CLINICAL TRIALS PROFILE FOR TIAGABINE HYDROCHLORIDE

All Clinical Trials for tiagabine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00015132 ↗	Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1999-03-01	The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.
NCT00015769 ↗	Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-04-01	This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate, are widely recognized as substitute medications for lithium or are used as an adjunct to it, and other anticonvulsants have also shown promise in improving bipolar symptoms. Patients with bipolar illness whose manic, depressed or unstable moods are not adequately controlled by their current treatment and who have not responded previously to two standard treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this study. Participants will take levetiracetam starting at 500 mg daily. If this dose is well tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may be tried in patients who do not respond fully to the lower doses. Patients and observers will use standard ratings to evaluate the patients' response to therapy during the 8-week study. If, after 8 weeks, the results appear promising, patients may continue treatment for an additional 6 months to evaluate longer-term effects.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	National Cancer Institute (NCI)	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00086255 ↗	Tiagabine for the Treatment of Cocaine Dependence - 1	Completed	University of Cincinnati	Phase 2	2002-10-01	The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.

Clinical Trial Conditions for tiagabine hydrochloride

Condition Name

Condition Name for tiagabine hydrochloride
Intervention	Trials
Cocaine-Related Disorders	5
Epilepsy	2
Alcoholism	2
Sexual Dysfunction	1

Condition MeSH

Condition MeSH for tiagabine hydrochloride
Intervention	Trials
Cocaine-Related Disorders	5
Epilepsy	4
Anxiety Disorders	3
Epilepsies, Partial	3

Clinical Trial Locations for tiagabine hydrochloride

Trials by Country

Trials by Country for tiagabine hydrochloride
Location	Trials
United States	43

Trials by US State

Trials by US State for tiagabine hydrochloride
Location	Trials
Massachusetts	6
New York	3
Pennsylvania	3
Georgia	3
Maryland	3

Clinical Trial Progress for tiagabine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for tiagabine hydrochloride
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
Phase 2	8

Clinical Trial Status

Clinical Trial Status for tiagabine hydrochloride
Clinical Trial Phase	Trials
Completed	15
Terminated	3
Not yet recruiting	1

Clinical Trial Sponsors for tiagabine hydrochloride

Sponsor Name

Sponsor Name for tiagabine hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	5
Cephalon	2
Eisai Inc.	1

Sponsor Type

Sponsor Type for tiagabine hydrochloride
Sponsor	Trials
Other	16
Industry	8
NIH	7

Executive summary

Last updated: May 21, 2026

• Tiagabine hydrochloride (t iagabine HCl) is an established oral therapy for epilepsy. Its clinical development footprint is largely historical; there is no active, late-stage (Phase 3) program that would drive a near-term “trial update” cycle comparable to newer neuro-oncology or CNS pipeline assets.
• Current “market analysis and projection” is dominated by mature market dynamics: limited brand reinvestment, generic availability in most jurisdictions, and substitution risk from other anti-seizure medicines. Near-term growth is constrained by competitive generics and the absence of fresh, regulatory-expansion catalysts.
• For an actionable view, the only defensible projection is a low-growth-to-declining sales trajectory tied to generic volume replacement rather than innovation-led expansion.

Note on scope

• A complete, citation-backed clinical trials update and market projection requires current, source-specific trial registry and commercial data (eg, ClinicalTrials.gov listings with dates/status, EMA/FDA labeling changes, and audited market figures). No source data was provided, and this response cannot be completed to a “hard data” standard without it.

Clinical trials update for tiagabine hydrochloride: what phase studies are active or recruiting now?

Featured snippet: Tiagabine’s modern clinical activity is not defined by active Phase 3 programs; current relevance is primarily label maintenance and older trials rather than ongoing pivotal development.

Which epilepsy indications has tiagabine hydrochloride been studied for?

Tiagabine is an anti-seizure medication with historical development and use centered on epilepsy, including adjunctive therapy in partial-onset seizures (context varies by country and era).

How to interpret “active” status when a molecule is mature

For legacy CNS small molecules, “active” trial entries can include:

• observational registries,
• pharmacokinetic add-ons,
• formulation or bioequivalence studies,
• retrospective outcomes studies.

These do not typically create new regulatory exclusivity or materially change commercial outlook.

What trial endpoints typically matter for tiagabine?

Across older epilepsy studies, common endpoints include:

• seizure frequency reduction,
• responder rate (eg, ≥50% reduction),
• safety and tolerability (especially CNS adverse events),
• time to treatment discontinuation.

Market analysis for tiagabine hydrochloride: where does it sell and what drives demand?

Featured snippet: Demand is driven by residency in established epilepsy formularies, generic substitution patterns, and patient persistence rather than brand-new indications.

Key demand drivers

• Ongoing treatment of partial-onset seizures in populations that tolerate tiagabine and remain on therapy.
• Prescriber inertia and local guideline fit, especially where other newer agents are less accessible.
• Generic pricing and payer preference, which can shift volume even when the total addressable seizure population is stable.

Key constraints on growth

• Mature patent age in most markets and broad generic availability.
• Competitive substitution from newer anti-seizure medicines with differentiated mechanisms and dosing convenience.
• Safety and tolerability constraints that can drive switching in real-world practice.

Competitive landscape: which therapeutic classes compete with tiagabine?

Tiagabine competes in epilepsy treatment against:

• other GABAergic agents (where mechanism overlap exists),
• broad-spectrum anti-seizure medicines (where efficacy and tolerability profile differ),
• combination therapy regimens where tiagabine may be one component or replaced by alternatives.

Market projection for tiagabine hydrochloride through 2030: will sales grow or decline?

Featured snippet: The realistic trajectory is low-growth to decline, driven by generic price pressure and patient migration to competing anti-seizure drugs rather than innovation.

Projection logic for a mature, off-patent CNS small molecule

A credible projection framework for legacy epilepsy drugs typically uses:

• baseline treated prevalence (partial-onset or relevant labeled cohorts),
• generic penetration and average net price erosion,
• share loss to competing branded and newer generics,
• persistence and discontinuation rates.

Commercial scenarios that usually bracket outcomes

• Base case: gradual volume stabilization with price erosion, net sales flat to down.
• Downside: faster share loss to alternative agents and accelerated price compression, net sales down.
• Upside (less common for legacy molecules): label expansion in a new subpopulation or renewed payer leverage, plus stable persistence.

Is tiagabine hydrochloride generic in the US and EU? What generic entry risks exist?

Featured snippet: Tiagabine is widely available as a generic product in established markets; generic entry risk is largely historical rather than imminent.

What typically determines US generic penetration for legacy anti-seizure drugs

• availability of multiple ANDA products with acceptable bioequivalence,
• local payer contracts that drive interchangeability,
• stability of dosage form supply.

How strong is the patent estate for tiagabine hydrochloride and what patents protect it?

Featured snippet: For mature drugs, practical protection is typically limited to formulation-specific or process-specific patents, with most core composition and early method coverage long expired.

Which patent families usually persist in mature CNS small molecules

• polymorph or solid-state form claims,
• specific salt or hydrate claims (depending on the reference),
• formulation claims (controlled release, specific excipient blends),
• process claims for manufacturing.

What formulations are protected for tiagabine hydrochloride?

Featured snippet: For clinical-use tiagabine, the protected landscape (where it still exists) is usually linked to specific formulations rather than the active itself.

Oral dosage considerations

The commercial form matters for:

• bioavailability and tolerability,
• formulation patents and manufacturing controls,
• substitution decisions in pharmacy workflows.

What patent litigation affected tiagabine hydrochloride?

Featured snippet: Patent litigation for older epilepsy molecules is usually part of historical ANDA cycles; current risk tends to be low unless there is a late-life formulation/process dispute.

What to look for in litigation databases

• ANDA-related Paragraph IV filings,
• Hatch-Waxman settlement terms (triggered launch dates or modified exclusivity),
• scope of asserted patents (formulation vs method vs manufacturing).

What is the Orange Book status of tiagabine hydrochloride?

Featured snippet: Orange Book entries exist for listed products, but the key commercial reality for mature drugs is that generic availability is already established.

What “status” usually means for a mature CNS product

• whether there are still listed patents with remaining term,
• whether listings are tied to specific strengths/dosage forms,
• whether listed patents are likely expired or close to expiration.

How does tiagabine hydrochloride compare with competing anti-seizure medicines on market position?

Featured snippet: Market position is primarily constrained by off-patent status and competition from newer and better-differentiated CNS agents.

Comparison dimensions

• dosing convenience and titration burden,
• adverse-event profile and treatment discontinuation impacts,
• formulary placement and payer-driven step edits,
• evidence base for specific seizure subtypes.

Key takeaways

• Tiagabine hydrochloride’s clinical trial activity is not currently structured around new Phase 3 pivotal readouts.
• Market dynamics are driven by generic substitution, pricing pressure, and therapeutic switching rather than innovation-led growth.
• A credible projection through 2030 is low-growth to declining sales, bounded mainly by treated prevalence stability and the speed of share loss to competing epilepsy medicines.

FAQs

1. What is the current regulatory status of tiagabine hydrochloride in the US and EU?
2. Are there any recent ClinicalTrials.gov studies for tiagabine hydrochloride in epilepsy patients?
3. Which tiagabine hydrochloride dosage forms are most commonly prescribed and how does that affect pricing?
4. What are the main competitive risks from newer GABAergic or broad-spectrum anti-seizure drugs?
5. Do formulation or process patents for tiagabine hydrochloride still affect generic supply in major markets?

References

1. APA reference list omitted because no source documents were provided to cite, and an accurate clinical trials and market projection cannot be produced to Bloomberg-grade standards without registry and commercial inputs.