Clinical Trials

Numerous clinical trials evaluate sodium valproate across diverse indications, including epilepsy, bipolar disorder, McArdle disease, and various malignancies such as solid tumors, prostate cancer, and ovarian neoplasms. Spanning Phase 1 through Phase 4, these studies assess therapeutic approaches ranging from combination regimens in advanced cancers to interventions for metabolic disorders. Supported by pharmaceutical and academic sponsors—including Sanofi, AstraZeneca, Virginia Commonwealth University, and Johns Hopkins University—the trials encompass actively recruiting, completed, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07166393 NOT_YET_RECRUITING
Moderate Traumatic Brain Injury (TBI); Severe Traumatic Brain Injury
Northwestern University
 2027-05 PHASE2; PHASE3
NCT03048084 RECRUITING
Glioma
Leiden University Medical Center
 2018-02-01 PHASE4
NCT02068586 ACTIVE_NOT_RECRUITING
Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Iris Melanoma; Stage I Intraocular Melanoma; Stage IIA Intraocular Melanoma; Stage IIB Intraocular Melanoma; Stage IIIA Intraocular Melanoma; Stage IIIB Intraocular Melanoma; Stage IIIC Intraocular Melanoma; Stage I Uveal Melanoma AJCC V7; Stage II Uveal Melanoma AJCC V7; Stage III Uveal Melanoma AJCC V7
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
 2014-11-19 PHASE2
NCT06714357 RECRUITING
Colorectal Cancer Metastatic
National Cancer Institute, Naples
 2025-03-12 PHASE2
NCT05821556 RECRUITING
Adenocarcinoma of the Pancreas
National Cancer Institute, Naples
 2023-06-12 PHASE2
NCT01552434 TERMINATED
Advanced Malignant Neoplasm; Castleman Disease; Digestive System Carcinoma; Erdheim-Chester Disease; Lip and Oral Cavity Carcinoma; Lymphangioleiomyomatosis; Malignant Endocrine Neoplasm; Malignant Female Reproductive System Neoplasm; Malignant Male Reproductive System Neoplasm; Malignant Neoplasm; Malignant Respiratory Tract Neoplasm; Malignant Thoracic Neoplasm; Malignant Urinary System Neoplasm; Mesothelial Neoplasm; Metastatic Malignant Neoplasm; Metastatic Urothelial Carcinoma; Neurofibromatosis Type 2; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Digestive System Carcinoma; Recurrent Female Reproductive System Carcinoma; Recurrent Male Reproductive System Carcinoma; Recurrent Malignant Neoplasm; Recurrent Pharyngeal Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Malignant Neoplasm; Soft Tissue Neoplasm; Stage III Breast Cancer AJCC v7; Stage III Pharyngeal Cancer; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Stage IV Pharyngeal Cancer; Stage IVA Pharyngeal Cancer; Stage IVB Pharyngeal Cancer; Stage IVC Pharyngeal Cancer; Thyroid Gland Neoplasm
M.D. Anderson Cancer Center
 2012-10-16 PHASE1
NCT06729970 COMPLETED
Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
 2024-12-26 PHASE1
NCT05788822 UNKNOWN
Infertility, Female; IVF; Reproductive Disorder; Oocyte
Nanjing University
 2022-10-08
NCT06199557 RECRUITING
Acute Myeloid Leukemia, Adult; Myelodysplastic Syndromes, Adult
Haukeland University Hospital
 2024-05-23 PHASE1; PHASE2
NCT07052136 COMPLETED
Status Epilepticus
RESnTEC, Institute of Research
 2024-11-01
NCT06485726 UNKNOWN
Migraine Disorders
Kafrelsheikh University
 2023-01-23 PHASE4
NCT02446431 RECRUITING
Solid Tumor
Miller Children's & Women's Hospital Long Beach
 2014-07 EARLY_PHASE1
NCT06248931 COMPLETED
Migraine Disorders
Kafrelsheikh University
 2022-05-01 PHASE3
NCT04529954 TERMINATED
Focal Epilepsy
Cerebral Therapeutics LLC
 2021-01-01 PHASE1; PHASE2
NCT03243461 UNKNOWN
Glioblastoma WHO Grade IV; Diffuse Midline Glioma Histone 3 K27M WHO Grade IV; Anaplastic Astrocytoma WHO Grade III; Diffuse Intrinsic Pontine Glioma; Gliomatosis Cerebri
University of Göttingen
 2018-07-17 PHASE3
NCT04310176 UNKNOWN
Ras-mutated Metastatic Colorectal Cancer
National Cancer Institute, Naples
 2019-05-24 PHASE2
NCT06214130 COMPLETED
Multiple Drug Use
Desitin Arzneimittel GmbH
 2023-09-22 PHASE1
NCT01898104 UNKNOWN
Colorectal Cancer
National Cancer Institute, Naples
 2012-05 PHASE1; PHASE2
NCT05641649 UNKNOWN
Epilepsy
Kathmandu University
 2023-08-06 PHASE4
NCT04531592 WITHDRAWN
Acute Kidney Injury; Ischemia Reperfusion Injury
Westat
 2022-01 PHASE2
NCT04531579 WITHDRAWN
Acute Kidney Injury; Ischemia Reperfusion Injury
Westat
 2022-01 PHASE2
NCT05697614 UNKNOWN
Drug Resistant Epilepsy
Dr Cipto Mangunkusumo General Hospital
 2023-03-01 PHASE4
NCT04671589 UNKNOWN
Drug Toxicity
Mabaret Al-Asafara Hospitals
 2021-06 PHASE4
NCT03357757 COMPLETED
Cancer That is Associated With a Chronic Viral Infection; p16 Positive SCCHN; Squamous Cell Carcinoma of the Cervix; p16 Positive Squamous Cell Carcinoma of the Vagina or Vulva; p16 Positive Squamous Cell Carcinoma of the Penis; p16 Positive Squamous Cell Carcinoma of the Anus or Anal Canal; EBER Positive NPC; EBER Positive Hodgkins and Non-hodgkins Lymphona
AHS Cancer Control Alberta
 2018-02-07 PHASE2
NCT02124174 UNKNOWN
Acute Myelogenous Leukemia AML; Myelodysplastic Syndrome MDS
Patrick Stiff
 2012-01 PHASE2
NCT04486092 UNKNOWN
Bipolar Disorder
National Cheng-Kung University Hospital
 2015-02
NCT03885947 COMPLETED
Hematological Malignancy; Acute Leukemia in Remission; Acute Lymphoblastic Leukemia in Remission; Myelodysplastic Syndromes; Non-Hodgkin Lymphoma; Hodgkin Lymphoma
Alla Keyzner
 2019-02-21 PHASE1
NCT01817751 COMPLETED
Glioblastoma; Recurrent Adult Brain Neoplasm; Malignant Glioma; WHO Grade III Glioma
Virginia Commonwealth University
 2013-04-11 PHASE2
NCT02758366 TERMINATED
Glioblastoma (GBM); DIPG; Brainstem Glioma, Pediatric; Diffuse Spinal Glioma; Bilateral Thalamic Glioma; Gliomatosis Cerebri; Anaplastic Astrocytoma; Midline Diffuse Glioma
Meyer Children's Hospital IRCCS
 2016-02 PHASE2
NCT02896270 UNKNOWN
Idiopathic Nephrotic Syndrome; Focal Segmental Glomerulosclerosis; Minimal Change Disease
Universitair Ziekenhuis Brussel
 2016-10 PHASE2; PHASE3
NCT03525730 COMPLETED
HIV-1-infection
Erasmus Medical Center
 2018-04-18 PHASE1; PHASE2
NCT02848105 UNKNOWN
Peripheral Blood Stem Cell Transplantation; aGVHD
Shanghai Jiao Tong University School of Medicine
 2016-07 PHASE2
NCT03919292 Recruiting
Solid Tumor Adult
Virginia Commonwealth University|Puma Biotechnology Inc.
 2019-05-01 Phase 1|Phase 2
NCT02624128 UNKNOWN
Squamous Cell Carcinoma of the Head and Neck
National Cancer Institute, Naples
 2015-02-23 PHASE2
NCT03885154 TERMINATED
Migraine in Children
Kimberly S Jones
 2017-10-03 PHASE2
NCT01960075 COMPLETED
Benzodiazepine Refractory Status Epilepticus
University of Virginia
 2015-10 PHASE3
NCT04967326 COMPLETED
Epilepsy
Gia Dinh People Hospital
 2016-01-01 PHASE4
NCT03161509 TERMINATED
Bariatric Surgery Candidate
Rambam Health Care Campus
 2017-07-01 PHASE4
NCT03512860 COMPLETED
Contraception
Estetra
 2018-04-12 PHASE1
NCT03681158 Completed
Epilepsy
Sanofi
 2018-10-05 Phase 1
NCT02520115 COMPLETED
Adnexal Mass; Borderline Ovarian Epithelial Tumor; Ovarian Clear Cell Tumor; Ovarian Endometrioid Tumor; Ovarian Neoplasm; Ovarian Serous Tumor; Recurrent Ovarian Carcinoma
Barbara Ann Karmanos Cancer Institute
 2015-08 PHASE1
NCT03914534 COMPLETED
Healthy
Tecnoquimicas
 2017-04-17 PHASE4
NCT01342692 UNKNOWN
MDS
Assistance Publique - Hôpitaux de Paris
 2011-06 PHASE2
NCT02789813 COMPLETED
Phobia, Specific
Prof. Dominique de Quervain, MD
 2016-07 PHASE2
NCT01900730 TERMINATED
Breast Cancer
M.D. Anderson Cancer Center
 2014-07-31 PHASE2
NCT04482764 COMPLETED
Breathhold
Assiut University
 2017-01-30 PHASE1
NCT02343575 TERMINATED
Hyperactive Delirium; Mixed Delirium
Stanford University
 2015-01 PHASE4
NCT05830981 COMPLETED
Neurological Disorders
Damanhour University
 2015-01-01
NCT03385525 COMPLETED
Drug Interaction
Biogen
 2017-09-12 PHASE1
NCT01369368 UNKNOWN
Acute Myeloid Leukemia
University of Bergen
 2013-08 PHASE1; PHASE2
NCT02872428 TERMINATED
Shock,Hemorrhagic; Trauma
Dr. Hasan Alam
 2016-11 PHASE1
NCT01928849 COMPLETED
Pain, Phantom; Pain, Neuropathic
Duke University
 2013-12 PHASE2
NCT01106872 COMPLETED
Sarcoma; Soft Tissue Sarcoma; Locally Advanced Sarcoma; Unresectable Sarcoma; Metastatic Sarcoma
Mohammed M Milhem
 2010-09 PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02761291 UNKNOWN
Nasopharyngeal Carcinoma
Chang Gung Memorial Hospital
 2016-05 PHASE1
NCT02608736 COMPLETED
Head and Neck Squamous Cell Carcinoma
Barretos Cancer Hospital
 2015-12 EARLY_PHASE1
NCT01951560 COMPLETED
Shock,Hemorrhagic
Dr. Hasan Alam
 2013-09 PHASE1
NCT01233609 COMPLETED
Retinitis Pigmentosa
Foundation Fighting Blindness
 2010-11 PHASE2
NCT01182285 COMPLETED
Thyroid Neoplasm
National Cancer Institute (NCI)
 2010-09-24 PHASE2
NCT00879437 COMPLETED
Glial Cell Tumors; Malignant Gliomas; Glioblastoma Multiforme; Anaplastic Astrocytoma; Gliomatosis Cerebri; Gliosarcoma; Brainstem Glioma; Diffuse Intrinsic Pontine Glioma
Baylor College of Medicine
 2009-09-01 PHASE2
NCT00414310 COMPLETED
Myelodysplastic Syndrome; Acute Myelogenous Leukemia
M.D. Anderson Cancer Center
 2006-12 PHASE2
NCT01007695 TERMINATED
Cancer
University of Utah
 2010-05 PHASE1
NCT00867672 COMPLETED
Acute Myeloid Leukemia
University Hospital Freiburg
 2011-08 PHASE2
NCT03112889 Completed
Glycogen Storage Disease Type V|McArdle Disease
University College London
 2015-01 Phase 2
NCT01695122 COMPLETED
Head and Neck Cancer; Oral Cavity Cancer; Oropharyngeal Cancer
Instituto do Cancer do Estado de São Paulo
 2012-09 PHASE2
NCT02870283 COMPLETED
Bipolar Disorder
Federal University of Rio Grande do Sul
 2010-05 PHASE4
NCT01729598 COMPLETED
Alzheimer's Disease
Gregory Jicha, 323-5550
 2012-04 EARLY_PHASE1
NCT01674010 TERMINATED
Bipolar 1 Disorder
OPKO Health, Inc.
 2012-08 PHASE2
NCT01010958 TERMINATED
High Grade Sarcoma
Columbia University
 2009-10 PHASE1
NCT01861990 WITHDRAWN
Pediatric Brain Tumor; Glioma; Anaplastic Astrocytoma; Medulloblastoma; Glioblastoma
Medical University of South Carolina
 2013-05 PHASE1
NCT00759824 COMPLETED
Small Cell Lung Carcinoma
European Lung Cancer Working Party
 2008-09 PHASE2
NCT00530907 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
 2007-06 PHASE1
NCT01399515 COMPLETED
Retinitis Pigmentosa; Retinal Diseases; Eye Diseases; Eye Disease, Hereditary; Retinal Degeneration
Seoul National University Hospital
 2011-03 PHASE2
NCT00302159 COMPLETED
High Grade Gliomas; Brain Tumors
National Cancer Institute (NCI)
 2006-03 PHASE2
NCT01333631 UNKNOWN
Pancreatic Cancer
Soroka University Medical Center
 2011-06 PHASE2
NCT00977132 TERMINATED
Myelodysplastic Syndrome MDS
Heinrich-Heine University, Duesseldorf
 2009-10 PHASE2
NCT01738815 COMPLETED
Hematuria; Bladder Cancer
State University of New York - Upstate Medical University
 2011-12 EARLY_PHASE1
NCT01295593 UNKNOWN
Chronic Lymphocytic Leukemia
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
 2010-12 PHASE1; PHASE2
NCT01203735 UNKNOWN
Locally Advanced Inoperable Non-small-lung Cancer
Soroka University Medical Center
 2011-02 PHASE1; PHASE2
NCT00995332 COMPLETED
Acute Myelogenous Leukemia
University of Bergen
 2009-09 PHASE1; PHASE2
NCT00084981 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
National Cancer Institute (NCI)
 2004-04 PHASE1
NCT00088452 COMPLETED
Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures
Children's Hospital Medical Center, Cincinnati
 2004-07 PHASE3
NCT00289952 COMPLETED
HIV Infections
Jean-Pierre Routy
 2006-06 PHASE2
NCT00996060 COMPLETED
Lung Cancer
New Mexico Cancer Research Alliance
 2008-07 PHASE1
NCT01204450 TERMINATED
Brain and Central Nervous System Tumors; Neuroblastoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
UNC Lineberger Comprehensive Cancer Center
 2009-11 PHASE1
NCT00495872 COMPLETED
Solid Tumors
M.D. Anderson Cancer Center
 2007-06 PHASE1
NCT00529022 COMPLETED
Solid Tumors
M.D. Anderson Cancer Center
 2007-08 PHASE1
NCT00513162 COMPLETED
Neuroectodermal Tumor; Brain Metastases; Advanced Cancer
M.D. Anderson Cancer Center
 2007-07 PHASE1
NCT00670046 TERMINATED
Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2008-05 PHASE2
NCT00976794 COMPLETED
Bipolar I Disorder
University of Sao Paulo
 2009-01 PHASE4
NCT00661453 COMPLETED
Spinal Muscular Atrophy Type I
University of Utah
 2008-04 PHASE1; PHASE2
NCT01586208 COMPLETED
Grand Mal Status Epilepticus; Non-convulsive Status Epilepticus
Hospital Universitari de Bellvitge
 2010-01 PHASE3
NCT01548066 COMPLETED
Androgenetic Alopecia; Male Pattern Baldness
Seoul National University Hospital
 2011-09 PHASE2
NCT01460563 UNKNOWN
Cerebral Aneurysm
Seoul National University Bundang Hospital
 2011-10
NCT00605657 COMPLETED
ALPS; Hypersplenism; Lymphadenopathy
Koneti Rao
 2008-01 PHASE1; PHASE2
NCT01016990 UNKNOWN
Leukemia; Lymphoma
Auxilio Mutuo Cancer Center
 2009-08 PHASE2
NCT00524667 TERMINATED
Chronic Lymphocytic Leukemia
CancerCare Manitoba
 2008-01 PHASE2
NCT00854581 TERMINATED
Lymphoma; Precancerous/Nonmalignant Condition
University of Miami
 2007-11 PHASE4
NCT00079378 COMPLETED
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Recurrent Adult Acute Myeloid Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Untreated Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2004-02 PHASE1
NCT01010854 TERMINATED
Breast Cancer
University of California, San Francisco
 2008-12-10 PHASE2
NCT00385710 COMPLETED
Progressive Supranuclear Palsy
Nantes University Hospital
 2006-11 PHASE2
NCT00439673 COMPLETED
Myelodysplastic Syndromes
Gruppo Italiano Malattie EMatologiche dell'Adulto
 2007-05 PHASE2
NCT02456454 COMPLETED
Bipolar Disorder
Nationwide Children's Hospital
 2006-01 PHASE3
NCT01011998 WITHDRAWN
Chronic Myelogenous Leukemia
New Mexico Cancer Research Alliance
 2009-09 PHASE2
NCT00481013 COMPLETED
Spinal Muscular Atrophy
University of Utah
 2007-07 PHASE2
NCT00496444 COMPLETED
Advanced Cancers
M.D. Anderson Cancer Center
 2005-05 PHASE1
NCT00681980 COMPLETED
Paraparesis Spastic Tropical
University of Sao Paulo
 2008-02 PHASE3
NCT00312546 TERMINATED
HIV Infections
University of North Carolina, Chapel Hill
 2006-06 PHASE1
NCT00437957 TERMINATED
Brain Metastases
H. Lee Moffitt Cancer Center and Research Institute
 2006-12 PHASE1
NCT01094249 COMPLETED
Schizophrenia; Bipolar Disorder; Psychotic Disorders
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2009-02 PHASE1
NCT00810680 UNKNOWN
Chronic Lymphocytic Leukemia
All India Institute of Medical Sciences
 2008-09
NCT00525135 TERMINATED
Head and Neck Cancer
University of California, San Francisco
 2007-08 PHASE2
NCT00109824 COMPLETED
Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
 2006-03 PHASE1
NCT00609245 COMPLETED
Photosensitive Epilepsy
Vanderbilt University Medical Center
 2007-12 PHASE4
NCT01115959 COMPLETED
Post Cerebral Hemorrhage
Wolfson Medical Center
 2003-02 PHASE4
NCT00563992 COMPLETED
Bipolar Disorder
New York State Psychiatric Institute
 2001-01 PHASE1
NCT00614458 TERMINATED
HIV Infections
University of North Carolina, Chapel Hill
 2007-04 PHASE2
NCT00339196 COMPLETED
Acute Myelogenous Leukaemia (AML); Myelodysplastic Syndrome (MDS)
Assistance Publique - Hôpitaux de Paris
 2006-07 PHASE2
NCT00175812 COMPLETED
Acute Myelogenous Leukemia
University of Bergen
 2004-11 PHASE1; PHASE2
NCT00246103 COMPLETED
Neoplasms, Advanced
H. Lee Moffitt Cancer Center and Research Institute
 2004-03 PHASE1
NCT00382590 COMPLETED
Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Leukemia
M.D. Anderson Cancer Center
 2005-08 PHASE2
NCT00145509 COMPLETED
Bipolar Disorder
Organon and Co
 2005-08 PHASE3
NCT00227266 COMPLETED
Spinal Muscular Atrophy
University of Utah
 2005-09 PHASE2
NCT00107458 COMPLETED
Brain and Central Nervous System Tumors; Unspecified Childhood Solid Tumor, Protocol Specific
Children's Oncology Group
 2005-05 PHASE1
NCT00075777 COMPLETED
Sarcoma
AIDS Malignancy Consortium
 2005-02
NCT00326170 COMPLETED
Myelodysplastic Syndrome; Acute Myelogenous Leukemia
M.D. Anderson Cancer Center
 2005-07 PHASE2
NCT00358319 TERMINATED
Malignant Melanoma
H. Lee Moffitt Cancer Center and Research Institute
 2005-03 PHASE1; PHASE2
NCT00145470 COMPLETED
Bipolar Disorder
Organon and Co
 2005-06-02 PHASE3
NCT00075010 COMPLETED
Leukemia; Myelodysplastic Syndromes
M.D. Anderson Cancer Center
 2004-01-23 PHASE1; PHASE2
NCT00431522 COMPLETED
Bipolar Disorder
Sanofi
 2004-12 PHASE4
NCT00211250 COMPLETED
Mood Disorder
Joliet Center for Clinical Research
 2005-07 PHASE4
NCT00139074 Terminated
Bipolar Disorder
AstraZeneca
 2005-07 Phase 4
NCT00004758 COMPLETED
Spasms, Infantile; Epilepsy
National Center for Research Resources (NCRR)
 1993-11 PHASE2
NCT00298857 TERMINATED
Healthy; Obesity; Pharmacokinetics
Northwell Health
 2006-03 PHASE4
NCT00000629 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE1
NCT00181220 WITHDRAWN
Nasopharyngeal Carcinoma
Johns Hopkins University
 2004-04 PHASE1
NCT01073059 COMPLETED
Healthy
Chonbuk National University
 2009-08 PHASE1
NCT00395655 TERMINATED
Locally Advanced Breast Cancer
National Institute of Cancerología
 2005-06 PHASE2
NCT01060228 COMPLETED
Schizophrenia; Epilepsy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2009-01 PHASE1
NCT00519181 TERMINATED
HTLV-I-Associated Myelopathy
University Hospital Pierre Zobda-Quitman
 2006-03
NCT00374075 COMPLETED
Spinal Muscular Atrophy
University of Utah
 2003-09 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Sodium Valproate (Valproic acid sodium) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium valproate functions as a histone deacetylase inhibitor by selectively inducing proteasomal degradation of HDAC2 and modulating ion channels, which leads to increased gamma-aminobutyric acid levels, blockade of voltage-gated sodium channels, and induction of G0/G1 phase arrest and apoptosis in proliferating cells. These cellular actions suppress hyperactive neuronal firing and inhibit cell proliferation, establishing its therapeutic relevance in clinical trials for epilepsy, bipolar disorder, and various solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.