VALPROIC ACID · CHARTWELL RX
Valproic acid oral solution is indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
Details
- Status
- Prescription
- First Approved
- 1978-02-28
- Routes
- ORAL
- Dosage Forms
- SYRUP, CAPSULE
Companies
VALPROIC ACID Approval History
What VALPROIC ACID Treats
4 indicationsVALPROIC ACID is approved for 4 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Complex Partial Seizures
- Simple Absence Seizures
- Complex Absence Seizures
- Epilepsy
VALPROIC ACID Boxed Warning
BOXED WARNING Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appeara...
BOXED WARNING Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months [see Warnings and Precautions ( 5.1 )] . Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When valproic acid products are used in this patient group, they should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups. Patients with Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g. Alpers Huttenlocher Syndrome). Valproic acid is contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children under two years of age who are clinically suspected of having a mitochondrial disorder [see Contraindications ( 4 )] . In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, valproic acid should only be used after other anticonvulsants have failed.
VALPROIC ACID Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VALPROIC ACID
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
Valproic acid oral solution is indicated for: Monotherapy and adjunctive therapy of complex partial seizures; sole and adjunctive therapy of simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures 1.1 Epilepsy Valproic acid oral solution is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproic acid oral solution is indicated for use as sole and adjunctive therapy in the treatment of sim...
BOXED WARNING Hepatotoxicity General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific s...
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Full clinical data, patents, trials, and competitive landscape for valproic acid.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.