Emiplacel is under clinical development by Pluri 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 Emiplacel’s likelihood of approval (LoA) and phase transition for Muscle Injury took place on 26 Sep 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 Emiplacel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Emiplacel overview

Emiplacel (PLX-PAD) is under development for the treatment of critical limb ischemia, graft versus host disease (GVHD), muscle injury following arthroplasty for hip fracture, COVID-19 infections intermittent claudication, mild to moderate knee osteoarthritis (OA). It is administered as intramuscular injection and intravenous infusion. The stem cell therapy is based on PLX (placental expanded) cells drug delivery platform that releases a cocktail of therapeutic proteins in response to a variety of local and systemic environmental signals. They are expanded using company's proprietary three dimensional (3D) bioreactor systems.

It was also under development for Buerger's disease, ischemic heart disease, diastolic heart failure, pulmonary fibrosis, pulmonary arterial hypertension, Duchenne muscular dystrophy, and pre-eclampsia.

Pluri overview

Pluri, formerly Pluristem Therapeutics is a clinical-stage biotherapy company that focuses on the development of placental-derived cell therapies. The company’s placental expanded cells are adherent stromal cells that can be administered to patients without tissue or genetic matching. Pluri’s product pipeline includes PLX-PAD for critical limb ischemia, intermittent claudication, orthopedic conditions, pulmonary arterial hypertension and women’s health. The company’s PLX-Immune for kidney, colorectal, breast, lung, muscle, skin and liver cancers, PLX-R18 for hematological system and acute radiation syndrome. Pluri harnesses its proprietary 3D cell expansion platform technology for developing its cell therapies. It works in partnership with medical, pharmaceutical and academic institutions. Pluri is headquartered in Haifa, Israel.

Quick View Emiplacel LOA Data

Report Segments
  • Innovator
Drug Name
  • Emiplacel
Administration Pathway
  • Intramuscular
  • Intravenous
  • Parenteral
Therapeutic Areas
  • Cardiovascular
  • Genetic Disorders
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
  • Respiratory
Key Developers
Highest Development Stage
  • Phase III

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.