This section highlights FDA-related milestones and regulatory updates for drugs developed by NLS Pharmaceutics (NCEL).
Over the past two years, NLS Pharmaceutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NCEL-101, iTOL-102, Mazindol, and AEX-2. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NCEL-101 FDA Regulatory Events
NCEL-101 is a drug developed by NLS Pharmaceutics for the following indication: for Type 1 Diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NCEL-101
- Announced Date:
- July 1, 2026
- Indication:
- for Type 1 Diabetes
Announcement
NewcelX Ltd. announced the successful completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration ("FDA").
AI Summary
NewcelX Ltd. said it successfully completed a Type B Pre-IND meeting with the U.S. Food and Drug Administration (FDA) for its stem cell therapy program. The company said the meeting gave it helpful feedback on its plans to move the program forward. NewcelX views this step as an important milestone as it works toward developing treatments for serious diseases.
The company highlighted that its AstroRx® therapy, which comes from its platform, has shown promise in research on remyelination, the process of repairing damaged myelin in the nervous system. In a study published in Stem Cell Reports, AstroRx® appeared to help clear myelin debris, support immune regulation, and speed up the growth of cells needed to form new myelin. NewcelX says these findings point to broad potential for its stem cell platform in chronic demyelinating diseases such as multiple sclerosis and other future therapies.
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ITOL-102 FDA Regulatory Events
ITOL-102 is a drug developed by NLS Pharmaceutics for the following indication: Type 1 Diabetes Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- iTOL-102
- Announced Date:
- October 29, 2025
- Indication:
- Type 1 Diabetes Treatment
Announcement
NLS Pharmaceutics Ltd announced that the ITOL-102 cell therapy program for Type 1 Diabetes, originally supported through a grant from the Israel-U.S. Binational Industrial Research and Development ("BIRD") Foundation awarded to Kadimastem, will continue under the combined company's development framework following the completion of the merger between NLS and Kadimastem.
AI Summary
After completing its merger with Kadimastem, NLS Pharmaceutics has announced that its joint cell therapy program, ITOL-102 for Type 1 Diabetes, will continue under the new company, NewCelX Ltd. The program, first funded by a grant from the Israel-U.S. Binational Research and Development (BIRD) Foundation awarded to Kadimastem, remains a top priority in the combined research and development portfolio.
The BIRD Foundation will keep supporting ITOL-102, reflecting its mission to back U.S.-Israeli industrial collaborations. NewCelX will maintain its partnership with iTolerance Inc., leveraging stem-cell-derived pancreatic islet cells to create a therapy that could free patients from lifelong immunosuppression. Company leaders say the ongoing BIRD funding and the merger strengthen their ability to move ITOL-102 toward clinical trials faster. This move also broadens NLS’s focus from central nervous system disorders to include regenerative treatments for metabolic diseases like Type 1 Diabetes.
Read Announcement- Drug:
- iTOL-102
- Announced Date:
- February 25, 2025
- Indication:
- Type 1 Diabetes Treatment
Announcement
NLS Pharmaceutics Ltd. announced y the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration ("FDA") on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression.
AI Summary
NLS Pharmaceutics Ltd. announced a significant milestone following a Type B pre-IND meeting held on February 24, 2025, with a committee from the U.S. FDA. This meeting, conducted jointly by Kadimastem and iTolerance, focused on the development of iTOL-102—a promising investigational therapy for Type 1 diabetes. iTOL-102 combines Kadimastem’s allogenic human stem cell-derived pancreatic islets with iTolerance’s immunomodulator, iTOL-100, to potentially cure diabetes without requiring lifelong immunosuppression. The FDA provided critical feedback on current preclinical and clinical development plans, paving the way for updated safety toxicology studies and the preparation for a First-in-Human clinical trial. This feedback marks an important advancement in the clinical development of iTOL-102, highlighting its potential to transform diabetes treatment by offering a solution that avoids chronic immune suppression.
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Mazindol FDA Regulatory Events
Mazindol is a drug developed by NLS Pharmaceutics for the following indication: For the treatment of narcolepsy, and potentially other sleep-wake disorders.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Mazindol
- Announced Date:
- May 21, 2025
- Indication:
- For the treatment of narcolepsy, and potentially other sleep-wake disorders
Announcement
NLS Pharmaceutics Ltd announces that it will present new preclinical data on Mazindol ER at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology ("ASCP").
AI Summary
NLS Pharmaceutics Ltd., a Swiss clinical-stage biopharmaceutical company focused on central nervous system disorders, announced that it will present new preclinical data on Mazindol ER at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP). The meeting is scheduled for May 27-30, 2025, in Scottsdale, Arizona, and NLS will showcase its poster titled “Evaluating the Effects of Mazindol on Fentanyl Reward and Dependence in C57BL/6J Mice and Sprague-Dawley Rats (Study KO-943)” on May 29, during the poster session.
The preclinical study, performed with Key-Obs SAS and European academic partners, shows that Mazindol significantly reduces the rewarding effects of fentanyl and lessens its withdrawal symptoms in rodent models. These findings support further exploration of Mazindol ER as a potential non-opioid treatment for opioid dependence.
Read Announcement- Drug:
- Mazindol
- Announced Date:
- January 28, 2025
- Indication:
- For the treatment of narcolepsy, and potentially other sleep-wake disorders
Announcement
NLS Pharmaceutics Ltd announce the launch of a preclinical program evaluating Mazindol ER (Extended-Release) as a novel treatment for fentanyl dependence.
AI Summary
NLS Pharmaceutics Ltd, a Swiss clinical-stage biopharmaceutical company, has launched a preclinical program to test Mazindol ER (Extended-Release) as a new treatment for fentanyl dependence. This program will study whether Mazindol ER can safely and effectively reduce the symptoms of fentanyl addiction, including withdrawal and cravings, by targeting different neurotransmitter systems in the brain. The treatment may help rebalance neurochemical disruptions that occur with opioid addiction. Researchers will assess the drug’s safety, its long-lasting effects, and how it impacts both opioid withdrawal symptoms and cravings in laboratory models. The extended-release format of the drug is designed to provide a steady therapeutic effect, which could be an important advantage in managing dependence. If the preclinical study shows positive results, NLS may move forward with clinical trials to further explore this novel non-opioid treatment approach.
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AEX-2 FDA Regulatory Events
AEX-2 is a drug developed by NLS Pharmaceutics for the following indication: Non-Sulfonamide Dual Orexin Receptor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AEX-2
- Announced Date:
- February 27, 2025
- Indication:
- Non-Sulfonamide Dual Orexin Receptor
Announcement
NLS Pharmaceutics Ltd. announce new preclinical findings on AEX-2, reinforcing its potential as a first-in-class non-sulfonamide dual orexin receptor agonist ("DOXA") for narcolepsy and related neurological disorders.
AI Summary
NLS Pharmaceutics Ltd. recently announced promising preclinical findings on AEX-2, a novel non-sulfonamide dual orexin receptor agonist (DOXA) aimed at treating narcolepsy and related neurological disorders. In studies using orexin-deficient mouse models, AEX-2 demonstrated a significant boost in wakefulness, maintaining stable wake architecture without causing disruptive sleep patterns. The compound also effectively preserved REM sleep and reduced the frequency and duration of cataplexy episodes, a key symptom in narcolepsy type 1. These early results suggest that AEX-2 could be a safer and more targeted alternative to current orexin-based therapies. With its potential to address both sleep disturbances and underlying neurodegenerative issues, this preclinical data reinforces AEX-2 as a first-in-class agent, paving the way for further development and eventual clinical trials for a broader range of neurological conditions.
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