TheraRadar
Data updated: Jun 17, 2026

ZARONTIN (ethosuximide)

Trial Activity: Stable 1 active trials
CNS Approved 1960-11-02

Zarontin (ethosuximide) is an antiepileptic medication indicated for the control of absence (petit mal) epilepsy.

Source: FDA Label • PARKE-DAVIS • Anti-epileptic Agent

How ZARONTIN Works

Ethosuximide exerts its anticonvulsant effect by inhibiting T-type voltage-gated calcium channels in thalamic neurons. By reducing these calcium currents, the drug suppresses the rhythmic 3-Hz spike-and-wave discharges in the thalamocortical pathway that are characteristic of absence seizures.

Development Insights

Tanta University conducting 1 trials (20%)
6 indications explored (Moderate)
ibs - irritable bowel syndrome (1 trials)
cancer (1 trials)
peripheral neuropathy (1 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
65
Years on Market

Details

Status
Prescription
First Approved
1960-11-02
Routes
ORAL
Dosage Forms
SYRUP, CAPSULE

Companies

Active Ingredient: ETHOSUXIMIDE

ZARONTIN Approval History

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Original
New Indication
New Form
Label Update
40 FDA actions from 1960 to 2021
Oct 2021 SUPPL
Label · Labeling
Oct 2021 SUPPL
Label · Labeling
May 2016 SUPPL
Label · Labeling

What ZARONTIN Treats

1 indications

ZARONTIN is approved for 1 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Epilepsy
Source: FDA Label

ZARONTIN Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT02973542 IBSET CHU-289 2016-002110-42 Ph 2 completed Ethosuximide to Treat IBS
NCT04217733 Sherief Protocol Ph 3 recruiting Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome
NCT01278004 CINE-E CCR3116 Ph 2 completed Chemotherapy Induced Painful Peripheral Neuropathy Ethosuximide (The CIN-E Study)
NCT01122381 results posted B5043-R Ph 1, Ph 2 terminated Comparison of a Drug and Placebo in the Prevention of Migraine Headaches
NCT00689585 GEN#07-062 Ph 2 terminated Safety and Efficacy Study of Ethosuximide for the Treatment of Complex Regional Pain Syndrome (CRPS)
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

ZARONTIN FDA Label Details

Indications & Usage

FDA Label (PDF)

ZARONTIN is indicated for the treatment of Epilepsy.

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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