Brand Name
Voyxact
Generic Name
Sibeprenlimab
View Brand Information FDA approval date: November 25, 2025
Form: Injection
What is Voyxact (Sibeprenlimab)?
VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. VOYXACT is an A Proliferation Inducing Ligand blocker, indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
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Brand Information
VOYXACT (sibeprenlimab)
1INDICATIONS AND USAGE
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. It has not been established whether VOYXACT slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
2DOSAGE FORMS AND STRENGTHS
Injection: 400 mg/2 mL (200 mg/mL) clear to opalescent, colorless to yellow, solution in a single-dose prefilled syringe.
3CONTRAINDICATIONS
VOYXACT is contraindicated in patients with serious hypersensitivity to sibeprenlimab-szsi or any of the excipients of VOYXACT.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Immunosuppression and Increased Risk of Infections
- Immunosuppression and Immunization Risks
4.1Clinical 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%). Most adverse reactions were reported as mild or moderate in severity and resolved without treatment interruption or discontinuation.
5DESCRIPTION
VOYXACT contains sibeprenlimab-szsi, an A Proliferation Inducing Ligand (APRIL) blocker and humanized immunoglobulin G2 (IgG2) monoclonal antibody produced by Chinese Hamster Ovary (CHO) cells.
The approximate molecular weight of sibeprenlimab-szsi is 146 kDa.
VOYXACT (sibeprenlimab-szsi) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe for subcutaneous use.
Each 2 mL prefilled syringe delivers 400 mg sibeprenlimab-szsi and the inactive ingredients: arginine (17.6 mg), glutamic acid (14.8 mg), histidine (4.34 mg), L-histidine hydrochloride monohydrate (4.62 mg), polysorbate 80 (0.40 mg), sorbitol (36.4 mg), and Water for Injection, USP. The pH is 6.2.
6CLINICAL STUDIES
The effect of VOYXACT on proteinuria was evaluated in a randomized, double-blind, placebo-controlled, multicenter, global study (VISIONARY, NCT05248646) in adults with biopsy-confirmed IgAN, an eGFR ≥30 mL/min/1.73 m
The study enrolled a total of 510 patients. An interim analysis for efficacy was conducted on the first 320 (63%) randomized patients who had the opportunity to reach the Month 9 visit, 152 of whom were randomized to receive VOYXACT while 168 were randomized to receive placebo. Baseline demographics and disease characteristics were generally balanced between treatment groups. At baseline, the median age was 42 years (range 18 to 83 years); 63% were male, 59% were Asian, 38% were White, and 3% were of Other race.
At baseline, mean uPCR-24h was 1.5 g/g, mean estimated glomerular filtration rate (eGFR) was 63 mL/min/1.73 m
The primary endpoint was the relative change from baseline in uPCR-24h at Month 9. The mean estimated percent change from baseline in uPCR-24h is shown in Figure 1. The observed geometric mean percent change from baseline over time for uPCR from spot first morning void samples is shown in Figure 2.
Figure 1: Estimated Percent Change Compared to Baseline in uPCR-24h at Month 9 in Patients with IgAN in the VISIONARY Study
Figure 2: Percent Change Compared to Baseline in Spot uPCR Over Time in Patients with IgAN in the VISIONARY Study
The treatment effect (percentage reduction in uPCR-24h between VOYXACT and placebo) was consistent across the following subgroups and pre-specified stratification factors: sex, age, race, ethnicity, and geographic region, baseline proteinuria (uPCR-24h), baseline eGFR, and SGLT2i use.
7HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
VOYXACT (sibeprenlimab-szsi) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to yellow solution in a single-dose prefilled syringe with a 27 gauge, ½ inch needle and a needle safety device.
VOYXACT prefilled syringe is not made with natural rubber latex.
VOYXACT 400 mg/2mL (200 mg/mL) prefilled syringe is packaged in an individual carton (NDC 59148-400-75).
8PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Infections
Inform patients that they may be more likely to develop infections when taking VOYXACT. Instruct patients to tell their healthcare provider if they develop signs or symptoms of an infection
Hypersensitivity
Inform patients about the signs and symptoms of hypersensitivity reactions. Advise patients to discontinue VOYXACT and seek immediate medical attention for signs or symptoms of hypersensitivity reactions
Pregnancy
Advise patients who are exposed to VOYXACT during pregnancy to contact Otsuka Pharmaceutical Development and Commercialization, Inc. at 1-833-869-9228 or www.VOYXACT.com.
9INSTRUCTIONS FOR USE
VOYXACT
This Instructions for Use contains information on how to inject VOYXACT. Read and follow this Instructions for Use before you inject VOYXACT prefilled syringe for the first time and each time you get a refill. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to prepare and inject VOYXACT the right way before you use or give it for the first time.
Important Information You Need to Know Before Injecting VOYXACT Prefilled Syringe
- VOYXACT prefilled syringe is for injection under the skin (subcutaneous injection) use only.
- Do not remove the grey needle cap from the prefilled syringe until you are ready to inject.
- Each prefilled syringe has a needle guard. It will automatically cover the needle after the injection is completed.
- Do not pull back on the plunger at any time.
- Do not use if the VOYXACT prefilled syringe has been damaged.
- Do not use if the VOYXACT prefilled syringe has been dropped after removing the needle cap.
Storing VOYXACT Prefilled Syringe
- Store your VOYXACT prefilled syringe in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep the prefilled syringe in its original box to protect it from light.
- Let the VOYXACT prefilled syringe come to room temperature up to 77°F (25°C) for 15 to 30 minutes before giving an injection.
- When the VOYXACT prefilled syringe has reached room temperature,
- Do not use the VOYXACT prefilled syringe if it has been at room temperature for 7 days or longer.
- Do not freeze the VOYXACT prefilled syringe.
- Do not shake the VOYXACT prefilled syringe.
- Keep the VOYXACT prefilled syringe away from heat and direct sunlight.
- Throw away (dispose of) any VOYXACT prefilled syringe if it is expired. See
- Keep VOYXACT prefilled syringe and all medicines out of the reach of children.
Your VOYXACT Single-Dose Prefilled Syringe
Getting Your Supplies Ready
Step 1: Remove the VOYXACT prefilled syringe box from the refrigerator
Take the box containing VOYXACT prefilled syringe out of the refrigerator and check the expiration date (EXP) on the side of the box.
- Do not use the prefilled syringe if the seals on the box have been broken.
- Do not use the prefilled syringe if the expiration date (EXP) printed on the box has passed.
Step 2: Wait 15 to 30 minutes before use
Wait 15 to 30 minutes to let the prefilled syringe come to room temperature naturally (see
- Do not warm the prefilled syringe any other way.
- Do not let the prefilled syringe sit in direct sunlight.
Step 3: Gather supplies
Gather supplies that are not included in the VOYXACT prefilled syringe box:
- Alcohol swabs
- Cotton balls or gauze
- Adhesive bandages
- Sharps disposal container (see
Preparing to Inject the VOYXACT Prefilled Syringe
Step 4: Take the VOYXACT prefilled syringe out of the box
Hold the middle of the prefilled syringe (near the viewing window) to carefully lift the prefilled syringe out of the box (see
- Do not lift the prefilled syringe by the plunger.
- Do not shake or roll the prefilled syringe.
- Do not remove the grey needle cap from the prefilled syringe until Step 8 and you are ready to inject.
Step 5: Inspect the VOYXACT Prefilled Syringe
- Make sure that VOYXACT appears on the labels.
- Check the expiration date (EXP) printed on the prefilled syringe (see
- Check the medicine in the prefilled syringe through the viewing window. It is normal to see air bubbles. The medicine inside should be clear to slightly pearly and colorless to yellow (see
- Do not use VOYXACT prefilled syringe if:
- the expiration date printed on the prefilled syringe label has passed.
- the medicine is cloudy, discolored, or has particles floating in it.
- any part of the prefilled syringe is damaged, broken, or the needle guard has been activated.
- Do not try to remove air bubble(s) from the prefilled syringe.
Step 6: Choose the injection site
Choose an injection site on your bare skin from 1 of the following areas (see
- front of upper thigh
- stomach area (abdomen), avoiding the area 2 inches around the belly button.
- Do not inject into the same spot you used for your last injection.
- Do not inject into moles, scars, or bruises or skin that is tender, damaged, hard or red.
Step 7: Clean the injection site
Wash your hands with soap and clean water (see
- Clean the injection site with an alcohol swab and let the skin dry (see
- Do not touch the area again before injecting.
- Do not fan or blow on the injection site after you have cleaned it.
Injecting VOYXACT
Step 8: Remove the needle cap
When you are ready to inject, hold the prefilled syringe with 1 hand, pull the needle cap straight off with the other hand (see
- You may see a drop of liquid at the end of the needle. This is normal.
- Do not touch or recap the needle or let it touch any surface.
- Do not touch or pull back the plunger.
- Do not use a prefilled syringe with a bent or broken needle.
Step 9: Pinch the skin and insert needle
With the needle cap off, hold the prefilled syringe in 1 hand. With your other hand, gently pinch the skin at the injection site (see
- It is important to pinch enough skin to inject under the skin and not into the muscle.
Insert the entire needle at a 45-degree angle into the pinched skin using a dart-like motion (see
- Avoid touching the plunger until the needle is inserted.
Step 10: Complete the Injection
Push the plunger as far as it will go and it stops, and all the medicine is injected (see
Take your thumb off the plunger to allow the needle guard to automatically cover the exposed needle (see
Gently lift the syringe away from the injection site (see
- There may be a small amount of blood or liquid at the injection site. Hold pressure over your skin with a cotton ball or gauze until any bleeding stops.
- Apply an adhesive bandage, if needed.
- Do not rub or massage the injection site.
Disposing of the VOYXACT Prefilled Syringe
Step 11: Throw away (dispose of) the VOYXACT prefilled syringe
Throw away (dispose of) the used prefilled syringe in a FDA-cleared sharps disposal container right away after use (see
- Throw away the remaining supplies in your household trash or sharps container.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how to throw away needles and syringes.
- For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
- Do not recycle your used sharps disposal container.
If you have questions or concerns about your VOYXACT prefilled syringe, please call your healthcare provider. You can also call 1-800-441-6763 or visit www.VOYXACT.com for more information.
Manufactured by:
Tokyo 101-8535 Japan
Distributed by:
10PRINCIPAL DISPLAY PANEL - 200 mg/mL Syringe Carton
NDC 59148-400-75
Rx only
Voyxact
400 mg/2 mL
For Subcutaneous Use Only
Contains one single-dose prefilled syringe.
