Metabolic disorders affect a person’s ability to process nutrients or vitamins, while endocrine disorders involve misregulated hormone production. These diseases include a wide variety of conditions that negatively impact millions of Americans.
More drugs have been approved by the FDA for metabolic and endocrine disorders than for any other therapeutic area. Despite this, the incidence of these diseases continues to rise worldwide, further increasing the need for safe and effective therapies.
While many drugs have been approved to treat metabolic and endocrine diseases, drug development challenges remain. For example, both hormones and the drugs used to modulate hormones can have effects throughout the entire body which is a primary concern. As such, possible off-target effects must be considered, along with the potential need for additional safety monitoring.
Given the pleiotropic effects of most metabolic and endocrine drugs, careful planning of clinical trials is essential. This includes having the appropriate level of experience and expertise with these types of studies onboard from the very earliest planning stages. Doing so will ensure that all relevant outcomes are captured and that the analysis of trial data is performed in a way that accurately describes the behavior of the drug in the body.
Nuventra’s Metabolic and Endocrine Experience
Nuventra can perform any of our wide range of services for drugs to treat Metabolic and Endocrine Disease indications.
Visit our services page to see our full range of services and to learn more about what our drug development consultants can offer your program.
Metabolic and Endocrine Indications
Nuventra has experience with a number of metabolic and endocrine indications, including:
- Hypoactive Sexual Desire Disorder
- Nonalcoholic Steatohepatitis (NASH)
- Testosterone Replacement
- Type I Diabetes
- Type II Diabetes
- Vaginal Atrophy