Pirepemat (IRL752)

Pirepemat (IRL752) is being developed to reduce risk of falling and falls in Parkinson’s disease. Besides impaired motor function, impaired balance, cognitive decline as well as falls are linked to the progression of Parkinson’s. Especially falls are a significant consequence of Parkinson’s that has severe complications, such as fractures, impaired mobility and reduced quality of life. Thus, pirepemat has potential to reduce the impairing consequences from falls, in people living with Parkinson’s.

45 percent of all people with Parkinson’s fall recurrently, leading to a significantly reduced quality of life due to a fear of falling affecting their daily life. There are no available treatments at present despite it representing a great unmet medical need. The societal burden for falls is also significant with the cost of treatment for a fall injury in the US is estimated to be USD 30 thousand in people over the age of 65.

Pirepemat is designed to reduce falls by strengthening nerve cell signalling in the prefrontal cortex via action at 5HT7 and alpha-2 receptors. Pirepemat also has potential as a treatment for dementia in Parkinson’s disease (PD-D).

Following successful completion of Phase I studies, an exploratory Phase IIa study was completed in 32 patients with advanced Parkinson’s including cognitive impairment. Pirepemat was found well tolerated in this patient population. Compelling treatment effects were reported indicating improvement in balance and reduced risk of falling, in concert with cognitive and psychiatric benefits. These results suggest that pirepemat has the potential to strengthen the frontal cortical function and be a valuable, first-of-its-kind treatment to prevent falls in people living with Parkinson’s.

A Phase IIb study (REACT-PD) with 104 patients was completed with top-line results reported in March 2025. Pirepemat (600 mg daily) demonstrated a reduction in fall rate by 42 percent among individuals with Parkinson’s disease after three months treatment; however, this effect did not reach statistical significance compared to placebo. Further results based on prespecified in-depth efficacy analyses of the data generated in the Phase IIb dose finding and efficacy study of pirepemat reveals that in a medium plasma concentration range, pirepemat reduced the fall rate by as much as 51.5% after three months of treatment. This effect is highly clinically meaningful and statistically significant (p<0.05 vs. placebo).

Based on these compelling results, the company now continues with further analyses of the study data to reach a decision on how to best design forthcoming studies during the continued clinical development of the drug candidate.

More information can be found on EudraCT number: 2019-002627-16 and clinicaltrials.gov: NCT05258071.

About the recommended INN, pirepemat

Since August 2020, IRL725 goes by the International Nonproprietary Name (INN), pirepemat. The World Health Organization (WHO) concluded that IRL752 should not be incorporated into any existing INN stem in the classification system. IRL752 therefore has the potential to becoming a first-in-class treatment. The INN will serve to identify the active pharmaceutical substance of pirepemat during its lifetime worldwide.

Strong intellectual property rights

Exclusivity based on patents

A family of substance patents covering pirepemat has been approved in all major markets across the globe. Provided the regulatory requirements are met, and granted supplementary protection certificate (SPC) or patent term extension (PTE) are used, the patent protection can be extended well into the 2040s in all major markets*

Exclusivity based on regulatory data protection

Independent of the patent-based exclusivity periods pirepemat will also enjoy customary market exclusivity, for ten years from market approval in Europe and five years from market approval in the US, based on regulatory data exclusivity as a new chemical entity (NCE).

* A medicinal product can only be granted an SPC/PTE extension for one patent.