Lexicon Pharmaceuticals is a fully integrated biopharmaceuticals company that 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, Lexicon works to discover and develop innovative medicines to safely and effectively treat disease and improve patient lives.
Our mission, through the Investigator-Initiated Study (IIS) Program, is to support research that advances medical and scientific knowledge in areas of interest for 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 IIS is a study in which the investigator or research institution is the study Sponsor. As the Sponsor, the Investigator is responsible for the initiation, design, implementation, and regulatory compliance of a research protocol. Lexicon may support an IIS in the form of drug product and/or financial support.
Currently, the IIS program is focused on research related to Xermelo® (telotristat ethyl), Lexicon’s first FDA-approved oral therapy for the treatment of carcinoid syndrome diarrhea. We prioritize clinical vs pre-clinical proposals.
IIS Areas of priority include but not limited to the following:
- Carcinoid Syndrome Diarrhea
- Carcinoid Syndrome
- Anti-tumor activity in Neuroendocrine Tumors (NETs)
- Anti-tumor activity in Biliary Tract Carcinoma (BTC)
- Anti-tumor activity in other indications
- Oncology supportive care
How to apply for IIS support
Lexicon accepts concept and full proposal IIS submissions. Investigators will be asked to submit their request for support in the following stages:
What happens after submission of an IIS Grant Request?
Applicant will be notified of approval or denial of an IIS submission decision within 10 business days of IIS Review Committee meetings, which are held on a monthly basis.