Dutasteride

Addressing the common issue of dihydrotestosterone overexpression in patients with benign prostatic hyperplasia (BPH), dutasteride, as the world's first dual 5α-reductase inhibitor, can simultaneously inhibit type Ⅰ and type Ⅱ 5α-reductase, block the pathway of testosterone conversion to dihydrotestosterone, and improve the prostate volume reduction effect by more than 30% compared with traditional single-target inhibitors. Its clinical indications cover symptom improvement of moderate to severe BPH, reduction of the risk of acute urinary retention, and reduction of the probability that BPH patients need to undergo transurethral resection of the prostate or prostatectomy. It is suitable for long-term use in BPH patients over 50 years old with a prostate volume of more than 30ml. Some clinical studies have also explored its application potential in the treatment of androgenetic alopecia.

The global dutasteride market size reached USD 1.28 billion in 2023, and the compound annual growth rate from 2024 to 2030 is expected to be 3.2%. The growth momentum mainly comes from the increase in the proportion of the global elderly population and the expansion of clinical demand for the androgenetic alopecia indication. In terms of the domestic market, with the implementation of the seventh batch of nationally organized drug centralized procurement in 2023, the average winning bid price of dutasteride soft capsules decreased by 78% compared with that before the centralized procurement, with an obvious volume release effect. The sales volume of domestic sample hospitals in 2023 increased by 117% year on year. At present, the domestic preparation market is mainly dominated by the original research drug and 3 domestic generic drug enterprises, and the supply gap of active pharmaceutical ingredients is gradually being released.

The original research enterprise of dutasteride is GlaxoSmithKline, with the original research brand name Avodart®. Its compound patent in China expired in October 2022, and the core patent in the US market expired in 2021. The main dosage form approved for the original research drug is soft capsule with a specification of 0.5mg. This dosage form has been included in the Reference Listed Drug Catalog of China Listed Medicines and also included in the FDA Reference Preparation Catalog. Up to now, there are 12 dutasteride API registration records on the API registration platform of China CDE, among which 7 are in status A (activated). A total of 4 enterprises in China, including the original research enterprise, have obtained marketing approval for dutasteride soft capsules. (Data as of April 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for dutasteride. All products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most impurities have sufficient spot inventory. Spot orders placed before 16:00 can be delivered on the same day, fully meeting the demand for impurity reference standards in the whole process of drug R&D, quality research and production.