Part of Lundbeckfonden
Danish international pharmaceutical company engaged in research, development, manufacturing, marketing and sale of pharmaceuticals worldwide, specializing in brain-disorder treatments including depression, schizophrenia, Alzheimer's disease and Parkinson's disease. Listed on Nasdaq Copenhagen (HLUN A / HLUN B).
Clinical Trials
686
444 active
Approvals
84
Total approvals
Agencies
5
Regulatory bodies
Founded
1915
Active, not recruiting
443
64.6%
Completed
180
26.2%
Not yet recruiting
1
0.1%
Recruiting
19
2.8%
Suspended
1
0.1%
Terminated
38
5.5%
Withdrawn
4
0.6%
- Japan's Ministry of Health, Labour and Welfare granted marketing authorization to eptinezumab for the prevention of migraine attacks in adults, Lundbeck announced on Sept. 16, 2026. - Eptinezumab is the only intravenous CGRP-targeted preventive migraine treatment approved in Japan and is now launched in more than 30 markets worldwide. - The authorization was supported by the Phase III SUNRISE trial in a predominantly Asian chronic migraine population and the SUNSET long-term extension study in Japanese patients. - The approval paves the way for Lundbeck's first launch in Japan as marketing authorization holder, enabling the company to operate independently in the Japanese market.
- Lundbeck has randomized the last patient in DEEp OCEAN, the broadest pivotal trial to date in developmental and epileptic encephalopathies, enrolling over 350 participants aged two to 65 years. - The Phase III trial evaluates bexicaserin, an oral, highly selective 5-HT2C receptor superagonist, against placebo for reducing countable motor seizure frequency across diverse DEE syndromes including more than 60 genetic etiologies. - Headline results are expected at the end of Q4 2026 or Q1 2027, with a second pivotal trial in Dravet syndrome (DEEp SEA) expected to complete randomization within months. - Bexicaserin has received Breakthrough Therapy Designation from both the FDA and China's regulatory authority, underscoring the significant unmet need in DEEs where no antiseizure medication is approved across all subtypes.
- Lundbeck announced ahead-of-schedule completion of patient randomization in the global Phase 3 MASCOT trial evaluating amlenetug for multiple system atrophy (MSA), a rare and fatal neurodegenerative disorder with no approved treatments. - Amlenetug is a novel monoclonal antibody targeting α-synuclein protein that showed promising results in Phase 2 trials and could become the first-in-class therapy for MSA. - The early enrollment completion reflects strong engagement from the global MSA community and underscores the urgent unmet medical need for this devastating disease. - Headline results are anticipated in Q3 2027 with expected market launch in Q1 2029, offering hope for patients with this rapidly progressing condition.
- Lundbeck's bocunebart (Lu AG09222) achieved its primary endpoint in the phase IIb PROCEED trial, demonstrating statistically significant reduction in monthly migraine days compared to placebo over 12 weeks. - The investigational anti-PACAP monoclonal antibody showed efficacy in 431 patients who had experienced 1-4 previous preventive treatment failures, representing a difficult-to-treat population. - Bocunebart targets a novel pathway distinct from anti-CGRP therapies, potentially offering the first PACAP-targeting option for migraine prevention. - Based on these positive results, Lundbeck plans to approach regulatory authorities to discuss phase III trial design options.
- Lundbeck announced positive long-term data for bexicaserin showing sustained seizure reduction in patients with Developmental and Epileptic Encephalopathies (DEEs) for up to two years. - Patients experienced median reductions in countable motor seizures of 60.2% at 18 months and 53.7% at 24 months compared to baseline. - The investigational 5-HT2C receptor superagonist demonstrated consistent efficacy across diverse DEE types with a favorable safety profile. - Bexicaserin has received FDA Breakthrough Therapy designation and is advancing to Phase 3 trials through the global DEEp Program.
- Lundbeck has filed marketing authorization applications for Vyepti (eptinezumab) in Japan, China, and South Korea, marking the company's first regulatory submissions for this migraine prevention therapy in Asia. - The applications are supported by Phase 3 SUNRISE trial data demonstrating eptinezumab's efficacy in predominantly Asian patients with chronic migraine, addressing a significant unmet medical need in the region. - If approved, this would represent Lundbeck's first marketing authorization in Japan and the first biologic launch by the company in China and South Korea, expanding access to CGRP-targeted migraine prevention.
- Lundbeck will present details of its Phase 3 MASCOT trial for amlenetug, a first-in-class monoclonal antibody targeting α-synuclein aggregation in Multiple System Atrophy patients. - The innovative trial design employs Bayesian progression modeling methods to address unique challenges in rare disease drug development with limited patient populations. - Multiple System Atrophy is a rapidly progressing neurodegenerative disease with no approved treatments, affecting patients who typically live 6-9 years after symptom onset. - Amlenetug has received Orphan Drug Designation from FDA and EMA, plus SAKIGAKE designation in Japan, highlighting its potential therapeutic significance.
- Lundbeck will present complete results from the PACIFIC trial extension study showing bexicaserin achieved a median 59.3% reduction in countable motor seizure frequency over 52 weeks in patients with developmental and epileptic encephalopathies. - The FDA Breakthrough Therapy-designated drug demonstrated sustained efficacy with 55% of participants experiencing ≥50% seizure reductions compared to baseline, with over 90% completion rate indicating strong tolerability. - New preclinical data reveals bexicaserin significantly reduced seizures and respiratory arrest in SUDEP models, addressing the leading cause of premature death in epilepsy patients. - The company has advanced bexicaserin into global Phase 3 trials (DEEp program) with DEEpSEA recruiting Dravet syndrome patients and DEEpOCEAN enrolling patients with various developmental and epileptic encephalopathies.
- Lundbeck received orphan drug designation from both the FDA and EMA for Lu AG13909, a novel humanized monoclonal antibody targeting ACTH for congenital adrenal hyperplasia treatment. - The first-in-class anti-ACTH antibody represents an innovative therapeutic approach for CAH, a rare genetic disorder affecting approximately 1 in 14,000-18,000 live births worldwide. - An expanded Phase I/II clinical trial is currently enrolling adults with classic CAH across North America and seven European countries, with monthly intravenous dosing. - Animal studies demonstrated significant and durable reductions in corticosterone/cortisol and aldosterone levels with no adverse effects after six months of treatment.
- H. Lundbeck A/S announced positive results from the SUNRISE phase III trial, demonstrating eptinezumab's efficacy in a predominantly Asian population with chronic migraine. - Patients receiving eptinezumab experienced significant reductions in monthly migraine days, with 300mg and 100mg doses showing -7.5 and -7.2 day reductions respectively versus -4.8 with placebo. - The trial met all primary and secondary endpoints, with patients four times more likely to achieve ≥75% reduction in migraine days within the first four weeks compared to placebo. - Based on these results, Lundbeck has initiated regulatory discussions to make eptinezumab available across Asia, addressing significant unmet medical needs in the region.
