At Helsinn, we have embedded technical know-how obtained over decades into a highly proactive and holistic product life-cycle design. In this way we always aim to develop value throughout the entire product life-cycle.
Our international teams include development and regulatory experts who address strategic and commercial challenges, starting from Chemistry, Manufacturing and Controls (CMC), then continuing the product development through initiatives, projects and various paths, to ultimately reach local approvals.
Partnerships with external Contract Research Organization (CROs) allow for an integrated approach, ensuring that our products are not only developed with the utmost care and precision but also managed effectively throughout their lifecycle.
Lifecycle development demands the running of rigorous clinical trials. Please find more information on ongoing clinical operations below.
AKYNZEO® new formulation for CINV
New Formulation Development
AKYNZEO® for pediatric use
Development for CINV Pediatric Patients
AKYNZEO® IV in China1
IV Liquid Formulation Bioequivalence Program In China
VALCHLOR® in China
Registrational study in China
ANAMORELIN 2
Anamorelin ex-Japan Registrational Program for Body Weight Loss and Anorexia in Cancer Patients
HM01
Co-development with Anacardio in Heart Failure with Reduced Ejection Fraction
Anamorelin for weight loss in CKD
Ghrelin agonist, potentially Phase 3-ready
Notes
The safety and efficacy of the agents identified for the investigational uses have not been established: these agents have not been approved for commercial use by any regulatory authority worldwide, except where noted. There is no guarantee that they will receive health authority approval or become commercially available in any country for the uses being investigated.
1. Approved in multiple territories, including USA and EU
2. Approved in Japan