Our Products

In Japan, there are significant unmet medical needs in the area of neurology.
Pipeline
Epileptic Seizure
Sleep Disorders

Pipeline

We are currently building a pipeline of three indications in the field of neuroscience diseases.

In order to meet the unmet needs of Japanese patients as quickly as possible, we have begun development of drugs that have already been approved for use overseas but not yet approved in Japan.

Development code

Generic name​

Potential indication​

Mechanism of action​

Development phase

Country

NRL-1

Diazepam nasal spray

Status epilepticus or epileptic seizures that may lead to status epilepticus

GABA-A receptor agonist

Regulatory submission

Japan

BF2.649

Pitolisant

Narcolepsy (Type1, Type2)

Histamine H3 receptor
antagonist / inverse agonist

Phase III patient recruitment completed and topline results analyzed

Japan

BF2.649

Pitolisant

Excessive daytime sleepiness associated with obstructive
sleep apnea syndrome

Histamine H3 receptor
antagonist / inverse agonist

Phase III Patient recruitment completed

Japan

Development code

NRL-1

Generic name​

Diazepam nasal spray

Potential indication​

Status epilepticus or epileptic seizures that may lead to status epilepticus

Mechanism of action​

GABA-A receptor agonist

Development phase

Regulatory submission

Country

Japan

Development code

BF2.649

Generic name​

Pitolisant

Potential indication​

Narcolepsy (Type1, Type2)

Mechanism of action​

Histamine H3 receptor
antagonist / inverse agonist

Development phase

Phase III patient recruitment completed and topline results analyzed

Country

Japan

Development code

BF2.649

Generic name​

Pitolisant

Potential indication​

Excessive daytime sleepiness associated with obstructive
sleep apnea syndrome

Mechanism of action​

Histamine H3 receptor
antagonist / inverse agonist

Development phase

Phase III Patient recruitment completed

Country

Japan

Epileptic seizure

We are working to reduce the physical and psychological burden of Epileptic Seizures on patients and their caregivers.
Epilepsy is a condition in which repetitive seizures are triggered by the overactivity of nerve cells in the brain (epileptic seizures)2 Medical advances have made it possible to control seizures in many patients, allowing them to lead a norm However, there are patients with refractory epilepsy who continue to have seizures despite treatment with antiepileptic drugs. Misconceptions and fear about epilepsy and seizures have stigmatized this disease, which causes social issues in Japan.

Refractory Epilepsy

There are an estimated 300,000 patients with refractory epilepsy in Japan who have difficulty in completely controlling their seizures despite treatment with antiepileptic drugs and other therapies. 3, 4

Accurate understanding

While understanding of epilepsy is improving, many people lack accurate information on the condition and its causes, in addition to how to respond when seizures occur. 5

Stigma

About half of caregivers believe that most people are uncomfortable with epilepsy….primarily because they are worried about a patient having a seizure. 6, 7

Sleep disorders

Sleep disorders results in severe health consequences for patients and significant economic loss for society. ACULYS aims to solve these issues.

Narcolepsy is a chronic neurologic sleep disorder that impacts the brain’s ability to control sleep-wake cycles. The primary symptom is “excessive daytime sleepiness.” In addition, as a result of the fact that narcolepsy often occurs along with other disorders, and there is a general low level of public awareness of disease, narcolepsy is highly underdiagnosed in Japan.

Economic loss

The impact of sleep deprivation on Japanese society is enormous. Research shows decreased productivity at work and absence or sick leave due to lack of sleep cause an economic loss of about 3% of Japanese GDP, equivalent to about 15 trillion yen.1

Psychosocial challenges

Associated symptoms with sleep disorders include memory loss, poor concentration, depression and anxiety, often resulting in psycho-social impairments on relationships, academic performance, professional success and leisure activities.

Therapies

Pharmacological therapies for sleep disorders are limited in Japan, and we believe there is significant room for improvement for new treatments that offer greater efficacy and safety.

References: 1. RAND Corp. report 2016 https://www.rand.org/pubs/corporate_pubs/CP1-2016.html 2. NCNP Hospital National Center of Neurology and Psychiatry https://www.ncnp.go.jp/hospital/patient/disease17.html (as of January 2023) 3. Epidemiological study on the prevalence of epilepsy and analysis of actual medical treatment status and improvement of treatment system_2013 4. Early identification of refractory epilepsy; N Engl J Med 2000 Feb 3;342(5):314-9 5. From the Epilepsy Association of Japan Public Opinion Survey on Epilepsy 2013. https://www.jea-net.jp/ 6. Epilepsy and social identity: the stigma of a chronic neurological disorder Lancet Neurol. 2005 Mar;4(3):171-8. 7. Have attitudes toward epilepsy improved in Germany over the last 50 years? Epilepsy Behav. 2022 Nov 29;138:108982.