TheraRadar
Data updated: May 26, 2026

VALPROIC ACID

CNS Approved 1986-02-28
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Discontinued
First Approved
1986-02-28
Routes
ORAL
Dosage Forms
SYRUP, CAPSULE

Companies

LANNETT CO INC CHARTWELL RX CATALENT PHARM ASSOC PHARMOBEDIENT CNSLTG QUAGEN Sun Pharma SCHERER RP Hikma PAI HOLDINGS PAR PHARM HIBROW HLTHCARE ANI PHARMS BIONPHARMA
Active Ingredient: VALPROIC ACID

VALPROIC ACID Approval History

1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
195 FDA actions from 1986 to 2026
May 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling

What VALPROIC ACID Treats

15 FDA approvals

Originally approved for its first indication in 1986 . Covers 15 distinct patient populations.

  • Other (15)
📋

Clinical Trial Registry

37 trials
Trial Sponsor ID Phase Status Title
NCT01552434 2012-0061 NCI-2012-00347, 2012-0061 Ph 1 terminated Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
NCT05821556 VESPA 1/23 Ph 2 recruiting Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients
NCT02068586 13P.377 2013-047, JT 2437 Ph 2 active not recruiting Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
NCT06729970 CN012-0035 Ph 1 completed A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
NCT06199557 HUVAMER HUVPA_6MPVPA Ph 1, Ph 2 recruiting A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
NCT03357757 LATENT LATENT Ph 2 completed Avelumab With Valproic Acid in Virus-associated Cancer
NCT03048084 STING 77353 Ph 4 recruiting Seizure Treatment in Glioma
NCT01817751 results posted MCC-14816 HM14816, NCI-2013-00705 Ph 2 completed Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma
NCT06248931 00000023988 Ph 3 completed Valproate Versus Topiramate in Migraine
NCT04531592 VPA-202 Ph 2 withdrawn Valproic Acid (VPA) for Acute Kidney Injury (AKI) in Liver Transplant Patients
NCT00879437 results posted 24549 Ph 2 completed Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma
NCT01960075 ESETT results posted 18078 119756, U01NS088034 Ph 3 completed Established Status Epilepticus Treatment Trial
NCT03885947 GCO 14-0451 Ph 1 completed VPA Expanded UCB Transplantation for Treatment of Patients With Hematological Malignancies
NCT03525730 LUNA 2017-002837-48 Ph 1, Ph 2 completed LRAs United as a Novel Anti-HIV Strategy.
NCT02870283 results posted 09-013 Ph 4 completed Cost- Effectiveness and Quality of Life Assessment in Mood Disorder
NCT04482764 BHS-VPA-SH-2017 Ph 1 completed Valproic Acid in Treating Cyanotic Breath Holding Spells
NCT01674010 results posted ELND005-BPD201 2012-001935-30 Ph 2 terminated Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
NCT02520115 2015-024 NCI-2015-01039, 1504013983 Ph 1 completed Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer
NCT02343575 results posted 28330 Ph 4 terminated Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU
NCT01928849 results posted Pro00047194 PT110575 Ph 2 completed Valproic Acid for the Prevention of Post-Amputation Pain
NCT02789813 VALPRO 2016DR2001 Ph 2 completed Influence of Valproic Acid on Extinction-based Therapy in Patients With Fear of Spiders.
NCT00670046 results posted J07122 P30CA068485, CDR0000595004 Ph 2 terminated Valproic Acid in Treating Patients With Progressive, Non-Metastatic Prostate Cancer
NCT01182285 results posted 100041 10-C-0041 Ph 2 completed A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin
NCT03385525 802HV109 Ph 1 completed Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT01233609 VPA results posted H-13371 Ph 2 completed Trial of Oral Valproic Acid for Retinitis Pigmentosa
NCT02872428 HUM00067452 VPA-C-002 Ph 1 terminated A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)
NCT01204450 LCCC 0901 P30CA016086, CDR0000665319 Ph 1 terminated Temsirolimus and Valproic Acid in Treating Young Patients With Relapsed Neuroblastoma, Bone Sarcoma, or Soft Tissue Sarcoma
NCT01951560 VPA-C-002 Ph 1 completed A Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1)
NCT01007695 VAST HCI36488 Ph 1 terminated Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot
NCT01399515 VPA_RP SNUH_OT_VPA Ph 2 completed Efficacy and Safety of Oral Valproic Acid for Retinitis Pigmentosa
NCT01695122 327/11 Ph 2 completed Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT00681980 278 Ph 3 completed Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
NCT01861990 VA2013 IRG-97-219-14 Ph 1 withdrawn Valproic Acid in Childhood Progressive Brain Tumors
NCT01010958 AAAD4523 Ph 1 terminated Adjuvant Valproate for High Grade Sarcomas
NCT00605657 results posted 080053 08-I-0053 Ph 1, Ph 2 completed Valproic Acid (Depakote[Registered Trademark]) to Treat Autoimmune Lymphoproliferative Syndrome (ALPS)
NCT01548066 VPA_hair Ph 2 completed The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VALPROIC ACID FDA Label Details

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Full clinical data, patents, trials, and competitive landscape for valproic acid.

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Data Sources

FDA Approval: ANDA077960 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.