Trifarotene

Acne is one of the most prevalent chronic inflammatory diseases in dermatology, with a global prevalence rate of over 9%. Severe patients often face long-term burdens such as scar formation and psychosocial impacts. Trifarotene is a fourth-generation retinoic acid receptor agonist, which can bind to retinoic acid γ receptors in the skin with high selectivity. It exerts its effects through multiple mechanisms: regulating keratinocyte differentiation, inhibiting excessive sebum secretion, and reducing inflammation of the pilosebaceous unit. Currently, it is clinically mainly used for the treatment of acne vulgaris in people aged 9 years and above. Compared with previous generations of retinoic acid drugs, its improved receptor selectivity brings a lower risk of skin irritation, which significantly improves patients' medication compliance.

The current global market size of topical acne treatments exceeds 6 billion US dollars, with retinoic acid drugs accounting for nearly 35%. As a representative new-generation product, trifarotene's global sales exceeded 420 million US dollars in 2023, with a compound annual growth rate of 28% in the past three years. In China's topical acne drug market, the penetration rate of new-generation highly selective retinoic acids is still less than 8%. With the increase in patients' demand for low-side-effect treatment regimens, the market growth rate of trifarotene is expected to remain above 30%. At present, only one originator formulation has been approved for marketing in China, and the development of generic drugs is still in the early stage, with a significant supply gap of active pharmaceutical ingredients (APIs).

The originator enterprise of trifarotene is Galderma (France), and the original brand name is "Aklief". The core compound patent of the originator expires in 2028 in the United States and in 2029 in China. The main dosage form approved for the originator product is topical cream with a specification of 0.005% (w/w). This preparation has been included in the FDA Reference Listed Drug Catalog, and is also included in the China Listed Drug Catalog as a reference preparation. As of now, there is no approved or under review registration number related to trifarotene on the API registration platform of China's Center for Drug Evaluation (CDE). Only the originator's 0.005% trifarotene cream has been approved for marketing in China, and no generic preparation has been approved yet. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of trifarotene impurity reference standards, covering all research needs such as process impurities and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully support various work links in the process of generic drug development, including impurity research and quality standard establishment.