Sibeprenlimab

VOYXACT binds to APRIL with a dissociation constant (K D ) of 0.95 pM, which blocks signaling at the B cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptors. Inhibition of APRIL results in reduced levels of serum galactose-deficient immunoglobulin A1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.

• VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria.

• VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT. Serious hypersensitivity to sibeprenlimab-szsi or any excipients in VOYXACT.contraindicated

Recommended dosage: 400 mg injected subcutaneously once every 4 weeks. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of VOYXACT is 400 mg administered by subcutaneous injection once every 4 weeks. 2.2 Missed Dose If a scheduled dose of VOYXACT is missed, administer the missed dose as soon as possible and then resume dosing every 4 weeks thereafter. 2.3 Preparation and Administration VOYXACT is intended for patient self-administration or for administration by a caregiver. Provide proper training to patients and/or caregivers on the administration of VOYXACT prior to use according to the "Instructions for Use". Visually inspect the prefilled syringe for particulate matter and discoloration. The solution should be clear to opalescent and colorless to yellow. Do not use the prefilled syringe if the solution contains visible particulate matter, is cloudy or discolored (other than clear to opalescent, colorless to yellow). Allow VOYXACT prefilled syringe to come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection. Keep VOYXACT prefilled syringe in the original carton to protect it from light. Once VOYXACT prefilled syringe has reached room temperature, do not return it to the refrigerator. Do not use VOYXACT if it has been at room temperature for 7 days or longer. Administer VOYXACT by subcutaneous injection only. Inject into the front of the thigh or abdomen. The back of the upper arm can also be used as an injection site if administered subcutaneously by a caregiver.

Immunosuppression and Increased Risk of Infections: Before initiating VOYXACT, assess for active infections. During treatment, monitor for signs and symptoms of infection. ( 5.1 ) Immunosuppression and Immunization Risks: Live vaccines not recommended within 30 days prior to initiation of VOYXACT or during treatment. ( 5.2 ) 5.1 Immunosuppression and Increased Risk of Infections VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic or recurring infections may have an increased risk of serious infection. In clinical trials, infections occurred in 49% of patients treated with VOYXACT compared with 45% of patients treated with placebo. Before initiating VOYXACT, assess patients for active infections. During treatment, monitor patients for signs and symptoms of infection. If a serious infection develops, consider interrupting VOYXACT until the infection is controlled. There are limited clinical study data with concomitant use of VOYXACT and systemic immuno-suppressants. Consider the potential for increased immunosuppression when coadministering VOYXACT and immuno-suppressants or when initiating VOYXACT before or after immuno-suppressive therapy. 5.2 Immunosuppression and Immunization Risks Because of its mechanism of action, VOYXACT may interfere with the immune responses to vaccines and increase the risk of infection from live vaccines. Live vaccines are not recommended within 30 days prior to initiation of VOYXACT or during treatment with VOYXACT as safety has not been established.

The following clinically significant adverse reactions are described elsewhere in the labeling: Immunosuppression and Increased Risk of Infections [see Warnings and Precautions (5.1) ] Immunosuppression and Immunization Risks [see Warnings and Precautions (5.2) ] Most common adverse reactions are upper respiratory tract infection and injection site erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, clinical study in patients with IgAN (VISIONARY). The median duration of exposure was 44 weeks in the 259 patients treated with VOYXACT and 48 weeks in the 251 patients administered placebo. The most common adverse reactions (reported in ≥10% of patients treated with VOYXACT and at a higher incidence than placebo) in patients treated with VOYXACT and placebo, respectively, were infections (49% versus 45%) and injection site reactions (24% versus 23%). The most common infection was upper respiratory infection (15% versus 14%), and the most common injection site reaction was injection site erythema (13% versus 12%).

8.1 Pregnancy Risk Summary There are no available data on VOYXACT use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Monoclonal antibodies, such as sibeprenlimab-szsi, can be actively transported across the placenta as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy (see Clinical Considerations ) . In an enhanced prenatal and postnatal development (ePPND) toxicity study, administration of sibeprenlimab-szsi subcutaneously to pregnant monkeys did not result in any adverse effects on embryofetal or postnatal development at exposures approximately 10-times the clinical exposure at the maximum recommended human dose (MRHD) based on area under the curve (AUC) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Pregnant women exposed to VOYXACT, or their healthcare providers, should report VOYXACT exposure by calling 1-833-869-9228 or visiting www.VOYXACT.com.

Metabolism

Following 400 mg doses of VOYXACT administered subcutaneously every 4 weeks to patients with IgAN, steady-state is reached by 20 weeks of dosing. Absorption Following a single subcutaneous dose of 400 mg VOYXACT in healthy subjects, the median time to reach peak concentration is 8 days.

• Nov 25, 2025BLABLA761434Otsuka Pharm Co Ltd

1. 1Injection Site Pain1119%
2. 2Fatigue712%
3. 3Injection Site Swelling611%
4. 4Injection Site Pruritus58.8%
5. 5Nasopharyngitis47.0%
6. 6Pain47.0%
7. 7Device Difficult To Use35.3%
8. 8Headache35.3%
9. 9Injection Site Mass35.3%
10. 10Abdominal Pain Upper23.5%
11. 11Chromaturia23.5%
12. 12Device Issue23.5%
13. 13Device Use Error23.5%
14. 14Incorrect Dose Administered23.5%
15. 15Incorrect Dose Administered By Device23.5%

The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Sibeprenlimab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
  Completed · Phase 3 · Interventional · 530 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT05248646updated 2026-06-03
• Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
  Enrolling by invitation · Phase 2 · Phase 3 · Interventional · 600 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT05248659updated 2026-05-05
• A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
  Active not recruiting · Phase 2 · Interventional · 83 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT06928142updated 2026-03-18
• Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject
  Completed · Phase 1 · Interventional · 24 enrolled · Otsuka Beijing Research Institute
  NCT07105124updated 2025-08-05
• Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
  Recruiting · Phase 2 · Interventional · 25 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.
  NCT06740526updated 2025-04-06

Frequently asked questions

How does Sibeprenlimab work?

VOYXACT binds to APRIL with a dissociation constant (K D ) of 0.95 pM, which blocks signaling at the B cell maturation antigen (BCMA) and transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptors. Inhibition of APRIL results in reduced levels of serum galactose-deficient immunoglobulin A1 (Gd-IgA1), which is implicated in the pathogenesis of IgAN.

What is Sibeprenlimab used for?

According to FDA labeling, Sibeprenlimab carries indications including: VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sibeprenlimab?

Sibeprenlimab is classified as Monoclonal antibodies, Antibody-Receptor Interactions, Decreased Protein Synthesis.

What are the brand names for Sibeprenlimab?

Sibeprenlimab is marketed under brand names including Voyxact.

What are the contraindications for Sibeprenlimab?

Sibeprenlimab labeling lists contraindications including: VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT. Serious hypersensitivity to sibeprenlimab-szsi or any excipients in VOYXACT.. Always consult the full prescribing information and a clinician.