Nicergoline-based products are steadily making their way into the market, positioning themselves to take over the brain metabolism enhancer segment previously dominated by choline alfoscerate. Although fierce competition has not yet emerged, the increasing entry of multiple companies indicates a growing influence in this space.

According to recent reports from the pharmaceutical industry, a significant number of new nicergoline-based dementia treatment products have launched in the latter half of this year.

Despite several nicergoline formulations receiving approval last year, their market entry was delayed, leaving the market primarily dependent on original products like Ildong Pharmaceutical’s Sermion tablets and Hanmi Pharmaceutical’s Nicegoline tablets. However, as these newly approved products become available this year, they are expected to see widespread prescription.

The introduction of nicergoline products is primarily targeting the brain metabolism enhancer market segment adjacent to dementia treatments.

Currently, the dementia treatment market includes cholinesterase inhibitors like donepezil, rivastigmine, and galantamine for early-stage patients, while moderate to severe cases typically involve combination therapies, such as donepezil/memantine or NMDA receptor antagonists like memantine.

Insurance guidelines permit reimbursement for combining one brain metabolism enhancer with these dementia treatments. Historically, choline alfoscerate has been the main option for this category.

Reimbursement criteria reveal that choline alfoscerate and nicergoline are the primary brain metabolism enhancers available for combination therapy, both commonly prescribed. Although other enhancers like citicoline, ibudilast, and efenprodil are also reimbursable, their limited availability hinders widespread prescription. On the other hand, acetyl-L-carnitine and oxiracetam have been removed from the market after failing reevaluation.

With ongoing concerns in the pharmaceutical industry about potential reimbursement risks from the reevaluation of choline alfoscerate, nicergoline has emerged as the leading alternative brain metabolism enhancer. Consequently, companies have focused on securing approvals for high-dose formulations of nicergoline.

In Korea, nicergoline has been approved in three dosages: 5 mg, 10 mg, and 30 mg. Of these, only the 30 mg dosage qualifies as a brain metabolism enhancer. The 5 mg and 10 mg formulations are restricted to post-stroke complications, as outlined by individual guidelines.

As of August 19th, a total of 37 nicergoline products with the 30 mg dosage—positioned as a versatile alternative to choline alfoscerate—have been approved. In contrast, only 10 products have been approved for the less versatile 10 mg dosage, while the 5 mg version remains limited to the original Sermion tablet.

Nicergoline is essentially being positioned as a "reimbursable brain metabolism enhancer" intended to replace choline alfoscerate.

In practice, industry insiders report that field sales teams are emphasizing nicergoline’s potential to replace choline alfoscerate, given that it is still less recognized compared to its predecessor.

As more companies ramp up marketing efforts, prescriptions for nicergoline as a brain metabolism enhancer are expected to rise.

A pharmaceutical industry representative noted, “While confidence in choline alfoscerate among prescribers remains solid, preventing immediate competitive tensions, the growing number of companies promoting their nicergoline products could shift market dynamics, especially if the reevaluation of choline alfoscerate leads to significant changes.”