Molecular biology laboratories + Life science laboratories
Molecular biology laboratories + Life science laboratories
At Amaterasu Life Sciences, we are dedicated to advancing patient care through innovative drug-delivery technologies. Alzheimer’s disease, a progressive neurodegenerative disorder affecting millions globally, presents significant challenges in long-term treatment adherence.
Donepezil, a commonly prescribed therapy, requires daily oral administration and is often associated with gastrointestinal side effects. Combined with cognitive decline, this frequently leads to poor compliance. Such nonadherence not only reduces therapeutic effectiveness but can also contribute to faster disease progression, increasing the burden on patients, caregivers, and healthcare systems.
Alzheimer’s disease progressively impairs memory and daily functioning, making consistent adherence to oral medications increasingly difficult as the condition advances. Conventional donepezil tablets require strict daily dosing and are often associated with gastrointestinal and systemic side effects, leading to treatment interruption and fluctuating therapeutic levels. For patients and caregivers, missed doses, complex regimens, and tolerability challenges can accelerate cognitive decline and significantly increase the burden of long-term care.
Donepezil SC XR is a once-monthly, subcutaneous extended-release depot injection designed to replace daily oral donepezil with a single, long-acting dose. Built on a biodegradable, polymer-based in-situ forming depot system, the formulation releases donepezil steadily over four weeks—minimising the peaks and troughs commonly associated with oral therapy.
By maintaining consistent drug exposure and reducing dosing frequency, this approach aims to improve treatment adherence, stabilise CNS drug levels, and enhance real-world clinical outcomes in Alzheimer’s care.
Patent status:
• India: Patent for the long-acting donepezil injectable formulation granted.
• USA: Patent under prosecution.
In Alzheimer’s disease, consistent drug exposure is essential, yet daily oral therapy often fails due to poor adherence as cognition declines. Missed doses and fluctuating drug levels reduce treatment effectiveness and increase caregiver burden.
Donepezil SC XR delivers stable, once-monthly therapy, improving adherence, reducing variability, and supporting more reliable long-term care outcomes for patients and caregivers.
• Transforms daily oral dosing into a once-monthly injection, enabling administration in clinical or home-care settings and significantly improving adherence
• Maintains stable plasma concentrations, with the potential to reduce gastrointestinal side effects while sustaining therapeutic benefit
• Simplifies treatment routines, lowering caregiver stress and reducing the risk of medication errors
• Supports improved long-term treatment outcomes through consistent therapy delivery
Donepezil SC XR is intended for individuals living with mild to moderate Alzheimer’s disease who struggle with—or are at high risk of—non-adherence to daily oral therapy. It also benefits caregivers, clinicians, and healthcare systems by enabling more consistent treatment, helping preserve function and quality of life through simplified, reliable dosing.
The formulation concept and preclinical pharmacology have been established as part of Amaterasu’s long-acting injectable portfolio. The regulatory strategy is designed to leverage existing donepezil safety and efficacy data through streamlined approval pathways, including the 505(b)(2) route in the United States and comparable mechanisms in other regions.
Donepezil SC XR is advancing toward clinical development, with opportunities for collaboration across clinical research, regulatory development, manufacturing scale-up, and commercialisation. Amaterasu welcomes partnerships with pharmaceutical companies, healthcare providers, academic groups, and funding organisations interested in accelerating patient access to long-acting Alzheimer’s therapies.
Strategic collaborations can help progress this innovation through clinical validation and into real-world use—supporting more consistent treatment and improved long-term outcomes for patients and caregivers.
Donepezil SC XR has been developed in collaboration with
for bringing deep formulation and drug delivery expertise.
as its incubation partner
as development partner bringing in its manufacturing, regulatory and business development expertise.
We are proud to announce that our Donepezil SC XR Injections have received a positive Pre-IND acceptance from the US FDA. Proof of concept in animal models has been successfully completed, and we are planning to submit an IND application soon. We are targeting a US submission under the 505(b)(2) regulatory pathway, expediting the path to potential approval and making this transformative treatment available to patients in need. Donepezil SC XR Injections represent a significant step forward in our mission to revolutionize healthcare through advanced drug delivery. We are excited about the potential of this innovation to transform the lives of Alzheimer’s patients and their families.