Drug Trials Snapshots: VOYXACT
HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your healthcare provider about the benefits and risks of a drug.
Some of the information in this Snapshot is for presentation purposes and does not represent the approved conditions of use of this drug. Refer to the VOYXACT Prescribing Information for all the approved conditions of use of this drug (e.g., indication(s), population(s), dosing regimen(s), safety information).
Snapshots are limited to the information available at the time of the original approval of the drug and do not provide information on who participated in clinical trials that supported later approvals for additional uses of the drug (if applicable).
VOYXACT (sibeprenlimab-szsi)
(VOY-ZAKT)
Otsuka Pharmaceutical Co., Ltd
Approval date: November 25, 2025
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
VOYXACT is an A Proliferation Inducing Ligand (APRIL) blocker that is approved to reduce proteinuria (protein in the urine) in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.
How is this drug used?
VOYXACT is an injection that is administered subcutaneously once every four weeks.
Who participated in the clinical trials?
The FDA granted accelerated approval to VOYXACT based on evidence from one clinical trial (VISIONARY, NCT05248646) in adult patients with primary IgAN. The trial was conducted at 242 sites in 31 countries in North America, Europe, Asia (East, Southeast, and South), and South America. The same trial was used to assess both efficacy and safety. The efficacy analyses were based on an interim analysis of 320 patients (152 on VOYXACT, 168 on placebo) who reached Month 9 in the trial. Of these 320 patients, 33 were from the United States. The safety analyses were based on 510 patients (259 on VOYXACT, 251 on placebo and standard of care) who received at least one dose of VOYXACT or placebo during the trial.
How were the trials designed?
VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, trial (VISIONARY) in adults with primary IgAN. Patients with primary IgAN and protein in the urine were randomly assigned to receive either VOYXACT or placebo once daily. The primary endpoint for accelerated approval was the percent reduction in urine protein at Month 9 compared to baseline.
How were the trials designed?
VOYXACT was evaluated in a randomized, double-blind, placebo-controlled, multicenter trial in adults with biopsy-proven IgAN (VISIONARY, NCT05248646). Patients with IgAN, an estimated glomerular filtration rate (eGFR; a measure of kidney function) ≥30 mL/min/1.73 m2, and total urine protein ≥1.0 g/day on a maximally-tolerated stable dose of a renin-angiotensin system (RAS) inhibitor with or without sodium-glucose co transporter 2 inhibitor (SGLT2i) treatment were enrolled. Patients were randomized (1:1) to either VOYXACT (400 mg) or a matched placebo injected subcutaneously every four weeks. Rescue immunosuppressive therapy could be initiated during the trial, per investigator discretion. The primary endpoint in the trial was the relative change from baseline in the amount of protein in the urine at Month 9 assessed using the urine protein-to-creatinine ratio (UPCR) from 24-hour urine collections.
DEMOGRAPHICS SNAPSHOT
Figure 1 summarizes how many males and females were enrolled in the clinical trial used to evaluate the efficacy of VOYXACT.
Figure 1. Baseline Demographics by Sex, Interim Analysis Set
Source: Adapted from FDA Review
Figure 2 summarizes the percentage of patients by race enrolled in the clinical trial used to evaluate the efficacy of VOYXACT.
Figure 2. Baseline Demographics by Race, Interim Analysis Set
Source: Adapted from FDA Review
Figure 3 summarizes the percentage of patients by age enrolled in the clinical trial used to evaluate the efficacy of VOYXACT.
Figure 3. Baseline Demographics by Age, Interim Analysis Set
Source: Adapted from FDA Review
Figure 4 summarizes the percentage of patients by ethnicity enrolled in the clinical trial used to evaluate the efficacy of VOYXACT.
Figure 4. Baseline Demographics by Ethnicity, Interim Analysis Set
Source: Adapted from FDA Review
Who participated in the trials?
Table 1 summarizes demographics for patients in the clinical trial.
Table 1. Baseline Demographics of Efficacy Trial by Age, Race, Sex, and Ethnicity
| Baseline Demographic | VOYXACT N=152 | Placebo N=168 | Total N=320 |
|---|---|---|---|
| Sex, n (%) | |||
| Female | 52 (34) | 68 (41) | 120 (38) |
| Male | 100 (66) | 100 (60) | 200 (63) |
| Age, years | |||
| Mean (SD) | 42 (12) | 43 (12) | 43 (12) |
| Median | 42 | 43 | 42 |
| IQR | 34, 51 | 35, 51 | 34, 51 |
| Min, max | 18, 75 | 18, 83 | 18, 83 |
| Age group, years, n (%) | |||
| ≤45 | 95 (62) | 98 (58) | 193 (60) |
| >45 | 57 (38) | 70 (42) | 127 (40) |
| Race, n (%) | |||
| Asian | 94 (62) | 95 (57) | 189 (59) |
| Black or African American | 0 | 1 (<1) | 1 (<1) |
| White | 55 (36) | 66 (40) | 121 (38) |
| Other | 3 (2) | 6 (4) | 9 (3) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 16 (11) | 22 (13) | 38 (12) |
| Not Hispanic or Latino | 132 (87) | 141 (84) | 273 (86) |
| Other | 4 (3) | 5 (3) | 9 (3) |
Source: Adapted from FDA Review
Abbreviations: IQR, interquartile range; SD, standard deviation
What are the benefits of this drug?
A trial comparing VOYXACT to placebo on top of standard of care evaluated the reduction of protein in the urine compared to baseline after nine months of treatment. Compared to baseline, there was, on average, a 50% reduction in the urine protein (assessed using UPCR) for VOYXACT compared to a 2% increase for placebo.
VOYXACT was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trial(s) to confirm that the drug works well.
What are the benefits of this drug (results of trials used to assess efficacy)?
Table 2 summarizes the efficacy results of the trial.
Table 2. Treatment Effect on UPCR at Month 9, Interim Analysis Set
| Treatment Effect on UPCR at Month 9 | VOYXACT N=152 | Placebo N=168 |
|---|---|---|
| % Reduction compared to baseline, % (95% CI) | 50 (43, 55) | -2 (-14, 8) |
| % Reduction compared to placebo, % (96.5% CI)a | 51 (42, 58) | |
| p-value | <0.0001 | |
Source: Adapted from FDA Review
a Corresponding to the two-sided significance level of 0.035 for the interim analysis.
Abbreviations: CI, confidence interval; N, number of subjects; UPCR, urine protein-to-creatinine ratio
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: The observed effect of VOYXACT was similar for females and males.
- Race: The observed effect of VOYXACT was similar for Asian and White patients. The number of patients of other races was small; therefore, differences in how VOYXACT worked among other races could not be determined.
- Age: The observed effect of VOYXACT was similar in patients younger and older than 45 years age.
- Ethnicity: The observed effect of VOYXACT was similar for Hispanic or Latino patients and not Hispanic or Latino patients.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
Table 3 presents efficacy results of the primary endpoint by subgroups of sex, race, age, and ethnicity.
Table 3. Treatment Effect on UPCR at Month 9 Compared to Placebo by Subgroup, Interim Analysis Set
| Subgroup | Subgroup | Relative % Reduction from Baseline % (95% CI) |
|---|---|---|
| Sex | Male | 51 (41, 60) |
| Female | 50 (38, 60) | |
| Age, years | ≤45 | 53 (44, 60) |
| >45 | 50 (35, 61) | |
| Race | Asian | 54 (44, 62) |
| White | 44 (31, 55) | |
| Ethnicity | Hispanic or Latino | 49 (25, 65) |
| Not Hispanic or Latino | 50 (42, 58) |
Source: Adapted from FDA Review
Note: Treatment differences and credible intervals include the relevance of outcomes from other subgroups.
Abbreviations: CI, confidence interval; UPCR, urine protein-to-creatinine ratio
What are the possible side effects?
VOYXACT suppresses the immune system by reducing antibody production, which may increase the risk of infections. The most common side effects of VOYXACT were infections and injection site reactions. The most common infection was upper respiratory infection, and the most common injection site reaction was injection site erythema.
What are the possible side effects (results of trials used to assess safety)?
Table 4 summarizes common side effects reported in ≥10% of patients with IgAN treated with VOYXACT and at a greater frequency than with placebo.
Table 4. Side Effects Reported in ≥10% of Patients With IgAN Treated With VOYXACT and at a Greater Frequency Than With Placebo, Safety Population, VISIONARY Study
| Side Effect | VOYXACT N=259 n (%) | Placebo N=251 n (%) |
|---|---|---|
| Infections* | 127 (49) | 113 (45) |
| Upper respiratory tract infection | 38 (15) | 35 (14) |
| Injection site reactions* | 61 (24) | 57 (23) |
| Injection site erythema | 34 (13) | 30 (12) |
Source: Adapted from FDA Review
* Infections and injection site reactions are comprised of several similar terms.
Abbreviations: IgAN, immunoglobulin A nephropathy
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar in males and females.
- Race: The occurrence of side effects was similar in White and Asian patients. The number of patients of races other than White or Asian was small; therefore, differences in side effects for other races could not be determined.
- Age: The number of patients older than 65 years of age in the clinical trial was small. The occurrence of side effects was similar in patients younger and older than45 years of age.
- Ethnicity: The occurrence of side effects was similar in Hispanic or Latino and Not Hispanic or Latino.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Table 5 summarizes adverse reactions (infections and injection site reactions) by subgroups.
Table 5. Infections and Injection Site Reactions Adverse Reactions by Subgroup, Safety Population, VISIONARY Study
| Subgroup | VOYXACT N=259 n/Ns (%) | Placebo N=251 n/Ns (%) | ||
|---|---|---|---|---|
| Infections* | ||||
| Sex, n (%) | ||||
| Female | 58/103 (56) | 66/107 (62) | ||
| Male | 69/156 (44) | 47/144 (33) | ||
| Race, n (%) | ||||
| American Indian or Alaska Native | 0/0 (NA) | 1/1 (100) | ||
| Asian | 74/159 (47) | 60/142 (42) | ||
| Black or African American | 1/1 (100) | 2/3 (67) | ||
| White | 48/91 (53) | 45/96 (47) | ||
| Other | 4/8 (50) | 5/9 (56) | ||
| Age group, years, n (%) | ||||
| ≤45 | 82/161 (51) | 67/142 (47) | ||
| >45 | 45/98 (46) | 46/109 (42) | ||
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 12/26 (46) | 17/32 (53) | ||
| Not Hispanic or Latino | 111/224 (50) | 92/209 (44) | ||
| Other | 4/9 (44) | 4/9 (44) | ||
| Unknown | 0/0 (NA) | 0/1 (0) | ||
| Injection site reactions* | ||||
| Sex, n (%) | ||||
| Female | 27/103 (26) | 31/107 (29) | ||
| Male | 34/156 (22) | 26/144 (18) | ||
| Race, n (%) | ||||
| American Indian or Alaska Native | 0/0 (NA) | 0/1 (0) | ||
| Asian | 34/159 (21) | 26/142 (18) | ||
| Black or African American | 1/1 (100) | 0/3 (0) | ||
| White | 23/91 (25) | 26/96 (27) | ||
| Other | 3/8 (38) | 5/9 (56) | ||
| Age group, years, n (%) | ||||
| ≤45 | 43/161 (27) | 38/142 (27) | ||
| >45 | 18/98 (18) | 19/109 (17) | ||
| Ethnicity, n (%) | ||||
| Hispanic or Latino | 6/26 (23) | 5/32 (16) | ||
| Not Hispanic or Latino | 52/224 (23) | 47/209 (22) | ||
| Other | 3/9 (33) | 5/9 (56) | ||
| Unknown | 0/0 (NA) | 0/1 (0) | ||
Source: Adapted from FDA Review
* Includes related terms
Abbreviations: N, number of patients in treatment arm; n, number of patients with adverse event; NA, not applicable; Ns, total number of patients for each specific subgroup and were assigned to that specific arm
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.