Approval Probability
TA Base Rate
Adjusted LOA
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Also known as NLS-2, mazindol extended release
Mazindol · 4 trials · 7 indications
Cataplexy episodes is a clinical outcome measure that assesses the frequency of cataplexy episodes.
Summaries of the number and percentage of subjects who experienced Treatment Emergent Adverse Events (TEAEs), TEAEs related to study drug, SAEs, or discontinued study drug or withdrew from the study due to an AE.
Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 4. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness.
| Arm | Type | Description |
|---|---|---|
| NLS-2 | EXPERIMENTAL | Participants will receive a single NLS-2 tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single NLS-2 placebo matching tablet orally once daily from Day 1 to Day 56 (until the end of Week 8). |
| NLS-2 (mazindol extended release) | EXPERIMENTAL | NLS-2 (mazindol extended release) administered once a day. |
| Mazindol Controlled Release | EXPERIMENTAL | Mazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily. |
| Name | Type | Description |
|---|---|---|
| NLS-2 | DRUG | Participants will receive NLS-2 tablets orally. |
| Placebo | DRUG | Participants will receive NLS-2 matching placebo tablets orally. |
| Mazindol | DRUG | Drug: NLS-2 |
| mazindol extended release | DRUG | Dosed orally, once daily for up to 3 weeks |
Key Inclusion Criteria: * Adults ≥ 18 years of age at the time of signing the informed consent. * Documented primary diagnosis of Narcolepsy Type 1 (NT1) according to the International Classification of Sleep Disorders-Third Edition (ICSD-3) criteria. * Willing and able to safely discontinue all pr...
Mazindol is being developed for attention deficit disorder with hyperactivity and for narcolepsy with cataplexy. NewcelX Ltd. is studying it in both adult ADHD and narcolepsy, including narcolepsy with and without cataplexy. It is an investigational small molecule in Phase 2 development, not an approved treatment for these indications.
Mazindol targets SLC6A4, SLC6A3, and SLC6A2, acting as an inhibitor of these transporters. SLC6A4 is the serotonin transporter, SLC6A3 is the dopamine transporter, and SLC6A2 is the norepinephrine transporter. Inhibiting these targets affects serotonin, dopamine, and norepinephrine signaling, which is the basis for its study in ADHD and narcolepsy.
NewcelX Ltd., which trades under the ticker NCEL, is developing mazindol. The company is advancing the drug as an extended-release formulation, referred to as NLS-2, in Phase 2 clinical studies for ADHD and narcolepsy with cataplexy.
Mazindol is in Phase 2 clinical development. It is investigational and has not been approved for the indications under study. NewcelX Ltd. has completed Phase 2 trials in adult ADHD and in narcolepsy, and no trials are currently listed as active.
Two completed Phase 2 trials are registered for mazindol. NCT02808104 studied mazindol controlled release in adults with ADHD and enrolled 84 participants in the United States. NCT05055024 studied NLS-2, mazindol extended release, in subjects with narcolepsy and enrolled 52 participants in the United States.
NLS-2 is an extended-release formulation of mazindol developed by NewcelX Ltd. The Phase 2 narcolepsy trial NCT05055024 was conducted under the NLS-2 name, while the ADHD trial NCT02808104 used the mazindol controlled-release name. Both refer to the same active drug, mazindol.