Evaluation of the Efficacy, Safety, and Tolerability of Lacosamide in Major Depressive Episodes of Bipolar Disorder Types I and II: a Randomized, Controlled, Double-blind, Parallel-group Clinical Trial.

Initially, observational studies suggested a possible effect of Lacosamide on depressive and anxious symptoms in individuals with epilepsy, and later, an open-label study demonstrated the efficacy of lacosamide in improving depressive and manic symptoms in individuals with bipolar disorder (BD). The primary objective of this study is to evaluate the efficacy of combining lacosamide as an augmentation treatment to first- or second-line medication treatments in moderate to severe major depressive episodes of treatment-resistant BD I and II (failure of at least two adequate treatments during the current episode). The main hypothesis of the study is that lacosamide produces a greater reduction in depression scores compared to a placebo treatment and that both groups will exhibit similar rates of side effects and adverse events. We will conduct a double-blind, randomized, parallel-group pilot study, comparing the enhancement of the treatment that patients had been using with lacosamide and placebo, over a duration of 12 weeks. Forty subjects aged between 18 and 65 years with a diagnosis of BD (I or II) in a moderate or severe major depressive episode, despite the use of first- or second-line treatments, will be selected. The primary outcome will be the assessment of lacosamide efficacy through the difference in scores on the Hamilton Depression Rating Scale (HAMD-17) from the initial visit to the end of week 12 of intervention between the lacosamide and placebo groups.

Start Date09 Jan 2026

Sponsor / Collaborator

University of Sao Paulo

[+1]

IRCT20250525065882N1

/ RecruitingPhase 3IIT

Evaluating the effect of Lacosamide treatment on the severity of headache attacks and CGRP-LI levels in people with migraine: A triple-blind randomized clinical trial

Start Date21 Jun 2025

Sponsor / Collaborator

Tehran University of Medical Sciences

NCT06966830

/ Not yet recruitingNot ApplicableIIT

A Multicenter, Prospective, Real-World Observational Study of Lacosamide Intravenous Injection for Emergency Termination of Status Epilepticus

Status epilepticus (SE) is an acute and critical form of neurological and systemic diseases involving multiple clinical disciplines, with an annual incidence of (20-73) per 100,000 people and a clinical case fatality rate of 20%. Although there are many causes of SE, the primary goal of treatment is to terminate the seizures quickly, and timely and standardized treatment can reduce mortality and improve prognosis. The prognosis is closely related to the duration of the episode, and the longer the episode, the worse the prognosis. If seizures of convulsive status epilepticus persist for more than 10 minutes and are not provided with optimal therapeutic intervention, serious adverse outcomes and even death are likely to occur. How to effectively terminate status epilepticus and actively find effective, reliable and safe treatment options is a key research problem at present. Due to critical illness, limited treatment options, and poor prognosis, new treatments are urgently needed to terminate persistent epileptic activity.
Lacosamide (LCM) is a third-generation new antiepileptic drug, which was approved in 2008 for the additive treatment of patients aged 16 years and older with focal seizures, with or without generalized seizures. In 2017, it was extended to patients over 4 years of age. Lacosamide is an anticonvulsant drug with a new dual mechanism of action: first, lacosamide antagonizes the glycine site of N-methyl-D-aspartate (NMDA) receptor; Second, lacosamide selectively acts on the slow inactivation of sodium channels and prolongs the inactivation time of sodium channels, which can more effectively reduce sodium influx and reduce the excitability of neurons, so as to achieve the purpose of treating epilepsy. Lacosamide exhibits linear pharmacokinetics, high oral bioavailability, protein binding of < 15%, rapid and almost complete absorption in a single oral dose, and maximum plasma concentrations within 1 to 4 hours. A number of randomized controlled clinical studies and real-world studies abroad have shown that lacosamide can significantly improve the effective rate and seizure-free rate of epilepsy control, and it is well tolerated and has fewer adverse reactions. The 2022 Chinese Expert Consensus on the Diagnosis and Treatment of Post-stroke Epilepsy recommended lacosamide injection as a first-line drug for non-convulsive status epilepticus after stroke, and the Chinese Expert Consensus on the Diagnosis and Treatment of Status Epilepticus in Children (2022) recommended that lacosamide be considered as an additive treatment for refractory convulsive status epilepticus in children > 60 minutes . There is a lack of clinical research data on the efficacy and safety of intravenous bolus lacosamide for status epilepticus, including convulsive status epilepticus and non-convulsive epilepticus.

Start Date06 Jun 2025

Sponsor / Collaborator

Second Affiliated Hospital of Guangzhou Medical University

[+4]

100 Clinical Results associated with Lacosamide

100 Translational Medicine associated with Lacosamide

100 Patents (Medical) associated with Lacosamide

1,783

Literatures (Medical) associated with Lacosamide

01 Oct 2026·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Recurrent bradycardia and hypotension after Oral Lacosamide during hospital boarding in the emergency department: A case report

Article

Author: Babineau, Matthew R ; Pope, Jennifer V ; Gorham, Jack W ; Wischmeyer, Jareth S

Lacosamide is a third-generation antiseizure medication that enhances slow inactivation of voltage-gated sodium channels. Although generally well tolerated, it has been associated with cardiac conduction abnormalities, most commonly in the setting of intravenous administration, overdose, or dose escalation. We report a case of a 79-year-old woman with a history of hypertension (treated with losartan and metoprolol), restless legs syndrome (treated with ropinirole), peripheral neuropathy, and seizure disorder who presented to the emergency department with several days of intermittent confusion and generalized weakness following a recent admission for seizure-like activity, during which lacosamide had been initiated. On arrival, she was afebrile with a heart rate of 74 beats per minute, blood pressure 165/88 mmHg, and oxygen saturation 98% on room air; she was oriented to person and year but not to place, which represented a change from her baseline. Initial laboratory evaluation, including complete blood count, comprehensive metabolic panel with normal renal and hepatic function, B12, and thyroid stimulating hormone, was unremarkable, and her admission electrocardiogram showed normal sinus rhythm with a PR interval of 208 ms. While boarding in the emergency department, she received her scheduled oral lacosamide 150 mg, and approximately two hours later was found unresponsive with a heart rate in the 30s and systolic blood pressure of 50 mmHg. She responded to atropine 1 mg IV and 50μg of epinephrine IV, with improvement of her vital signs and mental status. Six hours later, she received a second scheduled dose of lacosamide 150 mg along with her home medications, including metoprolol tartrate 50 mg, and again two hours later became minimally responsive with a heart rate of 49 beats per minute, blood pressure 64/32 mmHg, and a new first-degree atrioventricular block; she again responded to atropine. The second episode was more pronounced and associated with conduction delay not previously present. No seizure activity was observed during either episode. Lacosamide was discontinued, and the patient had no further bradycardic or hypotensive events. The reproducible temporal relationship between dosing and symptoms, along with resolution after medication cessation, supports a causal association. This case highlights that clinically significant cardiac adverse effects can occur with standard oral dosing of lacosamide, particularly in older adults and in the presence of other medications that affect cardiac conduction. Emergency physicians should maintain a high index of suspicion for medication-induced bradycardia and hypotension in patients receiving lacosamide. This case also underscores how hospital boarding can increase the risk of iatrogenic harm, as patients may receive routine medications in a high-acuity environment where evolving adverse effects can be more difficult to anticipate and detect.

01 Sep 2026·EPILEPSY & BEHAVIOR

Effective treatment for lithium pilocarpine-induced status epilepticus: clonazepam and lacosamide combination

Article

Author: Yildirim, Mehmet ; Yildirim, Hava ; Demirtas, Cumaali ; Aykin, Ugur ; Surmeneli, Yunus Emre ; Akca, Metehan

This study aimed to investigate the potential of clonazepam (CLZ), one of the benzodiazepines used in the first-line treatment of status epilepticus, in combination with anti-seizure medications such as levetiracetam (LEV), lacosamide (LCM), valproic acid (VPA), and fosphenytoin (fPHT), which are used in second-line treatment, in polytherapy. Fifty-six male Sprague-Dawley rats were randomly assigned to seven groups. A status epilepticus model was induced by injection of lithium Cl (5 mEq/kg, s.c.) and pilocarpine HCl (320 mg/kg, i.p.). After induction of status epilepticus, CLZ (1 mg/kg) was administered either alone or in combination with LEV (200 mg/kg), LCM (50 mg/kg), VPA (300 mg/kg), and fPHT (100 mg/kg). Video-EEG recordings were taken from the animals, and behavioral tests were performed. Mortality rates were significantly lower in the CLZ + LCM, CLZ + VPA, and CLZ + fPHT groups compared to the status epilepticus group (p < 0.01, p < 0.05, p < 0.01, respectively), and in the CLZ + LCM and CLZ + fPHT groups compared to CLZ monotherapy (p < 0.05). Spike frequency decreased in all combination groups (p < 0.01). Spike amplitude decreased in the CLZ + LCM and CLZ + VPA combinations (p < 0.01, p < 0.05, respectively). Anxiety levels increased in the CLZ + LCM and CLZ + VPA groups (p < 0.05). Performance impairment related to spatial memory was observed in the CLZ + fPHT group (p < 0.05). A decrease in forced motor functions was observed in the CLZ + VPA and CLZ + fPHT groups compared to the control group (p < 0.01). In conclusion, CLZ alone and the CLZ-LEV combination were insufficient to prevent epileptiform activity associated with status epilepticus, whereas CLZ-based polytherapies -most notably CLZ-LCM, followed by CLZ-VPA and CLZ-fPHT- were more effective in reducing epileptiform spike frequency and amplitude.

01 Sep 2026·EPILEPSY RESEARCH

Lacosamide versus brivaracetam as adjunctive therapy for drug-resistant focal epilepsy: A placebo-anchored indirect comparison and network meta-analysis

Review

Author: Sun, Yuhua ; Zheng, Donglin ; Wang, Yihang ; Zheng, Wanqiu ; Jiang, Fangchao

PURPOSE:

Previous multi-drug network meta-analyses have emphasized overall rankings of newer antiseizure medications, but whether current randomized evidence can distinguish between lacosamide (LCM) and brivaracetam (BRV) in adults with drug-resistant focal epilepsy remains unclear. We therefore conducted a placebo-anchored indirect comparison and network meta-analysis.

METHODS:

We searched PubMed, Embase, the Cochrane Library, Web of Science, and Scopus from inception to 15 January 2026 for double-blind, placebo-controlled randomized trials of adjunctive LCM or BRV in patients aged ≥ 16 years with drug-resistant focal epilepsy. Outcomes were extracted from the maintenance period or the closest comparable fixed-dose period. Relative effects were summarized as risk ratios (RRs) with 95% confidence intervals (CIs), comparing LCM with BRV. A random-effects network meta-analysis using placebo as the common comparator was performed alongside an anchored Bucher indirect comparison. Exploratory Asian subgroup and dose-aligned analyses were performed, and certainty of evidence was assessed using CINeMA.

RESULTS:

Eight trials contributed 3338 participants to the primary ≥ 50% responder analysis. In the overall population, LCM did not differ clearly from BRV for the ≥ 50% responder rate (RR 0.96, 95% CI 0.72-1.27) or seizure freedom (RR 0.41, 95% CI 0.09-1.81). Treatment-emergent adverse events were similar (RR 0.97, 95% CI 0.86-1.10). Serious adverse events were numerically higher with LCM but imprecise (RR 2.08, 95% CI 0.93-4.64), and discontinuation due to adverse events was also imprecise (RR 1.57, 95% CI 0.76-3.21). Exploratory Asian subgroup and dose-aligned analyses showed no clear efficacy separation but were limited by sparse events and imprecision. CINeMA ratings indicated generally low certainty for the principal indirect comparisons, mainly because of imprecision and transitivity concerns.

CONCLUSION:

In adults with drug-resistant focal epilepsy, placebo-anchored indirect evidence did not show a clear difference in short-term efficacy between adjunctive LCM and BRV. Estimates for selected tolerability outcomes were imprecise and based on low-certainty, fully indirect evidence. These findings do not establish a definitive comparative advantage of either treatment, and direct comparative studies are needed.

News (Medical) associated with Lacosamide

17 Apr 2026

·www.biopharmadive.com

UCB, betting on seizure cell therapy, to buy Neurona for up to $1.2B

Through an acquisition announced Friday, Belgian drug company UCB is wagering more than $1 billion on a cutting-edge medicine thats being tested as a potential therapy for a few seizure disorders as well as Alzheimers disease.UCB offered to buy privately held Neurona Therapeutics for $650 million up front while dangling another $500 million in future, milestone-based payments. If completed, the deal would hand UCB an experimental therapy that uses pluripotent stem cells engineered to calm the brain and repair neural networks.The therapy, codenamed NRTX1001, is currently being evaluated in clinical trials as a treatment for patients with hard-to-treat forms of a common epilepsy rooted in the mesial temporal lobe part of the brain.Such an asset would diversify UCBs arsenal of seizure treatments, which are all small molecule drugs. That list includes Vimpat, Keppra, Briviact and Fintepla with the last being the most recent to secure U.S. approval, for seizures associated with a rare, severe type of childhood epilepsy that often causes long-term disabilities. In 2025, UCB recorded close to 1.2 billion euros, or roughly $1.3 billion, in net sales from just Briviact and Fintepla.In a statement, the company said this acquisition marks a strategic expansion into regenerative medicine and advanced therapies, while showcasing a commitment to inorganic growth and to epilepsy solutions that go beyond symptomatic management.We believe this therapy has the potential to provide durable targeted repair of the nervous system following a single dose and could represent a major step forward for people living with mesial temporal lobe epilepsy, CEO Jean-Christophe Tellier said in the statement.Though often expensive to make and challenging to administer, cell therapies have proven to be powerful tools for fighting certain cancers. A growing body of evidence also indicates these treatments can be helpful combating diseases tied to the immune and nervous systems, which in turn has piqued investor interest. Back in 2024, for instance, Neurona raised $120 million to support its research, through a funding round co-led by Viking Global Investors and Cormorant Asset Management.More recently, Aspen Neuroscience, a biotech developing a cell therapy for Parkinsons disease, closed a $115 million Series C round. And just last month, Oryon Cell Therapies, another startup making a cellular medicine for Parkinson's, emerged from stealth with $42 million in funding.Early this year, analysts at the investment bank Stifel met with two prominent doctors in the epilepsy space, who said around one-third of patients with focal onset seizures a broad category that encompasses mesial temporal lobe epilepsy remain treatment-refractory despite a significant increase in the number of FDA-approved anti-seizure medications over the past 20 years.The statistic underscores a significant unmet need among this population, the analysts wrote.Additionally, the doctors described how community neurologists often prefer to prescribe drugs that are easy to use, like Vimpat or Keppra. They viewed azetukalner, a closely watched, ion-channel-opening medicine from Xenon Pharmaceuticals, as having many of the same attributes that made Vimpat or Keppra commercial successes. Xenon, notably, has become a top takeover target to some on Wall Street.A cell therapy like NRTX1001 may therefore face a bit of an uphill battle. But UCB sees an opportunity. Among other potentially advantageous characteristics, like being a durable, one-off treatment, the therapy is administered to the brain through a minimally invasive surgical procedure.UCB confirmed the deal wont impact the companys 2026 revenue guidance, which is expected to grow in a high single-digit to low double-digit percentage range at constant exchange rates. Underlying profitability, meanwhile, is now expected to grow in a high single-digit to mid-teens percentage range at constant exchange rates. '

Cell TherapyAcquisition

19 Mar 2026

·www.drugs.com

Prenatal Valproate Exposure Tied to Offspring Neurodevelopmental Risks

THURSDAY, March 19, 2026 -- Prenatal valproate exposure is associated with increased neurodevelopmental risks among offspring, according to a study published online March 11 in The BMJ . In a study using health care use data from 2000 to 2021, Loreen Straub, M.D., from Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues examined whether prenatal exposure to specific antiseizure drugs increases the risk for neurodevelopmental disorders in children. A total of 8,887 children who were unexposed prenatally were included in the cohort; exposed pregnancies ranged from 219 to 5,261 for lacosamide and levetiracetam, respectively. The researchers observed associations with several outcomes for valproate and zonisamide (adjusted hazard ratio range, 1.26 to 4.50), while no associations with an increased risk for any outcome were seen for levetiracetam and phenytoin. A twofold to fourfold increase in risk for intellectual disability was seen in association with several drugs; due to the small number of children with this disorder, the estimates were imprecise. Across most outcomes, no meaningful associations were seen for topiramate and lamotrigine, but a potential signal was seen for intellectual disability (both drugs) and learning difficulty (topiramate only; hazard ratio, 1.23 based on small numbers). A modest increase in risk for attention-deficit/hyperactivity disorder and behavioral disorders was seen in association with carbamazepine and oxcarbazepine (hazard ratio range, 1.23 to 1.40). "Our findings raise potential concerns for zonisamide, which was associated with several neurodevelopmental disorders in the main analysis," the authors write. "However, these estimates are based on small numbers and should be interpreted with caution." Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text

Clinical Result

26 Feb 2026

·www.ucb.com

Strong Execution Fueling Sustained Company Growth

Revenue in 2025 increased to € 7.74 billion, a plus of 26% (+29% CER1), Net sales were up by 32% to € 7.39 billion (+35% CER1) driven by strong launch execution of UCB's growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ®, more than doubling their combined net sales Underlying profitability (adj. EBITDA2) went up to € 2.64 billion, a plus of 79% (+87% CER1), 34% of revenue - 31.4% of revenue without other operating income one-offs ; Core EPS3 increased to € 9.99 R&D update: KYGEVVI™ approved in U.S. and positive opinion in EU for adults and children living with thymidine kinase 2 deficiency (TK2d); donzakimig in atopic dermatitis (phase 2a) met primary endpoint - portfolio prioritization towards other opportunities; Fast Track Designation for bepranemab granted; two new study starts: galvokimig in atopic dermatitis (phase 2b) and bimekizumab in Palmoplantar Pustulosis (Phase 3); BE BOLD head-to-head phase 4 study in psoriatic arthritis reads-out earlier: H1 2026. Sustainability with top ranking in global biotechnology sector Financial guidance for 2026: Revenues to grow in a high single-digit to low double-digit percentage range at CER. Adjusted EBITDA2 to grow in a high single-digit to high teens percentage range at CER. Corrected for other operating one-offs in 2025, adjusted EBITDA2 growth is expected in the high teens to high twenties percentage range at CER. UCB Full-Year Report 2025, Brussels (Belgium), February 26, 2026 – 7:00 (CET) – regulated information Jean-Christophe Tellier, CEO UCB says: "In 2025, we demonstrated unwavering consistency in executing our long-term growth strategy, solidifying a decade of growth. Our commitment to transforming the lives of people with severe diseases remains steadfast, enabling them to live as fully as possible, free from the burdens of their conditions. We are proud to have reached over 3.1 million patients worldwide, addressing severe immunological and neurological conditions. Our five growth drivers delivered exceptional results, more than doubling their combined net sales to exceed €3.3 billion in 2025. Our clinical pipeline continues to advance with eight innovative treatment options under study, setting the stage for significant milestones in 2026 and beyond. Looking ahead to 2026, we are poised to continue our trajectory of top- and bottom-line growth. Notably, we are bringing the first-ever treatment option to patients and families affected by thymidine kinase 2 deficiency. At the same time, we are expanding our impact by exploring additional indications through new clinical studies leveraging our existing pipeline assets. With strategic flexibility, this is the future we are building, one of innovation, impact, and unwavering dedication to those we serve." 1. CER = constant exchange rates2. adj. EBITDA = adjusted Earnings Before Interest, Taxes, Depreciation and Amortization charges3. Core EPS = core earnings per share Sandrine Dufour, CFO UCB says: “2025 was another strong year for UCB, marked by disciplined execution and consistently robust financial performance. We are building on this momentum by supporting our launches, investing in breakthrough science, and positioning our portfolio for sustained, long‑term growth. Our 2026 revenue guidance reflects this continued trajectory, and we anticipate a significant like‑for‑like increase in adjusted EBITDA versus 2025. With a strong balance sheet and disciplined capital allocation, we are well prepared to fuel continuous growth - underlined by a strong financial guidance for 2026. By moving to constant‑exchange‑rate guidance, we are setting a new standard for clarity, comparability, and financial transparency.” Regulatory and Pipeline Update Regulatory Update - Continued Approvals For Growth Drivers And Expansion Of UCB's NeuroMuscular Footprint In January 2025, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the 320 mg/2mL Autoinjector for BIMZELX®. In January 2025, RYSTIGGO® (rozanolixizumab) received EU approval for self-administration via an infusion (syringe pump) or a new manual push syringe method. And in May 2025, UCB received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for at-home self-administration with infusion pump or a new manual push syringe method for RYSTIGGO®. In November 2025, The U.S. Food and Drug Administration (FDA) approved KYGEVVI™ (doxecitine and doxribtimine), marking the first and only approved therapy for adults and children living with thymidine kinase 2 deficiency (TK2d). This decision was closely followed in January 2026, by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) who issued a positive opinion recommending granting marketing authorization for KYGEVVI®. Upon approval, KYGEVVI® will be the first and only treatment option in the European Union indicated for the treatment of pediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d). These milestones expand UCB’s neuromuscular footprint and demonstrate continued execution in areas of high unmet medical need. Clinical Pipeline Update - Eight Assets With Nine Ongoing Studies And More Studies To Start In 2026 Galvokimig is a multi-specific antibody based therapy that inhibits IL-13 and IL-17A and IL-17 F with albumin binding to moderate half-life. The phase 2a study in moderate-to-severe atopic dermatitis (AtD) – a type of eczema, which is the most common inflammatory skin disease – showed positive and convincing proof-of-concept data. In December 2025, UCB has started a Phase 2b program with galvokimig in participants with atopic dermatitis to investigate the optimal dose and dosing regime using a subcutaneous application, with blinded dosing until week 52. First headline results are expected in 2028. UCB will explore the potential of galvokimig in respiratory diseases: two respiratory indications, Chronic Obstructive Pulmonary Disease (COPD) and Non-Cystic Fibrosis Bronchiectasis (NCFB), with respective proof of concept studies (phase 2a) starting later in 2026. Donzakimig (UCB1381) is a multispecific, Fc free antibody based therapeutic that inhibits IL-13, a key mediator of inflammation, and IL-22, which impairs skin barrier integrity in atopic dermatitis (AtD). The Phase 2a proof-of-concept study in AtD achieved its primary endpoint and no new safety risks were identified. In line with UCB’s portfolio discipline and focus, at this stage priority will be given to other opportunities, including the galvokimig program. Bepranemab is targeting pathological tau to transform the treatment of Alzheimer’s disease (AD). Bepranemab's benefit in low-tau early disease in the TOGETHER phase 2 study paves a development path forward. UCB is engaging constructive interactions with regulatory agencies, aligning the development strategy for bepranemab in AD. In February 2026, US FDA granted Fast Track Designation for bepranemab - a process designed to facilitate the development of drugs to treat serious conditions and fill an unmet medical need. Glovadalen (UCB0022), an orally available, brain-penetrant, small molecule under investigation for the treatment of Parkinson’s Disease reported positive phase 2a study results. The company is assessing next steps for the development program and is exploring opportunities for the asset in neurological conditions associated with dopamine deficiency. UCB has started a Phase 3 program, BE SEEN, to evaluate the efficacy and safety of bimekizumab in Palmoplantar Pustulosis (PPP). PPP is a rare, chronic inflammatory dermatological condition without any approved treatment options in the US, EU, and China. First headline results are expected in 2028. Also in 2025, UCB has initiated three global Phase 3 studies for bimekizumab in pediatric indications: psoriasis, hidradenitis suppurativa, and juvenile idiopathic arthritis. For STACCATO® alprazolam (benzodiazepine, prolonged seizures), headline results are still expected in 2026. Recruiting patients and their caregivers to this ambitious and innovative phase 3 program is progressing well and UCB's plan for first headline results has moved into H2 2026. In June 2025, UCB announced positive results from the GEMZ phase 3 study of fenfluramine in CDKL5 Deficiency Disorder (CDD). CDD is an ultra-rare developmental and epileptic encephalopathies (DEE) with refractory infantile-onset epilepsy and severe global neurodevelopmental delays resulting in intellectual, motor, cortical visual, and sleep impairments as major features. It is caused by pathogenic variants in the Cyclin Dependent Kinase-like 5 (CDKL5) gene located on the X chromosome. It is estimated that CDD affects approximately 1 in 40,000 to 60,000 live births, with a median age of onset of six weeks. UCB will send the submission dossiers for regulatory approval in Q1 2026. In 2026, the company plans to launch a phase 3 program with fenfluramine for patients with Rett-syndrome. BE BOLD is a head-to-head post-approval Phase 4 study, comparing bimekizumab, an IL-17A and IL-17F inhibitor, with risankizumab, an IL-23 inhibitor, in the treatment of adults with active psoriatic arthritis (PsA). BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor. Thanks to faster recruitment than anticipated, first headline results are now expected in H1 2026.In addition, the company plans to launch in 2026 a phase 3 program with rosanolixizumab in ocular myasthenia gravis (oMG). All other clinical studies are continuing as planned. Sustainability In 2025, patient access to reimbursement of UCB’s medicines reached 78%, continuing to improve access to its innovative treatments in the countries where UCB operates. UCB also strengthened its environmental performance and achieved the CDP Climate A List, placing it among the top 4% of companies globally. Sustainalytics further ranked UCB #2 in the global biotechnology sector for ESG performance. Net sales break-down for UCB’s five growth drivers, CIMZIA® and BRIVIACT® Combined Net Sales of the Five Growth Drivers more than doubled reaching € 3.3bn net salesDue to rounding, some financial data may not add up in the tables BIMZELX® (bimekizumab) the first and only IL-17A & IL-17F inhibitor is now available in more than 50 countries around the globe, across five indications: psoriasis (PSO), active psoriatic arthritis (PSA), active ankylosing spondylitis (AS), active non-radiographic axial spondyloarthritis (nr-axSpA) and hidradenitis suppurativa (HS). The increase by more than 200% is driven by strong demand in all indications, including a strong momentum in HS, and all regions coupled with a favorable U.S. payer mix. More than 116 000 patients accessed the product by the end of 2025. FINTEPLA® (fenfluramine) at the end of 2025, reached over 14 000 patients and their families living with seizures associated with rare epileptic syndromes. Fintepla® is a potential transformative therapy for multiple Developmental and Epileptic Encephalopathies (DEEs) offering a foundational therapy option in Dravet Syndrome and a recognized option in Lennox Gastaut Syndrome. RYSTIGGO® (rozanolixizumab-noli), is a treatment option for people living with generalized myasthenia gravis (gMG) providing rapid and durable efficacy. RYSTIGGO® reached more than 2 400 people living with gMG by the end of 2025. ZILBRYSQ® (zilucoplan) is the first and only once-daily subcutaneous, targeted C5 complement inhibitor and reached more than 1 300 people living with myasthenia gravis (gMG) by the end of 2025. ZILBRYSQ® is being launched since April 2024. EVENITY® (romosozumab) the only sclerostin-inhibitor and leader in several bone builder markets has, since its global launch in 2019, reached more than 1.3 million (2024: 900 000) women living with postmenopausal osteoporosis at high risk of fracture around the world. Net sales in Europe went up by 33% reaching € 137 million (+33% CER). EVENITY® is being brought to people living with osteoporosis globally by Amgen, Astellas and UCB, with net sales outside Europe reported by the partners. The worldwide net earnings contribution from EVENITY® is recognized under ‘Other operating income’. CIMZIA® (certolizumab pegol) reported global net sales of € 1 954 million (-4%; 0% CER). This performance reflects volume growth (+ 4%) overcompensated by net price declines. Since 2024, CIMZIA® is no longer patent protected in the U.S. and EU. There is no biosimilar competition, neither today nor expected near-term. BRIVIACT® (brivaracetam) increased net sales to € 758 million, an increase of 11% (+14% CER) and over achieving its peak sales target of “at least € 600 million” already in 2024, well before 2026, the year of the end of exclusivity in the U.S. (February) and Europe (August). This was driven by continued, strong growth in all regions where BRIVIACT® is available to patients. In June 2024, BRIVIACT® was approved in Japan as monotherapy and adjunctive therapy in the treatment of partial onset seizures. BRIVIACT® has a different mode of action from VIMPAT® and differentiates from KEPPRA®. 2025 FY financial highlightsDue to rounding, some financial data may not add up in the tables. "The statutory auditor has issued an audit report containing an unmodified opinion dated 25 February 2026 on the consolidated accounts as of and for the year ended 31 December 2025, and has confirmed that the accounting data reported in the press release is consistent, in all material respects, with the consolidated accounts from which it has been derived. The statutory auditor has issued a limited assurance report containing an unmodified conclusion dated 25 February 2026 on the consolidated sustainability statements, and has confirmed that the sustainability data reported in the press release is consistent, in all material respects, with the consolidated sustainability statements from which it has been derived." 1. Due to rounding, some financial data may not add up in the tables included in this management report2. CER = constant exchange rates Consistent Revenue and Earnings Growth Driven by Strong Execution Revenue in 2025 increased to € 7 741 million (+26%; +29% CER1) and net sales went up to € 7 388 million (+32%; +35% CER1). This growth was driven by the strong, consistent growth of UCB’s growth drivers: BIMZELX®,EVENITY®,FINTEPLA®,RYSTIGGO® and ZILBRYSQ®, thanks to strong execution. Royalty income and fees were € 88 million (+12%; +17% CER1). Other revenue which include payments from R&D licensing partners or sales milestones decreased by 43% (-41% CER1) to € 265 million. This contains in 2025 Biogen for dapirolizumab pegol in Lupus (SLE, phase 3 program) and sales milestones for FINTEPLA®. In 2024, the successful completion of the sale of rights of two established brands for Europe and selected countries in Latin-America and Asia-Pacific in November 2024, led to other revenue of € 157 million, which did not reoccur in 2025. Certain payments from R&D licensing partners in 2024 did not reoccur in 2025: Like the termination revenue for minzasolmin (€ 92 million) or the milestone payments in connection with the approval of FINTEPLA® for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in Japan. Also, the partnership for CIMZIA® in Japan ended in April 2025. Gross profit before “amortization of intangible assets linked to sales” was € 6 134 million (+27%; +31% CER1) and showed an even better performance than the topline, reflecting the improved product mix thanks to the five growth drivers. The adjusted gross margin reached 79.2% and improved over 2024 when the adjusted grow margin was 78.3%. Gross profit after “amortization of intangible assets linked to sales” reached € 5 751 million – with an improved gross margin of 74.3% after 71.5%. Operating expenses increased to € 3 742 million (+5%; +7% CER1). Total operating expenses are consisting of: Underlying operational profitability – adjusted EBITDA2 – increased by 79% to € 2 636 million (+87% CER1) reflecting double-digit revenue growth, improved gross margin due to improved product mix, higher operating expenses with good cost control driven by the strong investments behind the global launches combined with higher operating income due to the continued net earnings contribution for EVENITY® and the higher other operating income. The adjusted EBITDA ratio for 2025 (in % of revenue) reached 34.0%, vs 24.0% in 2024. Corrected for other operating income one-offs, the adjusted EBITDA was € 2 431 million, representing an adjusted EBITDA ratio of 31.4%. Total impairment, restructuring and other income/expenses were expenses of € 61 million. In 2024, UCB reported an income of € 488 million driven by the successful closing of the divestment of UCB’s mature neurology and allergy portfolio in China. Net financial expenses reached € 126 million after € 161 million in 2024. Debt reduction and return on cash investments drove this evolution, partially offset by higher cost of hedging. Income tax expenses went up to € 264 million. The average effective tax rate was 14% compared to 8% in 2024. The tax rate in 2024 was impacted by the divestment in China, and corrected for this, the effective tax rate was 14%. Driven by double-digit revenue growth, higher operating expenses reflecting the strong investments behind the launches, the net contribution from EVENITY® and higher other operating income, the profit of the Group amounted to € 1 558 million after € 1 065 million (+46%; +59% CER1). Core earnings per share, adjusted for the after-tax impact of to be adjusted items, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached € 9.99 after € 4.98 in 2024 based on stable € 190 million weighted average shares outstanding. Dividend – the Board of Directors of UCB proposes a dividend of € 1.45 per share (gross), +4%. Financial Guidance 2026 - The year 2026 will reflect UCB’s unwavering focus on innovation and execution excellence continuing to deliver results. The company’s strong momentum and resilience is supported by a portfolio of five differentiated growth drivers — BIMZELX®, RYSTIGGO®, ZILBRYSQ®, FINTEPLA®, and EVENITY® — each addressing significant unmet medical needs through unique mechanisms of action. The growth will be supported by expanding patient access for BIMZELX® and will overcompensate the expected net sales decline of BRIVIACT® due to loss of exclusivity in the U.S. and Europe. For 2026, UCB is providing guidance at constant exchange rates. Providing financial guidance at constant exchange rates (CER) is a common practice among global companies. It supports understanding the underlying operational performance, improves comparability year over year and cross companies. Revenues are expected to grow in a high single-digit to low double-digit percentage range at CER. UCB will continue to invest behind strong execution around the globe to offer potential new solutions for people living with severe diseases and remains committed to invest into research and development advancing its early and late-stage development pipeline. Underlying profitability, adjusted EBITDA, is expected to grow in a high single-digit to high teens percentage range at CER. Corrected for the other operating one-offs in 2025, adjusted EBITDA growth is expected in the high teens to high twenties percentage range at CER. The financial guidance 2026 as mentioned above is calculated on the same basis as the actual figures for 2025 and is based on current rules and regulations. ----------------------- 1. CER = constant exchange rates Find the financial reports on UCB website: http://www.ucb.com/investors/Download-center Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00 (GMT) / 14.00 (CET)Register here: https://www.ucb.com/investors For further information, contact UCB: Investor RelationsAntje WitteT +32.2.559.9414antje.witte@ucb.com Sahar YazdianT: +32.2.559.9137sahar.yazdian@ucb.com Global CommunicationsLaurent SchotsT+32.2.559.9264laurent.schots@ucb.com About UCBUCB, 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). Forward looking statements This document contains forward-looking statements, including, without limitation, statements containing the words “potential”, “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 guaranteeing 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 be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, 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, supply chain disruption and business continuity risks; 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 or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring, retention and compliance of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, 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 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, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.UCB expressly disclaims any obligation to update any forward-looking statements in this document, 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.

Phase 2Phase 3Drug ApprovalClinical ResultFast Track

100 Deals associated with Lacosamide

External Link

KEGG	Wiki	ATC	Drug Bank
D07299	Lacosamide	N03AX18	DB06218

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Epilepsy	European Union	Accord Healthcare SL	18 Sep 2017
Epilepsy	Iceland	Accord Healthcare SL	18 Sep 2017
Epilepsy	Liechtenstein	Accord Healthcare SL	18 Sep 2017
Epilepsy	Norway	Accord Healthcare SL	18 Sep 2017
Epilepsy, Tonic-Clonic	Japan	UCB Japan Co., Ltd.	04 Jul 2016
Epilepsy, Idiopathic Generalized	Australia	UCB Australia Pty Ltd.	20 Jul 2009
Seizures	Australia	UCB Australia Pty Ltd.	20 Jul 2009
Epilepsies, Partial	European Union	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Iceland	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Liechtenstein	UCB Pharma SA	29 Aug 2008
Epilepsies, Partial	Norway	UCB Pharma SA	29 Aug 2008

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bipolar Disorder	Phase 3	Brazil	Libbs Farmacêutica Ltda.	09 Jan 2026
Bipolar I disorder	Phase 3	Brazil	Libbs Farmacêutica Ltda.	09 Jan 2026
Depressive Disorder, Major	Phase 3	Brazil	Libbs Farmacêutica Ltda.	09 Jan 2026
Epilepsy, Complex Partial	Phase 3	United States	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Australia	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Austria	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Canada	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Denmark	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	France	UCB Biosciences, Inc.	01 Aug 2007
Epilepsy, Complex Partial	Phase 3	Germany	UCB Biosciences, Inc.	01 Aug 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04627285 (CTgov)	Phase 3	Epilepsy	48	Lacosamide (Lacosamide: >=2 to <4 Years)	moebwmhlyb = zrwqjmsjux avecvhgslx (euybcydrki, zlvdsxmcqx - tbzngutksv) View more	-	28 Aug 2025
NCT04627285 (CTgov)	Phase 3	Epilepsy	48	Lacosamide (Lacosamide: >=4 to <6 Years)	moebwmhlyb = onqtoysvba avecvhgslx (euybcydrki, uzzuqddohu - ryezmtocqf) View more	-	28 Aug 2025
P9-9.015 (AAN2025)	Not Applicable	Excessive Daytime Sleepiness	207	Clonazepam	zgwzxlrtti(ddsruqlooq) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. lfaeotwwsc (nczfsnrzqx )	Positive	07 Apr 2025
P9-9.015 (AAN2025)	Not Applicable	Excessive Daytime Sleepiness	207	Levetiracetam		Positive	07 Apr 2025
NCT02408549 (EP0012, Pubmed \| Epilepsia) Manual	Phase 3	Seizures	239	Lacosamide	ebnzdrzlmk(seclqxjsgq) = fcmcqyercn xnoibscdnj (qlkzhltbji ) View more	Positive	01 Dec 2024
NCT00350103 (CTgov)	Phase 3	Diabetic peripheral neuropathic pain	551	Placebo	xqrkzjvzhs(xfxtbzeuvb) = pfhxemsdql ecdansacyc (xfkxxvnzom, 2.20) View more	-	22 Mar 2024
NCT02477839 (SP0967, Pubmed \| Ann Clin Transl Neurol)	Phase 3	Seizures	255	Lacosamide	ebykbyzybf(vsllgcwfzt) = geodnyyskr ggiunxspvf (zobenrosao ) View more	Negative	01 Mar 2024
NCT02477839 (SP0967, Pubmed \| Ann Clin Transl Neurol)	Phase 3	Seizures	255	Placebo	ebykbyzybf(vsllgcwfzt) = noulmbxjcw ggiunxspvf (zobenrosao ) View more	Negative	01 Mar 2024
NCT02408549 (EP0012 \| VALUE, CTgov)	Phase 3	Epilepsy, Idiopathic Generalized \| Epilepsy, Tonic-Clonic	239	Lacosamide	zxvmjgrmma = wtpegqlqls xwufezvvcc (gftmcjlnif, xvrubbqzsc - ufmvzbabpm) View more	-	14 Dec 2023
NCT01969851 (SP0966, Pubmed \| Epilepsia)	Phase 2	Seizures \| Epileptic Syndromes	-	Lacosamide up to 12 mg/kg/day or 600 mg/day	opwffaqfks(wusirprjso) = emcddciimm rpdrsncyib (vfzlbcuklu )	Positive	01 Nov 2023
CNS2023	Not Applicable	Epilepsy, Benign Neonatal	62	Lacosamide	rgkbjvgbbi(jyjvwiehog) = Adverse events (AEs) were reported in 53%, none of which were attributed to lacosamide kylzocfdtf (ytimriearo ) View more	-	01 Oct 2023
IEC2023	Not Applicable	Second line	67	Intravenous Lacosamide	hwxmprosfh(oavwoaxrro) = 18 (26.9%) patient experienced bradycardia fllnxplxwl (famoyfamdk ) View more	Positive	04 Sep 2023
IEC2023	Not Applicable	Seizures	-	Lacosamide	mturrkjzro(motmcbxxoy) = No side effects olxmbuplls (xydcgopzyv ) View more	-	04 Sep 2023

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

Regulation

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

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

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.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis