Lasofoxifene

Postmenopausal osteoporosis is one of the core causes of the increased fracture risk in middle-aged and elderly women. Long-term application of traditional estrogen replacement therapy carries the risk of reproductive system tumors, so there is always an urgent clinical need for safer selective estrogen receptor modulators. Lasofoxifene is a third-generation selective estrogen receptor modulator, which can bind to estrogen receptors with high affinity, exert estrogen-like effects in bone tissue to inhibit osteoclast activity and increase bone density, while exhibiting estrogen antagonistic effects in breast and endometrial tissues, greatly reducing the safety risks of traditional therapies. It is clinically mainly used for the prevention and treatment of osteoporosis in postmenopausal women, which can simultaneously reduce the risk of vertebral, non-vertebral and hip fractures, and can also be used to improve moderate to severe vasomotor symptoms after menopause. The applicable population covers postmenopausal women aged 50 and above with reduced bone mass or diagnosed osteoporosis.

The current global market size of lasofoxifene is approximately USD 320 million. Benefiting from the expansion of the global postmenopausal women population base and the improvement of osteoporosis screening rate, the compound annual growth rate is expected to remain at 4.7% by 2028. The domestic market is still in the introduction stage. The original research product has not yet entered China, and a number of pharmaceutical companies have deployed generic drug research and development, with no centralized procurement related records yet. If subsequent products are approved for marketing, it is expected to fill the existing gap in clinical demand relying on better clinical cost performance. If there is no verifiable market segment data, it will be updated in time later.

The original research enterprise of lasofoxifene is Pfizer, with the original research trade name Osphena. Its core compound patent in the United States expired in 2021, and the European compound patent will expire in 2027. The main dosage form approved for the original research is oral tablet, with the specification including 0.5mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the Chinese Catalog of Chemical Medicines. Up to now, there is no A-status registration number of lasofoxifene API in China, and no related preparation products have been approved for marketing. (Data as of July 2025, please refer to the official website of CDE for the latest information)

In response to the needs of generic drug research and development and quality control of lasofoxifene, CATO can provide a full set of impurity reference standards for this API. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can be directly used for impurity qualitative and quantitative research as well as stability investigation, helping enterprises accelerate the research and development and registration process.