NCT07096674

A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Centessa Pharmaceuticals (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

Conditions

• Narcolepsy Type 1
• Narcolepsy Type 2
• Idiopathic Hypersomnia

Interventions

Type	Name	Description
DRUG	ORX750	Oral ORX750
DRUG	ORX750	Oral ORX750
DRUG	ORX750	Oral ORX750

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-07-31
• Last updated: 2026-04-16

Locations

24 sites across 4 countries: United States, Canada, Italy, Spain

Regulatory

• FDA-regulated drug study