Drugs / TESP-0401
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07658638 | Jul 2026 → Mar 2027 expected | — | Tes Pharma S.r.l. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Tes Pharma S.r.l. | Regulatory Tes Pharma Receives FDA Orphan Drug Designation for TESP-0401 for the Prevention of Delayed Graft Function after Renal Transplantation tespharma.com ↗
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. |
| 2026-06-12 | Tes Pharma S.r.l. | Regulatory Tes Pharma Receives HREC Approval to Initiate Phase I Clinical Trial of the Lead Drug TESP-0401 for Prevention of DGF Following Kidney Transplantation tespharma.com ↗
Tes Pharma, a biopharmaceutical company focused on developing first-in-class therapeutics for high unmet medical needs in renal diseases, announced today that has received approval by the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the Phase I clinical trial of TESP-0401. |
| 2026-06-03 | Tes Pharma S.r.l. | Results Tes Pharma Presents Results on TESP-0401 in the Adenine-Induced model of Chronic Kidney Disease at the European Renal Association (ERA) Congress 2026 tespharma.com ↗
These data validate the scientific rationale of targeting the ACMSD enzyme to rescue mitochondrial dysfunction in the kidney and, importantly, expand the therapeutic potential of TESP-0401 for CKD, representing a key milestone for our growth. |
All press releases naming this drug 4 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TESP-0401 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07658638 ↗ |
| Route | Intravenous | “IV infusion, single administration, over 60 minutes, in a fasted state” NCT07658638 ↗ |