A Phase 3, Open-label, Multicenter Continuation Trial to Evaluate the Long-term Safety and Efficacy of Mezagitamab Subcutaneous Injection in Adults With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time.
Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met.
During the study, participants will visit their study clinic several times.

开始日期2025-08-29

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06963827

/ Not yet recruiting临床3期

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy

Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.
Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.
In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.
During the study, participants will visit their study clinic several times.

开始日期2025-08-15

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

NCT06722235

/ Recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Mezagitamab Subcutaneous Injection in Participants With Chronic Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a low number of platelets, making it easier to bruise or bleed. The main aim of this study is to learn whether mezagitamab, when given just under the skin (subcutaneously [SC]), is effective in keeping the platelet count of adults with ITP stable when compared to a placebo. A placebo looks like medicine but doesn't have any active ingredients in it.
The participants will be treated with mezagitamab for up to 6 months.
During the study, participants will visit their study clinic several times.
Participants who complete the TAK-079-3002 study or do not have any response to study treatment by week 16 (according to study criteria) will be given the opportunity to participate in a continuation study to receive open label mezagitamab (if they are eligible and the site is able to open the continuation study).

开始日期2025-02-27

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与 Mezagitamab 相关的临床结果

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100 项与 Mezagitamab 相关的转化医学

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100 项与 Mezagitamab 相关的专利（医药）

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项与 Mezagitamab 相关的文献（医药）

2025-05-01·Clinical Lymphoma Myeloma & Leukemia

Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody

Article

作者: Gu, Tao ; Rifkin, Robert M ; Dhanasiri, Sujith ; Ailawadhi, Sikander ; Cowan, Andrew J ; Marshall, Thomas S ; Ramasamy, Karthik ; Abonour, Rafat ; Cella, David ; Samuel, Amir ; Ho, Carrie ; Liu, Liang ; Katz, Jessica ; Fish, Susan ; Kuter, David ; Jagannath, Sundar ; Durie, Brian G M ; Fang, Jiaqi ; Dhamane, Amol D ; Lee, Hans C ; Yu, Edward ; Vij, Ravi

BACKGROUND:

This analysis explored real-world characteristics, treatment patterns and clinical outcomes in patients with relapsed or refractory multiple myeloma (RRMM) previously treated with lenalidomide and an anti-CD38 monoclonal antibody (mAb) and requiring subsequent treatment.

MATERIALS AND METHODS:

The PREAMBLE and Connect MM prospective registries of patients with multiple myeloma (MM), and the US nationwide Flatiron Health electronic health record-derived de-identified database were analysed. MM-specific treatment patterns (prior/index therapies) and outcomes (progression-free survival [PFS]/overall survival [OS]) were assessed.

RESULTS:

This analysis included: PREAMBLE n = 215; Connect MM n = 232; Flatiron Health n = 845. Median age at index was 69.0 years, median 3 prior lines of therapy; > 50% male. The most common index regimens accounted < 15% of treatments (most common PREAMBLE, Connect MM: carfilzomib±dexamethasone; Flatiron Health: pomalidomide+daratumumab+dexamethasone); most patients received classes that they had previously; ≥ 93% were triple-class exposed (immunomodulatory drug, proteasome inhibitor, anti-CD38 mAb). In PREAMBLE, Connect MM and Flatiron Health, respectively: 80.9%, 68.1% and 77.2% were lenalidomide- and anti-CD38 mAb-refractory; 69.3%, 67.2% and 71.1% were triple-class refractory (TCR); median PFS: 5.2 (95% CI 3.7-6.7), 4.4 (3.5-5.6) and 5.3 months (4.8-6.0); median OS: 19.3 (15.8-26.1), 14.2 (11.0-16.9) and 23.1 months (19.0-28.6). PFS and OS were shorter in lenalidomide- and anti-CD38 mAb-refractory patients versus those who were not refractory to both. A similar pattern was observed for TCR patients versus non-TCR patients.

CONCLUSION:

There is no uniform standard of care for patients with RRMM with prior exposure to lenalidomide and anti-CD38 mAbs. Survival outcomes are poor, with a need for effective treatments for these patients.

2025-03-01·ANNALS OF HEMATOLOGY

Evolution of frontline treatment for multiple myeloma: clinical investigation of quadruplets containing carfilzomib and anti-CD38 monoclonal antibodies

Review

作者: Ertel, Franziska ; Landgren, Ola ; Moreau, Philippe ; McFadden, Ian ; Touzeau, Cyrille ; Weisel, Katja ; Najdi, Rani ; Costa, Luciano J ; Gay, Francesca ; Mateos, María-Victoria

Although survival rates for patients with newly diagnosed multiple myeloma (NDMM) have improved over recent decades, multiple myeloma (MM) remains without a cure for most. There is increasing consensus that achievement of deep remissions, especially minimal residual disease negativity (MRD -), in frontline treatment is crucial and translates into improved survival. The standard of care (SOC) for NDMM consists at minimum of a triplet regimen of therapies, with or without an autologous stem cell transplant, or a doublet regimen for certain ineligible, particularly frail patients who may have specific limitations. Recently, anti-CD38 monoclonal antibodies (mAbs), such as daratumumab (Dara) or isatuximab (Isa), have been integrated into frontline SOC regimens. Seeking to further deepen and prolong responses, several clinical trials have commenced investigating the addition of anti-CD38 mAbs to carfilzomib, lenalidomide, and dexamethasone (KRd). These quadruplet regimens (Isa/Dara-KRd) are being evaluated in the context of evolving treatment considerations for the heterogeneous population of patients with NDMM. In clinical trials, the addition of Isa/Dara to KRd achieved high rates of deep responses and MRD - . Favorable outcomes were observed in patients with NDMM independent of age, transplant eligibility, and cytogenetic risk, while these treatments did not result in unexpected or emergent safety risks. The efficacy observed with intensified, yet well-tolerated therapy may offer further development of risk- and response-adapted therapy for individualized patient needs. This review summarizes the clinical outcomes of quadruplet-based therapy with Isa/Dara-KRd in NDMM.

2025-01-01·Therapeutic Advances in Hematology

Efficacy and safety of anti-CD38 monoclonal antibodies-based therapy versus standard therapy in newly diagnosed multiple myeloma patients: a systematic review and meta-analysis

Article

作者: Ullah, Ubaid ; Khan, Muhammad Haris ; Khan, Safeena ; Rehman, Wajeeh Ur ; Tahir, Ammara ; Afridi, Abdullah ; Osama, Muhammad ; Ullah, Mehran ; Hussain, Amna

Background::

Anti-CD38 monoclonal antibodies (mAbs) have significantly changed the multiple myeloma treatment landscape. This meta-analysis compared the efficacy and safety of anti-CD38 mAb-based therapy versus standard therapy in newly diagnosed multiple myeloma (NDMM) patients.

Methods::

We performed a comprehensive literature search on PubMed, the Cochrane Database, and ClinicalTrials.gov. The primary outcomes were progression-free survival (PFS) and minimal residual disease (MRD) status. Dichotomous outcomes were pooled using risk ratio (RR) along with the 95% confidence interval (CI) in RevMan 5.4. Subgroup analysis and meta-regression analysis were performed. The RoB 2.0 tool was used to assess the risk of bias.

Results::

Our meta-analysis included 11 randomized controlled trials. There were 5270 patients; 3040 TEs and 2230 TIEs. Anti-CD38 mAbs significantly improved MRD negativity (RR 1.94, 95% CI: 1.59–2.37; p < 0.00001) and PFS (RR 0.51, 95% CI: 0.45–0.58; p < 0.00001). Subgroup analyses revealed better outcomes for both the TE (MRD: RR 1.52, 95% CI: 1.37–1.68; PFS: RR 0.43, 95% CI: 0.34–0.54) and TIE (MRD: RR 3.49, 95% CI: 2.65–4.61; PFS: RR 0.55, 95% CI: 0.47–0.64) populations. Meta-regression revealed that Eastern Cooperative Oncology Group (ECOG) score 0 significantly influenced MRD status (β = −0.015, p < 0.05), whereas ECOG scores 1 and 2 lacked statistical significance. Subgroup analysis revealed that PFS was significantly different between standard (RR 0.47) and high (RR 0.81) cytogenetic risk groups.

Conclusion::

In NDMM patients, anti-CD38 mAb-based therapy significantly improved MRD status, and PFS compared with standard therapy alone, in both TE and TIE patients, suggesting a favorable benefit–risk profile.

项与 Mezagitamab 相关的新闻（医药）

2025-05-29

·GlobeNewswire-Health Care

XOMA Royalty Purchases Mezagitamab Royalty and Milestone Rights Held by BioInvent International for up to USD $30 Million

May 27, 2025 -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced XOMA Royalty has purchased the future mezagitamab (TAK-079) royalty and milestone interests held by BioInvent for USD $20 million at closing, with a total transaction of up to USD $30 million. “This transaction further builds the potential of XOMA Royalty’s late-stage royalty portfolio by increasing our economics in a promising Phase 3 program already in our portfolio,” stated Brad Sitko, Chief Investment Officer of XOMA Royalty. “We appreciate the longstanding relationship with BioInvent stemming from XOMA’s legacy technology, which gave rise to mezagitamab. We are pleased to provide BioInvent non-dilutive capital to further advance its proprietary pipeline to a key inflection point.” Martin Welschof, Chief Executive Officer of BioInvent said, “Today’s announcement highlights the value to BioInvent of our n-CoDeR® platform, which has led to the identification of multiple promising therapeutic antibody drug candidates, many of which are now in mid-to late-stage clinical trials. As well as reflecting XOMA Royalty’s expanded interest in mezagitamab, this transaction supports our strategy of creating value via partnerships and gives us a non-dilutive capital injection that bolsters our balance sheet so that we can continue to focus on advancing our own clinical drug development programs.” The future royalty and milestone economics interest in mezagitamab originated from a 2003 cross-licensing agreement covering XOMA Royalty’s legacy bacterial protein expression technology and BioInvent’s n-CoDeR® antibody library. Under the terms of XOMA Royalty’s purchase of BioInvent’s economic interest in mezagitamab, XOMA Royalty paid USD $20 million to BioInvent at closing today and will pay an additional USD $10 million upon mezagitamab achieving a specific pre-defined regulatory milestone associated with receiving marketing approval in the IgA nephropathy indication from the U.S. Food and Drug Administration. With its existing entitlement, plus the newly acquired economics from BioInvent, XOMA Royalty will be entitled to milestones of up to USD $16.25 million from Takeda and mid-single digit royalties on future mezagitamab commercial sales. In its Fiscal Year 2024 financial results, Takeda, the company developing mezagitamab, announced it has initiated a Phase 3 clinical trial in patients with immune thrombocytopenia (ITP)1. Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb) with high affinity for CD38 expressing cells (including plasmablasts, plasma cells, natural killer cells) resulting in their depletion that has the potential of becoming the best-in-class anti-CD38 mAb2. XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health. XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies. When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes. The Company has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. 1 https://assets-dam.takeda.com/image/upload/v1746766844/Global/Investor/Financial-Results/FY2024/Q4/qr2024_q4_p01_en.pdf 2 https://assets-dam.takeda.com/image/upload/Global/Investor/events/2024/RD_Presentation_2024_EN.pdf The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法引进/卖出

2025-05-29

·药融圈

3000万美元！武田CD38单抗权益被收购

▲8月1-2日 2025生物医药创新博览会扫码报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。5月27日，生物技术特许权使用整合商 XOMA Royalty Corporation(NASDAQ: XOMA)和专注于发现和开发癌症免疫治疗的生物技术公司BioInvent International 宣布，XOMA Royalty以2000万美元的价格收购BioInvent 持有的未来CD38抗体药物mezagitamab （TAK-079）特许权使用费和里程碑权益，并将在mezagitamab实现与获得美国食品和药物管理局的IgA肾病适应症上市批准相关的特定预先定义的监管里程碑后额外支付1000万美元，总交易高达3000万美元。凭借其现有的授权，加上从BioInvent获得的经济效益，XOMA特许权使用费将有权从mezagitamab的开发公司武田获得高达1625万美元的里程碑，以及未来mezagitamab商业销售的中等个位数特许权使用费。武田在其2024财年财报中宣布，该公司已经启动了一项针对免疫性血小板减少症（ITP）患者的三期临床试验。mezagitamab是一种全人免疫球蛋白IgG1单克隆抗体（mAb），对表达CD38的细胞（包括浆母细胞、浆细胞、自然杀伤细胞）具有高亲和力，具有成为同类最佳抗CD38 mAb2的潜力。mezagitamab未来的特许权使用费和里程碑式的经济利益源于2003年的交叉授权协议，涵盖XOMA royalty的传统细菌蛋白表达技术和BioInvent的n-CoDeR®抗体库。 Brad Sitko XOMA Royalty 首席投资官 Brad Sitko 表示，此次交易通过提高我们投资组合中已有的有前景的 3 期计划的经济效益，进一步构建了 XOMA Royalty 后期特许权使用费投资组合的潜力。我们感谢与 BioInvent 的长期合作关系，这源于 XOMA 的传统技术，该技术催生了 mezagitamab。同时，我们也很高兴为BioInvent提供非稀释性资本，以进一步推进其专有管线到达关键拐点。Martin WelschofBioInvent首席执行官Martin Welschof表示，此次合作凸显了我们的n-CoDeR®平台对BioInvent的价值，该平台已经确定了多种有前途的治疗性抗体候选药物，其中许多药物目前处于中后期临床试验阶段。这笔交易不仅反映了XOMA Royalty对mezagitamab的兴趣扩大，还支持了我们通过合作创造价值的战略，并为我们提供了非稀释性的资本注入，以便我们能够继续专注于推进我们自己的临床药物开发项目。BioInvent在研管线关于 BioInvent BioInventBioInvent （纳斯达克斯德哥尔摩股票代码：BINV）是一家临床阶段的生物技术公司，致力于发现和开发用于癌症治疗的新型和同类首创的免疫调节抗体，目前在六个正在进行的临床项目中拥有五种候选药物，用于治疗血液癌和实体瘤的 1/2 期试验。公司经过验证的专有 F.I.R.S.T™ 技术平台可识别靶点和与其结合的抗体，产生许多有前景的新型免疫调节候选药物，以推动公司的临床开发管线，并提供许可和合作机会。参考资料:https://xoma.com/www.bioinvent.com版权声明：本文转自生物药大时代，如不希望被转载的媒体或个人可与我们联系，我们将立即删除植根上海、辐射全球,药融圈作为生物医药产业级战略平台,以"让智慧与人脉无界流动"为使命,构建覆盖药物研发、生产、流通、商业化的全产业链赋能体系。通过智能化云服务、精准资源链接、产业智库与生态社群四大核心引擎,打造中国医药价值流动的基础设施。在全球化与数字化双重浪潮下,药融圈正重新定义医药资源的流通范式--这里不仅是信息与人脉的枢纽站,更是催生产业变革的化学反应器。我们以中国为原点,编织全球医药智慧网络,让每一次精准链接都成为企业跨越式增长的催化剂。点点赞点分享点推荐

临床3期并购财报

2025-05-27

·PRNewswire

FILSPARI to Transform Kidney Disease Care with Its Revolutionary Treatment Approach | DelveInsight

FILSPARI holds strong market potential as the first FDA-approved non-immunosuppressive therapy for IgA nephropathy, a rare kidney disease with significant unmet needs. As more patients and providers seek disease-modifying options, FILSPARI is well-positioned to capture substantial market share, especially with favorable long-term data. LAS VEGAS, May 27, 2025 /PRNewswire/ -- DelveInsight's " FILSPARI Market Size, Forecast, and Market Insight Report" highlights the details around FILSPARI, the first and only oral, once-daily, non-immunosuppressive therapy approved in both the US and Europe for IgAN. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FILSPARI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Travere Therapeutics' FILSPARI (sparsentan) Overview FILSPARI (sparsentan) is a once-daily oral treatment that uniquely targets two key pathways, endothelin-1 and angiotensin II (also known as DEARA), in the progression of IgA nephropathy. It is the first approved non-immunosuppressive therapy for this condition. Endothelin-1 and angiotensin II contribute to kidney function decline by promoting inflammation and fibrosis, altering podocyte structure, causing podocyte loss, and increasing the permeability of the glomerular filtration barrier. Additionally, both are vasoconstrictors that narrow blood vessels and raise pressure in the glomeruli. The drug received accelerated approval based on its ability to reduce proteinuria. Due to potential safety concerns, it is distributed under the FILSPARI Risk Evaluation and Mitigation Strategy (REMS) program. In Europe, it is marketed by CSL Vifor, and in Japan by Renalys Pharma. Results from the registration-enabling study are expected in the second half of 2025. Learn more about FILSPARI projected market size for IgAN @ FILSPARI IgA Nephropathy IgA nephropathy (IgAN) is an autoimmune disorder that disrupts kidney function by damaging the small blood vessels responsible for filtration. This damage is caused by an abnormal protein that harms the glomeruli, the kidneys' main filtering units. According to DelveInsight, there were approximately 415,000 diagnosed prevalent cases of IgAN across the seven major markets in 2024, and this number is projected to grow at a CAGR of 0.6% through 2034. Current standard care involves the use of ACE inhibitors and angiotensin II receptor blockers (ARBs), primarily to manage associated symptoms like hypertension. Currently, only a few drugs have been approved for IgAN treatment, including VANRAFIA (Atrasentan) and FABHALTA (Iptacopan) by Novartis, FILSPARI (Sparsentan) by Travere Therapeutics, and TARPEYO/KINPEYGO (budesonide) by Asahi Kasei (Calliditas Therapeutics), among others. The treatment landscape is expected to undergo major changes between 2024 and 2034, driven by the introduction of innovative therapies. DelveInsight estimates the IgAN market across the seven key regions was valued at around USD 730 million in 2024 and is projected to grow at a strong CAGR of 30.5% from 2025 to 2034. With targeted treatment options for IgAN only recently emerging and a pressing need for therapies that can delay progression to end-stage kidney disease (ESKD), significant advancements in this area are likely to profoundly reshape the market in the coming years. Discover more about the IgAN market in detail @ IgA Nephropathy Market Assessment Emerging Competitors of FILSPARI Key companies advancing therapies for IgA nephropathy include Novartis (Zigakibart/FUB523), F. Hoffmann-La Roche and Ionis Pharmaceuticals (Sefaxersen/RG6299/IONIS-FB-LRx), AstraZeneca's Alexion Pharmaceuticals (ULTOMIRIS), Vera Therapeutics (Atacicept), Vertex Pharmaceuticals (Povetacicept), Otsuka Pharmaceutical (Sibeprenlimab), Biogen (Felzartamab), Arrowhead Pharmaceuticals (ARO-C3), NovelMed (NM8074), Q32 Bio (ADX-097), Walden Biosciences (WAL0921), and Takeda Pharmaceutical (TAK-079), among others. In April 2025, Vera Therapeutics announced it had completed patient enrollment for its pivotal Phase III ORIGIN trial assessing atacicept in IgA nephropathy. The previous month, Otsuka Pharmaceutical submitted a Biologics License Application (BLA) to the FDA for sibeprenlimab, a monoclonal antibody aimed at inhibiting APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN. Additionally, in July 2022, the European Commission granted Orphan Drug Designation (ODD) to BION-1301 for primary IgAN, offering regulatory benefits to support its European development. Strengthening its renal pipeline, Novartis acquired Chinook Therapeutics in August 2023 for up to $3.5 billion, adding zigakibart and other late-stage kidney-focused assets to its portfolio. To know how does FILSPARI compare to other treatments for IgA nephropathy, visit @ FILSPARI Approval Date Key Milestones of FILSPARI In November 2024, FILSPARI was approved by the MHRA for primary IgAN treatment, and sparsentan received approval in Germany for the same indication. In September 2024, the FDA granted full approval for FILSPARI to slow kidney function decline in IgAN patients, based on positive long-term results from the PROTECT Study. In April 2024, CSL Vifor and Travere Therapeutics received Conditional Marketing Authorization (CMA) from the European Commission for FILSPARI in the EU, targeting adults with IgAN and significant proteinuria. In February 2023, the US FDA granted accelerated approval to FILSPARI (sparsentan) to reduce proteinuria in adults with primary IgAN at risk of rapid progression, with priority review. Discover how FILSPARI is shaping the IgAN treatment landscape @ FILSPARI IgAN FILSPARI Market Dynamics FILSPARI, developed by Travere Therapeutics, represents a significant advancement in the treatment of IgA Nephropathy, a rare and chronic autoimmune kidney disease. Approved under the FDA's accelerated approval program in early 2023, FILSPARI is the first non-immunosuppressive therapy specifically targeting proteinuria in IgAN. It is a dual endothelin angiotensin receptor antagonist (DEARA), a novel mechanism that distinguishes it from conventional RAAS inhibitors. Its market entry has been notable for both its scientific innovation and potential to reshape the standard of care for IgAN, particularly in patients at high risk of progression to end-stage kidney disease (ESKD). The market dynamics are influenced by multiple factors, including the unmet need in IgAN, the orphan drug designation, and the limited competition in the space. Prior to FILSPARI's launch, treatment was largely supportive, focusing on blood pressure control and proteinuria reduction via ACE inhibitors or ARBs. FILSPARI's ability to deliver greater proteinuria reduction without the side effects associated with corticosteroids or immunosuppressants provides a compelling clinical and commercial value proposition. Competition is evolving, with several companies advancing novel IgAN therapeutics. Calliditas Therapeutics' TARPEYO (budesonide) was approved ahead of FILSPARI for a similar indication, but works through a corticosteroid pathway. Other players are also advancing programs, suggesting the market could become more segmented based on patient profile and mechanism of action. FILSPARI's differentiated profile, especially its dual-acting mechanism and oral administration, positions it favorably among nephrologists and specialists, but maintaining this edge will require strong real-world evidence and ongoing clinical data. From a market access and adoption standpoint, Travere has made early efforts in physician education, patient support programs, and collaboration with nephrology groups to accelerate uptake. However, broader adoption will depend on securing favorable formulary placements, long-term safety data, and sustained efficacy in delaying disease progression. As I gAN awareness grows and diagnosis rates improve through genetic and biomarker testing, the addressable patient population may expand, offering a significant growth opportunity for FILSPARI over the next 5–10 years. Dive deeper to get more insight into FILSPARI's strengths & weaknesses relative to competitors @ FILSPARI MoA Table of Contents Related Reports IgA Nephropathy Market IgA Nephropathy Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key IgAN companies such as Calliditas Therapeutics AB, Travere Therapeutics, Inc., Omeros, Novartis Pharmaceuticals, Chinook Therapeutics, Inc., Vera Therapeutics, Inc., among others. IgA Nephropathy Pipeline IgA Nephropathy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key IgA nephropathy companies, including Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., Vera Therapeutics, Inc., Eledon Pharmaceuticals, Guangdong Hengrui Pharmaceutical Co., Ltd, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Rohto Pharmaceutical, Alexion Pharmaceuticals, Apellis Pharmaceuticals, Inc., Arrowhead Pharmaceuticals, Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, among others. Chronic Kidney Disease Market Chronic Kidney Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic kidney disease companies, including ProKidney, Reata Pharmaceuticals, Inc., Novo Nordisk A/S, Boehringer Ingelheim, Eli Lilly and Company, KBP Biosciences, Kibow Pharma, Cincor Pharma, AstraZeneca, Allena Pharmaceuticals, DiaMedica Therapeutics Inc, Lexicon Pharmaceuticals, Sanofi , among others. Chronic Kidney Disease Pipeline Chronic Kidney Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products and the key chronic kidney disease companies, including KBP Biosciences, Eli Lilly and Company, Novo Nordisk, Prokidney, Boryung Pharmaceutical, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床3期并购孤儿药免疫疗法

100 项与 Mezagitamab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16370

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
免疫球蛋白a肾病	临床3期	-	Takeda Pharmaceutical Co., Ltd.	2025-08-15
免疫性血小板减少症	临床3期	美国	Takeda Pharmaceutical Co., Ltd.	2025-02-27
免疫性血小板减少症	临床3期	中国	Takeda Pharmaceutical Co., Ltd.	2025-02-27
免疫性血小板减少症	临床3期	日本	Takeda Pharmaceutical Co., Ltd.	2025-02-27
免疫性血小板减少症	临床3期	澳大利亚	Takeda Pharmaceutical Co., Ltd.	2025-02-27
免疫性血小板减少症	临床3期	保加利亚	Takeda Development Center Americas, Inc.	2025-02-27
免疫性血小板减少症	临床3期	克罗地亚	Takeda Development Center Americas, Inc.	2025-02-27
免疫性血小板减少症	临床3期	法国	Takeda Development Center Americas, Inc.	2025-02-27
免疫性血小板减少症	临床3期	德国	Takeda Development Center Americas, Inc.	2025-02-27
免疫性血小板减少症	临床3期	希腊	Takeda Development Center Americas, Inc.	2025-02-27

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04278924 (TAK-079-1004, CTgov)	临床2期	免疫性血小板减少症	41	Placebo (Part A & B: Double Blind Period: Placebo)	構齋淵鬱醖膚鬱簾艱蓋 = 衊醖壓廠範構網網願鏇壓範顧鬱淵鑰憲鏇壓艱 (繭淵鹽廠顧鬱齋鬱選獵, 憲窪壓製壓憲憲觸艱簾 ~ 鹽壓蓋築憲鹹餘鑰築衊) 更多	-	2025-06-15
				TAK-079 (Part A: Double Blind Period: TAK-079 100 mg)	構齋淵鬱醖膚鬱簾艱蓋 = 糧獵壓襯蓋選獵艱願獵壓範顧鬱淵鑰憲鏇壓艱 (繭淵鹽廠顧鬱齋鬱選獵, 築製構顧遞獵膚繭鑰鹹 ~ 遞構願衊餘餘窪構鹹網) 更多
NCT05174221 (ASN2024) 人工标引	临床1期	免疫球蛋白a肾病	17	Mezagitamab	網鑰鏇襯襯構構顧構鹹(構範鬱蓋構製窪觸網鏇) = None 鹹製簾淵壓夢廠艱顧觸 (糧襯醖遞襯蓋醖觸範廠 ) 更多	积极	2024-10-25
NCT04278924 (TAK-079-1004, PipelineReview) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	獵夢鬱遞獵廠鏇襯構壓(鹹夢艱鹹憲廠糧壓蓋窪) = 醖鏇顧觸顧願鹹構衊膚蓋壓艱膚憲積醖餘選積 (製鹽襯鏇餘廠選築顧簾 ) 更多	积极	2024-06-22
				Placebo	獵夢鬱遞獵廠鏇襯構壓(鹹夢艱鹹憲廠糧壓蓋窪) = 構艱膚糧繭鏇觸觸壓鹽蓋壓艱膚憲積醖餘選積 (製鹽襯鏇餘廠選築顧簾 ) 更多
NCT03724916 (CTgov)	临床1期	系统性红斑狼疮	23	TAK-079 Placebo (Pooled Placebo)	膚選膚壓構廠構積餘窪 = 範蓋網願艱製網淵構鹽鏇壓顧衊餘簾衊夢遞齋 (顧鑰觸艱觸夢願壓遞壓, 艱糧範壓選鹹顧廠夢製 ~ 積鬱繭構願鹹餘夢夢醖) 更多	-	2024-03-29
				TAK-079 (TAK-079 90 mg)	膚選膚壓構廠構積餘窪 = 窪餘遞積鏇構鑰觸顧窪鏇壓顧衊餘簾衊夢遞齋 (顧鑰觸艱觸夢願壓遞壓, 構艱醖蓋糧醖觸遞衊齋 ~ 窪觸壓簾鑰獵鏇選衊鑰) 更多
NCT04278924 (TAK-079-1004, Biospace) 人工标引	临床2期	免疫性血小板减少症	-	Mezagitamab	淵繭襯壓廠顧選齋觸餘(糧顧構築願顧蓋襯齋夢) = Mezagitamab has been generally safe and well tolerated across all three cohorts. 觸繭廠襯艱鹽築繭憲艱 (衊簾鑰製顧糧選觸憲壓 ) 更多	积极	2024-03-13
				Placebo
NCT04159805 (CTgov)	临床2期	重症肌无力	36	TAK-079 Placebo (TAK-079 Placebo-matching)	製齋鹽憲鏇遞選積窪鬱 = 淵襯願夢壓觸鹹繭衊鹽窪壓遞襯觸築積鹹艱艱 (願獵壓糧簾製鬱積鹹顧, 範顧鬱鹹顧獵夢網窪遞 ~ 範簾膚選選艱淵構顧獵) 更多	-	2023-06-02
				TAK-079 (TAK-079 300 mg)	製齋鹽憲鏇遞選積窪鬱 = 積構鬱鬱夢觸製鏇選鏇窪壓遞襯觸築積鹹艱艱 (願獵壓糧簾製鬱積鹹顧, 窪糧鹽憲壓獵夢築繭廠 ~ 願顧襯顧觸鑰選鹽鹽顧) 更多
IMS2021	N/A	多发性骨髓瘤 anti-CD38 mAb \| BCMA-targeted treatment	320	anti-CD38 mAb (MM patients)	鹹鹹憲憲築築膚願製鏇(蓋廠齋觸獵鏇窪遞淵鹹) = 願憲遞選壓衊觸範膚構鹹窪餘鬱簾鑰鹹齋獵鹽 (鹽觸觸憲選鹽艱淵鏇獵 )	-	2021-09-08
				anti-CD38 mAb (Control group)	鹹鹹憲憲築築膚願製鏇(蓋廠齋觸獵鏇窪遞淵鹹) = 窪齋築艱簾艱鑰窪遞觸鹹窪餘鬱簾鑰鹹齋獵鹽 (鹽觸觸憲選鹽艱淵鏇獵 )
NCT02219256 (Pubmed \| Br J Clin Pharmacol)	临床1期	-	74	TAK-079	願蓋製積鏇鬱襯淵願網(鹽鑰遞齋衊憲積築選簾) = 築鑰觸夢構壓獵醖糧繭憲鏇艱選願網簾願範窪 (夢壓遞築夢艱顧蓋廠糧, 52) 更多	-	2020-07-01
NCT03439280 (ASCO2020)	临床1/2期	复发性多发性骨髓瘤	34	TAK-079	顧願襯憲廠壓夢鬱繭鑰(夢鏇選餘廠遞廠積醖遞) = 18% 鬱衊獵獵蓋壓積願窪簾 (構獵艱壓膚鏇艱淵簾憲 ) 更多	积极	2020-05-25
ACR2016	N/A	系统性红斑狼疮 CD38 \| CD20 \| CD27 ... 更多	-	TAK-079	網衊廠餘製膚襯鬱鬱觸(鹽鏇鹹襯廠鑰壓簾遞鏇) = 鑰觸鹹鏇廠遞鹹糧憲觸衊鬱淵餘廠壓構鏇膚蓋 (積醖繭窪憲遞繭齋鏇鹹 ) 更多	积极	2016-11-14