Narcolepsy Type 1

7
Pipeline Programs
4
Companies
8
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
4
1
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
3 programs
1
1
1
ALKS 2680 Dose 1Phase 31 trial
ALKS 2680, 4mgPhase 2/31 trial
ALKS 2680Phase 21 trial
Active Trials
NCT06358950CompletedEst. Jul 2025
NCT06767683RecruitingEst. Jun 2028
NCT07455383Not Yet RecruitingEst. Jun 2027
Takeda
TakedaTOKYO, Japan
2 programs
1
1
TAK-861Phase 31 trial
TAK-861Phase 21 trial
Active Trials
NCT05687903Completed112Est. Dec 2023
NCT06505031Completed105Est. Jun 2025
Centessa Pharmaceuticals
2 programs
2
ORX750Phase 21 trial
ORX750Phase 21 trial
Active Trials
NCT06752668Recruiting96Est. Dec 2025
NCT07096674Recruiting90Est. Apr 2026
Beacon Therapeutics
Beacon TherapeuticsMA - Cambridge
1 program
Dreem 3S recordingN/A1 trial
Active Trials
NCT06531876Active Not RecruitingEst. Dec 2025

Trial Timeline

Clinical trial activity over time

2023
2024
2025
2026
2027
2028
AlkermesALKS 2680 Dose 1
TakedaTAK-861
AlkermesALKS 2680, 4mg
Centessa PharmaceuticalsORX750
Centessa PharmaceuticalsORX750
AlkermesALKS 2680
TakedaTAK-861
Beacon TherapeuticsDreem 3S recording

Clinical Trials (8)

Total enrollment: 403 patients across 8 trials

NCT07455383AlkermesALKS 2680 Dose 1

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Start: Mar 2026Est. completion: Jun 2027
Phase 3Not Yet Recruiting
NCT06505031TakedaTAK-861

A Study of TAK-861 in People With Narcolepsy Type 1

Start: Oct 2024Est. completion: Jun 2025105 patients
Phase 3Completed
NCT06767683AlkermesALKS 2680, 4mg

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Start: Jan 2025Est. completion: Jun 2028
Phase 2/3Recruiting
NCT07096674Centessa PharmaceuticalsORX750

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

Start: Aug 2025Est. completion: Apr 202690 patients
Phase 2Recruiting
NCT06752668Centessa PharmaceuticalsORX750

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Start: Dec 2024Est. completion: Dec 202596 patients
Phase 2Recruiting
NCT06358950AlkermesALKS 2680

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

Start: Mar 2024Est. completion: Jul 2025
Phase 2Completed
NCT05687903TakedaTAK-861

A Study of TAK-861 in Participants With Narcolepsy Type 1

Start: Jan 2023Est. completion: Dec 2023112 patients
Phase 2Completed
NCT06531876Beacon TherapeuticsDreem 3S recording

Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy

Start: Jul 2024Est. completion: Dec 2025
N/AActive Not Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 403 patients
4 companies competing in this space