CLINICAL TRIALS PROFILE FOR VALPROIC ACID

All Clinical Trials for VALPROIC ACID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000629 ↗	The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	Primary objective: To study the pharmacokinetic interaction between zidovudine (AZT) and valproic acid in asymptomatic HIV-infected patients, characterizing AZT's oral bioavailability, plasma elimination half-time, plasma levels, and urinary excretion of AZT, 5'-O-glucuronide (GAZT), and 3'-amino-3'-deoxythymidine (AMT). Secondary objective: To establish the safety of short-term administration of AZT and valproic acid in combination with regard to hematologic parameters and liver function in asymptomatic HIV-infected patients. Preliminary studies using human liver tissue have shown that valproic acid inhibits the metabolic inactivation of zidovudine (AZT), which may prolong the plasma half-life of AZT and thus prolong the duration of the drug's effects in the body.
NCT00004758 ↗	Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1993-11-01	OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
NCT00004758 ↗	Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment	Completed	University of California, Los Angeles	Phase 2	1993-11-01	OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
NCT00004758 ↗	Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment	Completed	National Center for Research Resources (NCRR)	Phase 2	1993-11-01	OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
NCT00005658 ↗	Glycine to Treat Psychotic Disorders in Children	Completed	National Institute of Mental Health (NIMH)	Phase 2	2000-05-01	This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication. Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted. Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood. During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment: 1. Comprehensive psychiatric examination 2. Blood pressure and pulse monitoring once a week 3. Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels 4. Eye movement study at week eight - Using a technique called infrared oculography, special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor. 5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals. Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed. NIMH will follow patients by phone every six months and with visits at two-year intervals.
NCT00006773 ↗	Bortezomib in Treating Patients With Recurrent Glioma	Terminated	National Cancer Institute (NCI)	Phase 1	2001-05-01	Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

Clinical Trial Conditions for VALPROIC ACID

Condition Name

Condition Name for VALPROIC ACID
Intervention	Trials
Epilepsy	16
Bipolar Disorder	10
Seizures	7
Schizophrenia	6

Condition MeSH

Condition MeSH for VALPROIC ACID
Intervention	Trials
Leukemia	21
Epilepsy	20
Leukemia, Myeloid, Acute	14
Leukemia, Myeloid	14

Clinical Trial Locations for VALPROIC ACID

Trials by Country

Trials by Country for VALPROIC ACID
Location	Trials
United States	255
Germany	23
Italy	23
Canada	14
Brazil	8

Trials by US State

Trials by US State for VALPROIC ACID
Location	Trials
Texas	26
Maryland	18
California	16
Ohio	13
New York	13

Clinical Trial Progress for VALPROIC ACID

Clinical Trial Phase

Clinical Trial Phase for VALPROIC ACID
Clinical Trial Phase	Trials
PHASE2	5
PHASE1	4
Phase 4	34

Clinical Trial Status

Clinical Trial Status for VALPROIC ACID
Clinical Trial Phase	Trials
Completed	106
Terminated	26
Unknown status	24

Clinical Trial Sponsors for VALPROIC ACID

Sponsor Name

Sponsor Name for VALPROIC ACID
Sponsor	Trials
National Cancer Institute (NCI)	19
M.D. Anderson Cancer Center	14
Abbott	12

Sponsor Type

Sponsor Type for VALPROIC ACID
Sponsor	Trials
Other	233
Industry	69
NIH	30

VALPROIC ACID Market Analysis and Financial Projection

Last updated: April 23, 2026

Clinical Trials Update, Market Analysis, and Projection: Valproic Acid

What is the current clinical-trials landscape for valproic acid?

Valproic acid is an established anticonvulsant and mood-stabilizing agent. Public trial activity continues largely in two buckets: (1) regulatory-cycle studies for new formulations (including delayed-release and generic equivalency packages) and (2) clinical research that expands use into specific seizure syndromes, adjunct regimens, and treatment settings where dosing, tolerability, or patient selection is studied.

Clinical-trials publication and registration pattern

• The most visible global signal around valproic acid remains ongoing comparator and equivalency work tied to marketed formulations and line extensions.
• Trial activity also tracks safety-management work (monitoring and mitigation of known risks such as hepatotoxicity and teratogenicity), which tends to be less prominent in company-led press releases but remains common in clinical databases.

Trial focus map (typical ongoing categories)

• Epilepsy indications
  • adjunct and monotherapy comparisons in defined seizure populations
  • pediatric and adolescent subgroups (where historical prescribing patterns generate ongoing evidence-generation)
• Bipolar disorder
  • regimen comparisons against other mood stabilizers and add-on strategies
• Formulation and pharmacokinetics
  • bioequivalence studies for generic products
  • dose-formulation refinements (e.g., delayed-release vs immediate-release for tolerability)

What market does valproic acid address, and how is demand structured?

Valproic acid has long commercial history and today is dominated by generic supply in most major markets, with demand tied to:

• chronic epilepsy prevalence and persistent prescribing
• bipolar disorder maintenance treatment patterns
• institutional formularies and payer coverage behavior
• continued uptake of generics and switching driven by pricing pressure

Demand drivers

• Epilepsy remains the main demand pillar.
• Bipolar disorder contributes a smaller but durable share.
• Formulation substitution is common (immediate-release vs delayed-release; tablet vs sprinkle/capsule equivalents), with payer contracting often determining mix more than therapeutic innovation.

Supply-side structure

• The market is structurally competitive due to generic entry once brand exclusivities end.
• Commercial differentiation concentrates in:
  • dosing convenience and tolerability profile
  • manufacturing reliability and contracted sourcing
  • packaging, stability, and patient-support programs (where still used by manufacturers)

How do pricing and payer dynamics shape revenue for valproic acid?

Revenue growth for valproic acid tends to track:

• volume stability (chronic patients)
• price erosion (generic price competition)
• cycle-time contracting (tender and formulary renewals)
• substitution rates across formulations (IR to DR, brand to generic)

Typical market behavior for mature generics

• If a region’s tender environment tightens, net prices compress.
• Volume can offset partially through high prevalence and repeat prescribing, but long-term growth depends on whether new contracting cycles restore pricing or whether switching accelerates toward lower-priced products.

What is the revenue outlook and how should projections be built?

Because valproic acid is largely off-patent in most markets, projection work should be framed as:

• market size (units) tied to prevalence and persistence of therapy
• realized price trajectory tied to generics competition
• mix (formulation and route)
• geography (US vs EU vs ROW demand and tender behavior)

Below is a projection framework consistent with mature generic dynamics. It is presented as a modeling template rather than a single-point forecast, because valproic acid’s pricing can move materially with contracting and new generic entrants.

Projection model (template)

Annual revenue = Units dispensed × Realized net price × Mix index

Where:

• Units dispensed grows at the rate of diagnosed prevalence plus treatment persistence minus switches away from valproate
• Realized net price declines with generic competition, partially stabilized by contracting scale
• Mix index accounts for delayed-release and patient-preferred formulations

Base-case assumptions for mature generics (directional)

• Units: low-to-mid single digit growth in established geographies where epilepsy prevalence and treatment adherence persist
• Net price: gradual decline, with sharper dips in tender-heavy markets or after major generic entry
• Mix: modest shift within oral formulations depending on tolerability/persistence

What could change the trajectory for valproic acid?

Key variables that move outcomes for the segment:

• Regulatory restrictions for teratogenic risk management in women of childbearing potential
• Clinical guideline emphasis on valproate avoidance or restricted use in pregnancy contexts
• Alternative antiseizure and mood stabilizer competition (substitution pressure)
• Payer policy updates that tighten or relax formulary restrictions
• Supply events (manufacturing constraints can temporarily lift realized price, then normalize)

Where does IP and lifecycle activity exist today?

Valproic acid is a foundational chemical entity with mature product history. Current lifecycle work generally shows up as:

• formulation protections (where any exist)
• manufacturing-process and polymorph or stability-related IP for specific products
• branded generics or long-acting/optimized delivery products under separate proprietary development (less dominant for valproate than for newer CNS agents)

In a valproic acid investment or R&D screen, the practical implication is:

• blue-sky growth from new chemical entity development is not the baseline expectation
• the most feasible incremental upside is tied to differentiated formulations, evidence for specific subpopulations, or access and contracting advantages.

---

Key Market-Action Implications

What does this mean for investors and R&D leaders?

• Valproic acid demand is durable because therapy is chronic and switching costs exist for stable patients.
• The competitive center of gravity is price and access, not innovation.
• Any growth program should target one of three levers:
  1. Formulation differentiation that reduces intolerance or improves adherence
  2. Payer-ready evidence that supports restricted-use pathways and persistence under monitoring requirements
  3. Manufacturing and contracting execution that keeps net price from collapsing at the tender level

Where to focus for best commercial lift?

• Prioritize formulation submissions that improve patient experience in real-world settings (tolerability and dosing convenience).
• Build data packages that align with payer and regulator concerns around pregnancy risk management and monitoring compliance.

---

Key Takeaways

• Valproic acid clinical activity is dominated by mature-evidence workflows: formulation and safety-focused studies rather than breakthrough efficacy claims.
• Market demand persists due to chronic epilepsy treatment patterns, with bipolar disorder as a secondary contributor.
• The revenue trajectory is governed by generic price erosion and formulary contracting more than therapeutic innovation.
• Projections should be modeled through dispensed units, realized net price, and formulation mix, with scenario analysis around tender cycles and competitive entry.
• The biggest swing factors are pregnancy-risk restrictions, guideline-driven prescribing behavior, and substitution pressure from alternative therapies.

---

FAQs

1) Is valproic acid still active in clinical trials today?

Yes. Trial activity continues, with emphasis typically on formulation equivalence, pharmacokinetics, and safety/monitoring in defined patient settings.

2) What is the main revenue driver for valproic acid?

Units dispensed driven by long-term epilepsy therapy, with realized net price constrained by generic competition.

3) How do pregnancy-risk restrictions affect the market?

They can reduce prescribing in women of childbearing potential, shifting demand toward alternative therapies and increasing monitoring requirements.

4) What type of innovation has the strongest commercialization fit for valproic acid?

Differentiated formulations that improve tolerability or adherence, supported by payer-aligned evidence packages.

5) What should dominate a market forecast model for valproic acid?

A unit-volume plus net-price framework that explicitly models tender-driven price changes and formulation mix shifts.

---

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. Valproate product information and safety communications. https://www.ema.europa.eu/
[3] U.S. Food and Drug Administration. Drug Safety Communications and prescribing information updates for valproate. https://www.fda.gov/