Data updated: May 26, 2026
DEPAKENE (valproic acid)
Trial Activity: Declining 5 active trials
CNS
Approved 1978-02-28
Development Insights
Dr. Hasan Alam conducting 2 trials (5%)
134 indications explored (Broad Platform)
→ glioma (2 trials)
→ glioblastoma (2 trials)
→ anaplastic astrocytoma (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
48
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1978-02-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, SYRUP
DEPAKENE Approval History
1979
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Original
New Indication
New Form
Label Update
91 FDA actions from 1978 to 2020
Dec 2000 SUPPL Priority
Mfg
Jun 2000 SUPPL Priority
Mfg
Jun 2000 SUPPL
Label
May 2000 SUPPL
Label
Dec 1999 SUPPL Priority
Mfg
Sep 1998 SUPPL Priority
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May 1998 SUPPL Priority
Mfg
Dec 1996 SUPPL Priority
Mfg
Mar 1995 SUPPL Priority
Mfg
Mar 1989 SUPPL Priority
Mfg
Dec 1987 SUPPL Priority
Mfg
Aug 1986 SUPPL
Label
May 1986 SUPPL
Label
Dec 1985 SUPPL
Label
Oct 1983 SUPPL Priority
Mfg
Sep 1982 SUPPL Priority
Mfg
Dec 1981 SUPPL
Label
Nov 1981 SUPPL
Label
Sep 1980 SUPPL Priority
Mfg
Jun 1980 SUPPL Priority
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Dec 1979 SUPPL Priority
Mfg
May 1979 SUPPL
Label
Feb 1978 ORIGINAL Priority
New Drug
What DEPAKENE Treats
1 FDA approvalsOriginally approved for its first indication in 1978 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 1978) Priority
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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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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
DEPAKENE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment