Anamorelin hydrochloride is under clinical development by Helsinn Group and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Anamorelin hydrochloride’s likelihood of approval (LoA) and phase transition for Cancer Anorexia-Cachexia Syndrome took place on 25 Jan 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Anamorelin hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Anamorelin hydrochloride overview

Anamorelin hydrochloride (Adlumiz) is a synthetic, small-molecule ghrelin mimetic with appetite-stimulating and anabolic activities. It is formulated as film coated tablets for oral route of administration. Adlumiz is indicated for the treatment of cancer cachexia in malignant tumors of non-small cell lung cancer, gastric cancer, pancreatic cancer or colorectal cancer.

Anamorelin hydrochloride (RC-1291, ONO-7643) is under development for the treatment of cancer cachexia/anorexia in non-small cell lung cancer (NSCLC) patients and cancer-related fatigue. It is a new molecular entity which is formulated as a tablet and is administered orally. The drug candidate acts by targeting the ghrelin receptor.

It was also under development for the treatment of cancer cachexia/anorexia in EU.

Helsinn Group overview

Helsinn Group (Helsinn) is a pharmaceutical group focused on building quality cancer care and rare diseases products. Helsinn is headquartered in Lugano, Switzerland.

Quick View Anamorelin hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Anamorelin hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Oncology
  • Toxicology
Key Developers
  • Sponsor Company: Helsinn Group
  • Originator: Novo Nordisk
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.