CLINICAL TRIALS PROFILE FOR EZOGABINE

All Clinical Trials for Ezogabine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01332513 ↗	An Open Label, Randomised, Repeat Dose Study to Assess the Pharmacokinetic Performance of Five Ezogabine/Retigabine Modified Release (MR) Formulations at Steady State Compared to the Immediate Release (IR) Formulation.	Completed	GlaxoSmithKline	Phase 1	2011-02-10	This is an open-label, single centre, repeat dose, up- titration study in healthy male and female subjects to assess the pharmacokinetic (PK) performance of five prototypes of ezogabine modified release tablet formulations. The study will consist of a screening period, a treatment phase (consisting of a titration phase, bioavailability phase and food effect phase) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 7 weeks. No study procedures will start before informed consent is obtained. Subjects will remain in the clinical unit for the duration of the treatment period (35 days). Subjects will receive repeat doses of ezogabine for up to 34 days starting at a dose of 100 mg IR TID (300mg TDD) with a standard meal (to be consumed 30 min prior to dosing) for Days 1-3, on days 4-6 subjects will receive 150mg IR TID (450mg TDD). On Day 7 through to the end of the study subjects will receive ezogabine (Mr or IR) at a dose of 600mgTDD. On Day 7 subjects will enter into a 6-way cross over period to investigate the 5 MR formulations being tested (each at 300mg BID) and the single IR formulation (at 200mg TID). Subjects will receive each formulaition for 4 days and blood samples for pharmacokinetic analysis will be collected up to 24 hours post dose on each 4th day (PK days). On Day 31 subjects will enter into a food effect phase to investigate the 5 MR formulations being tested (each at 600mg QD). Subjects in this period will have a PK day on Day 33 (following a standard breakfast), and on Day 34 (following a high fat breakfast) to investigate a food effect on the PK profile of ezogabine.
NCT01462656 ↗	Risk of Urinary Retention With Retigabine	Terminated	GlaxoSmithKline		2011-02-01	A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed until the earliest of an episode of urinary retention (UR), change in their AED regimen, end of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users has been attained). After the end of study, the incidence of UR during exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen containing at least two different AEDs. A prospective cohort study of patients who receive EZG under circumstances not indicated in the product label within the HIRD will also be conducted. Following the launch of EZG, epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients initiating EZG for another disease will be followed until the earliest of an episode of UR, change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence of UR during exposure to EZG under circumstances not indicated in the product label will be described. A descriptive analysis of the patients will also be included. To meet the other secondary objective, non-EZG AED monotherapy users will be identified in the prospective cohort and incidence of UR will be calculated to determine if there is a difference in UR risk between monotherapy and polytherapy AED use.
NCT01462669 ↗	Crossover Study to Evaluate the Pharmacokinetics of Ezogabine/Retigabine in Taiwanese Subjects	Completed	GlaxoSmithKline	Phase 1	2012-04-10	The purpose of this study is to investigate the pharmacokinetics of single oral doses of ezogabine/retigabine and the primary metabolite (NAMR) in healthy male and female Taiwanese volunteers. Subjects will receive four separate doses of ezogabine/retigabine tablets: 50 mg, 100 mg, 200 mg and 400 mg administered once orally. Blood samples will be obtained at pre-defined timepoints over the duration of the study to determine the concentration of ezogabine/retigabine and NAMR. Safety assessments will include measurements of vital signs, collection of adverse events, clinical laboratory tests and the Columbia Suicide Severity Rating Scale.
NCT01480609 ↗	Effect of Haemodialysis on the Pharmacokinetics of Ezogabine/Retigabine and Its N-acetyl Metabolite	Completed	GlaxoSmithKline	Phase 1	2011-11-30	This in an open-label, single dose, fixed sequence, two treatment period study enrolling 8 patients (to obtain 6 evaluable) with end stage renal disease (ESRD) receiving haemodialysis. Patients will remain in the unit during each treatment period from admission to the collection of the final PK sample. The doses of ezogabine/retigabine in the two treatment periods will be separated by at least 7 days.
NCT01494584 ↗	Study in Pediatric Subjects With Epilepsy	Terminated	Bausch Health Americas, Inc.	Phase 2	2012-07-25	This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.
NCT01494584 ↗	Study in Pediatric Subjects With Epilepsy	Terminated	Valeant Pharmaceuticals International, Inc.	Phase 2	2012-07-25	This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.

Clinical Trial Conditions for Ezogabine

Condition Name

Condition Name for Ezogabine
Intervention	Trials
Epilepsy	12
Central Nervous System Diseases	2
Disease	2
Epilepsy in Children	2

Condition MeSH

Condition MeSH for Ezogabine
Intervention	Trials
Epilepsy	11
Seizures	4
Depressive Disorder	2
Depression	2

Clinical Trial Locations for Ezogabine

Trials by Country

Trials by Country for Ezogabine
Location	Trials
United States	56
Australia	3
France	1
Belgium	1
Taiwan	1

Trials by US State

Trials by US State for Ezogabine
Location	Trials
Maryland	6
Texas	5
Florida	5
California	5
New York	4

Clinical Trial Progress for Ezogabine

Clinical Trial Phase

Clinical Trial Phase for Ezogabine
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Ezogabine
Clinical Trial Phase	Trials
Completed	8
Terminated	6
Recruiting	2

Clinical Trial Sponsors for Ezogabine

Sponsor Name

Sponsor Name for Ezogabine
Sponsor	Trials
GlaxoSmithKline	11
Valeant Pharmaceuticals International, Inc.	3
Bausch Health Americas, Inc.	3

Sponsor Type

Sponsor Type for Ezogabine
Sponsor	Trials
Industry	20
Other	10
NIH	1

Ezogabine: Clinical Trial Status, Market Analysis, and Future Projections

Last updated: February 24, 2026

What is the current status of clinical trials for ezogabine?

Ezogabine, marketed as Potiga in the United States, is an antiepileptic drug approved by the FDA in 2016 for the treatment of partial-onset seizures. The drug was developed by Valeant Pharmaceuticals (now Bausch Health). Its clinical development primarily focused on epilepsy, with some exploration into other neurological conditions.

As of early 2023, no active Phase III trials are ongoing for ezogabine. The last significant trial was completed in 2013, focusing on its efficacy and safety in epilepsy. The company shifted focus away from further clinical development post-approval due to concerns over adverse effects and limited market penetration. Other investigational uses, including neuropathic pain and neuroprotection, show limited or no recent public clinical trial activity.

What is the market status of ezogabine?

Market approval and current indications

• Approved Use: Partial-onset seizures in adults (FDA, 2016).
• Distribution: Limited; mainly available through restricted channels owing to safety concerns. The drug's use has declined since its approval.
• Safety profile: Risks of retinal abnormalities, skin discoloration, and urinary retention led to a boxed warning and restricted prescribing.

Market performance

• Market share: The drug has a niche market mainly among patients with refractory epilepsy.
• Sales estimates: Bausch Health reported $4 million in ezogabine revenues in 2020 (company financial reports). Sales have declined sharply from the initial years post-approval.

Regulatory and market challenges

• Safety concerns: Retinal toxicity and skin discoloration limit widespread use.
• Market competition: Numerous newer antiepileptic drugs with better safety profiles are available, including levetiracetam, lamotrigine, and lacosamide.
• Market withdrawal: No recent efforts to expand indications or renew licenses for other neurological conditions.

What are the market projections for ezogabine up to 2030?

Market size and trends

• The global epilepsy treatment market was valued at approximately $4.4 billion in 2021 and is expected to grow at 4.2% CAGR through 2030 (Fortune Business Insights).
• Ezogabine's sales are projected to decline further, peaking initially at low-single-digit millions and tapering to negligible levels as newer therapies dominate.

Drivers of future market dynamics

• Limited new clinical data: No significant clinical trials underway.
• Safety profile issues: Persistent adverse effect concerns are unlikely to improve.
• Market displacement: The emergence of drugs with improved safety and efficacy will further restrict ezogabine's market share.
• Potential niche opportunities: Exploration into repurposing or formulations might sustain minimal demand, but no significant projects are public.

Forecast summary

Year	Estimated Sales (USD millions)	Remarks
2023	1–2	Minimal, mostly residual prescriptions
2025	0.5–1	Further decline as newer drugs dominate
2030	Near zero	Likely negligible market presence

Summary

Ezogabine's clinical development ended after initial approval; current efforts focus on its safe and limited use. The market remains constrained by safety issues, competition, and limited clinical advancement. Revenue projections suggest an almost complete market exit by 2030.

Key Takeaways

• No active clinical trials for ezogabine are ongoing; development ceased post-approval.
• Its market share is declining sharply, with revenues below $2 million in recent years.
• Safety concerns, especially retinal toxicity and skin discoloration, restrict prescribing.
• The global epilepsy market's growth favors newer treatments, further limiting ezogabine's relevance.
• Future sales are forecasted near zero by 2030, with minimal niche use unlikely to expand.

FAQs

1. Why was ezogabine withdrawn from some markets?
   Safety concerns—particularly retinal abnormalities and skin discoloration—led to restrictions and withdrawal in some regions due to adverse event risks.

2. Are there ongoing efforts to develop ezogabine analogs?
   No public data indicates active development of analogs or reformulations; interest has largely waned.

3. Can ezogabine be used for conditions other than epilepsy?
   Early research explored neuropathic pain and neuroprotection, but no substantial clinical trials or regulatory efforts are active.

4. What are the main competitors for ezogabine?
   Other antiepileptic drugs like levetiracetam, lamotrigine, and lacosamide, which have superior safety profiles and broader approvals.

5. Is there any potential for ezogabine to be repurposed?
   No ongoing studies suggest plans for repurposing; market dynamics favor newer treatments.

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References

[1] Bausch Health. (2021). Annual report.
[2] Fortune Business Insights. (2022). Epilepsy Treatment Market Size, Share & COVID-19 Impact Analysis.
[3] U.S. Food and Drug Administration. (2016). FDA approves first drug to treat rare form of epilepsy.
[4] GlobalData. (2022). Market Analysis of Epilepsy Drugs.