Baclofen

Central muscle spasm is a common disabling symptom in patients with multiple sclerosis, spinal cord injury, cerebrovascular accident and other diseases, which seriously affects motor function and quality of life. For a long time, there has been a lack of intervention regimens with both high potency and high tolerability in clinical practice. Baclofen, as a γ-aminobutyric acid (GABA_B) receptor agonist, can inhibit the release of excitatory neurotransmitters in the spinal cord and reduce the conduction excitability of monosynaptic and polysynaptic reflexes, thereby relieving the spastic state of skeletal muscle. Meanwhile, it has a certain central analgesic effect. It is currently the first-line drug for spasm management in adult and pediatric patients, and can also be used for the symptomatic treatment of some intractable hiccups.

At present, the global baclofen market size is about USD 230 million, with an annual compound growth rate maintained at around 4.2%. The growth momentum mainly comes from the rising prevalence of nervous system diseases and the expansion of demand for postoperative rehabilitation of spinal cord injury. The Chinese market accounts for about 17% of the global market. Affected by medical insurance coverage and the promotion of hierarchical diagnosis and treatment, the growth rate of the domestic market has reached 7.8% in the past three years, which is higher than the global average. The competitive landscape is dominated by generic drugs, with the original research product accounting for less than 30% of the market. The domestic API supply is mainly concentrated in compliant pharmaceutical enterprises in North China and East China, and there is no relevant record of national centralized procurement yet.

The original research enterprise of baclofen is Novartis, and the original brand name is Lioresal. Its core compound patent expired globally in 2003. At present, the approved mainstream dosage forms include 10mg tablets, 20mg tablets and intrathecal injection. The original research preparation has been included in the FDA Reference Listed Drug Catalog and the Chinese *Catalog of Reference Preparations for Chemical Drugs*. In China, 3 enterprises have obtained A status for their baclofen APIs through CDE registration, and another 11 domestic baclofen oral preparations have been approved for marketing, all of which select the original Lioresal as the reference preparation. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for baclofen API, and most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, which can fully meet the reference substance needs in the whole process of API R&D, quality research and registration declaration.