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® oral suspension for CINV

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

New Oral Liquid Formulation Development

FOSNETUPITANT single agent for U.S.

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Fosnetupitant Development as Single Agent for the US Market

AKYNZEO® for pediatric use

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Development for CINV Pediatric Patients

AKYNZEO® IV in China1

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

IV Liquid Formulation Bioequivalence Program In China

VALCHLOR® in China

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Registrational study in China

ANAMORELIN 2

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

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

HM01

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Co-development with Anacardio in Heart Failure with Reduced Ejection Fraction

Anamorelin for weight loss in CKD

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Ghrelin agonist, potentially Phase 3-ready

HM03 for weight loss in CKD

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Ghrelin agonist

HM04 for Hyperphagia in PWS

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Ghrelin antagonist for hyperphagia in patients with Prader-Willi Syndrome

H1498 for obesity

Pre-clinical Phase 1 Phase 2 Phase 3 Regulatory

Ghrelin inverse agonist

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