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Narcolepsy Type 1

2
Pipeline Programs
4
Companies
12
Clinical Trials
6 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
0
0
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Alkermes
AlkermesDUBLIN 4, Ireland
1 program
1
ALKS 2680Phase 35 trials
Active Trials
NCT07540897Not Yet Recruiting150Est. Jul 2027
NCT07455383Recruiting150Est. Jun 2027
NCT07502443Recruiting176Est. Jun 2027
+2 more trials
NLS Pharmaceutics
NLS PharmaceuticsSwitzerland - Zurich
1 program
1
NLS-2Phase 31 trial
Active Trials
NCT05914194Not Yet Recruiting48Est. Jul 2025
Centessa Pharmaceuticals
2 programs
ORX750PHASE_21 trial
ORX750PHASE_21 trial
Active Trials
NCT06752668Recruiting248Est. Dec 2026
NCT07096674Recruiting90Est. Apr 2026
Takeda
TakedaTOKYO, Japan
2 programs
TAK-861PHASE_21 trial
TAK-861PHASE_31 trial
Active Trials
NCT05687903Completed112Est. Dec 2023
NCT06505031Completed105Est. Jun 2025

Trial Timeline

Clinical trial activity over time

2023
2024
2025
2026
2027
2028
AlkermesALKS 2680
AlkermesALKS 2680
AlkermesALKS 2680
TakedaTAK-861
NLS PharmaceuticsNLS-2
AlkermesALKS 2680
Centessa PharmaceuticalsORX750
AlkermesALKS 2680
Centessa PharmaceuticalsORX750
AlkermesALKS 2680
AlkermesALKS 2680
TakedaTAK-861

Clinical Trials (12)

Total enrollment: 1,616 patients across 12 trials

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

Start: May 2026Est. completion: Jul 2027150 patients
Phase 3Not Yet Recruiting

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

Start: Apr 2026Est. completion: Jun 2027150 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Start: Apr 2026Est. completion: Jun 2027176 patients
Phase 3Recruiting

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

Start: Oct 2024Est. completion: Jun 2025105 patients
Phase 3Completed

A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

Start: Jul 2024Est. completion: Jul 202548 patients
Phase 3Not Yet Recruiting

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

Start: Jan 2025Est. completion: Jun 2028256 patients
Phase 2/3Recruiting

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

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

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Start: May 2025Est. completion: Jun 202696 patients
Phase 2Recruiting

A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia

Start: Dec 2024Est. completion: Dec 2026248 patients
Phase 2Recruiting

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Start: Jul 2024Est. completion: Nov 202593 patients
Phase 2Completed

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 202592 patients
Phase 2Completed

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

Start: Jan 2023Est. completion: Dec 2023112 patients
Phase 2Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
6 actively recruiting trials targeting 1,616 patients
4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.