Pipeline

Therapies in Development

Our research and development teams aim to target the underlying mechanisms of brain disease. We move together towards a singular goal to deliver novel therapies that redefine the standard of care for patients and address the areas in brain disease where we see the greatest need.
Hormonal / neuropeptide signaling
Project Area Phase 1 Phase 2 Phase 3 Filing
Eptinezumab (anti-CGRP mAb) Migraine prevention Filing

Mode of Action

Eptinezumab is a monoclonal immunoglobulin G1 (IgG1) antibody that binds to human calcitonin gene-related peptide (CGRP) with high specificity and high affinity for the CGRP α- and β-form. CGRP is a signaling molecule in the pathophysiology of migraine and cluster headache.

Eptinezumab (anti-CGRP mAb)* Migraine prevention (Asia) 3

Mode of Action

Eptinezumab is a monoclonal immunoglobulin G1 (IgG1) antibody that binds to human calcitonin gene-related peptide (CGRP) with high specificity and high affinity for the CGRP α- and β-form. CGRP is a signaling molecule in the pathophysiology of migraine and cluster headache.

*Three phase III clinical trials, supporting registration in Asia, including China and Japan: SUNLIGHT, SUNRISE, and SUNSET trials.

Eptinezumab (anti-CGRP mAb) Episodic cluster headache 3

Mode of Action

Eptinezumab is a monoclonal immunoglobulin G1 (IgG1) antibody that binds to human calcitonin gene-related peptide (CGRP) with high specificity and high affinity for the CGRP α- and β-form. CGRP is a signaling molecule in the pathophysiology of migraine and cluster headache.

Lu AG09222 (anti-PACAP mAb) Migraine prevention 2

Mode of Action

Lu AG09222 is an investigational monoclonal antibody designed to bind and inhibit signaling mediated by pituitary adenylate cyclase-activating polypeptide (PACAP); a neuropeptide that is implicated in migraine pathophysiology.

Circuitry / neuronal biology
Project Area Phase 1 Phase 2 Phase 3 Filing
Aripiprazole 2-month injectable* Schizophrenia + Bipolar I disorder Filing

Mode of Action

A 2-month injectable aripiprazole formulation in an extended dosing interval has the potential to improve adherence to treatment and provide continuous exposure to medication, relevant to the clinical outcomes in adult patients with schizophrenia or BP-I. 

*Clinical program finalized; Lundbeck and Otsuka Pharmaceutical have submitted the aripiprazole 2-month injectable formulation to the European Medicines Agency (EMA) for marketing authorization application (MAA) review and as well as to the US Food & Drug Administration (FDA). 

Brexpiprazole* Agitation in Alzheimer's disease 3

Mode of Action

Brexpiprazole is a small molecule and a potent serotonin–dopamine activity modulator. It acts as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors, and as an antagonist at serotonin 5-HT2A and noradrenaline α1B/α2C receptors. The serotonin, dopamine, and noradrenaline neurotransmitter systems may be implicated in behavioral symptoms of dementia, including agitation.

*Life cycle management. In partnership with Otsuka Pharmaceutical Development & Commercialization, Inc.

Brexpiprazole* PTSD 3

Mode of Action

Brexpiprazole is a small molecule and a potent serotonin–dopamine activity modulator. It acts as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors, and as an antagonist at serotonin 5-HT2A and noradrenaline α1B/α2C receptors. The serotonergic, dopaminergic, and especially the noradrenergic systems are believed to be involved in PTSD (post-traumatic stress disorder) symptomatology with re-experiencing, Negative cognition and mood, Avoidance and Arousal.

*Life cycle management. In partnership with Otsuka Pharmaceutical Development & Commercialization, Inc.

Lu AF28996 (D1-D2 agonist) Parkinson's disease 1

Mode of Action

Lu AF28996 is a small molecule with agonistic properties towards D1 and D2 receptors. Concerted D1 and D2 dopamine receptor stimulation may play an important role in motor control of Parkinson’s disease patients.

Lu AG06466 (MAGL inhibitor) PTSD, MS spasticity 1

Mode of Action

Lu AG06466 is a small molecule and a highly selective inhibitor of monoacylglycerol lipase (MAGL), the primary enzyme responsible for the degradation of the endocannabinoid ligand 2-arachidonoylglycerol (2-AG). Enhancing the actions of 2-AG on CB1 and CB2 receptors may restore altered neuronal transmission and decrease neuroinflammation and thereby it may produce beneficial effects across a range of symptoms and related indications including post-traumatic stress disorder (PTSD) and spasticity in patients with multiple sclerosis (MS).

Protein aggregation, folding and clearance
Project Area Phase 1 Phase 2 Phase 3
Lu AF82422 (anti-alpha-synuclein mAb) Synucleinopathies (MSA) 2

Mode of Action

Lu AF82422 is a monoclonal antibody (mAb) targeting alpha-synuclein. Misfolding, aggregation and extracellular spreading of alpha-synuclein is believed to play a major role in disease pathology and progression in Multiple System Atrophy (MSA), Parkinson’s disease and other neurodegenerative disorders.

Lu AF87908 (anti-Tau mAb) Tauopathies 1

Mode of Action

Lu AF87908 is a monoclonal antibody (mAb) targeting the pathological form of the protein tau which is believed to play a pivotal role in the development and progression of Alzheimer’s disease and other neurodegenerative disorders.

Neuroinflammation / Neuroimmunology
Project Area Phase 1 Phase 2 Phase 3
Lu AG22515 (CD40L inhibitor)* Neurology 1

Mode of Action

Lu AG22515 is a CD40L inhibitor which interferes with the activation of the adaptive immune response by blocking the CD40L/CD40 co-stimulatory interaction on immune cells; an interaction which plays a role in the pathophysiology of several immune-mediated diseases. 

* CD40L/serum-albumin bispecific antibody-fragment ((scFv)2-Fab)) based on AprilBio’s SAFA™ technology platform.

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Understanding Brain Diseases

The journey to brain health starts with understanding the diseases in the brain.