Company Overview and Mission
Lexicon Pharmaceuticals is a fully integrated biopharmaceuticals company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for people with serious, chronic conditions. Using a patient driven approach, we are working to discover and develop innovative medicines to safely and effectively treat disease and improve patient lives. Our mission through the Investigator-Initiated Study Program is to support research that advance medical and scientific knowledge about Lexicon’s products and their therapeutic potential across various disease states. In alignment with our Company mission, the program seeks to continue to generate truly impactful solutions for patients that will make meaningful, long-term improvements in their lives.
What is an Investigator-Initiated Study?
An Investigator-Initiated Study (IIS) is a study in which the investigator or research institution is the study Sponsor. As the Sponsor, the Investigator is responsible for the design, implementation, and regulatory compliance of a research protocol. Lexicon may support an IIS in the form of product, funding, and/or technical input. Currently, the IIS program is accepting proposals for development of telotristat ethyl, Lexicon’s first FDA-approved oral therapy for the treatment of carcinoid syndrome diarrhea.
IIS Areas of priority include but not limited to the following:
- Biomarker (serotonin, tryptophan hydroxylase I, etc.) studies using tumor specimens (biobanks)
- Anti-tumor activity of telotristat ethyl (pre-clinical/clinical)
- Serotonin-driven valvular disease
- Diarrheal diseases
- Fibrotic diseases
How do I submit an IIS Grant Request?
What happens after submission of an IIS Grant Request?
If a Concept submission is of interest, Lexicon’s Grant Review Committee will issue a Full Proposal Submission requesting additional details.
What if I wish to only request drug, do I still have to submit an IIS Grant Request?