Momelotinib dihydrochloride is under clinical development by GSK and currently in the Phase III and Pre-Registration 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 Momelotinib dihydrochloride’s likelihood of approval (LoA) and phase transition for Myelofibrosis took place on 21 Oct 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Momelotinib dihydrochloride overview

Momelotinib (CYT-387) is under development for the treatment of primary myelofibrosis (PMF), secondary myelofibrosis, polycythemia vera myelofibrosis (PPV-MF), thrombocythaemia myelofibrosis. It is administered orally. It is Janus Kinase (JAK) 1/2 and Activin Receptor Type 1 (ACVR1) Inhibitor. It was also under development for the treatment of metastatic pancreatic ductal adenocarcinoma, metastatic non-small cell lung cancer, post-polycythemia vera (PV) and essential thrombocythemia.

GSK overview

GSK is a healthcare company that focuses on developing, manufacturing and commercializing pharmaceuticals, vaccines and consumer healthcare products. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular and urogenital, anti-bacterials, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastro-intestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.

Quick View Momelotinib dihydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Momelotinib dihydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: GSK
  • Originator: Cytopia
Highest Development Stage
  • Pre-Registration

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.