Tianeptine

The global prevalence of depression has exceeded 3.8%. Most existing antidepressants focus on the 5-hydroxytryptamine reuptake inhibition mechanism, and some patients suffer from insufficient response and obvious adverse reactions. As an antidepressant of the 5-hydroxytryptamine reuptake enhancer class, tianeptine regulates neurotransmitter balance by promoting the reuptake of 5-hydroxytryptamine in the synaptic cleft, and at the same time can repair hippocampal neuron damage and improve stress-related abnormal neuroplasticity. It is clinically applicable to all types of depression in adults, especially depressed patients with anxiety symptoms and somatic discomfort. It can effectively relieve core symptoms such as low mood and anhedonia, and the incidence of adverse reactions such as sexual dysfunction and weight gain is lower than that of traditional SSRI drugs, providing a differentiated treatment option for clinical practice.

The current global market size of tianeptine is approximately USD 1.2 billion. Driven by the rising prevalence of depression and the growing clinical demand for differentiated antidepressants, the compound annual growth rate remains around 4.2%. In terms of the domestic market, the drug has not been included in the national centralized procurement at present, and the original research product still occupies the main market share. With the improvement of clinical accessibility of psychotropic drugs, the market coverage is expected to be further expanded after the launch of generic drugs in the future. Relevant patents have expired in many countries, and many domestic enterprises have laid out the generic drug R&D of this variety, and the demand for API supply has continued to rise accordingly.

The original research enterprise of tianeptine is Servier of France, with the trade name Stablon, and the core compound patent expired globally in 2003. The main dosage form approved for the original research product is tablet, with a specification of 12.5mg. It has been included in the Reference Preparation List of the China Listed Drug Catalogue, and is also included in the FDA Reference Preparation List. As of the search time point, tianeptine APIs from multiple enterprises have obtained Class A registration on the domestic CDE API Registration Platform, and the approved preparation varieties are mainly tianeptine sodium tablets, which can meet the raw material supply demand for domestic generic drug production. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for tianeptine API. Most products are in stock, and in-stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the R&D and quality control links of APIs and preparations.