Expanded Access to Fosigotifator

NCT06594016 | Unknown

• 2 other identifiers: 2025-10780C25-693
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Fosigotifator prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Conditions

Vanishing White Matter; Cree Leukoencephalopathy

Keywords

Expanded Access; Pre-approval Access; Compassionate Use; Special Access Program; Named Patient Basis; Special Access Scheme; Fosigotifator; FGT; ABBV-CLS-7262; 2025-10780; C25-693; Vanishing White Matter; Cree Leukoencephalopathy

Interventions

Fosigotifator DRUG

Oral

Also known as: FGT, ABBV-CLS-7262

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Leukoencephalopathies

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01