MedPath

NLS Pharmaceutics

NLS Pharmaceutics logo
🇨🇭Switzerland
Ownership
Public
Employees
4
Market Cap
-
Website
http://www.nlspharma.com
Introduction

NLS Pharmaceutics AG engages in the discovery and development of drug therapies to treat rare and complex central nervous systems disorders. These disorders include narcolepsy, idiopathic hypersomnia and other rare sleep disorders, and of neurodevelopmental disorders, such as ADHD. The company was founded by Ronald Hafner and Alexander Zwyer in August 2015 and is headquartered in Stans, Switzerland.

Clinical Trials

4

Active:0
Completed:3

Trial Phases

2 Phases

Phase 2:3
Phase 3:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (4 trials with phase data)• Click on a phase to view related trials

Phase 2
3 (75.0%)
Phase 3
1 (25.0%)

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

Phase 3
Not yet recruiting
Conditions
Narcolepsy Type 1
Narcolepsy With Cataplexy
Interventions
Drug: Placebo
First Posted Date
2023-06-22
Last Posted Date
2024-05-21
Lead Sponsor
NLS Pharmaceutics
Target Recruit Count
48
Registration Number
NCT05914194

An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

Phase 2
Completed
Conditions
Narcolepsy
Narcolepsy With Cataplexy
Narcolepsy Without Cataplexy
Interventions
First Posted Date
2021-09-23
Last Posted Date
2023-03-13
Lead Sponsor
NLS Pharmaceutics
Target Recruit Count
52
Registration Number
NCT05055024
Locations
🇺🇸

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States

🇺🇸

Stanford Sleep Medicine Center, Redwood City, California, United States

🇺🇸

Pacific Research Network, San Diego, California, United States

and more 19 locations

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

Phase 2
Completed
Conditions
Excessive Daytime Sleepiness
Narcolepsy
Cataplexy Narcolepsy
Interventions
First Posted Date
2021-06-11
Last Posted Date
2022-08-12
Lead Sponsor
NLS Pharmaceutics
Target Recruit Count
67
Registration Number
NCT04923594
Locations
🇺🇸

Sleep Disorders Center of Alabama, Birmingham, Alabama, United States

🇺🇸

Stanford Sleep Medicine Center, Redwood City, California, United States

🇺🇸

Pacific Research Network, San Diego, California, United States

and more 19 locations

Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 2
Completed
Conditions
Attention Deficit Disorder With Hyperactivity
Interventions
First Posted Date
2016-06-21
Last Posted Date
2017-04-06
Lead Sponsor
NLS Pharmaceutics
Target Recruit Count
84
Registration Number
NCT02808104
Locations
🇺🇸

AVIDA Clinic, Newport Beach, California, United States

🇺🇸

CNS Healthcare, Jacksonville, Florida, United States

🇺🇸

South Shore Psychiatric Services, Marshfield, Massachusetts, United States

and more 4 locations

News

BIRD Foundation Approves Additional Funding for iTOL-102 Type 1 Diabetes Cell Therapy Following FDA Pre-IND Meeting

The BIRD Foundation approved a fifth milestone payment of approximately $166,000 USD to support continued development of iTOL-102, a potential cure for Type 1 diabetes that would eliminate the need for lifelong immunosuppression.

Mazindol ER Shows Promising Dual Action Against Fentanyl Addiction in Preclinical Studies

NLS Pharmaceutics' preclinical study demonstrates Mazindol ER significantly reduces both fentanyl's rewarding effects and withdrawal symptoms in rodent models, suggesting potential as a novel non-opioid treatment for opioid addiction.

NLS Pharmaceutics Secures $28 Million in Financing to Advance Merger with Kadimastem and Cell Therapy Pipeline

• NLS Pharmaceutics has closed a $2 million equity financing at a 10% premium to market price, with potential for an additional $1 million, alongside a $25 million committed equity facility to support its planned merger with Kadimastem. • The funding will enable the merged company to advance Kadimastem's AstroRx® Phase IIa clinical trial for Amyotrophic Lateral Sclerosis (ALS) and IsletRx Phase I trial for type 1 diabetes following the merger completion. • The strategic merger aims to create a leading regenerative medicine company combining NLS's CNS expertise with Kadimastem's cell therapy platform for neurodegenerative diseases and diabetes.

NLS Pharmaceutics and NewAmsterdam Pharma File Mixed Securities Shelves Worth $75M and $500M Respectively

• NLS Pharmaceutics has filed a $75 million mixed securities shelf, signaling potential capital raising activities to support its clinical development pipeline in the near future. • NewAmsterdam Pharma has filed a significantly larger $500 million mixed securities shelf, positioning the company for substantial financing flexibility as it advances its cardiovascular therapeutics. • These strategic financial moves by both pharmaceutical companies indicate preparation for expanded research operations, clinical trials, or possible acquisitions in a competitive biotech funding landscape.

Kadimastem and iTolerance Seek FDA Input for Novel Type 1 Diabetes Therapy, iTOL102

Kadimastem and iTolerance have submitted a request for a Pre-IND meeting with the FDA for iTOL102, a novel treatment for Type 1 Diabetes.

Kadimastem and NLS Pharmaceutics Merge to Advance ALS Therapy AstroRx

• Kadimastem and NLS Pharmaceutics are merging to advance their respective drug portfolios, including AstroRx for amyotrophic lateral sclerosis (ALS). • A Phase 2a clinical trial of AstroRx is planned in the U.S. after January 2025, following FDA clearance of the investigational new drug application. • The merger will also support the development of NLS's dual orexin receptor agonists (DOXA) platform for neurodegenerative conditions. • Previous Phase 1/2a trial results showed AstroRx significantly reduced disease progression in ALS patients, with repeat dosing to be tested in the upcoming trial.

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