List of Repurposed/505(b)(2) Drugs Companies in New York - 10

Auxilius Pharma is an emerging specialized pharmaceutical company with a focus on further developing and optimizing medications well established in some markets but not in the others, for the benefit of patients and to address major unmet needs in an increasingly cost conscious health care market environment. We are a versatile team with multifunctional healthcare experience in both the US and EU. We feature diverse backgrounds and strong core competencies in pharmaceutical marketing, drug development, pharmacology, health care management, corporate finance, and asset management.

CMTx Biotech is commercializing a pipeline of proprietary, non-antibiotic, chemically-modified tetracycline (CMT) compositions and formulations for the host-modulatory treatment of diseases with high unmet needs. The company’s lead drug candidate is a clinical-stage, orally-administered small molecule (incyclinide / CMT-3 / COL-3) for the treatment of hospitalized sepsis patients at risk of septic shock, multiple organ dysfunction syndrome (MODS) and acute respiratory distress syndrome (ARDS), including from SARS-CoV-2 infection (COVID-19) and other infectious diseases. Our clinical-stage drug candidate has already demonstrated impressive efficacy in a number of animal models of sepsis/ARDS/MODS across multiple species (rats, mice, pigs, sheep). It has also been evaluated in over 450 patients across eleven Phase I/II clinical studies, which showed that the drug is well-tolerated. CMTx Biotech also has a pipeline of pre-clinical stage analogues for the treatment of diseases with high unmet need.

At Epistemic AI we are building the next generation of tools to accelerate biomedical research with AI and NLP. We are a group of senior scientists and engineers from the likes of Google, New York University, Stanford and more. We are dedicated to enabling advances in biomedical research and practice with AI and NLP.

Intrance Medical Systems, Inc., is a private, U.S.-based biopharmaceutical company focused on the development and commercialization of its lead clinical product for the treatment of advanced Parkinson's disease in the U.S., Canada, South America, Japan and Taiwan. Intrance's lead product, known as Lecigon® in the European market, is a fixed-dose combination treatment of levodopa, carbidopa and entacapone for enteral infusion in advanced Parkinson's disease patients. The company is rapidly advancing its streamlined U.S. clinical development program in this target indication. Our team is comprised of industry veterans with extensive expertise in advanced Parkinson's disease including proven track records in regulatory, clinical development and commercialization. Intrance is backed by a strong syndicate of investors. The product, which was acquired by a neurology specialty pharma company for commercialization in Europe, has been rapidly gaining market share and user acceptance.

PsychoGenics is a preclinical CRO with expertise in CNS and orphan disorders. Our mission is to provide the best validated disease models and comprehensive preclinical capabilities to help companies discover the next generation of treatments for severely disabling CNS and orphan disorders, and reduce the attrition rate in clinical development. We are known for our cutting-edge translational approach to research, our customized solutions, the breadth and quality of our work, as well as for our ability to identify statistically relevant phenotypic changes that help our clients quantify the efficacy of their treatments before they move into the clinic. With an extensive portfolio of highly predictive disease models and unparalleled experience performing studies for biopharmaceutical companies of all sizes, we enable clients to deliver much needed superior clinical candidates to patients. Our capabilities include behavioral testing, electrophysiology, translational EEG, quantitative histology, molecular biology, and microdialysis. We offer a variety of validated mouse models including in-licensed transgenic models that support research in areas such as Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, autism spectrum disorders, psychosis and schizophrenia, spinal muscular atrophy, muscular dystrophy and a broad array of pain models.

Founded in 2008, S1 Biopharma is developing first-in-class drugs for the treatment of sexual dysfunction and hypoactive sexual desire disorder (HSDD) in both women and men. The company’s non-hormonal therapies work uniquely by restoring the natural balance of neurotransmitters in the brain. Since our company’s inception, we have been committed to innovation, integrity, the use of the highest quality science and a deep understanding of the biology underlying these disorders to develop effective treatments with safety as a priority. See our social media community guidelines at http://bit.ly/1kLpD6M

Sen-Jam Pharmaceutical is focused on improving clinical outcomes for patients battling inflammation-based diseases such as viral respiratory infections from coronaviruses such as COVID-19 and other painful inflammation and toxin-induced conditions, including arthritis, vaccinations, opioid withdrawal and even the infamous hangover. Using our patented proprietary technology of “next generation anti-inflammatories” and the accelerated 505(b)2 pathway, we’re addressing the root causes of autoimmune inflammation—much like how Ozempic targets metabolic inflammation.. Our mission: to transform how we treat inflammation and reshape the business of pain relief for the betterment of humanity..

Visiox biopharmaceutical company focused on the development and commercialization to address highly prevalent diseases.

Vitalis is a pre-clinical stage pharmaceutical company that is dedicated to changing the treatment of multiple sclerosis, post-op pain (non-opioid), and dyslipidemia through innovative therapies. Vitalis hopes to address major side effects of some of these treatments, such as flush, while also improving outcomes.

Woolsey Pharmaceuticals is a biopharmaceutical company that provides therapeutics common diseases.