[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of DAPIROLIZUMAB PEGOL in subjects with moderately to severely active SLE

评价使用DZP作为标准治疗药物的辅助治疗是否能够长期改善中重度疾病活动度的临床相关症状评价使用DZP作为标准治疗药物的辅助治疗是否能够快速改善中重度疾病活动度的临床相关症状评价使用DZP作为标准治疗药物的辅助治疗是否能够长期控制疾病活动度评价使用DZP作为标准治疗药物的辅助治疗是否能够实现和维持治疗达标目的：使用低/可接受剂量的皮质类固醇即可长期保持低疾病活动度评价使用DZP作为标准治疗药物的辅助治疗是否能够改善疾病活动度（通过临床实践中常用的疾病状态数值评分量表进行判定）评价使用DZP作为标准治疗药物的辅助治疗是否能够达到复合主要终点各组成部分的评分改善评价使用DZP作为标准治疗药物的辅助治疗是否能够达到替代终点应答评价使用DZP作为标准治疗药物的辅助治疗是否能够达到对其他关键次要终点提供支持的终点评价使用DZP作为标准治疗药物的辅助治疗的安全性和耐受性

[Translation]

To evaluate whether DZP as adjunctive treatment to standard treatment can improve clinically relevant symptoms of moderate to severe disease activity in the long term To evaluate whether DZP as adjunctive treatment to standard treatment can quickly improve clinically relevant symptoms of moderate to severe disease activity To evaluate whether DZP as adjunctive treatment to standard treatment can control disease activity in the long term To evaluate whether DZP as adjunctive treatment to standard treatment can achieve and maintain treatment goals: low disease activity can be maintained for a long time using low/acceptable doses of corticosteroids To evaluate whether DZP as adjunctive treatment to standard treatment can improve disease activity (determined by a numerical disease status rating scale commonly used in clinical practice) To evaluate whether DZP as adjunctive treatment to standard treatment can achieve improvements in the scores of each component of the composite primary endpoint To evaluate whether DZP as adjunctive treatment to standard treatment can achieve surrogate endpoint responses To evaluate whether DZP as adjunctive treatment to standard treatment can achieve endpoints that support other key secondary endpoints To evaluate the safety and tolerability of DZP as adjunctive treatment to standard treatment

Start Date04 Dec 2024

Sponsor / Collaborator

UCB Trading (Shanghai) Co., Ltd.

NCT06617325

/ RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

Start Date21 Nov 2024

Sponsor / Collaborator

UCB Biopharma SRL

NCT04976322

/ Enrolling by invitationPhase 3

A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus

The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment.

Start Date27 Jul 2021

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Dapirolizumab pegol

100 Translational Medicine associated with Dapirolizumab pegol

100 Patents (Medical) associated with Dapirolizumab pegol

496

Literatures (Medical) associated with Dapirolizumab pegol

01 Apr 2025·NEUROSCIENCE

Tangeretin enhances sedative activity of diazepam in Swiss mice through GABAA receptor interaction: In vivo and in silico approaches

Article

Author: Mia, Emon ; Islam, Md Amirul ; Ansari, Irfan Aamer ; Al Hasan, Md Sakib ; Saifuzzaman, Md ; Islam, Md Torequl ; Bhuia, Md Shimul ; Ansari, Siddique Akber ; Akbor, Md Showkoth ; Chowdhury, Raihan ; Yana, Noshin Tasnim ; Husain, Zakir

The citrus peel flavonoid tangeretin (TAN) has diverse biological activities, including antioxidant, anti-inflammatory, antitumor, hepatoprotective, and neuroprotective effects. This study investigates the sedative effects of TAN, in Swiss albino mice using in vivo and in silico approaches. TAN (10 and 20 mg/kg, i.p.) was administered alone and in combination with diazepam (DZP, 2 mg/kg, i.p.) and flumazenil (FLU, 0.1 mg/kg, i.p.) to evaluate its impact on thiopental sodium (TS)-induced sleep, locomotor activity, and dark-light behavior. Results demonstrated that TAN at 10 mg/kg significantly (p < 0.05) reduced sleep onset latency and increased sleep duration, with a synergistic effect observed when combined with DZP. In locomotor activity tests, TAN dose-dependently decreased the distance traveled, while the combination with DZP further enhanced this effect. Dark-light tests revealed that TAN increased dark residence time, indicating potential anxiolytic properties. Molecular docking studies showed that TAN binds to the GABA_A receptor (α1 and β2 subunits) with a binding affinity of -6.6 kcal/mol, suggesting its interaction with GABAergic pathways. Pharmacokinetic analysis indicated high intestinal absorption and compliance with Lipinski's rule of five, with a favorable safety profile (LD₅₀ = 5000 mg/kg). Overall, TAN enhances the sedative effects of DZP through GABA_A receptor modulation, highlighting its potential as a natural sedative agent. Further research should explore the long-term effects, bioavailability, blood-brain barrier permeability, and synergistic interactions of TAN, with comprehensive in vitro studies and clinical trials needed to validate its potential as a natural sedative.

01 Apr 2025·ANALYTICA CHIMICA ACTA

Multiplex immunochromatographic assay based on triple-color aggregation-induced emission fluorescent microspheres with good biocompatibility for the simultaneous detection of veterinary drugs in aquatic products

Article

Author: Zhang, Ganggang ; Lai, Xiaocui ; Zhang, Gan ; Liu, Cong ; Su, Liu ; Lai, Weihua ; Deng, Shengliang ; He, Weihua

BACKGROUND:

The simultaneous presence of multiple veterinary drug residues in a single sample poses a significant challenge for food safety analysis. Compared with traditional single-target detection, multiplex detection can not only provide richer sample information to raise the detection efficiency and reduce the possibility of false positives and omissions, but also decrease sample volume, shorten detection time, and lower costs. The luminance of aggregation-induced emission fluorescent microspheres (AIEFMs) can be enhanced by loading more fluorophores. The AIEFMs exhibit more advantages such as bright colors, excellent monodispersity, and high photostability, making them widely applicable in food safety.

RESULTS:

We successfully developed a multiplex immunochromatographic assay (ICA) using triple-color AIEFMs as signal labels for the simultaneous detection of three veterinary drugs: chloramphenicol (CAP), diethylstilbestrol (DES), and diazepam (DZP). AIEFMs with good biocompatibility were synthesized via a simple and quick one-pot method based on the self-aggregation of AIEgens and the coating of metal-polyphenol network formed through the coordination of proanthocyanidin and Fe³⁺ in a tetrahydrofuran/water mixed solution. The as-prepared AIEFMs were rapidly conjugated with antibodies to synthesize AIEFM probes without any coupling reagent, and the multiplex AIEFMs-ICA was established for the detection of CAP, DES, and DZP. Under optimal conditions, the detection limits for CAP, DES, and DZP were 1.67, 410, and 5 pg/mL, respectively. The average recoveries of these veterinary drugs in fish and shrimp samples ranged from 85.40 % to 113.15 %, demonstrating the reliability and stability of the multiplex AIEFMs-ICA.

SIGNIFICANCE:

The multiplex AIEFMs-ICA exhibited excellent signal output capacity, high specificity, and remarkable sensitivity. In brief, the developed multiplex AIEFMs-ICA shows great potential in the on-site detection of veterinary drugs and other targets.

01 Apr 2025·TALANTA

An organic-inorganic polyacrylamide-based surface imprinted quantum dots for the impedimetric and voltammetric detection of diazepam in saliva with smartphone readout

Article

Author: Daeid, Niamh Nic ; Adeniyi, Kayode Omotayo ; Adegoke, Oluwasesan ; Yang, Zhugen ; Achadu, Ojodomo J ; Oyinlola, Kayode

Diazepam (DZP) is a muscle-relaxing, anxiety-relieving sedative drug; nonetheless, it is also an addictive drug that may be abused. This work reports on the development of a novel electrochemical nanosensor for diazepam using SiO₂-encapsulated-3-mercaptopropionic acid-capped AuZnCeSeS quantum dots (QDs) overcoated with a molecularly imprinted polymer (MIP) on screen-printed carbon electrodes (SPCEs). Electrochemical, spectroscopic and electron microscopic characterization of the nanomaterial and modified electrode surface was carried out and is reported herein. Specifically, electrochemical characterization of the QDs/SPCE using cyclic voltammetry (CV) revealed that the QDs exhibit a higher electrode surface area whilst electrochemical impedance spectroscopy (EIS) characterization demonstrated a lower charge transfer resistance (R_ct). To fabricate the electrochemical nanosensor, firstly, alloyed AuZnCeSeS QDs were synthesized in the organic phase and thereafter capped with 3-mercaptopropionic acid (MPA) via a ligand exchange reaction. The MPA-AuZnCeSeS QDs were encapsulated in a SiO₂ layer to form a SiO₂-MPA AuZnCeSeS QDs system. The QDs were drop-casted onto SPCEs to form a SiO₂-MPA AuZnCeSeS QDs/SPCE transducer interface. Organic based acrylamide, used as a functional monomer, was electropolymerized via CV on the QDs/SPCE in the presence of the diazepam template with ethylene glycol dimethacrylate as a crosslinker and 2,2'-azobis(2-methylpropionitrile) as an initiator. Under optimum experimental conditions, DZP was detected using EIS and square wave voltammetry (SWV). Using a portable potentiostat and a hand-held smartphone-based potentiostat, DZP was quantitatively detected in saliva using the MIP@QDs/SPCE with a limit of detection (LOD) of 2.3 μM and 2.7 μM, respectively. The LOD for DZP from SWV analysis was 1.0 μM.

News (Medical) associated with Dapirolizumab pegol

12 Feb 2025

·endpts.com

Biogen gets $250M in Royalty Pharma deal for Phase 3 lupus program

Biogen is turning to Royalty Pharma for some cash in exchange for rights to a lupus program, the companies announced Wednesday. The two have agreed on a deal for litifilimab, an anti-BDCA2 drug currently in Phase 3 trials for two kinds of lupus. Biogen will get $250 million in cash, which it will use to continue developing the program, while Royalty Pharma may get undisclosed payments based on regulatory milestones, as well as royalty payments in the mid-single digits. The announcement coincided with Biogen’s fourth-quarter earnings, in which Biogen beat Wall Street expectations for earnings per share, as well as sales of the Alzheimer’s drug Leqembi. Biogen investors have begun growing restless , as the company looks for ways to create long-term growth. CEO Chris Viehbacher and other executives have previously said the company has between $5 billion and $10 billion to make an acquisition before the end of the year. During last quarter’s call with analysts, Viehbacher faced questions about Biogen’s lupus efforts, with some wondering why the company wasn’t focusing on bringing CAR-T to lupus like many other biopharmas. In addition to litifilimab, Biogen also has an anti-CD40 program in Phase 3 testing for lupus called dapirolizumab pegol, which succeeded in one Phase 3 study last year and has a second trial that has launched. Biogen also noted that it’s completed $400 million in net savings of its cost-cutting program announced in mid-2023. The goal of $1 billion in gross savings is still on track to wrap up by the end of 2025. (Last month’s research reorganization is not part of these cuts.) In addition, Biogen announced that it is trimming four programs from its early-stage pipeline: BIIB113, an oral inhibitor of tau aggregation for Alzheimer’s disease; BIIB094, an antisense oligonucleotide targeting LRRK2 for Parkinson’s disease; BIIB101, an Ionis-partnered antisense drug for multiple system atrophy; and BIIB143/cemdomespib, a drug from Reata in diabetic neuropathic pain.

OligonucleotidePhase 3

15 Jan 2025

·www.biospace.com

Under Pressure to Deal, Biogen Executives Deflect Urgency at JPM25

iStock, Agustin Vai While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation. Biogen’s Head of Development Priya Singhal, and CEO Chris Viehbacher for that matter, are well aware of the pressure from investors. The company’s shares have fallen to a five-year low of $143. Investors are repeatedly asking when they might strike another deal. “The stock price is down, but we are trying to focus on, how do we continue to show the momentum and the growth? Because I think people didn’t believe us on a lot of the things, but we were able to kind of bring the proof forward,” Singhal told BioSpace in an interview on the sidelines of the J.P. Morgan Healthcare Conference. “Hopefully the stock price will follow. We’re trying to focus on what we can control, which is growth and scientific conviction in the pipeline.” Investors have always underestimated Biogen’s ability to follow through on lofty goals, from getting an Alzheimer’s drug approved to now filing a request to clear a subcutaneous version in an attempt to ease the administration burden, Singhal said. But they did that on Monday, proving again that they can execute. “I can understand it, because in the past, there were [proof of concept] failures, but now I think the proof’s in the pudding,” Singhal said. “And in 2024 I think we’ve been able to show the proof, and we have set it up for successive positive readouts potentially.” A major milestone in 2024 was the positive readout for dapirolizumab pegol (dapi), which had previously failed a Phase II test in 2018. The Phase III PHOENYCS GO trial met its primary endpoint with a 49.5% response rate among patients with systemic lupus erythematosus, clearing a path for a regulatory filing. This compared to 34.6% in those who received just standard of care. “I can tell you that before dapi read out positive, there wasn’t a lot of excitement about dapi. But now the equation’s changed,” Singhal said. Other milestones were data for high-dose Spinraza in spinal muscular atrophy, global approvals for Friedreich’s ataxia treatment Skyclaris and enrollment for the tau-targeting Alzheimer’s treatment BIIB080 in a Phase II trial. Biogen also bought Human Immunology Biosciences last year for $1.15 billion upfront, at least momentarily silencing the constant drum beat of analysts and investors asking for a deal. But of course heading into J.P. Morgan that call had picked up again. Biogen did announce a potential deal, an unsolicited bid for partner Sage Therapeutics. Singhal could not talk about the deal, only saying that they were required to disclose the offer under SEC rules. In his J.P. Morgan presentation, Viehbacher stressed that Biogen is not desperate for deals. “I see some proposals that we should be prepared to overpay. We’re never going to do that, not knowingly anyway. So I think that’s where the discipline of capital is,” he said during the Tuesday fireside chat. Biogen is facing some tough changes with the multiple sclerosis franchise declining, which was pointed out in a note from BMO Capital Markets. “While we agree with Mr. Viehbacher’s strategy, we expect limited acquisition opportunities will make it increasingly challenging to patch the hole that continues to widen with MS franchise erosion,” BMO’s Evan Seigerman wrote. “Business development continues to be needed, but limited revenue-generating opportunities at a reasonable price continue to box Biogen in to investing in early-stage assets.” Singhal agreed that the MS business is declining, but said it’s taking “more of a glide.” Viehbacher said another company like Reata Pharmaceuticals, which brought with it Skyclarys, would be a perfect match. Singhal underscored an all of the above approach that spans early science to early stage revenue-generating assets. She said Biogen has outlined most importantly what it won’t do, which includes oncology and “big immunology” diseases like rheumatoid arthritis or psoriasis. Instead, the company will stick to specialty immunology, rare diseasesand of course neuroscience. “The Reatas and HiBios of the world are hard to find, so we’re being very purposeful about how we’re looking,” Singhal said. Singhal too, deflected the urgency to conduct a deal. “There’s the sentiment that we have to do a deal, and I think what I want to clarify is that that’s just our everyday business. We’re always looking at internal and external innovation. But do we believe that a deal at any cost is critical to drive Biogen growth? That’s not the case, because we believe that we are really positioned very well.”

Phase 2Phase 3AcquisitionClinical Result

19 Nov 2024

·www.prnewswire.com

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 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 lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, 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

Phase 3Phase 2Fast TrackCell Therapy

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 3	United States	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Argentina	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Australia	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Austria	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Belgium	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Bulgaria	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Canada	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Chile	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Colombia	UCB Biopharma SRL	12 Aug 2020
Systemic Lupus Erythematosus	Phase 3	Czechia	UCB Biopharma SRL	12 Aug 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04294667 (PHOENYCS GO, ACR2024) Manual	Phase 3	Systemic Lupus Erythematosus	315	Dapirolizumab pegol + SOC	lbwbryegic(tuytpumwyg) = gnejolzhqc urjdrwgsza (tjjpkyxqcc ) Met View more	Positive	24 Oct 2024
				Placebo+SOC	lbwbryegic(tuytpumwyg) = pxuivkuehm urjdrwgsza (tjjpkyxqcc ) Met View more
NCT04294667 (PHOENYCS GO, NEWS) Manual	Phase 3	Systemic Lupus Erythematosus	321	dapirolizumab pegol	xfxubqvrnw(mtdmlvokdu) = The trial achieved its primary endpoint. blfxjdgmav (lkldvitsvj ) Met View more	Positive	24 Sep 2024
NCT02804763 (Pubmed) Manual	Phase 2	Systemic Lupus Erythematosus	-	PBO+SOC	tnuqlzjyve(llankzqkrf) = qgaelinmpg ebvmnjqgoo (jrtfpqxbgc ) Not Met View more	Negative	03 Nov 2021
				dapirolizumab pegol 6 mg/kg+SOC	tnuqlzjyve(llankzqkrf) = micfeuxxca ebvmnjqgoo (jrtfpqxbgc ) Not Met View more
NCT01764594 (Pubmed \| Arthritis Rheumatol) Manual	Phase 1	Systemic Lupus Erythematosus	24	dapirolizumab pegol	jyceenwfbo(mghxuejkwg) = mxgxcnspak mvasylflpa (ladtwgldtv ) View more	Positive	01 Nov 2017
				Placebo	jyceenwfbo(ogbhepismt) = qljhypdlux evgrpxbczc (gnzqxlphcv ) View more
NCT01764594 (Pubmed \| Ann Rheum Dis)	Phase 1	Systemic Lupus Erythematosus antidouble stranded DNA \| antinuclear antibodies	-	Dapirolizumab pegol 30 mg/kg followed by 15 mg/kg every 2 weeks	vowczfaems(nyoowvcjfs) = yxnquichrp zaxznnbzlw (yujrehaoqk )	Positive	01 Nov 2017
				Placebo regimen	vowczfaems(nyoowvcjfs) = mwxccjtvsn zaxznnbzlw (yujrehaoqk )
NCT01093911 (Pubmed) Manual	Phase 1	Systemic Lupus Erythematosus	28	CDP7657 (healthy individuals)	shglucpexo(lqfkjjoodo) = kqqoijnutm naaltqlfpi (ufbvatjarx )	Positive	16 Mar 2015
				Placebo (healthy individuals)	-

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