Singapore’s iX Biopharma Secures Approval for Erectile Dysfunction Drug Silcap

Singapore-listed specialty pharmaceutical company iX Biopharma Ltd announced that Silcap®, a sildenafil drug used in the treatment of male erectile dysfunction (“ED”), has obtained approval and registration by the Health Sciences Authority (HSA) in Singapore.

While patients suffering from ED have access to a variety of generic treatment options, iX Biopharma’s Silcap® has been designed as a novel small capsule, unlike existing alternatives which are typically delivered in tablet form. Silcap® is the first capsule sildenafil product to obtain marketing approval in Singapore.

Silcap® is iX Biopharma’s second drug for the treatment of male erectile dysfunction after Wafesil®, a novel dose form of sildenafil delivered using iX Biopharma’s proprietary WaferiX® drug delivery technology, a sublingual wafer that delivers drug actives safely, conveniently, and rapidly into the bloodstream.

iX Biopharma also supplies Silcap® and Wafesil® in Australia since obtaining approval and registration in 2018 from the Therapeutic Goods Administration (TGA), the regulatory authority in Australia.

Eva Tan, Director, Corporate and Commercial Strategy of iX Biopharma said: “We are delighted with the approval and registration of Silcap® in Singapore. Apart from offering a unique value proposition when compared to existing sildenafil products in the market, Silcap®’s approval continues to reaffirm our ability to bring products successfully from clinical development to registration and launch.”

Silcap® is available in dosage strengths of 25 mg and 50 mg in pack sizes of 4, 8 and 12 capsules. Following the approval, the Group will be preparing for marketing launch of Silcap® in Singapore. As sildenafil drugs are classed as prescription medication in Singapore, Silcap® will be supplied to the local market via licensed medical practitioners.

Erectile dysfunction is a common condition affecting one in five men over the age of 40 years1. In a population-based survey conducted in Singapore on men greater than 30 years old, a prevalence rate of male erectile dysfunction of 51.3% was observed, whereas another study on the ageing population in the country reported a prevalence rate of 73.0%2. – BusinessNewsAsia.com