RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Japan)

Structure/Sequence

Sequence Code 9474006L

Source: *****

Sequence Code 9474023H

Source: *****

Clinical Trials associated with Rozanolixizumab

NCT07465289

/ Not yet recruitingPhase 3

A Phase 3, Open-Label, Extension Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Start Date27 Jul 2026

Sponsor / Collaborator

UCB Biopharma SRL

NCT07570589

/ Not yet recruitingNot ApplicableIIT

An Observational, Prospective, Multicenter, Open-label Study to Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)

Generalized Myasthenia Gravis (gMG) is a rare autoimmune disease (a disease in which the body attacks its own tissues) that causes muscle weakness and significant fatigue.
Current treatments (corticosteroids, plasma exchange, intravenous immunoglobulin infusions) improve symptoms in many patients. However, many continue to suffer from fatigue and fatigability that are not well measured by standard tools. Moreover, these treatments can cause significant long-term side effects, reducing quality of life.
New treatments such as Rozanolixizumab (ROZ) are now available. They act rapidly and are well tolerated, allowing better symptom control while reducing the risks associated with conventional treatments.
To properly evaluate these new treatments, it is essential to understand patients' perspectives on their effectiveness. The scales used by physicians do not always capture all the symptoms experienced by patients, particularly fatigability. This is why a new tool has been developed: the MG symptoms PRO. This questionnaire allows patients to assess their own symptoms (fatigue, weakness of the eyes, mouth, breathing, muscle fatigability) in detail.
This research aims to better understand the effectiveness of treatments from the patients' perspective in order to improve their care.
The goal of the study is to evaluate the impact of Rozanolixizumab administration in real-world practice through the MG symptoms PRO questionnaire. This is an observational study, meaning that the medication is prescribed by the physician according to current regulations, and the study simply collects routine medical data during your follow-up, over a period of approximately 9 months.

Start Date01 Jun 2026

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

NCT07463521

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.

Start Date29 May 2026

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Rozanolixizumab

100 Translational Medicine associated with Rozanolixizumab

100 Patents (Medical) associated with Rozanolixizumab

Literatures (Medical) associated with Rozanolixizumab

01 Apr 2026·ADVANCES IN THERAPY

Assessing the Value Contribution of Vyvgart® (Efgartigimod Alfa) in the Treatment of Generalized Myasthenia Gravis with Acetylcholine Receptor Antibody in Spain Through Multi-criteria Decision Analysis

Article

Author: Gil, Alicia ; Martínez, Eva ; Toja-Camba, Francisco J ; Díaz, Carmina ; Serra, José M ; Trillo, Jose L ; Martín Machín, Celia ; Guerrero, Antonio ; Abad, María R ; Cortés-Vicente, Elena

INTRODUCTION:

Generalized myasthenia gravis (gMG) is a rare, chronic autoimmune neuromuscular disorder that currently lacks a curative treatment. Efgartigimod alfa is the first human IgG1 Fc fragment approved in Spain for the management of this condition. This study aims to evaluate the value of efgartigimod for treating gMG with anti-acetylcholine receptor (gMG AChR+) antibodies compared with ravulizumab, zilucoplan, and rozanolixizumab using a multi-criteria decision analysis (MCDA) framework.

METHODS:

A multidisciplinary group of eight experts evaluated the value of efgartigimod against ravulizumab, zilucoplan, and rozanolixizumab. The MCDA framework adapted for evaluating orphan drugs (ODs) in Spain, comprising nine quantitative and three qualitative criteria, was used.

RESULTS:

gMG AChR+ has been recognised as a severe and debilitating condition with considerable unmet needs. Efgartigimod achieved favourable average scores compared with ravulizumab, zilucoplan, and rozanolixizumab across all comparative parameters, including efficacy, safety, and patient-reported outcomes (PROs), potentially resulting in cost savings. Efgartigimod was deemed to have a significant therapeutic impact, with supporting data considered high quality. Efgartigimod alfa showed a higher overall value contribution than the three comparators, with the difference being most notable for ravulizumab. Furthermore, it was concluded that efgartigimod aligns well with the specific priorities, objectives, and capacities of the National Healthcare System (NHS).

CONCLUSION:

Efgartigimod has been recognised as a valuable option for gMG AChR+ treatment in Spain by a multidisciplinary panel of experts through the application of MCDA, receiving higher scores compared with ravulizumab, zilucoplan, and rozanolixizumab.

01 Apr 2026·JOURNAL OF NEUROLOGY

Efficacy and safety of complement inhibitors and FcRn blockers in generalized AChR antibody-positive myasthenia gravis: a meta-analysis

Review

Author: Di Giovanni, Simone ; Filippakopoulou, Eugenia ; Arnaoutoglou, Marianthi ; Gavriilaki, Maria ; Kimiskidis, Vasilios

BACKGROUND:

Antibody status is increasingly used to inform treatment strategies in generalized myasthenia gravis (gMG). We evaluated the efficacy and safety of complement inhibitors and neonatal Fc receptor (FcRn) blockers versus placebo or standard care in adults with acetylcholine receptor antibody-positive (AChR-Ab⁺) gMG.

METHODS:

We systematically searched MEDLINE, EMBASE, Cochrane Central Register Controlled Trials, and ClinicalTrials.gov through November 2024. Eligible randomized controlled trials (RCTs) informed short-term analyses while long-term outcomes were extracted from open-label extension (OLE) studies. Pooled mean difference (MD) and odds ratio (OR) were calculated using random-effects model.

RESULTS:

Six RCTs (n = 739) and four OLEs (n = 588) evaluating eculizumab, ravulizumab, zilucoplan, efgartigimod, rozanolixizumab, and batoclimab were included. Both drug classes significantly improved mean changes from baseline versus placebo in Myasthenia Gravis Activities of Daily Living [MD 1.7, 95% confidence interval (CI) 1.1-2.3], Quantitative Myasthenia Gravis [MD 2.7, 95%(CI)1.8-3.5], Myasthenia Gravis Composite [MD 6.3, 95%(CI) 5-7.6], MGQoL15r [MD 3.4, 95%(CI)1.2-5.6], and Neuro-QoL [MD 4.5, 95%(CI)1.2-7.7]. Odds of achieving clinically meaningful MG-ADL and QMG improvements were more than doubled (ORs 2.7 and 3.5). Risks of clinical worsening and rescue therapy use were reduced by 72% and 48%, respectively. Complement inhibitors OLEs showed durable benefit up to 156 weeks; 30% of patients reduced corticosteroid doses. Rates of serious adverse events, discontinuation, and mortality were comparable to placebo.

CONCLUSION:

In AChR-Ab⁺ gMG, complement inhibitors and FcRn blockers yield clinically meaningful improvements with favourable safety profiles. Complement inhibition additionally confers sustained benefits and corticosteroid-sparing effects in this population over long-term.

PROTOCOL REGISTRATION:

PROSPERO ID: CRD42024513406.

01 Mar 2026·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Pharmacological and speech-language pathology management of dysphagia in patients with myasthenia gravis

Review

Author: Ferrara, F ; De Berardinis, F

Myasthenia gravis (MG) is a rare, complex autoimmune neuromuscular disorder characterized by fluctuating muscle weakness. Bulbar involvement, particularly dysphagia (difficulty swallowing), is a common and debilitating symptom that significantly increases the risk of aspiration pneumonia, malnutrition, and dehydration, profoundly impacting quality of life. The management of myasthenic dysphagia requires a sophisticated, interdisciplinary approach. This review aims to provide a comprehensive overview of the current and emerging pharmacological treatments for myasthenia gravis and to detail the specific assessment and management strategies employed by speech-language pathologists (SLPs) for associated dysphagia. A narrative review of the literature was conducted, focusing on the pathophysiology, classification, and treatment of MG, with a specific emphasis on bulbar dysfunction. The review synthesizes evidence for traditional immunosuppressants, novel targeted biologics (complement inhibitors and FcRn antagonists), and evidence-based speech-language pathology interventions. Pharmacological management has evolved from symptomatic treatment (anticholinesterases) and broad immunosuppression (corticosteroids, azathioprine) to highly specific, targeted therapies. Complement inhibitors (e.g., eculizumab, ravulizumab) and neonatal Fc receptor (FcRn) antagonists (e.g., efgartigimod, rozanolixizumab) have demonstrated significant and rapid efficacy in reducing autoantibody load and improving clinical scores (MG-ADL, QMG) in generalized MG, including for patients with refractory disease. Concurrently, SLP management is critical for functional safety and efficacy. This includes precise assessment using clinical (e.g., EAT-10, bedside swallowing evaluations) and instrumental methods (VFSS, FEES) to characterize the pathophysiology of weakness and fatigability. Management is individualized, focusing on compensatory strategies (e.g., postural adjustments, diet modification standardized by the IDDSI framework) and behavioral techniques, all timed to coincide with peak medication efficacy. The treatment landscape for MG has been revolutionized by targeted biologics, offering profound improvements for many patients. Effective management of dysphagia, however, relies on the synergy between optimal medical therapy and specialized SLP intervention. This integrated approach is essential to ensure swallowing safety, nutritional adequacy, and improved quality of life for individuals living with myasthenia gravis.

News (Medical) associated with Rozanolixizumab

21 May 2026

·allsci.com

Immunovant posts hopeful data for FcRn inhibitor in rheumatoid arthritis post batoclimab failure

Immunovant reported preliminary Week 16 data for its FcRn inhibitor IMVT-1402 in heavily pretreated rheumatoid arthritis patients, with ACR20, ACR50, and ACR70 response rates of 72.7%, 54.5%, and 35.8%, respectively, according to results disclosed alongside the company’s fiscal year 2026 financial results. The data arrive weeks after Immunovant discontinued development of batoclimab following failed Phase III thyroid eye disease studies, increasing investor focus on IMVT-1402 as the company’s lead FcRn inhibitor franchise. The open-label study enrolled adults with difficult-to-treat rheumatoid arthritis who had failed at least two prior advanced therapies, including biologic and targeted synthetic DMARDs. Among 165 evaluable participants, response rates remained consistent in a subgroup previously treated with both JAK and anti-TNF inhibitors. The IMVT-1402 rheumatoid arthritis study is a two-period trial enrolling heavily pretreated adults with difficult-to-treat rheumatoid arthritis who have failed at least two prior mechanisms of advanced therapy, including biologic and targeted synthetic DMARDs. Period 1 is an open-label, 16-week phase in which all 170 enrolled participants received IMVT-1402 600 mg weekly by subcutaneous injection. Of the 170 enrolled, 165 were evaluable at Week 16. The primary endpoint for the trial is the proportion of Period 1 ACR20 responders who maintain that response at Week 28. At Week 16, the observed ACR20, ACR50, and ACR70 response rates across the 165 evaluable participants were 72.7%, 54.5%, and 35.8%, respectively, with participants who discontinued before Week 16 counted as non-responders. Within the subset of 107 participants who had failed at least one JAK inhibitor and at least one anti-TNF inhibitor — a group representing a particularly refractory population — the ACR20, ACR50, and ACR70 rates were 72.0%, 53.3%, and 37.4%, respectively, showing minimal attenuation compared to the overall cohort. IMVT-1402 was described as safe and well-tolerated, with no new drug-related safety signals identified during Period 1. These are preliminary, open-label data from a single-arm period, and the absence of a concurrent placebo arm limits direct causal interpretation. The randomized Period 2, with topline data expected in the H2 2026, will provide the controlled evidence needed to assess whether response is maintained and whether dose differentiation emerges between the 600 mg and 300 mg cohorts. IMVT-1402 is an FcRn-targeting monoclonal antibody that blocks neonatal Fc receptor-mediated IgG recycling, accelerating lysosomal degradation of circulating IgG autoantibodies. The rationale in difficult-to-treat rheumatoid arthritis rests on the IgG-driven inflammatory pathology that persists in patients who have exhausted conventional biologic and targeted synthetic DMARD options. The FcRn inhibitor class has established proof of concept in other IgG-mediated autoimmune diseases. argenx’s Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) and UCB’s Rystiggo (rozanolixizumab) are both approved in generalized myasthenia gravis, demonstrating meaningful IgG reduction and clinical benefit in antibody-driven disease. Neither has an approved indication in rheumatoid arthritis, and the application of FcRn inhibition to D2T RA remains investigational. Immunovant clinical trial data from the D2T RA program are particularly relevant in the context of the company’s recent pipeline setback. In April 2026, Immunovant disclosed that two Phase III studies of batoclimab in active, moderate-to-severe thyroid eye disease failed to meet their primary endpoints, prompting discontinuation of batoclimab development across all indications. The company stated that clinical data, operational experience, and investigator relationships from the batoclimab program have been applied to inform IMVT-1402 development. IMVT-1402 is described as having a potentially improved albumin-sparing profile relative to batoclimab, a differentiation the company has cited as supporting broader chronic use across multiple autoimmune indications. Beyond the D2T RA program, Immunovant reported that its proof-of-concept trial evaluating IMVT-1402 in cutaneous lupus erythematosus has completed enrollment, with topline data also expected in the second half of calendar year 2026. The IMVT-1402 cutaneous lupus study adds to a pipeline that now spans five active autoimmune indications, including potentially registrational trials in Graves’ disease, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, and Sjögren’s disease — all of which the company said remain on track. The Immunovant financial results release noted that the company’s current cash position provides runway to the potential launch of IMVT-1402 in Graves’ disease, with topline data from the potentially registrational trials in Graves’ disease and myasthenia gravis expected in calendar year 2027. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Clinical ResultPhase 3Drug ApprovalFinancial StatementPhase 2

21 Apr 2026

·www.fiercepharma.com

UCB partners with Myasthenia Gravis Foundation of America on meal program targeting nutrition deserts

The MGFA Food Support Program is providing premade, packaged meals delivered directly to the homes of patients with MG. Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease that can cause muscle weakness, fatigue and problems swallowing, issues that can make mealtimes especially difficult for patients with MG.Households affected by MG often struggle to prepare regular, healthy meals because the disease can make cooking and eating difficult for the family member living with MG, according to the Myasthenia Gravis Foundation of America. Those challenges can be even greater for families living in areas considered nutrition deserts or facing food insecurity, increasing the risk of poor health outcomes.To help, UCB is partnering with the Myasthenia Gravis Foundation of America and meal-prep company Factor Meals to ease the burden of making nutritious meals.Known as the MGFA Food Support Program, the collaboration provides premade, packaged meals delivered directly to the homes of patients with MG. The aim is to have MG patients apply over the next month, with deliveries beginning in June. The foundation said it plans to support 250 families in 2026 and will close enrollment once that target is reached.“If we want to support improving health outcomes, we have to address the barriers that exist outside of the healthcare setting,” said Aprill Lane, U.S. advocacy lead for rare disease at UCB, in an April 20 release.“Our collaboration with MGFA is an example of how we can lead and partner differently by co-creating programs that support the whole person not just the diagnosis.” UCB markets Rystiggo and Zilbrysq for certain patients with MG, generating €332 million and €217 million, respectively, in 2025 sales.

13 Apr 2026

·www.prnewswire.com

UCB announces new clinical data from its generalized myasthenia gravis (gMG) portfolio at the 2026 American Academy of Neurology (AAN) meeting

UCB will present additional studies and data analyses highlighting UCB's ongoing commitment to improving outcomes for people living with gMG Two studies assessed the bioequivalence and effectiveness of zilucoplan auto-injector (ZLP-AI) administration compared with pre-filled syringe (ZLP-PFS)1 UCB is presenting 21 abstracts in total from its innovative neurology portfolio including 14 epilepsy abstracts and six myasthenia gravis (MG) abstracts at AAN 2026 April 13, 2026 -- UCB, a global biopharmaceutical company, today announced data from two clinical studies assessing ZLP-AI in adult patients who are anti-AChR antibody positivegMG as well as in healthy volunteers. The studies evaluated the effectiveness of a ZLP- AI as a potential new alternative administration option, and the bioequivalence of ZLP-AI relative to ZLP-PFS. ZLP-AI is an investigational administration option for the treatment of gMG in adult patients who are anti-AChR antibody positive and the presentation is currently not approved in the U.S. DV0013 was a Phase 3b open-label, multicenter study in adult patients with gMG self-administering zilucoplan via auto-injector once daily.1 DV0012 was a Phase 1, open-label, single-center, two-period crossover study in healthy adult volunteers to establish bioequivalence of zilucoplan delivered via an auto-injector pen compared with a pre-filled syringe.1 "While symptom control is of course essential, successfully treating gMG should go beyond symptom management and consider tailored therapies that align with a patient's needs, lifestyle and quality-of-life goals," said Omar Sinno, MD, US Medical Strategy Lead, US Rare Disease. UCB will also present five additional studies and data analyses, further highlighting UCB's ongoing commitment to improving outcomes for people living with gMG including: Response to Rozanolixizumab Across Treatment Cycles in Patients with Generalized Myasthenia Gravis: A Post Hoc Analysis of Final Pooled Phase 3 Data: An analysis evaluated the response to rozanolixizumab over multiple treatment cycles in adult patients with gMG, based on their Cycle 1 response.2 Sustained Minimal Symptom Expression in Generalized Myasthenia Gravis: A 120-Week Post Hoc Analysis of RAISE-XT: A post hoc analysis assessed the durability of minimal symptom expression (MSE) response during treatment with zilucoplan in patients with gMG.3 Treatment Goals in Myasthenia Gravis: Expert Consensus Recommendations. Using the RAND/UCLA Appropriateness Method: Seventeen myasthenia gravis experts from North America, Europe and Asia reached consensus on 21 recommendations to define and operationalize treatment goals for patients with MG. Recommendations emphasize the importance of patient engagement and education, reassessing and changing treatment to achieve goals and care coordination with other specialists.4 Treatment Characteristics and Healthcare Resource Utilization Among Adult Patients With Generalized Myasthenia Gravis Initiating Rozanolixizumab in the United States: This real-world, retrospective, non-interventional cohort study of adult patients (N=719) receiving rozanolixizumab in the US evaluated treatment patterns and healthcare resource utilization (HCRU).5 Missed Opportunities for Pharmacist Intervention Among Medicare Fee-for-Service Beneficiaries with Myasthenia Gravis: A Real-World Claims Analysis.6 "At UCB, our approach to rare disease goes beyond developing effective medicines; it's about improving overall experience and outcome for patients," said Kimberly Moran, PhD, SVP & Head, US Rare Disease. "By offering innovative solutions designed around patient needs and preferences, we continue in our mission to help people living with rare diseases better manage their condition through targeted therapies." gMG is a rare neuromuscular autoimmune disease that has a global prevalence of 150–350 cases per 1 million people.7 People living with gMG can experience a variety of symptoms, including severe muscle weakness that can result in double vision, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the muscles of respiration. In gMG, pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction (NMJ) by targeting specific proteins on the post-synaptic membrane. This disrupts the ability of the nerves to stimulate the skeletal muscle and results in a weaker contraction. gMG can occur in any race, gender or age. UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). References: Petrulis et al. DV0012 and DV0013 Study Teams. Bioequivalence and effectiveness of auto–injector–delivered, self–administered zilucoplan compared with pre–filled syringe. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Pascuzzi et al. Response to rozanolixizumab across treatment cycles in patients with generalized myasthenia gravis: A post hoc analysis of final pooled phase 3 data. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Howard et al. RAISE–XT Study Team. Sustained minimal symptom expression in generalized myasthenia gravis: A 120–week post hoc analysis of RAISE–XT. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Narayanaswami et al. Treatment goals in myasthenia gravis: Expert consensus recommendations using the RAND/UCLA Appropriateness Method. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Kumar et al., Treatment characteristics and healthcare resource utilization among patients with generalized myasthenia gravis initiating rozanolixizumab in the United States. Abstract presented at the American Academy of Neurology Annual Meeting, April 2026. Thompson et al. Missed opportunities for pharmacist intervention among Medicare fee–for–service beneficiaries with myasthenia gravis: a real–world claims analysis. Abstract presented at: American Academy of Neurology Annual Meeting, April 2026. Rodrigues, E., Umeh, E., Aishwarya, Navaratnarajah, N., Cole, A., & Moy, K. (2024). Incidence and prevalence of myasthenia gravis in the United States: A claims-based analysis. Muscle & nerve, 69(2), 166–171. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultVaccine

100 Deals associated with Rozanolixizumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14919

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Thrombocytopenia	Canada	UCB SA	01 Mar 2025
Myasthenia Gravis	United States	UCB, Inc.	26 Jun 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis, Ocular	Phase 3	-	UCB Biopharma SRL	29 May 2026
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	United States	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Japan	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Australia	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Belgium	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Brazil	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Czechia	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	France	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Germany	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	Greece	UCB Biopharma SRL	02 Feb 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MDA2026	Not Applicable	Myasthenia Gravis anti-acetylcholine receptor antibody-positive \| anti-muscle-specific tyrosine kinase antibody-positive	26	Rozanolixizumab + Rozanolixizumab (gMG)	njurbckbvn(vvpzlehmsz) = zvmjwbfphz pbnhacrvoa (opxqlutbva ) View more	Positive	08 Mar 2026
NCT03971422 (MycarinG, Pubmed \| J Neurol)	Phase 3	Myasthenia Gravis	200	Rozanolixizumab 7 mg/kg	casiuvswhk(ppjwepnknl) = zhvgjvryde pblmscamzk (rddfzbpmst ) View more	Positive	01 Dec 2025
				Rozanolixizumab 10 mg/kg	casiuvswhk(ppjwepnknl) = gjnjykpwky pblmscamzk (rddfzbpmst ) View more
NCT05681715 (MG0020, Pubmed \| J Neurol)	Phase 3	Myasthenia Gravis	55	Rozanolixizumab	eoznkhznlk(grezwrzuda) = xymvetebae ktqffenjdt (jyltnphval ) View more	Positive	01 Oct 2025
NCT03971422 (MycarinG, Pubmed \| Eur J Neurol)	Phase 3	Myasthenia Gravis	164	Rozanolixizumab 7 mg/kg	mdugkvfvci(xikhfmbpud) = tfmmlkcjem pbjlxlbwvi (gxiyiqtvqu ) View more	Positive	01 Aug 2025
				Rozanolixizumab 10 mg/kg	mdugkvfvci(xikhfmbpud) = ptkqqhuelc pbjlxlbwvi (gxiyiqtvqu ) View more
NCT04875975 (CTgov)	Phase 2	Autoimmune Encephalitis	12	Placebo	jtmmkiawzn = ashbiuqyfo lylsawyepp (jrpmkxuuex, bvewgkmmim - auoohmqduv) View more	-	31 May 2025
NCT05681715 (MG0020, CTgov)	Phase 3	Myasthenia Gravis	62	RLZ SRD (Period 1: RLZ SRD)	sjtubtijbd = pzpnqfssrf ibtuxbjybt (sguhlevhfu, qxpzawoldt - ukgqogogrw) View more	-	07 May 2025
				RLZ (Period 1: RLZ MP)	sjtubtijbd = rexxzgevhx ibtuxbjybt (sguhlevhfu, utzdfbefck - zfgforczzz) View more
NCT04650854 (CTgov)	Phase 3	Myasthenia Gravis	165	Rozanolixizumab (Rozanolixizumab ~7 mg/kg)	rkrvggvvox = jxgpcapcyn gfwakbeyry (ttvuwuliwi, wntaeyktxy - bfybedrwtz) View more	-	18 Apr 2025
				Rozanolixizumab (Rozanolixizumab ~10 mg/kg)	rkrvggvvox = xzzzpyoyvt gfwakbeyry (ttvuwuliwi, rrgggdzpal - ulqlswgudg) View more
NCT04124965 \| NCT04650854 (MG0004, Pubmed \| J Neurol)	Phase 3	Myasthenia Gravis acetylcholine receptor \| muscle-specific tyrosine kinase autoantibody-positive	70	Rozanolixizumab 7mg/kg	cqllytnqji(swmqjgzdwm) = 11/70 [15.7%] pvulhrlcch (emphszdpsi ) View more	Positive	01 Apr 2025
				Rozanolixizumab 10mg/kg
NCT04124965 (MG0004, MDA2025)	Phase 3	Myasthenia Gravis	70	Rozanolixizumab 7mg/kg	hqfrqmqxad(xscmtsxjzu) = nzmubyehnb nxgmntmtkl (kzobqywoqi ) View more	Positive	16 Mar 2025
				Rozanolixizumab 10mg/kg	hqfrqmqxad(xscmtsxjzu) = dfsepdapzp nxgmntmtkl (kzobqywoqi ) View more
NCT04051944 \| NCT03861481 (CIDP04, Pubmed) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Maintenance	34	Rozanolixizumab 10 mg/kg	zaouzjclox(vrvsqjtbsx) = lzuajaebuh kwwtmwaffo (oapttntohn, 3.2) View more	Positive	10 May 2024
				Placebo	zaouzjclox(vrvsqjtbsx) = esyqdkhkrx kwwtmwaffo (oapttntohn, 2.6) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis