Ibutamoren mesylate is under clinical development by Lumos Pharma and currently in the Phase I and Phase II 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 Ibutamoren mesylate’s likelihood of approval (LoA) and phase transition for Growth Hormone Deficiency took place on 16 Nov 2022, 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 Ibutamoren mesylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ibutamoren mesylate overview

Ibutamoren mesylate (MK-677) is under development for the treatment of pediatric growth hormone deficiency (PGHD), Turner syndrome, children born small for gestational age (SGA), idiopathic short stature, nonalcoholic fatty liver disease (NAFLD) and Prader Willi syndrome. It is administered orally. MK-0677 is a synthetic GHRS, ghrelin mimetic compound. MK-0677 is active growth hormone secretagogue that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone. It was under development for the treatment of Alzheimer's disease, fibromyalgia, sarcopenia in post-hip fracture patients and chronic renal failure in end-stage renal disease patients.

Lumos Pharma overview

Lumos Pharma, formerly NewLink Genetics is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of new therapies for the treatment of unmet medical needs of rare diseases. The company’s lead investigating candidate, LUM-201 (ibutamoren) is an oral growth hormone stimulating therapy for the treatment of pediatric growth hormone deficiency (PGHD), turner syndrome, children born small for gestational age (SGA), and other rare endocrine disorders. Lumos Pharma is headquartered in Austin, Texas, the US.

Quick View Ibutamoren mesylate LOA Data

Report Segments
  • Innovator
Drug Name
  • Ibutamoren mesylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Genetic Disorders
  • Genito Urinary System And Sex Hormones
  • Hormonal Disorders
  • Musculoskeletal Disorders
  • Women’s Health
Key Developers
Highest Development Stage
  • Phase II

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.