Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AT-1501
Tegoprubart · 5 trials · 3 indications
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Maximum observed plasma concentration (Cmax)
Time to reach maximum observed plasma concentration (Tmax)
Terminal elimination rate constant (Ke)
Terminal phase half-life (t1/2)
Clearance (CL)
Volume of distribution at steady state (Vdss)
| Arm | Type | Description |
|---|---|---|
| Investigative Arm | EXPERIMENTAL | Tegoprubart |
| Comparator Arm | ACTIVE_COMPARATOR | Tacrolimus |
| AT-1501 | EXPERIMENTAL | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | ACTIVE_COMPARATOR | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
| Investigative | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Comparator | ACTIVE_COMPARATOR | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
| AT-1501 Single Arm | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Name | Type | Description |
|---|---|---|
| Tegoprubart | DRUG | Tegoprubart administered via IV infusion |
| Tacrolimus | DRUG | Tacrolimus administered orally |
| AT-1501 | DRUG | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
Inclusion Criteria: * Undergoing kidney transplant with a living or deceased donor kidney * Adult participants that have reached the age of consent and are ≥18 years of age * Written informed consent prior to any study assessment Exclusion Criteria: * Conditions or circumstances that, in the inve...
Tegoprubart is an investigational small molecule developed by Eledon Pharmaceuticals, Inc. (ticker ELDN). It is being studied in kidney transplant rejection and prevention of rejection in kidney transplant, and in amyotrophic lateral sclerosis. It has received an orphan drug designation from the FDA.
Tegoprubart is being developed for prevention of rejection in kidney transplant and for kidney transplant rejection, and it is also being studied in amyotrophic lateral sclerosis. It is investigational and has not been approved for any use.
Tegoprubart targets CD40LG, also known as CD40 ligand. It is an inhibitor of this target. By binding CD40LG, the drug is designed to interfere with CD40-CD40L costimulatory signaling, a pathway involved in immune activation relevant to transplant rejection.
Tegoprubart is developed by Eledon Pharmaceuticals, Inc., which trades under the ticker ELDN. Eledon is the sponsor of the clinical program studying the drug in kidney transplant recipients and in amyotrophic lateral sclerosis.
Tegoprubart is in Phase 2 development overall, with a Phase 3 trial planned in kidney transplantation. It is investigational and has not been approved by the FDA. The program includes one completed Phase 2 trial, one active Phase 2 trial, and a Phase 3 study that is not yet recruiting.
Tegoprubart trials include NCT07835581, a Phase 3 study comparing it with tacrolimus in kidney transplantation that is not yet recruiting; NCT06126380, a Phase 2 long-term safety and efficacy study enrolling by invitation; NCT05983770, a completed Phase 2 study; and NCT05027906, a recruiting Phase 1 study.
Yes, Tegoprubart is also known as AT-1501. AT-1501 is the earlier name used for the same investigational compound, and it appears in the title of the Phase 1 trial NCT05027906. Searches for either name refer to the same Eledon Pharmaceuticals drug candidate.