The purpose of the study is to assess the concentration of rozanolixizumab in mature breast milk of healthy study participants following administration of a single dose of rozanolixizumab

Start Date03 Dec 2024

Sponsor / Collaborator

UCB Biopharma SRL

NCT06540144

/ Enrolling by invitationPhase 3

An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006.

Start Date08 Oct 2024

Sponsor / Collaborator

UCB Biopharma SRL

NCT06149559

/ RecruitingPhase 2/3

An Open-label, Single-arm Study Evaluating the Activity, Safety, and Pharmacokinetics of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis

The purpose of the study is to assess the safety and tolerability of subcutaneous (sc) administration of rozanolixizumab in pediatric participants aged ≥2 to <18 years with generalized Myasthenia Gravis (gMG).

Start Date14 Jun 2024

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 Mar 2025·REPRODUCTIVE TOXICOLOGY

Evaluation of the effect of rozanolixizumab on pregnancy outcomes and pre- and postnatal development in cynomolgus monkeys

Article

Author: Cavagnaro, Joy ; Cauvin, Annick ; Luetjens, C Marc ; Brady, Kevin

Rozanolixizumab, a humanised immunoglobulin (Ig) G4 monoclonal antibody that selectively inhibits binding of IgG to the neonatal Fc receptor (FcRn), was evaluated in an embryo-foetal enhanced pre- and postnatal development (ePPND) study. Pregnant female cynomolgus monkeys (19 per group) received subcutaneous rozanolixizumab 50 mg/kg or 150 mg/kg or vehicle every 3 days from gestation day 20 until delivery. The proportion of pregnancy losses was 15.8%, 21.1% and 5.3% in the rozanolixizumab 50 mg/kg, 150 mg/kg and control groups, respectively. Based on eNormograms for groups of 18 or 20 animals, these results were considered to be within the range of spontaneous prenatal losses naturally observed in cynomolgus monkeys. Foetal examinations revealed no treatment-related effects. All infants had normal postnatal development, although higher mortality was observed in female infants from the control group during the first 3 weeks. All infants were able to mount a normal immune response to keyhole limpet haemocyanin when vaccinated at the age of 4 months. Offspring from 150 mg/kg-treated mothers had very low IgG levels at birth, indicating blockade of maternal IgG transfer; infants from mothers who received 50 mg/kg had variable IgG levels at birth, with mothers who had developed significant anti-drug antibodies conferring maternal IgG transfer to varying degrees. Rates of infection in infants were similar across treatment groups. IgG levels in infants from rozanolixizumab-treated groups normalised within 2 months. Treatment of pregnant cynomolgus monkeys with the FcRn inhibitor rozanolixizumab had no adverse effects on pre- or postnatal development of offspring, including immune system development.

01 Feb 2025·BRITISH JOURNAL OF HAEMATOLOGY

Inhibition of FcRn with rozanolixizumab in adults with immune thrombocytopenia: Two randomised, double‐blind, placebo‐controlled phase 3 studies and their open‐label extension

Article

Author: Snipes, Rose ; Miyakawa, Yoshitaka ; Lledó García, Rocío ; Cooper, Nichola ; Singh, Puneet ; Haier, Birgit ; Lavrov, Andreea ; Bussel, James B. ; Kaźmierczak, Maciej ; Kuter, David J. ; Cluck, Sarah

Summary:

Primary immune thrombocytopenia (ITP) is an antiplatelet‐antibody‐mediated disorder with accelerated platelet clearance and decreased platelet production. Rozanolixizumab, a monoclonal IgG4 anti‐FcRn antibody, blocks IgG recycling and decreases IgG levels. We report efficacy and safety of rozanolixizumab in adults with persistent/chronic ITP in 24‐week phase 3 studies (TP0003; TP0006), and their 52‐week open‐label extension (OLE). Primary end‐point was durable clinically meaningful platelet response (DCMPR) of ≥50 × 109/L for 8/12 weeks during Weeks 13–25 in the double‐blind studies. Operational delays and evolving ITP treatment landscape led the sponsor to terminate these studies early; thus, only 21 and 12 (TP0003) and 20 and 10 (TP0006) patients were randomised to rozanolixizumab or placebo. Forty‐three patients enrolled in the OLE: 42 started on every 2‐week dosing; 21 later switched to weekly dosing. More rozanolixizumab‐treated than placebo‐treated patients achieved DCMPR: 4/21 versus 0 (TP0003) and 1/20 versus 0 (TP0006). Platelet increases to ≥50 × 109/L were observed on Day 8 in 52.4% (TP0003; 2/12 placebo) and 45.0% (TP0006; 1/10 placebo) of rozanolixizumab‐treated patients. OLE platelet increases were maintained while on weekly dosing. The most frequent treatment‐emergent adverse events overall were headache, pyrexia and nausea, as seen previously. Weekly dosing appears more efficacious than every 2‐week dosing.

01 Jan 2025·Clinical Pharmacology in Drug Development

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants

Article

Author: Watanabe, Shikiko ; Sidhu, Jagdev ; Lledó‐García, Rocío ; Lowcock, Romana ; Wilkes, Denisa ; el Baghdady, Assem ; Gayfieva, Maryam

Abstract:

Rozanolixizumab is an anti‐human neonatal Fc receptor humanized immunoglobulin (Ig) G4 monoclonal antibody that reduces IgG, including pathogenic IgG autoantibodies. Rozanolixizumab safety and tolerability have been assessed in previous clinical studies with predominantly White participants. We assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of rozanolixizumab in healthy Japanese and Chinese participants compared with White participants. This double‐blind, single‐center, UK‐based, Phase 1 study randomized 65 participants to rozanolixizumab 4 mg/kg (Japanese and White participants only), 7 mg/kg, or 10 mg/kg. All treatment‐emergent adverse events (TEAEs) were mild to moderate in severity; no severe TEAEs, serious TEAEs, or TEAEs leading to discontinuation occurred. Incidences of TEAEs in Japanese and Chinese participants were comparable to those in White participants. Japanese and Chinese participants had lower systemic rozanolixizumab exposure relative to Caucasian participants, attributable to lower actual doses administered due to lower body weight in Chinese and Japanese participants, indicating that body weight is not a relevant predictor of rozanolixizumab pharmacokinetics. All 3 ethnicities demonstrated dose‐dependent IgG reductions, with IgG nadir achieved around Day 10 and gradual return to baseline levels by Day 56. These data support the applicability of safety data from previous clinical studies of rozanolixizumab to individuals of Japanese and Chinese ethnicity.

News (Medical) associated with Rozanolixizumab

16 Dec 2024

·endpts.com

Biohaven’s protein degrader cuts antibodies by 60%

Biohaven said the lowest dose of BHV-1300 cut the levels of the autoimmune antibody IgG by more than 60%, according to a new cut of data from an ongoing multiple ascending dose trial. This falls short of the IgG reductions of around 70% to 80% that Jefferies analysts were seeking in this update, though it’s still unclear whether higher doses might hit this goal. The product is intended to treat rheumatoid arthritis and other autoimmune conditions in which IgG is implicated. The lowest dose of BHV-1300 tested in the Phase 1 study led to progressive reduction in IgG “within hours of each weekly dose,” the company said in a news release . The subcutaneous drug’s pharmacodynamic effects lasted across the four-week study, and plasma IgG3 levels held steady to the end of the study. The company did not specify whether the trial was in healthy volunteers or patients, but the data likely come from the early-stage trial in RA patients, according to the Jefferies analysts. Biohaven plans to present more Phase 1 data in the first quarter of 2025. The company said the IgG degrader was well-tolerated, with no clinically significant effects on albumin or liver function and no increases in cholesterol. All side effects were mild, drug-related adverse events were resolved, and there were no discontinuations due to drug-related events. An optimized formulation also tested in the trial was more consistent between patients compared with previously reported data for intravenous BHV-1300, the company said; this appears to be in a separate Phase 1 study in Australia . Biohaven and Ypsomed are developing an autoinjector for use with the optimized form. In May, the company said BHV-1300 prompted a reduction in IgG of just 37% in a different trial in healthy subjects, disappointing Biohaven’s investors . Other drugs that cut IgG — such as UCB’s Rystiggo and argenx’s Vyvgart — work by inhibiting FcRn, a protein that sustains levels of IgG in the blood. BHV-1300’s different mechanism means it could be combined with Fc-containing biologics, according to Biohaven. Several of Biohaven’s other programs have also moved forward. The FDA accepted an IND for BHV-1310. Like BHV-1300, it’s an IgG degrader, and a trial is expected to start next quarter. The Jefferies analysts’ model predicts risk-adjusted peak sales of $1.5 billion for BHV-1300 and BHV-1310 combined.

Phase 1INDPROTACsClinical Result

31 Oct 2024

·endpts.com

Argenx reports Vyvgart sales streak, bolstered by launch in rare neuro disorder

Argenx’s Vyvgart has beat sales expectations for the eleventh quarter in a row, supported by strong uptake of a subcutaneous version of the drug in its newest indication. Vyvgart made $573 million in the third quarter, according to a Thursday earnings release , passing consensus projections of $531 million. The sales were driven in part by patients with an autoimmune disorder called chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) taking subcutaneous Vyvgart Hytrulo following an FDA approval in June. The company’s shares $ARGX crept up around 5% at market open Thursday. At the end of Q3, more than 300 CIDP patients were taking Vyvgart Hytrulo, according to the company. William Blair analysts said the figure was “substantially higher” than their estimate of 122 patients. They added that a quarter of prescribers are new to the franchise, with access expected to increase over the coming quarters. Vyvgart won its first FDA approval for certain patients with generalized myasthenia gravis (gMG) back in 2021, with the subcutaneous version greenlit in June last year. Argenx has also submitted a filing for a pre-filled syringe formulation that would allow gMG and CIDP patients to administer the drug themselves, with a PDUFA date set for April 10. Meanwhile, the company has dropped development of Vyvgart in membranous nephropathy, although it is still targeting 10 labeled indications by 2030. Vyvgart is in registrational development for thyroid eye disease, seronegative gMG and ocular myasthenia gravis, with a pivotal test in Sjögren’s disease to start by the end of the year. Nonetheless, competition is heating up in myasthenia gravis after UCB’s Rystiggo was greenlit by the FDA in June 2023. It was the first treatment to secure approval for both anti-acetylcholine receptor and anti-muscle-specific tyrosine kinase antibody-positive patients.

Drug ApprovalPhase 3Financial Statement

11 Oct 2024

·www.prnewswire.com

UCB showcases new data for gMG management at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session

UCB will contribute 14 presentations, including an oral presentation, selected to feature across the AANEM and MGFA meeting, emphasizing UCB's leadership in neuromuscular research Presentations showcase new data for UCB's gMG treatments, including post hoc analyses highlighting the long-term safety and efficacy of ZILBRYSQ® (zilucoplan)1 and RYSTIGGO® (rozanolixizumab-noli) 2 BRUSSELS, Oct. 11, 2024 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that it will be presenting results from across its portfolio in generalized myasthenia gravis (gMG) at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) annual meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session taking place October 15—18, 2024 at the Savannah Convention Center in Savannah, Georgia, U.S. A total of 14 abstracts, including one oral presentation, will feature data from studies of UCB's recently approved medicines for the treatment of gMG, RYSTIGGO® and ZILBRYSQ®, along with findings from real-world studies of clinical outcomes and patient experience in gMG. "At UCB, we are committed to transforming the lives of those living with generalized myasthenia gravis through ongoing innovation and comprehensive clinical research," commented Manuela Maronati, Global Asset Head, Neuroimmunology & Rare. "Our presentations at the 2024 AANEM Annual Meeting and MGFA Scientific Session underscore our dedication to advancing understanding and treatment of this challenging condition. We are particularly excited to share insights from our RAISE-XT and MycarinG studies, which reflect significant progress in the management of generalized myasthenia gravis." Key UCB scientific and real-world data to be presented at AANEM and the MGFA Scientific Session include: An oral presentation focusing on UCB's innovative work on enhancing global education standards for myasthenia gravis.3 Phase 3b study results on switching to subcutaneous zilucoplan from IV complement component 5 inhibitors in myasthenia gravis.4 Data from the RAISE-XT trial for zilucoplan - including an interim analysis of long-term safety and efficacy over a period of up to 120 weeks, compliance to daily self-administered subcutaneous zilucoplan, and a post-hoc analysis of corticosteroid sparing and non-steroidal immunosuppressant therapy changes up to 120 weeks - offering new insights into the management potential for generalized myasthenia gravis in a clinical setting.5,6,7 For rozanolixizumab, post hoc analyses from the Phase 3 MycarinG trial in patients with generalized myasthenia gravis describe the impact of treatment on specific muscle group weaknesses, evaluate rozanolixizumab in those aged 65 years and older, and highlight its use for individualized treatment regimens.8,9,10 UCB will also host an industry-sponsored therapeutic update session on an expert-led discussion on generalized myasthenia gravis treatment choices on October 16, 2024. "At this year's AANEM Annual Meeting and MGFA Scientific Session, we are proud to share data from UCB's innovative work, which is advancing the standard of education for generalized myasthenia gravis globally. This program not only underscores our dedication to empowering healthcare professionals with knowledge and tools but also highlights our ongoing commitment to addressing the complex challenges faced by the MG community," commented Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, UCB. UCB presentations during AANEM and MGFA 2024 Additionally, for registered healthcare professionals, UCB has arranged a program of sponsored scientific and therapeutic updates. Visit us at our booth for more information. UCB For further information, contact UCB: U.S. Rare Disease Communications Daphne Teo T +1 (770) 880-7655 [email protected] Global Communications Nick Francis T: +44 7769 307745 [email protected] Corporate Communications, Media Relations Laurent Schots T +32.2.559.92.64 [email protected] Investor Relations Antje Witte T +32.2.559.94.14 [email protected] IMPORTANT SAFETY INFORMATION ABOUT RYSTIGGO® (rozanolixizumab-noli) in the US2 INDICATION: RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Infections: RYSTIGGO may increase the risk of infection. Delay RYSTIGGO administration in patients with an active infection until the infection is resolved. During treatment with RYSTIGGO, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding RYSTIGGO until the infection has resolved. Immunization Immunization with vaccines during RYSTIGGO treatment has not been studied. The safety of immunization with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because RYSTIGGO causes a reduction in IgG levels, vaccination with live-attenuated or live vaccines is not recommended during treatment with RYSTIGGO. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with RYSTIGGO. Aseptic Meningitis: Serious adverse reactions of aseptic meningitis (also called drug-induced aseptic meningitis) have been reported in patients treated with RYSTIGGO. If symptoms consistent with aseptic meningitis develop, diagnostic workup and treatment should be initiated according to the standard of care. Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema and rash, were observed in patients treated with RYSTIGGO. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor patients during treatment with RYSTIGGO and for 15 minutes after for clinical signs and symptoms of hypersensitivity reactions. If a reaction occurs, institute appropriate measures if needed. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of RYSTIGGO-treated patients) were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea. Serious infections were reported in 4% of patients treated with RYSTIGGO. Three fatal cases of pneumonia were identified, caused by COVID-19 infection in two patients and an unknown pathogen in one patient. Six cases of infections led to discontinuation of RYSTIGGO. Please see the full Prescribing Information for additional Important Safety Information. IMPORTANT SAFETY INFORMATION ABOUT ZILBRYSQ® (zilucoplan) in the US1 INDICATION: ZILBRYSQ is a complement inhibitor indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING WARNING: SERIOUS MENINGOCOCCAL INFECTIONS Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors ; ZILBRYSQ is a complement inhibitor. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update meningococcal vaccination (for serogroups A, C, W, and Y, and serogroup B) at least 2 weeks prior to administering the first dose of ZILBRYSQ, unless the risk of delaying therapy outweighs the risk of developing a meningococcal infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccinations in patients receiving a complement inhibitor. Persons receiving ZILBRYSQ are at increased risk for invasive disease caused by N. meningitidis, even if they develop antibodies following vaccination. Monitor patients for signs of meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, ZILBRYSQ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ZILBRYSQ REMS. CONTRAINDICATIONS ZILBRYSQ is contraindicated in patients with unresolved Neisseria meningitidis infection. WARNINGS AND PRECAUTIONS Serious Meningococcal Infections Life-threatening and fatal meningococcal infections have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors; ZILBRYSQ is a complement inhibitor. The use of ZILBRYSQ increases a patient's susceptibility to serious and life-threatening meningococcal infections (septicemia and/or meningitis) caused by any serogroup, including non-groupable strains. Complete or update meningococcal vaccination (for both serogroups A, C, W, and Y [MenACWY] and serogroup B [MenB]) at least 2 weeks prior to administering the first dose of ZILBRYSQ, according to current ACIP recommendations for meningococcal vaccinations in patients receiving a complement inhibitor. If urgent ZILBRYSQ therapy is indicated in a patient who is not up to date with both MenACWY and MenB vaccines according to ACIP recommendations, administer meningococcal vaccine(s) as soon as possible and provide the patient with antibacterial drug prophylaxis. Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Withhold administration of ZILBRYSQ in patients who are undergoing treatment for meningococcal infection until the infection is resolved. ZILBRYSQ REMS Due to the risk of meningococcal infections, ZILBRYSQ is available only through a restricted program under a REMS called ZILBRYSQ REMS. Under the ZILBRYSQ REMS, prescribers must enroll in the program. Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. Additional information on the REMS requirements is available at or 1-877-414-8353. Other Infections ZILBRYSQ blocks terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Persons receiving ZILBRYSQ are at increased risk for infections due to these bacteria, even after vaccination. Pancreatitis And Other Pancreatic Conditions Pancreatitis and pancreatic cysts have been reported in patients treated with ZILBRYSQ. Patients should be informed of this risk before starting ZILBRYSQ. Obtain lipase and amylase levels at baseline before starting treatment with ZILBRYSQ. Discontinue ZILBRYSQ in patients with suspected pancreatitis and initiate appropriate management until pancreatitis is ruled out or has resolved. ADVERSE REACTIONS In a placebo-controlled study, the most common adverse reactions (reported in at least 10% of gMG patients treated with ZILBRYSQ) were injection site reactions, upper respiratory tract infections, and diarrhea. Please see the full Prescribing Information for additional Important Safety Information. About UCB UCB, Brussels, Belgium () 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 approximately 9 000 people in approximately 40 countries, the company generated revenue of € 5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to differ materially from those that may be expressed or implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring and retention of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. References 1 ZILBRYSQ® US PI. . (Accessed: October 2024). 2 RYSTIGGO® US PI. . (Accessed: October 2024). 3 Howard J, et al. Developing needs-driven medical education for healthcare professionals in myasthenia gravis. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 4 Freimer M, et al. Switching to subcutaneous zilucoplan from IV complement component 5 inhibitors in myasthenia gravis: A Phase 3b study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 5 Howard J, et al. Long-term safety and efficacy of zilucoplan in generalized myasthenia gravis: 120-week interim analysis of RAISE-XT. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 6 Ruzhansky K, et al. Compliance to daily self-administered subcutaneous zilucoplan in patients with generalized myasthenia gravis: a post hoc analysis of the RAISE-XT study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 7 Freimer M, et al. Corticosteroid dose tapering during treatment with zilucoplan in patients with generalized myasthenia gravis: 120-week follow-up of RAISE-XT. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 8 Pascuzzi R, et al. Effect of rozanolixizumab on myasthenia gravis–specific outcome subdomain scores: post hoc analyses from the phase 3 MycarinG study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 9 Vu T, et al. Rozanolixizumab in patients aged ≥65 years with generalized myasthenia gravis: a post hoc analysis of the Phase 3 MycarinG study. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. 10 Ali A. Habib, et al. Rozanolixizumab treatment patterns in patients with generalized myasthenia gravis: post hoc analysis. Poster presented at: The American Academy of Neurology and Electrodiagnostic Medicine Annual Meeting (AANEM); 2024, October 15-18; Georgia, USA. RYSTIGGO® and ZILBRYSQ® are registered trademarks of the UCB Group of Companies. ©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-RZ-2400542 SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

100 Deals associated with Rozanolixizumab

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14919

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Myasthenia Gravis	US	UCB, Inc.	26 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	US	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	JP	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	AU	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	BE	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	BR	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	CZ	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	FR	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	DE	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	IT	UCB Biopharma SRL	02 Feb 2022
Myelin oligodendrocyte glycoprotein antibody-associated disease	Phase 3	MX	UCB Biopharma SRL	02 Feb 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04051944 \| NCT03861481 (CIDP04, Pubmed) Manual	Phase 2	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Maintenance	34	Rozanolixizumab 10 mg/kg	gfdamnabwk(xeddvvihmc) = culrrtnsaw uvjjcosyld (vszebnligh, 3.2) View more	Positive	10 May 2024
				Placebo	gfdamnabwk(xeddvvihmc) = ybvdcdxccg uvjjcosyld (vszebnligh, 2.6) View more
NCT03971422 (MycarinG, AAN2024)	Phase 3	Myasthenia Gravis	127	Rozanolixizumab 7mg/kg	spusakfsqe(agckzwcumo) = xhjgfowucx tzmpdhkxuh (wcorilikcv ) View more	Positive	09 Apr 2024
				Rozanolixizumab 10mg/kg	spusakfsqe(agckzwcumo) = xkwoqlbozo tzmpdhkxuh (wcorilikcv ) View more
AAN2024	Not Applicable	Myasthenia Gravis	-	Rozanolixizumab	aohsnedcbf(kcnalwhwjy) = prcrqeqhmu ojsaaqoeao (hllpwgcjdp, 3.5) View more	-	09 Apr 2024
AAN2024	Not Applicable	Myasthenia Gravis	-	Rozanolixizumab 7mg/kg	wwewsuzuog(jgikhcdhif) = mean reduction from baseline between Weeks 7–33 ranged from -2.6 to -5.4 (7mg/kg) and -4.2 to -6.2 points (10mg/kg) nlporkdixk (mwehaafiwh ) View more	-	09 Apr 2024
				Rozanolixizumab 10mg/kg
AAN2024	Not Applicable	Meibomian Gland Dysfunction	-	Rozanolixizumab 7mg/kg	sbcrgitxwc(yphkhtiyux) = qquevpxxbc gvuwgrelbk (poscuherhj ) View more	-	09 Apr 2024
				Rozanolixizumab 10mg/kg	sbcrgitxwc(yphkhtiyux) = dpiawggved gvuwgrelbk (poscuherhj ) View more
NCT04828343 (CTgov)	Phase 1	-	32	RLZ (Cohort 1: Syringe Driver- RLZ Dose 1 (>=35 kg to <50 kg))	gidpbfvnbi(oxoazmhcpb) = jpgngygixb mdcpzltpjx (yrlnximrqr, zuvomspqxn - qdikuykejn) View more	-	07 Mar 2024
				placebo (PBO) (Cohort 1: Syringe Driver- PBO (>=35 kg to <50 kg))	gidpbfvnbi(oxoazmhcpb) = vgtenoiwkg mdcpzltpjx (yrlnximrqr, skqrbudgxx - zplntvsacb) View more
NCT03971422 (MG0003, MDA2024) Manual	Phase 3	Myasthenia Gravis	188	Rozanolixizumab 7mg/kg	vcadowwvkn(jcsyymjwkv) = nbrfcuoniq yaxvcdcvfj (wilwvdufbl ) View more	Positive	03 Mar 2024
				Rozanolixizumab 10mg/kg	vcadowwvkn(miqtpodttk) = uffifgwvpc reocvtmswv (ztydueoiao ) View more
NCT04596995 (myOpportunITy3, CTgov)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	43	Rozanolixizumab	bmhqenzhje(juvkqeqnis) = vawqzptsgx ssbtbbdbes (rpchkgdtdo, scbmvizpno - ghrulillcl) View more	-	05 Feb 2024
NCT04124965 (CTgov)	Phase 3	Myasthenia Gravis	71	Rozanolixizumab (Rozanolixizumab ~7 mg/kg)	bulsntkect(fvldpgrrdg) = ineyxmqsov jcdbbuurih (enlbogedlq, dyfowoajlw - npwiyqhquv) View more	-	21 Aug 2023
				Rozanolixizumab (Rozanolixizumab ~10 mg/kg)	bulsntkect(fvldpgrrdg) = kkxlrnawxn jcdbbuurih (enlbogedlq, pmsalnghus - wcqltngdkq) View more
NCT03971422 (MG0003 \| MycarinG, CTgov)	Phase 3	Myasthenia Gravis	200	Placebo	rhcqytekpf(zqlzsibgsf) = xcpddsqlic nclxgutcir (vvyuiewsym, ekvzttmwks - uaabznypfl) View more	-	21 Aug 2023

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