“Saw Palmetto Extract and the Growing Market for Benign Prostatic Hyperplasia Treatment Options”

Amid the recent trend of increasing patients with benign prostatic hyperplasia due to the aging population, the related treatment market is also excited.

Among them, ‘Saw Palmetto Extract (Serenoa repens)’ is attracting attention again. In the clinical field, it has already been recognized for its therapeutic effect in Europe, etc.

According to the pharmaceutical industry on the 28th, pharmaceutical companies are competitively launching over-the-counter medicines and health functional foods one after another in line with the recent increase in patients with benign prostatic hyperplasia.

In the case of over-the-counter medicines, recent Dongkuk Pharmaceutical and Hyundai Pharm’s ‘Karitopoten’ and ‘Urintamine Capsule’ are representative. Here, Karitopoten is composed of herbal medicine ingredient cucurbit seed oil extract (Western pumpkin seed oil extract), and urintamine is composed of three main ingredients: L-glutamic acid, L-alanine, and glycine.

Both products claim to improve symptoms of benign prostatic hyperplasia, and have recently been actively engaged in sales and marketing.

Their direct competitor items are dry season foods with ‘saw palmetto extract’ valued at a market of about 100 billion won.

Since last year, the Ministry of Food and Drug Safety has strengthened management, such as establishing new ingredient standards for quality control of dried foods made with saw palmetto extract. While announcing that there is no basis, it is attracting attention as an item that replaces it.

The market is rapidly being reorganized as over-the-counter drugs targeting the niche market are appearing while the withdrawal of dry food items with insufficient content is accelerating due to the stricter ingredient standards for Serenoa Repens, an extract of saw palmetto.

However, in the clinical field, it is evaluated that the need for Serenoa Refens ingredient medicine, which means saw palmetto extract, is still needed in the treatment of mild benign prostatic hyperplasia. This means that it is still used in the pharmaceutical market, apart from dry food, which has an insufficient content.

A representative item is Someto 320mg soft capsule (Serenoa Repens), a treatment for prostatic hyperplasia of Pharmbio Korea.

“In fact, in the early 2000s, the Serenoa Repens component was negative for improving prostate enlargement, but in recent years, it has been changing positively,” said Min Seung-gi, vice president of the Korean Urology Association (Goldman Urology Department, Jamsil Branch).

In fact, Serenoa Repens, the main ingredient of Someto, has already been recognized for its effectiveness in treating enlarged prostates in the European Union and elsewhere.

According to the global medical journal ‘Biological and Pharmaceutical Bulletin’, free fatty acids such as ‘oleic acid’ and ‘lauric acid’, the main ingredients of Serenoa repens, produce dihydrotestosterone, which causes enlargement of the prostate. It was found to inhibit the enzyme ‘5α-Reductase’.

If the dry season food contains 40% of such free fatty acids, Someto, which is classified as a drug, contains 80%, twice as much.

In addition, through Urology Times (Urology Times 2022), although not constant, an interview was published saying that Serenoa Repens ingredients should not be overlooked in the treatment of benign prostatic hyperplasia.

Accordingly, in the clinical field, it is evaluated that Someto, the only Serenoa Refens product that can be applied by health insurance, can be used as a treatment for benign prostatic hyperplasia. Moreover, it is believed that there is an advantage in that it has sufficient clinical data compared to other drugs that have recently been sold and marketed.

Min Seung-ki, Vice Chairman of Insurance, said, “As the Ministry of Food and Drug Safety strengthens the standards for dry foods, many of them are expected to be withdrawn from the market. Accordingly, it seems that OTC drugs are also attracting attention recently.” Medicines still have uses in the clinical field,” he explained.

He added, “It is possible to use medicines sufficiently for patients with mild benign prostatic hyperplasia,” adding, “Moreover, in the case of pharmaceuticals with the corresponding component, reimbursement is possible, but even if they are prescribed for non-reimbursement, they are cheaper than dry food on the market.”