Tes Pharma Receives FDA Orphan Drug Designation for TESP-0401 for the Prevention of Delayed Graft Function after Renal Transplantation
Solomeo-Corciano (PG), Italy, July 15, 2026 â Tes Pharma, a biopharmaceutical company focused on developing first-in-class therapeutics for high unmet medical needs in renal diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to TESP-0401 for the prevention of delayed graft function (DGF) after renal transplantation.
Orphan Drug Designation is granted by the FDA to support the development of medicines intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. The designation provides certain development incentives, including eligibility for seven years of market exclusivity in the United States upon marketing approval of the drug for the designed indication, tax credits for qualified clinical trials and exemption from certain FDA user fees.
âReceiving FDA Orphan Drug Designation for TESP-0401 further validates our strategy to advance a differentiated therapy for delayed graft function, a serious complication following kidney transplantation with no approved preventive treatment,â said Luca Benatti, Ph.D., Chief Executive Officer of Tes Pharma. âThis recognition strengthens the development path of TESP-0401 and reinforces our commitment to addressing areas of high unmet medical need in nephrology.â
Delayed graft function is a frequent and clinically relevant complication after kidney transplantation, particularly in recipients of deceased-donor kidneys, and is associated with worse long-term graft outcomes. Preventing early allograft dysfunction represents a critical goal in transplantation medicine, as graft loss can lead to a return to dialysis and renewed placement on the transplant waiting list.
Andrea Pellacani, M.D., Ph.D., Chief Medical Officer of Tes Pharma, said: âTESP-0401 is a first-in-class inhibitor of the ACMSD enzyme designed to restore de novo NADâș biosynthesis in the kidney. By targeting a key metabolic pathway involved in mitochondrial function and tubular cell resilience, TESP-0401 has the potential to address a fundamental mechanism of kidney injury and to support graft function after transplantation.â
About TESP-0401
TESPâ0401 is a firstâinâclass ACMSD inhibitor that restores NADâș levels by enhancing its de novo biosynthesis. Dysregulation of this pathway, and the resulting decline in NADâș levels, are key drivers of mitochondrial dysfunction and cellular energy failure across multiple indications, including acute (AKI) and chronic kidney diseases (CKD), as well as metabolic disorders.
By inhibiting ACMSD, selectively and highly expressed in tubular epithelial cells, TESPâ0401 restores NADâș levels in the kidney, thereby supporting mitochondrial function and cellular energetics. This mechanism targets a fundamental driver of disease progression, enabling recovery of essential cellular processes and improving cellular homeostasis under conditions of stress and injury.
Importantly, TESPâ0401 not only confers protection in AKI but also extends its therapeutic potential to CKD, where mitochondrial dysfunction and tubular injury contribute to progressive loss of renal function and fibrosis. By targeting NADâș metabolism, TESPâ0401 represents a novel and differentiated approach to prevent tubular damage, reduce fibrosis, and preserve kidney function in renal diseases.
About Tes Pharma
Tes Pharma, a biopharmaceutical company focused on developing first-in-class therapeutics for high unmet medical needs in renal diseases. The companyâs lead compound TESP-0401 demonstrated significant effect in models of acute (AKI) and chronic kidney diseases (CKD). TESP-0401 is entering first-in human studies in 2026 for prevention of delayed graft function in kidney transplantation. Tes Pharma pipeline includes a series of compounds for CKD and renal fibrosis in different stages of preclinical development.
For more information, please visit www.tespharma.com or connect with the Company on LinkedIn
For further information, please contact:
Sara Malincarne
smalincarne@tespharma.com