Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vonsetamig · 2 trials · 2 indications
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Experimental Arm 1: Vonsetamig | EXPERIMENTAL | - |
| Experimental Arm 2: Odronextamab | EXPERIMENTAL | - |
| Vonsetamig | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Vonsetamig | DRUG | Administered as per the protocol |
| Odronextamab | DRUG | Administered as per the protocol |
Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General Exclusion Criteria: 1. History of or active severe or unstable lupus-associated...
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Vonsetamig is an investigational small molecule being developed for Lupus Nephritis (LN) and Chronic Kidney Disease (CKD). It is currently in Phase 1 clinical trials, including a study in adult patients with CKD who need kidney transplantation and are highly sensitized to human leukocyte antigen (HLA), and a dose escalation study in adults with Lupus Nephritis.
Vonsetamig is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting Phase 1 clinical trials to evaluate the safety and tolerability of Vonsetamig in patients with Chronic Kidney Disease and Lupus Nephritis.
Vonsetamig is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. There is one active Phase 1 trial in Chronic Kidney Disease and one recruiting Phase 1 trial in Lupus Nephritis, with a combined planned enrollment of 90 participants.
Vonsetamig is being studied in two Phase 1 trials. NCT05092347 is an active, not recruiting study in Chronic Kidney Disease patients needing kidney transplantation who are highly sensitized to HLA, enrolling 43 participants in the United States. NCT06975787 is a recruiting dose escalation study in Lupus Nephritis, enrolling 90 participants across the US, France, Germany, South Korea, Spain, and Taiwan.
No alternative names for Vonsetamig have been disclosed. The drug is identified solely by its name Vonsetamig in clinical trial records. It is a distinct investigational small molecule being developed by Regeneron Pharmaceuticals for nephrology indications.