Late Stage Projects

Focus: Treatment of Pain

Global Clinical Development at Grünenthal is focused on providing new options for the treatment of pain. This is achieved by innovative clinical development of new chemical entities, most of which are derived from Grünenthal’s own pre-clinical research. In addition, new therapeutic entities are developed in order to extend the product portfolio and to provide state-of-the-art application technologies for established substances.

About 200 dedicated employees in departments within Global Clinical Development contribute to the overall success of the clinical development programs. We work in team structures following a matrix approach. A cross-functional, multidisciplinary clinical project team is set up for each new compound and is responsible for the planning, conduct, analysis and reporting of all corresponding clinical development activities. This is supported by cross-functional clinical study teams. These teams are comprised of many highly skilled specialists, such as medical experts, scientists and operational managers.

The clinical development program of a new compound at Grünenthal consists of scientifically customized trials in healthy subjects (Phase 1) and patients with a medical need for the compound in development (Phase 2 and Phase 3). After initial pre-clinical research activities, a new chemical entity is evaluated in a dedicated First in Human (FIH) trial to obtain the initial information on the pharmacokinetics, pharmacodynamics, safety and tolerability of the new compound in healthy subjects after administration in escalating doses. Biomarkers, like exploratory human pain models, are used to establish so-called Proof of the (pharmacological) Principle and a first dose-response relationship for the new compound. Furthermore, modeling and simulation techniques are utilized in order to estimate clinical outcomes and to optimize dose finding for the first trials in patients.

The Proof of Concept (PoC) for the efficacy of a new compound is achieved in Phase 2 trials in patients using well established clinical settings representative for the intended therapeutic use like surgical correction of bunions or painful diabetic peripheral neuropathy. In addition, dose-response relationship, safety and tolerability are evaluated in more detail. In the next steps, the efficacy, safety and tolerability of the development compound compared to standard analgesics are confirmed in multi-center Phase 3 trials using a larger patient population. For the late stage development of new chemical entities, Grünenthal follows a partnering approach with other reputable international pharmaceutical companies. One example is the successful partnership with Johnson & Johnson for the development and U.S. approval of tapentadol, a new centrally acting analgesic with a dual mode of action. As depicted in the portfolio chart, Grünenthal has currently several new drug candidates in different phases of development.

Overall, Global Clinical Development is engaged in all development steps of a new compound from the transition of pre-clinical research to the preparation of the dossier for marketing authorization approval providing multidisciplinary scientific and operational input.