Acella
Established Therapy
An established desiccated thyroid extract (DTE) product manufactured and distributed by Neuvosyn's sister company, Acella Pharmaceuticals.
Neuvosyn Laboratories is dedicated to developing innovative thyroid therapies through clinical research and regulatory work. Our team is focused on advancing promising treatments from development through FDA approval.
Explore North Star
THE SCIENCE BEHIND THE INNOVATION
Neuvosyn Laboratories is a pharmaceutical research and development company dedicated to advancing innovative therapies through clinical research, regulatory strategy, and scientific excellence.
Neuvosyn oversees the clinical, scientific, and regulatory activities required to pursue FDA approvals to support a growing pipeline of investigational therapies across multiple areas.
North Star is an investigational, next-generation desiccated thyroid extract (DTE) formulation being developed through the formal clinical and regulatory process with the goal of pursuing FDA approval.
Neuvosyn recently completed a Phase II clinical trial comparing North Star to levothyroxine in patients with primary hypothyroidism. The study met its primary endpoints, representing an important milestone in the program's development.
Neuvosyn Laboratories is the sister company of Acella Pharmaceuticals, the manufacturer and distributor of a leading desiccated thyroid extract (DTE) therapy that has served patients for decades.
Drawing on this expertise, Neuvosyn was established to lead the clinical research and regulatory work required to develop North Star—an investigational DTE formulation designed to provide a next-generation DTE product based on similar active ingredients.
North Star is being evaluated through FDA-guided clinical development with the goal of pursuing FDA approval as a new therapeutic option that meets today’s formal clinical and regulatory requirements.
Learn About the Clinical Trial
Acella
An established desiccated thyroid extract (DTE) product manufactured and distributed by Neuvosyn's sister company, Acella Pharmaceuticals.
North Star
A next-generation DTE formulation being developed with data from pre-clinical to clinical trials based on the same active ingredients as a leading thyroid therapy.
Neuvosyn
Leading the scientific, clinical, and regulatory strategy to advance North Star through the FDA approval process.
If you are interested in learning more about the clinical trial, please click the link below.
Learn MoreA small sample of projects in development.
| Therapeutic Area | Phase | Project | Indication | Expected Regulatory Pathway | Expected Submission Timeline |
|---|---|---|---|---|---|
| Endocrinology | RD-1 | Hypothyroidism | BLA | 2029 | |
| Women's Health | RD-3 | Prevention of Pregnancy | NDA | 2028 | |
| Analgesic | RD-4 | Treatment of Seizures | NDA | 2029 |
all individuals depicted are models used for illustrative purposes only.