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NLS-2
NLS-2 is a selective orexin-2 receptor agonist that promotes wakefulness by enhancing neural signaling in brain regions responsible for arousal and alertness.
NLS-2 is a selective orexin-2 receptor agonist that promotes wakefulness by enhancing neural signaling in brain regions responsible for arousal and alertness. Used for Narcolepsy type 1 and type 2, Excessive daytime sleepiness.
At a glance
| Generic name | NLS-2 |
|---|---|
| Also known as | mazindol extended-release (ER), mazindol controlled-release (CR) |
| Sponsor | NLS Pharmaceutics |
| Drug class | Orexin-2 receptor agonist |
| Target | Orexin-2 receptor (OX2R) |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
Orexin neuropeptides regulate sleep-wake cycles and maintain wakefulness through activation of orexin receptors in the brain. By selectively targeting the orexin-2 receptor, NLS-2 enhances wakefulness promotion while potentially minimizing off-target effects associated with dual orexin receptor agonism. This mechanism is designed to treat excessive daytime sleepiness and narcolepsy with improved tolerability.
Approved indications
- Narcolepsy type 1 and type 2
- Excessive daytime sleepiness
Common side effects
- Headache
- Insomnia
- Nausea
- Anxiety
Key clinical trials
- A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1 (PHASE3)
- An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy (PHASE2)
- Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NLS-2 CI brief — competitive landscape report
- NLS-2 updates RSS · CI watch RSS
- NLS Pharmaceutics portfolio CI