Mycophenolate mofetil is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Lupus Nephritis. According to GlobalData, Phase II drugs for Lupus Nephritis have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Mycophenolate mofetil’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.

Mycophenolate mofetil overview

Mycophenolate Mofetil (Cellcept) is an immunosuppressant drug. It is formulated as tablets, hard gelatin capsules, suspension and powder for suspension for oral route of administration and injection solution for intravenous route of administration, solution for cutaneous route of administration. CellCept is indicated for the prophylaxis treatment of organ rejection in patients receiving allogeneic renal, cardiac or hepatic and pancreatic transplants. CellCept should be used for the concomitant therapy along with cyclosporine and corticosteroids. Cellcept is also indicated for the suppression of rejection in lung transplantation and pancreas transplantation. Cellcept is also indicated for the treatment of lupus nephritis. It is also indicated for the prevention of graft-versus-host disease (GVHD) in hematopoietic stem-cell transplantation (adults and children). Cellcept is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants in combination with other immunosuppressants.

The therapeutic candidate is under development for the treatment of systemic lupus erythematosus.

The drug candidate was under development for the treatment of myasthenia gravis and nephrotic syndrome, pemphigus vulgaris, psoriasis, vasculitis, nephropathy, myelodysplastic syndrome, sarcoidosis, systemic sclerosis (scleroderma), interstitial lung diseases (diffuse parenchymal lung disease), multiple sclerosis, bullous pemphigoid, lupus nephritis.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, healthcare professionals, commercial laboratories, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

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

This content was updated on 7 February 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.