Remestemcel-L is under clinical development by Mesoblast and currently in Phase II for Ulcerative Colitis. According to GlobalData, Phase II drugs for Ulcerative Colitis have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Remestemcel-L’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Remestemcel-L overview

Remestemcel-L (Prochymal, Temcell) is a stem cell drug therapy. It is formulated as solution for intravenous route of administration. Remestemcel-L is indicated in the management of acute Graft versus Host Disease (aGvHD) in pediatric patients. Temcell is indicated for treatment in children and adults with acute Graft Versus Host Disease in Japan. Prochymal is an intravenous formulation of mesenchymal stem cells (MSCs). The stem cells are obtained from the bone marrow of healthy adult donors. Mesenchymal stem cells (MSCs) are nonhematopoietic stem cells of mesodermal origin, with the capacity to differentiate into both mesenchymal and nonmesenchymal lineages likewise bone, cartilage and muscle, tendon, fat and liver.

Prochymal is under development for the treatment of  ulcerative colitis, Crohn's disease, cutaneous ulcers, hypoxic-ischemic encephalopathy. It is administered through intravenous and subcutaneous routes. The therapeutic candidate is developed based on mesenchymal precursor cell (MPC) technology platform.

It was also under development for the treatment of acute steroid refractory graft versus host disease (GvHD) in adults and pediatrics as first line therapy and for acute epidermolysis bullosa, type 1 diabetes, chronic obstructive pulmonary disease (COPD), myocardial infarction and acute radiation syndrome (ARS), osteoarthritis, cartilage repair.

It is also under development for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19).

Mesoblast overview

Mesoblast is a regenerative medicine company that develops regenerative cell-based products. Its most advanced candidate remestemcel-L is in phase III trials under the brand name RYONCIL for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast is advancing rexlemestrocel for localized inflammatory diseases including advanced heart failure, end-stage ischemic heart failure, and MPc-06-ID (rexlemestrocel) for the treatment of chronic low back pain. The company employs its proprietary technology platform, mesenchymal lineage adult stem cells (MLCs), to discover and treat cardiac diseases, and hematological diseases, spine and musculoskeletal disorders and immune-mediated and inflammatory conditions. The company has operations in the US, Australia, and Singapore. Mesoblast is headquartered in Melbourne, Victoria, Australia.

For a complete picture of Remestemcel-L’s drug-specific PTSR and LoA scores, buy the report here.


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.