase 2 (Phase 2)Jan 25, 2024Helse Bergen, University of Bergen
NCT06081283Phase 4Nov 20, 2023University of North Carolina at Chapel Hill
NCT05973786Phase 4Nov 1, 2023University of Munster, Utrecht University
NCT06214130Phase 1Sep 22, 2023BioPharma Services, Desitin Arzneimittel GmbH
NCT06211283Phase 1Sep 11, 2023BioPharma Services, Desitin Arzneimittel GmbH
NCT06020898Phase 2Sep 1, 2023Jiao Tong University
NCT05603104Phase 4Aug 1, 2023University of Munster, Utrecht University
NCT05881928Phase 4Jul 25, 2023Assiut University
NCT05821556Phase 2Jun 12, 2023Fondazione Giovanni Pascale
NCT05694936Phase 2Jan 23, 2023Australasian Gastro-Intestinal Trials Group, Olivia Newton-John Cancer Research Institute
NCT06485726Phase 4Jan 23, 2023Kafrelsheikh University
NCT06089356Phase 4Jan 1, 2023Kafrelsheikh University, Tanta University
NCT05431595Phase 2/Phase 3 (Phase 3)Dec 30, 2022State of Texas, University of Texas at Houston
Showing 20 of 334 trials
Page 1 / 17

Organizations

Research & Development (304)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit411251997
National Institute of Mental Health (NIMH)Government17551997
National Cancer Institute (NCI)Government14642004
University of Texas at HoustonAcademic/Hospital131332004
Department of Veteran AffairsGovernment7232003
Dr. Reddy's LaboratoriesFor profit7712006
Harvard UniversityAcademic/Hospital7631998
National Institute of Neurological Disorders and Stroke (NINDS)Government7321991
AstraZenecaFor profit6522002
Bristol-Myers SquibbFor profit6242003
Case Western Reserve UniversityAcademic/Hospital6521997
Department of DefenseGovernment6032008
SanofiFor profit6632004
Bioserve Clinical ResearchFor profit5012006
Columbia UniversityAcademic/Hospital5441997
Eli LillyFor profit5332003
Fondazione Giovanni PascaleAcademic/Hospital5512012
Government of MexicoGovernment5522005
Jiao Tong UniversityAcademic/Hospital5522008
National Institutes of Health (NIH)Government5132003
304 organizations
Page 1 / 16

Marketing (63)

OrganizationOrg typeRelationshipDate
ACP NimbleFor profitMKTGAug 3, 2009
AbbVieFor profitSYNFeb 28, 1978
AbbVieFor profitNDA2Mar 24, 2008
AbbVieFor profitNDAFeb 28, 1978
AbbottFor profitMKTGJul 11, 1990
AbbottFor profitNDA2Jul 11, 1990
ActavisFor profitMKTGFeb 25, 2011
Ajanta Pharma LtdFor profitMKTGFeb 28, 2020
Amneal PharmaceuticalsFor profitMKTGMay 29, 2015
AmtaFor profitMKTGMar 15, 2021
Anchen Pharmaceuticals, IncFor profitMKTGNov 3, 2008
Ani PharmaceuticalsFor profitMKTGAug 25, 1992
Ani PharmaceuticalsFor profitSYNAug 25, 1992
ApotexFor profitMKTGJul 29, 2005
ApotexFor profitSYNJul 29, 2008
Athenex, Inc.For profitMKTGNov 14, 2002
Aurobindo PharmaFor profitMKTGApr 21, 2011
Bionpharma IncFor profitNDA2Jun 29, 1993
Bionpharma IncFor profitMKTGJun 29, 1993
CatalentFor profitMKTGOct 29, 1991
CelltrionFor profitMKTGJul 31, 2008
Chartwell PharmaceuticalsFor profitMKTGDec 22, 2000
CosetteFor profitMKTGAug 3, 2009
Dr. Reddy's LaboratoriesFor profitSYNJul 29, 2008
Dr. Reddy's LaboratoriesFor profitMKTGMar 12, 2012
Eci Pharmaceuticals LlcFor profitMKTGMay 28, 2010
Eywa PharmaFor profitMKTGAug 5, 2019
FreseniusFor profitMKTGJun 26, 2003
G & W Laboratories Inc.For profitMKTGAug 3, 2009
Hi Tech PharmaceuticalsFor profitMKTGJan 13, 1995
HikmaFor profitMKTGFeb 17, 2010
Impax LaboratoriesFor profitMKTGMay 6, 2009
InvatechFor profitMKTGJul 29, 2008
Lannett Company, Inc.For profitMKTGOct 13, 2006
LupinFor profitMKTGJul 29, 2008
LupinFor profitSYNOct 18, 2019
MylanFor profitMKTGJun 9, 2006
Nostrum LaboratoriesFor profitMKTGJul 29, 2005
Novelgenix TherapeuticsFor profitMKTGAug 5, 2019
Orbion PharmsFor profitMKTGNov 25, 2008
Orchid PharmaFor profitMKTGNov 25, 2008
Par PharmaceuticalsFor profitMKTGFeb 28, 1986
Pharma Life Sciences LLCFor profitMKTGMay 28, 2010
Pharmaceutical AssociatesFor profitMKTGDec 15, 2000
Prinston IncFor profitMKTGNov 30, 2009
Quagen PharmaFor profitMKTGMay 28, 2010
R.P. SchererFor profitMKTGJul 2, 1987
Rising PharmaceuticalsFor profitMKTGMar 28, 2011
SandozFor profitMKTGJul 29, 2008
Sun PharmaceuticalsFor profitMKTGJul 29, 2008
Sun PharmaceuticalsFor profitSYNFeb 22, 2013
TTY BiopharmFor profitMKTGMay 28, 2010
TevaFor profitMKTGNov 17, 2020
TevaFor profitSYNJul 29, 2008
UnichemFor profitSYNFeb 25, 2022
UnichemFor profitMKTGApr 5, 2011
Upsher-Smith LaboratoriesFor profitMKTGJul 29, 2008
Upsher-Smith LaboratoriesFor profitSYNJun 11, 1987
VistaPharm, Inc.For profitMKTGDec 22, 2000
WockhardtFor profitSYNJul 31, 2008
WockhardtFor profitMKTGJul 1, 1986
Xttrium LaboratoriesFor profitMKTGJul 1, 1986
Zydus Discovery DMCCFor profitMKTGJan 27, 2009