Léčivé přípravky ve výzkumu

Léčivé látky ve výzkumu

Naši pracovníci ve výzkumu a vývoji se soustřeďují na mechanismy vzniku a rozvoje onemocnění mozku. Směřujeme společně k cíli přinést nové přístupy k léčbě, které stanoví novou definici standardní péče o pacienty a prozkoumávat oblasti, kde je největší nenaplněná potřeba léčby.

Léčivé přípravky ve výzkumu

Circuitry / neuronal biology

Projekt Oblast Fáze 1 Fáze 2 Fáze 3 Filing
Brexpiprazole⁵ PTSD⁶
Filing

Mechanizmus účinku

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.

Bexicaserin (5HT2C agonist) Developmental and epileptic encephalopathies
3
Lu AF28996 (D1-D2 agonist)⁷ Parkinson's disease
1

Mechanizmus účinku

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.

MAGLi program⁸ Neurology
1

Protein agregation, folding and clearance

Projekt Oblast Fáze 1 Fáze 2 Fáze 3
Amlenetug (anti α-synuclein mAb) Multiple System Atrophy
3

Mechanizmus účinku

Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein and thereby intended to prevent uptake and inhibit seeding of aggregation.

Neuroninflamation / Neuroimmunology

Projekt Oblast Fáze 1 Fáze 2 Fáze 3
Lu AG22515 (CD40L blocker)⁹ Neurology
1

Our pipeline

Project Biology Area Phase
1
Phase
2
Phase
3
Filing/
Launch
Mode of action
Eptinezumab
(anti-CGRP mAb)¹
Hormonal / neuropeptide signaling Migraine prevention²      

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)³
Hormonal / neuropeptide signaling Migraine prevention      

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.

Lu AG13909
(anti-ACTH mAb)⁴
Hormonal / neuropeptide signaling Neurohormonal dysfunctions      

 

Brexpiprazole5 Circuitry / neuronal biology PTSD6      

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.

Bexicaserin (5HT2C agonist) Circuitry / neuronal biology Developmental and Epileptic Encephalopathies      

 

Lu AF28996 (D1-D2 agonist)7 Circuitry / neuronal biology Parkinson’s disease      

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.

MAGLi program8 Circuitry / neuronal biology Neurology      

 

Amlenetug (anti α-synuclein mAb) Protein aggregation, folding and clearance Multiple System Atrophy      

 

Lu AG22515 (CD40L blocker)9 Neuroinflammation /
neuroimmunology
Neurology      

 

  1. CGRP: Calcitonin gene-related peptide.
  2. Two phase III clinical trials, supporting registration in Asia, including China and Japan: SUNRISE, and SUNSET trials
  3. PACAP: Pituitary adenylate cyclase activating peptide.
  4. ACTH: Adrenocorticotropic hormone. Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and Cushing’s Disease. For technical reasons, the latter has been officially categorized as a Phase II trial to adhere to local requirements in Georgia
  5. Acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
  6. Post-traumatic stress disorder.
  7. Dopamine receptor D1 and D2.
  8. MAGLi: Monoacylglycerol lipase (“MAGlipase”) inhibitor.
  9. Ph1b trial ongoing in TED (Thyroid Eye Disease)
Project    Biology    Area    Status    Mode of action
Eptinezumab
(anti-CGRP mAb)¹
  Hormonal / neuropeptide signaling   Migraine prevention²   Launch / Filing  

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)³
  Hormonal / neuropeptide signaling   Migraine prevention   Phase 2  

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.

Lu AG13909
(anti-ACTH mAb)⁴
  Hormonal / neuropeptide signaling   Neurohormonal dysfunctions   Phase 1  

 

Brexpiprazole5   Circuitry / neuronal biology   PTSD6   Launch / Filing  

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.

Bexicaserin
(5HT2C agonist)
  Circuitry / neuronal biology   Developmental and Epileptic Encephalopathies   Phase 1  

Bexicaserin (LP352) is an oral, centrally acting, 5-HT2C superagonist in development for the potential treatment of seizures associated with DEEs such as Dravet syndrome, Lennox-Gastaut syndrome (LGS), tuberous sclerosis complex (TSC), CDKL5 deficiency disorder (CDD), and other epileptic disorders. Bexicaserin is designed to modulate GABA and, as a result, suppress the central hyperexcitability that is characteristic of seizures. It was designed to be more specific and selective for the 5-HT2C receptor subtype, giving it the potential to reduce seizures in patients with DEEs while overcoming the known or perceived safety limitations of available drugs in the 5-HT2 class. Bexicaserin has no detected activity at the 5-HT2B and 5-HT2A receptor subtypes. Longboard plans to advance bexicaserin (LP352) into a global Phase 3 program. Longboard reported topline data from a Phase 1b/2a clinical trial for bexicaserin, the PACIFIC Study, evaluating participants ages 12 to 65 years old with a broad range of DEEs.

Lu AF28996
(D1-D2 agonist)7
  Circuitry / neuronal biology   Parkinson’s disease   Phase 1  

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.

MAGLi program8   Circuitry / neuronal biology   Neurology   Phase 3  

 

Amlenetug
(anti α-synuclein mAb)
  Protein aggregation, folding and clearance   Multiple System Atrophy   Phase 3  

 

Lu AG22515
(CD40L blocker)9
  Neuroinflammation /
neuroimmunology
  Neurology   Phase 1  

 

Circuitry / neuronal biology

Projekt Oblast Fáze 1 Fáze 2 Fáze 3 Filing
Brexpiprazole⁵ PTSD⁶
Filing

Mechanizmus účinku

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.

Bexicaserin (5HT2C agonist) Developmental and epileptic encephalopathies
3
Lu AF28996 (D1-D2 agonist)⁷ Parkinson's disease
1

Mechanizmus účinku

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.

MAGLi program⁸ Neurology
1

Protein aggregation, folding and clearance

Projekt Oblast Fáze 1 Fáze 2 Fáze 3
Amlenetug (anti α-synuclein mAb) Multiple System Atrophy
3

Mechanizmus účinku

Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular α-synuclein and thereby intended to prevent uptake and inhibit seeding of aggregation.

Neuroinflammation / Neuroimmunology

Projekt Oblast Fáze 1 Fáze 2 Fáze 3
Lu AG22515 (CD40L blocker)⁹ Neurology
1
  1. CGRP: Calcitonin gene-related peptide.
  2. Two phase III clinical trials, supporting registration in Asia, including China and Japan: SUNRISE, and SUNSET trials.
  3. PACAP: Pituitary adenylate cyclase activating peptide.
  4. ACTH: Adrenocorticotropic hormone. Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and Cushing’s Disease. For technical reasons, the latter has been officially categorized as a Phase II trial to adhere to local requirements in Georgia.
  5. Acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
  6. Post-traumatic stress disorder.
  7. Dopamine receptor D1 and D2.
  8. MAGLi: Monoacylglycerol lipase (“MAGlipase”) inhibitor.
  9. Ph1b trial ongoing in TED (Thyroid Eye Disease).

Neuroinflammation / Neuroimmunology

Projekt Oblast Fáze 1 Fáze 2 Fáze 3
Lu AG22515 (CD40L blocker)⁹ Neurology
1
  1. CGRP: Calcitonin gene-related peptide.
  2. Two phase III clinical trials, supporting registration in Asia, including China and Japan: SUNRISE, and SUNSET trials.
  3. PACAP: Pituitary adenylate cyclase activating peptide.
  4. ACTH: Adrenocorticotropic hormone. Two phase Ib trials are currently ongoing in Congenital Adrenal Hyperplasia and Cushing’s Disease. For technical reasons, the latter has been officially categorized as a Phase II trial to adhere to local requirements in Georgia.
  5. Acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
  6. Post-traumatic stress disorder.
  7. Dopamine receptor D1 and D2.
  8. MAGLi: Monoacylglycerol lipase (“MAGlipase”) inhibitor.
  9. Ph1b trial ongoing in TED (Thyroid Eye Disease).

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