TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DIACOMIT

STIRIPENTOL
Approved 2018-08-20
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-08-20
Routes
ORAL
Dosage Forms
FOR SUSPENSION, CAPSULE

Companies

BIOCODEX SA
Active Ingredient: STIRIPENTOL

DIACOMIT Approval History

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What DIACOMIT Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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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

ClinicalTrials.gov ↗ Pro

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.

DIACOMIT FDA Label Details

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DIACOMIT Patents & Exclusivity

Exclusivity: Jul 2029

Exclusivity

ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA207223 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.