Nicergoline-based brain enhancers get regulatory nods

A host of nicergoline-based brain-enhancing treatments have won approval recently, government and business officials said Thursday.

Nicergoline-based formulations are emerging as an alternative to choline alfoscerate and other brain enhancers that have failed to demonstrate efficacy in clinical reassessments. In addition to the 30mg version of nicergoline, a lower dose of 10mg has also won approval, they added.

The Ministry of Food and Drug Safety (MFDS) said it approved six nicergoline-based products this month -- Whanin Pharm's Niceon Tablet 10 milligrams, Hyundai Pharmaceutical's Nicerin Tablet 10 milligrams, Alvogen Korea's Genicer Tablet 10 milligrams, Hana Pharm's Serline Tablet 10 milligrams, Binex's Dimenceline Tablet 30 milligrams, and Mother's Pharmaceutical's Ni Ce M Tablet 10 milligrams.

Nicergoline-based drugs have drawn attention, with 38 new products approved by the KFDA in the first half of this year. The original of these items is Ildong Pharmaceutical's nicergoline-based drug Sermion Tablet approved in 1978.

Nicergoline 5 mg and 10 mg are used to improve demotivation due to chronic cerebral circulation disorders accompanying the sequelae of cerebral infarction and treat arteriosclerotic headaches in the elderly as well as an adjunctive therapy for hypertension.

Nicergoline 30 mg is indicated for the first-line treatment of symptoms of dementia syndrome associated with primary degenerative vascular dementia and mixed dementia, including memory impairment, impaired concentration, impaired judgment, and lack of agitation.

The drug, which has been on the market for nearly 50 years, has recently garnered renewed attention because the existing brain-enhancing drugs are on the verge of disappearing due to the failure of clinical reevaluation. Acetyl-L-Carnitine and oxiracetam have failed to prove their efficacy in clinical re-evaluation. Choline alfoscerate, a leading formulation, has also entered clinical reevaluation but has been stuck in patient recruitment.

Due to these limitations in existing drugs, nicergoline-based formulations have emerged as an alternative. The majority of nicergoline-based formulations that have been approved are in the 30 mg dose and are intended to replace traditional brain enhancers. Of the 38 nicergoline-based formulations approved in the first half of the year, 32 were in the 30 mg dose.

The market for lower doses of nicergoline is also expected to expand.

Starting with Hanmi Pharmaceutical's Nicergoline Tablet 10mg in January last year, seven companies have received separate approvals for nicergoline 10mg doses. They are Chong Kun Dang's Nexcholine Tablet 10mg, Whanin Pharma's Niceon Tablet 10mg, Hyundai Pharmaceutical's Nicerin Tablet 10mg, Alvogen Korea's Genicer Tablet 10mg, Hana Pharm's Serline Tablet 10mg, and Mother’s Pharmaceutical's Ni Ce M Tablet 10mg,

With so many pharmaceutical companies entering the nicergoline market, business insiders are paying keen attention to how they will reshape the market landscape.