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Vonsetamig

Phase 1

Chronic Kidney Disease (CKD) | Small molecule | Nephrology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 13, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

Vonsetamig · 2 trials · 2 indications

Phase 1 2
NCT06975787Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus NephritisLupus Nephritis (LN)
RECRUITING90 Analytics
NCT05092347A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)Chronic Kidney Disease (CKD)
ACTIVE NOT_RECRUITING43 Analytics
PHASE1RECRUITING
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
Lupus Nephritis (LN)Unlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
Chronic Kidney Disease (CKD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of Dose Limiting Toxicities (DLT)
Up to 56 days
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Through week 76
Severity of TEAEs
Through week 76
Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
Up to approximately 6 weeks
Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study
Up to 78 weeks

TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)

Secondary Endpoints

Proportion of participants no longer receiving a corticosteroid
At 6 months
Cumulative total exposure to corticosteroids
At 76 weeks
Absolute values of urine Protein-Creatinine Ratio (uPCR)
Through week 76
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental Arm 1: VonsetamigEXPERIMENTAL -
Experimental Arm 2: OdronextamabEXPERIMENTAL -
VonsetamigEXPERIMENTAL -

Interventions

NameTypeDescription
VonsetamigDRUGAdministered as per the protocol
OdronextamabDRUGAdministered as per the protocol
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites18

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...

Countries:United StatesFranceGermanySouth KoreaSpainTaiwan
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT06975787primaryCompletionDate: changed
LOWAug 14, 2026NCT06975787primaryCompletionDate: changed
LOWAug 14, 2026NCT06975787primaryCompletionDate: changed
LOWJul 9, 2026NCT06975787lastUpdatePostDate: changed
LOWJul 9, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed
LOWJun 18, 2026NCT06975787lastUpdatePostDate: changed

Frequently asked questions about Vonsetamig

What is Vonsetamig used for?

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.

Who makes Vonsetamig?

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.

What phase is Vonsetamig in?

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.

What clinical trials is Vonsetamig in?

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.

Is Vonsetamig the same as any other drug?

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.