Technology

Life-Cycle Development

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

Regulatory
New Formulation Development

AKYNZEO® for pediatric use

Phase 2
Development for CINV Pediatric Patients

AKYNZEO® IV in China1

Regulatory
IV Liquid Formulation Bioequivalence Program In China

VALCHLOR® in China

Phase 3
Registrational study in China

ANAMORELIN2

Regulatory
Anamorelin ex-Japan Registrational Program for Body Weight Loss and Anorexia in Cancer Patients

HM01

Phase 2
Co-development with Anacardio in Heart Failure

HM04

Phase 2
Development for Hyperphagia in Prader-Willi Syndrome

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

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