APRIL inhibitors(Tumor necrosis factor ligand superfamily member 13 inhibitors), BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors)

Therapeutic Areas

Immune System DiseasesUrogenital DiseasesOther Diseases

Active Indication

Glomerulonephritis, IGAGlomerular diseaseNephrosis, Congenital

Inactive Indication

Clinically isolated syndromeLupus NephritisMultiple sclerosis relapse+ [4]

Originator Organization

ZymoGenetics, Inc.

Active Organization

Vera Therapeutics, Inc.Merck Serono SA

Inactive Organization

License Organization

Vera Therapeutics, Inc.

ZymoGenetics, Inc.

+ [1]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (United States), Orphan Drug (European Union), Orphan Drug (Japan), Priority Review (United States)

Structure/Sequence

Sequence Code 102889

Source: *****

Clinical Trials associated with Atacicept

NCT06983028

/ RecruitingPhase 2

A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)

The purpose of this study is to evaluate the safety and tolerability of atacicept in adult and adolescent participants and to measure the effect in reducing proteinuria and preserving renal function.

Start Date07 Jul 2025

Sponsor / Collaborator

Vera Therapeutics, Inc.

NCT07020923

/ RecruitingPhase 2

A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients With IgAN

This is a Phase 2, open-label, multicenter, randomized study comprising parallel groups of participants receiving weekly and/or monthly doses of atacicept

Start Date29 May 2025

Sponsor / Collaborator

Vera Therapeutics, Inc.

NCT06674577

/ Enrolling by invitationPhase 2

A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept

The purpose of this study is to collect long-term safety and tolerability data for atacicept in patients with IgAN that completed Vera trial investigating atacicept in IgAN population.

Start Date01 Dec 2024

Sponsor / Collaborator

Vera Therapeutics, Inc.

100 Clinical Results associated with Atacicept

100 Translational Medicine associated with Atacicept

100 Patents (Medical) associated with Atacicept

121

Literatures (Medical) associated with Atacicept

01 Apr 2025·JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY

Long-Term Results from an Open-Label Extension Study of Atacicept for the Treatment of IgA Nephropathy

Article

Author: Brenner, Robert M. ; Jha, Vivekanand ; Maes, Bart ; Wei, Xuelian ; Tesař, Vladimír ; Kim, Sung Gyun ; Barbour, Sean J. ; Phoon, Richard K.S. ; Eren, Necmi ; Singh, Harmeet ; Barratt, Jonathan ; Floege, Jürgen ; Cooper, Kerry ; Lafayette, Richard

Key Points:

Participants who completed a 36-week double-blind study of atacicept were eligible for a 60-week, open-label extension study.Atacicept 96-week treatment resulted in sustained reductions in galactose-deficient IgA1, hematuria, and urine protein-creatinine ratio.The slope of the eGFR was similar to that observed in the general population without kidney disease.

Background:

B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) play key roles in the pathogenesis of IgA nephropathy. Atacicept is a novel fully humanized fusion protein, self-administered at home by subcutaneous injection, that binds and inhibits BAFF and APRIL. By inhibiting BAFF and APRIL, atacicept targets the underlying B-cell–mediated pathogenesis driving disease progression. This study evaluated the long-term efficacy and safety of atacicept in patients with IgA nephropathy over 96 weeks.

Methods:

Participants with IgA nephropathy who received atacicept (25, 75, or 150 mg) or placebo in a 36-week phase 2b, randomized, blinded trial were enrolled in an open-label extension study and received atacicept 150 mg for an additional 60 weeks. Key efficacy outcomes were changes in galactose-deficient IgA1 (Gd-IgA1), percentage of participants with hematuria, urine protein-creatinine ratio (UPCR), and eGFR over 96 weeks. Long-term safety data were also evaluated.

Results:

There were 113 participants (67 [59%] male; 46 [41%] female) who ranged in age from 18 to 67 years who received ≥1 atacicept dose. Over 96 weeks, safety data demonstrated that atacicept was generally well tolerated. There were also sustained reductions (mean±SEM) in Gd-IgA1 (−66%±2%), percentage of participants with hematuria (−75%; 95% confidence intervals, −87 to −59; in participants with baseline hematuria), and UPCR (−52%±5%). The mean annualized slope of eGFR was −0.6±0.5 ml/min per 1.73 m2 through 96 weeks.

Conclusions:

Atacicept was well tolerated over the duration of the study. Atacicept treatment reduced Gd-IgA1, hematuria, and UPCR with stabilization of eGFR through 96 weeks.

Clinical Trial registry name and registration number::

Atacicept in Subjects with IgA Nephropathy (ORIGIN 2), NCT04716231.

Podcast:

This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2024_10_26_KTS_October2024.mp3

19 Dec 2024·Iranian Journal of Kidney Diseases

TACI Ig Fusion Protein Inhibits TLR4/MyD88/NF-κB Pathway Alleviates Renal Injury in IgA Nephropathy Rats.

Article

Author: Cheng, Yue ; Chen, Peng ; Sun, Jianhua ; Wang, Caili ; Zhang, Wei ; Li, Zengyan ; Chen, Xinnan

INTRODUCTION:

To evaluate the impact of TACI fusion protein (TACI-Ig) on IgA nephropathy (IgAN) in rats, and to explore its mechanism and relationship with TLR4/MyD88/NF-κB pathway.

METHOD:

Sprague Dawley(SD)rats were divided into six groups: control, model, TACI-Ig low dose (TACI-Ig-L), medium dose (TACI-Ig-M), high dose (TACI-Ig-H), and prednisone acetate (PAT) group. The control group and model group received physiological saline injections, while the TACI-Ig groups were administered doses of 7.18, 14.36, and 28.72 mg/kg of TACI-Ig, respectively. PAT group was pretreated with prednisone acetate. After 8 weeks, kidney weight/body weight ratios, 24-hour urine protein (24 h UP), serum creatinine (SCr), and blood urea nitrogen (BUN) levels were measured. Additionally, concentrations of B cell activating factor (BAFF), APRIL, and Gd-IgA1 were evaluated by using ELISA. Pathological changes in kidney tissues were scored, and TLR4, MyD88, NF-κB expression levels were detected through western blot (WB) and RT-qPCR.

RESULTS:

Renal function assessments showed that the IgAN model group exhibited increased in 24 h UP, SCr, BUN, and elevated serum levels of BAFF, APRIL, Gd-IgA1, alongside higher TLR4/MyD88/NF-κB protein expression. TACI-Ig treatment significantly reduced proteinuria, SCr, BUN, levels of BAFF, APRIL, and Gd-IgA1 in IgAN rats. Pathologically, TACI-Ig ameliorated glomerular mesangial deposition and fibrosis. It also inhibited TLR4/MyD88/NF-κB protein expression, demonstrating anti-inflammatory and immune regulatory effects.

CONCLUSIONS:

TACI-Ig mitigates renal injury in IgAN rats by reducing inflammatory infiltration and IgA deposition and suppressing the pathway of TLR4/MyD88/NF-κB, offering data for developing effective treatments for IgAN.

01 Nov 2024·International Journal of Clinical Oncology

Current status of BAFF targeting immunotherapy in B-cell neoplasm

Review

Author: Tagami, Nami ; Yuda, Junichiro ; Goto, Yasuyuki

Abstract:

B-cell activating factor belonging to the TNF family (BAFF), also known as B-lymphocyte stimulator (BLyS), plays a crucial role in B-cell development. It has multiple receptors, including BCMA, TACI, and BAFF-R, with diverse roles in different cell types. BAFF induces B-cell proliferation and immunoglobulin secretion, and acts as a survival factor for immature, naive, and activated B cells. Consequently, BAFF-deficient mice often show suppressed humoral responses, while BAFF-overexpressing mice show the higher number of mature B cells and may develop autoimmune-like manifestations and B-cell lymphoproliferative diseases. Elevated BAFF levels are also associated with various hematological malignancies, and its expression correlates with disease progression in some cases. Therefore, BAFF-targeted therapies, such as belimumab, atacicept, and tabalumab, are being explored in clinical trials for conditions like chronic lymphocytic leukemia (CLL) and multiple myeloma. Belimumab, an anti-BAFF monoclonal antibody, is being investigated in combination with rituximab/venetoclax for CLL. Atacicept, a decoy receptor for BAFF and APRIL, showed tolerability in a phase 1b trial for CLL. Tabalumab, another monoclonal antibody targeting BAFF, did not demonstrate significant efficacy in a phase 2 study for relapsed/refractory multiple myeloma. BAFF ligand-based CAR-T cells are designed to target BAFF receptors and show promise in preclinical studies, particularly for B-cell malignancies. The review emphasizes the importance of understanding the roles of BAFF and its receptors in the microenvironment of hematologic malignancies. Targeting BAFF and its receptors presents potential therapeutic avenues, and ongoing clinical trials provide valuable insights.

119

News (Medical) associated with Atacicept

07 Jan 2026

·www.biospace.com

Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy

FDA assigned PDUFA target action date of July 7, 2026. If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN. Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN. BRISBANE, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the atacicept Biologics License Application (BLA) for the treatment of adults with immunoglobulin A nephropathy (IgAN) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). The BLA, which was submitted using the Accelerated Approval Program, was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept could offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection. “Atacicept offers a distinct approach through dual targeting of BAFF and APRIL, which we believe could advance the standard of care in IgAN, if approved,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “FDA’s Priority Review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape. We remain committed to working with the FDA to facilitate a thorough review of the BLA. Our team is focused on bringing a potential treatment to patients with the urgency they deserve.” The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. The safety pro atacicept across the ORIGIN program appears favorable, and comparable to placebo. Results of the interim analysis were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting and published in a manuscript in the New England Journal of Medicine on November 6. 1 IgAN is a serious and progressive autoimmune disease of the kidney for which there remains a high unmet need for new disease-modifying treatments that target the upstream source of the disease. In at least 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has considerable morbidity and impact on patients’ lives. Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases. Lafayette R, et al. N Engl J Med. 2025 Nov 6. doi: 10.1056/NEJMoa2510198. Online ahead of print. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. About the Atacicept Clinical Program The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety pro the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a pro with that of the general population without IgAN. ORIGIN 3 (NCT04716231) is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour UPCR compared to placebo. ORIGIN 3 met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36. Across the ORIGIN program in IgAN, the safety pro atacicept appears favorable, and comparable to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR, with results expected in 2027. For more information about ORIGIN 3, please visit . Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including immunoglobulin A nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. Forward-looking Statements . Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, approval of atacicept by the FDA; the distinct approach of atacicept; atacicept's ability to advance the standard of care in IgAN; the strength of Vera Therapeutics’ clinical evidence; the timing of expected results of ORIGIN 3; atacicept’s positioning for best-in-class potential; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 jallaire@lifesciadvisors.com Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 corporatecommunications@veratx.com

Clinical ResultPhase 2License out/inBreakthrough TherapyPriority Review

10 Dec 2025

·www.globenewswire.com

Vera Therapeutics Announces Pricing of Public Offering of Class A Common Stock

BRISBANE, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera Therapeutics”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced the pricing of an underwritten public offering of 6,138,108 shares of its Class A common stock at a price to the public of $42.50 per share. The gross proceeds to Vera Therapeutics from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $261 million. In addition, Vera Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 920,716 shares of Class A common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on December 11, 2025, subject to the satisfaction of customary closing conditions. J.P. Morgan, Goldman Sachs & Co. LLC, Evercore ISI and Cantor are acting as joint book-running managers for the proposed offering. LifeSci Capital is acting as lead manager for the proposed offering. The proposed offering is being made pursuant to an automatic shelf registration statement on Form S-3, including a base prospectus, that was filed with the U.S. Securities and Exchange Commission (the “SEC”) on October 28, 2024 and became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at http://www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at prospectus-eq_fi@jpmchase.com and postsalemanualrequests@broadridge.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at prospectusny@ny.email.gs.com; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th St., 6th Floor, New York, NY 10022, or by email at prospectus@cantor.com. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Vera Therapeutics Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including immunoglobulin A nephropathy (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. Forward-Looking Statements Statements contained in this press release regarding Vera’s expectations regarding the offering are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon Vera Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, Vera’s expectations regarding the completion of the offering. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Investor Contact:Joyce AllaireLifeSci Advisors212-915-2569jalllaire@lifesciadvisors.com Media Contact:Debra CharlesworthVera Therapeutics415-854-8051corporatecommunications@veratx.com

License out/inClinical Study

26 Nov 2025

·www.fiercepharma.com

In crowded kidney disease space, Otsuka receives FDA approval for first-in-class Voyxact

Vertex, Novartis and Vor Bio are developing anti-APRIL drugs against IgAN, too. A new FDA approval for a first-in-class drug has vaulted Otsuka into immunoglobulin A nephropathy (IgAN), an increasingly competitive kidney disease field targeted by multiple biopharma companies.The new drug, called Voyxact, has won an FDA accelerated approval to be used to reduce proteinuria in adults with primary IgAN who are at risk of progression, Otsuka said Tuesday.A self-administered injection given once per month, the drug works by blocking A proliferation-inducing ligand (APRIL), a protein that promotes autoantibody production that may trigger inflammation and kidney damage, causing IgAN.The drug, also known as sibeprenlimab, is the first in a growing list of candidates to reach the market targeting this pathway. Other drugmakers, including Vertex, Novartis and Vor Bio are working on anti-APRIL agents against IgAN and other disorders. Voyxact is also the first biologic drug approved for IgAN, whereas all four earlier IgAN FDA approvals went to small molecules.Voyxact won the FDA’s endorsement by proving its ability to reduce proteinuria, or protein in the urine, as measured by the urinary protein-to-creatinine ratio (UPCR). In a phase 3 trial coded Visionary, Voyxact led to a significant placebo-adjusted 51% reduction in proteinuria at nine months of treatment. Patients enrolled in the trial were receiving standard therapies such as ACE inhibitors, angiotensin II receptor blockers and/or SGLT2 inhibitors.After one year of treatment, Voyxact’s placebo-adjusted treatment effect on proteinuria reached 54.3%, according to results presented a few days ago at the American Society of Nephrology Kidney Week 2025 and published in The New England Journal of Medicine.“The availability of Voyxact represents a novel targeted approach to help manage this complex disease for patients living with IgAN,” John Kraus, M.D., Ph.D., chief medical officer of Otsuka, said in a Nov. 25 release. “With its targeted mechanism, strong efficacy, safety profile, and once-every-four-weeks dosing, Voyxact offers a new option for IgAN patients.”Unlike previous accelerated approvals in IgAN, the FDA is not restricting the patient population eligible for Voyxact based on a specific UPCR level. Novartis’ endothelin A receptor antagonist (ERA) Vanrafia, the most recent accelerated approval in IgAN doled out by the FDA in April, is currently allowed for patients with UPCR of at least 1.5 g/g. Travere Therapeutics’ dual ARB/ERA drug Filspari shook off that same UPCR limitation only after winning a full approval last year.To win a traditional nod, Otsuka is on the hook to show whether Voyxact can slow disease progression, as measured by estimated glomerular filtration rate (eGFR) decline, at two years in the ongoing Visionary study. Otsuka said it expects to have that data in early 2026.“We think FDA is comfortable with the eGFR trajectory of this class of drugs to allow broad use,” Jefferies analysts said of Voyxact’s label in a Nov. 25 note.The FDA’s decision here bodes well for future contenders in the APRIL class, the Jefferies team observed.According to Jefferies’ calculations, IgAN represents a large market worth around $6 billion to $10 billion in potential sales per year. But competition within the APRIL class will be intense, the analysts said, and the space is poised to get crowded fast.Several companies are developing BAFF/APRIL duo inhibitors. BAFF, or B-cell activating factor, is another key mediator in the production of abnormal proteins and autoantibodies involved in IgAN.Vera Therapeutics announced on Nov. 7 that it has submitted an FDA application for its BAFF/APRIL med, atacicept, which yielded a 42% reduction in UPCR compared with placebo at nine months at an interim analysis of the phase 3 Origin 3 trial.Through its $4.9 billion acquisition of Alpine Immune Sciences last year, Vertex is preparing an FDA application for an accelerated approval for its BAFF/APRIL drug, povetacicept, in IgAN. The company has said it will begin an FDA rolling submission this year and intends to use a priority review voucher to expedite the regulatory process, potentially leading to a go-ahead by the end of 2026.In the phase 2 Ruby-3 trial, povetacicept elicited absolute proteinuria reductions of 64% at 48 weeks, according to data presented at the recent ASN annual meeting. The trial does not have a placebo control arm.Meanwhile, Vor Bio’s partner RemeGen just reported positive China phase 3 data for its BAFF/APRIL duo inhibitor telitacicept in IgAN, although the drug’s U.S. clinical development plan in the disease remains unclear. What’s more, Novartis has an anti-APRIL drug called zigakibart in addition to FDA-approved Vanrafia and factor B inhibitor Fabhalta, which the company said has shown it can slow kidney function decline and IgAN progression in the final analysis of a phase 3 trial.Otsuka has some experience in the kidney disease space with Jynarque, which was approved by the FDA in 2018 as the first treatment to slow kidney function decline in patients with autosomal dominant polycystic kidney disease (ADPKD).

Clinical ResultDrug ApprovalPhase 3AcquisitionPhase 2

100 Deals associated with Atacicept

External Link

KEGG	Wiki	ATC	Drug Bank
D09704	Atacicept	-	DB06399

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glomerulonephritis, IGA	NDA/BLA	United States	Vera Therapeutics, Inc.	07 Jan 2026
Systemic Lupus Erythematosus	Phase 3	United States	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Argentina	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Australia	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Austria	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Bulgaria	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Croatia	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Czechia	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	France	Merck KGaA	01 Jan 2008
Systemic Lupus Erythematosus	Phase 3	Germany	Merck KGaA	01 Jan 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04716231 (ORIGIN 3, N Engl J Med \| ASN2025 \| GlobeNewswire) Manual	Phase 3	Glomerulonephritis, IGA	203	Atacicept 150 mg	ptcusknbbv(fvogremuge) = yhqvtiswuf knitdpvwrg (dnwavwamdb ) View more	Positive	06 Nov 2025
				Placebo	ptcusknbbv(fvogremuge) = jvdvtphygp knitdpvwrg (dnwavwamdb ) View more
NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	116	Atacicept	ocfqbvudkd(amlykdodiz) = ypzfxasyvf hciiqfyjzu (vhcemjhgwc ) View more	Positive	26 Oct 2024
				Placebo	-
ISN WCN2024	Not Applicable	Glomerulonephritis, IGA	-	Atacicept 150 mg	jfiaojdhbv(gclpovujbl) = ieiwadufng ivtntspmdv (aelctwyjyt )	-	01 Apr 2024
				Placebo	jfiaojdhbv(gclpovujbl) = rnoqygeews ivtntspmdv (aelctwyjyt )
NCT04716231 (ORIGIN, Literature) Manual	Phase 2	Glomerulonephritis, IGA	116	atacicept 25 mg	qfbdqtqlkk(aksimvvwul) = similar across the atacicept dose groups and placebo. blykumgfdn (wjghefweud )	Positive	27 Mar 2024
				atacicept 75 mg
NCT04716231 (ORIGIN, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	Atacicept	bxchoqzlzp(qohnpededn) = met its primary endpoint ipwousepuv (edwngludyp ) Met View more	Positive	08 Jan 2024
				Placebo
NCT04716231 (ORIGIN \| JANUS, GlobeNewswire) Manual	Phase 2	Glomerulonephritis, IGA	-	atacicept (JANUS)	tdxgqrcfdl(gwkidzfwrj) = Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies. yxbwrgvkbf (bfngxnuyrv )	Positive	04 Nov 2023
				placebo (JANUS)
NCT02808429 (Phase II study, CTgov)	Phase 2	Glomerulonephritis, IGA	16	Placebo (Placebo)	zyrrqvwbcl = qpptvheaxo vuyagnxpal (nbgaggbklg, kdjftqcxmi - rmhkecgjef) View more	-	25 Feb 2021
				Atacicept 25 mg (Atacicept 25 mg)	zyrrqvwbcl = yvlcgxaqlh vuyagnxpal (nbgaggbklg, zxbxgtcfrn - aizgkvbhwx) View more
NCT02070978 (ADDRESS II, Pubmed \| Rheumatology (Oxford))	Phase 2	Systemic Lupus Erythematosus	253	Atacicept 75 mg	jvfuxvlmeo(nawgyoahmw) = jkqijcsseb elbetttzak (jqfxesjaby ) View more	-	06 Feb 2021
				Atacicept 150 mg	jvfuxvlmeo(nawgyoahmw) = zdeqammfje elbetttzak (jqfxesjaby ) View more
NCT02808429 (Phase II study, ERA2020)	Phase 2	Proteinuria \| Glomerulonephritis, IGA Gd-IgA1	-	Placebo	xshqdnikpy(ddatlntbag) = tfeqttxiqh vmyfgbyoeb (mxzuvlvpjm )	Positive	06 Jun 2020
				Atacicept 25mg	xshqdnikpy(ddatlntbag) = inxwcgilcp vmyfgbyoeb (mxzuvlvpjm )

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