Complement 3 Glomerulopathy Market Set for Transformation: 4 Emerging Therapies Leading the Next Growth Phase | DelveInsight
Emerging therapies targeting novel mechanisms such as dual complement inhibitors (C5 and Factor H (KP104), MASP-3 inhibitors (Zaltenibart), RNA interference (RNAi) therapeutics targeting complement C3 (ARO-C3), and others are showing promise as potential treatment options. The expected launch of these therapies shall further create a positive impact on the C3G market.
LAS VEGAS, July 16, 2026 /PRNewswire/ -- The treatment landscape for C3G has historically depended on the off-label use of multiple prescription therapies, underscoring the substantial unmet need for disease-specific treatment options. Conventional management primarily involves immunosuppressive agents, corticosteroids, Renin-Angiotensin-Aldosterone System (RAAS) inhibitors, along with supportive therapies such as calcineurin inhibitors and monoclonal antibodies to help control disease progression and preserve kidney function.
The therapeutic landscape has recently evolved with the approval of FABHALTA, the first drug specifically indicated for the treatment of C3G, followed by EMPAVELI/ASPAVELI, developed by Apellis Pharmaceuticals and Sobi. Despite these advances, safety concerns remain a key consideration. Both therapies carry a boxed warning for the risk of life-threatening infections caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type b, making vaccination at least two weeks before treatment initiation essential.
Discover what is the future of the complement 3 glomerulopathy treatment market @ https://www.delveinsight.com/report-store/complement-3-glomerulopathy-c3g-market
Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that FABHALTA and EMPAVELI/ASPAVELI represent the currently available and clinically validated therapies for C3G, positioning them as established options with regulatory approval and real-world treatment experience.
Beyond the currently approved therapies, the C3G pipeline continues to expand with several promising investigational candidates. Notable programs include KP104 (Kira Pharmaceuticals), Zaltenibart (OMS906) (Omeros Corporation), Ruxoprubart (NM8074) (NovelMed Therapeutics), ARO-C3 (Arrowhead Pharmaceuticals), TAVNEOS (avacopan) (Amgen), CPV-104 (Eleva), and other emerging therapies that have the potential to further reshape the C3G treatment landscape.
As per Thakur, the absence of oral route of administration therapies in the emerging pipeline presents a significant opportunity for development, addressing unmet patient preferences for more convenient and non-invasive treatment options.
Reflecting the strong commercial and clinical momentum in this space, DelveInsight estimates that the C3G market across the 7MM, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 1 billion in 2025, and it is expected to grow at a phenomenal CAGR of 28% by 2036.
Below, we highlight 4 emerging C3G therapies poised to reshape the future of C3G management.
Novo Nordisk/Omeros Corporation's Zaltenibart
Phase III
Zaltenibart is an investigational human monoclonal antibody that selectively targets Mannan-binding lectin-associated serine protease-3 (MASP-3), the primary upstream activator of the alternative complement pathway. By inhibiting MASP-3, the therapy is intended to suppress activation of the alternative pathway, offering a targeted approach for treating complement-mediated disorders. In December 2025, Omeros Corporation completed an asset sale and licensing agreement with Novo Nordisk for zaltenibart.
As part of the transaction, Novo Nordisk obtained exclusive worldwide rights to develop and commercialize the therapy across all indications. Under the agreement, Omeros is entitled to receive USD 340 million in upfront and near-term milestone payments, with the total deal value potentially reaching USD 2.1 billion through additional development and commercial milestone payments, as well as tiered royalties on future net sales. In October 2024, Omeros Corporation announced that zaltenibart received RPDD from the US FDA for the treatment of C3G.
Kira Pharmaceuticals' KP104
Phase II
KP104 is a novel, first-in-class bifunctional biologic engineered to simultaneously and selectively inhibit both the alternative and terminal complement pathways. This dual mechanism is designed to provide a synergistic therapeutic effect by targeting two well-established drivers of complement-mediated diseases.
The candidate is currently undergoing Phase II proof-of-concept clinical studies across several diseases with substantial unmet medical need, including IgA nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), Systemic Lupus Erythematosus-associated Thrombotic Microangiopathy (SLE-TMA), and Paroxysmal Nocturnal Hemoglobinuria (PNH).
Discover more about which pipeline drugs could transform complement 3 glomerulopathy treatment @ Best Medication for Complement 3 Glomerulopathy
Arrowhead Pharmaceuticals' ARO-C3
Phase I/II
ARO-C3 is an investigational RNA interference (RNAi) therapy developed to suppress hepatic production of complement component 3 (C3), to treat a range of complement-mediated kidney diseases. The therapy is currently being evaluated in the Phase I/IIa first-in-human dose-escalation study (NCT05083364/AROC3-1001), which is assessing its safety, tolerability, pharmacokinetic profile, and pharmacodynamic effects in both healthy adult volunteers and patients with complement-mediated renal disorders.
In March 2025, Arrowhead Pharmaceuticals reported positive topline results from Part 2 of the ongoing Phase I/II clinical trial of ARO-C3. The investigational RNAi therapy is designed to reduce liver-derived C3 production and is being developed as a potential treatment for multiple complement-mediated diseases.
Eleva's CPV-104
Phase I
Eleva is advancing Factor H (CPV-104), a recombinant human complement Factor H therapy, with C3 glomerulopathy (C3G) as its lead clinical indication. In addition to C3G, the therapy has demonstrated potential across several complement-mediated disorders, including atypical hemolytic uremic syndrome (aHUS) and dry age-related macular degeneration (dry AMD).
Preclinical studies have generated encouraging results for Factor H (CPV-104), including positive in vivo findings in a well-established animal model of C3G. Treatment with CPV-104 restored serum C3 levels to normal within 24 hours of administration and promoted the rapid clearance of C3 deposits from the kidneys, supporting its potential to address the underlying disease pathology.
Building on these findings, Eleva initiated its first clinical study evaluating Factor H (CPV-104) in patients with C3G in July 2025. Following the successful completion of the single ascending dose (SAD) phase in healthy volunteers, with no significant safety concerns observed, the trial progressed to dosing C3G patients in October 2025.
Download the report to understand the top emerging therapies in C3G @ Complement 3 Glomerulopathy Clinical Trials
Source: Complement 3 Glomerulopathy Market Report
Complement 3 Glomerulopathy Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C3G companies, including Novartis, Apellis Pharmaceuticals, Sobi, Kira Pharmaceuticals, Novo Nordisk, Omeros Corporation, Arrowhead Pharmaceuticals, and others.
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