Diacomit

(Stiripentol)

Phase 3Small molecule

BBiocodex

Diacomit is one of 45 small molecule programs targeting Primary Hyperoxaluria Type 1. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Primary Hyperoxaluria Type 1Active, not recruiting

Primary HyperoxaluriaActive, not recruiting

Dravet SyndromeActive, not recruiting

Status EpilepticusActive, not recruiting

Primary Hyperoxaluria Type 1Phase 3

Active, not recruiting

Primary HyperoxaluriaPhase 2

Active, not recruiting

Dravet SyndromePreclinical

Active, not recruiting

Status EpilepticusPreclinical

Active, not recruiting

Competition

Competitive Landscape

41 competitors in Status Epilepticus

#DrugCompanyPhaseTrials

Keppra

UCB

Approved

12 2

Ketalar

AAultman Health Foundation

Approved

8 3

Versed

CConrado Roberto Hoffmann Filho

Approved

5 4

Epidiolex

Depakote

3 6

Vimpat

UCB

Phase 3

3 7

Actemra

Roche

Phase 3

1 8

Ativan

BBausch Health Americas, Inc.

Phase 3

4 9

Luminal

BBiomed Industries, Inc.

Phase 3

4 10

Fintepla

IImmedica Pharma AB

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2030

Phase 3Not yet recruiting

Primary Hyperoxaluria Type 1

NCT06465472

Clinical

Trials by Indication[1]

Dravet syndrome4 trials

Compassionate Use of Stiripentol in Dravet Syndrome

No longer available·UUniversity of Colorado, Denver··NCT01835314

Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies

No longer available·CCook Children's Health Care System··NCT02239276

Stiripentol in Dravet Syndrome

No longer available·MMayo Clinic··NCT01533506

Show 1 more trial

Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Approved for marketing·—··NCT01983722

Oral2 trials

Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)

Completed·BBiocodex·Phase 1·NCT07176832·24 enrolled

Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers

Completed·BBiocodex·Phase 1·NCT03866928·14 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Status Epilepticus1 trial

Stiripentol for the Treatment of Refractory Status Epilepticus

Completed·—··NCT06540378·25 enrolled

Primary Hyperoxaluria Type 11 trial

Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3

Not yet recruiting·BBiocodex·Phase 3·NCT06465472·42 enrolled

2 more indications

Primary Hyperoxaluria1 trial

Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria

Completed·BBiocodex·Phase 2·NCT03819647·15 enrolled

Treatment1 trial

Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies

Completed·BBiocodex·Phase 4·NCT05419180·52 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 20, 2018

DIACOMIT

NDA NDA206709

Aug 20, 2018

DIACOMIT

NDA NDA207223

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Stiripentol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Stiripentol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Stiripentol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA206709). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Biocodex company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: BBiocodex

Diacomit

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2030

Trials by Indication[1]

Dravet syndrome4 trials

Oral2 trials

Pediatrics1 trial

Status Epilepticus1 trial

Primary Hyperoxaluria Type 11 trial

Primary Hyperoxaluria1 trial

Treatment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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