伐度司他国内上市了吗

Valostat is an oral HIF-PH inhibitor mainly used to treat anemia caused by dialysis-dependent chronic kidney disease (CKD). The drug is produced by the German company MEDICE and has been approved for marketing in Japan and the United States, but it has not yet been launched in China as of August 2025. This article will analyze its domestic marketing status, drug preparation and contraindications from three aspects to help understand the current status and usage details of this innovative drug.

Is vadostat available on the domestic market?

As a new anemia treatment drug, its domestic launch progress has attracted much attention.

Current listing status

As of August 2025, vadostat has not yet been approved for marketing in mainland China. The drug is produced by the German company MEDICE and has a specification of 300mg*98 tablets/box. Domestic patients currently cannot purchase it through formal channels.

International Approval Status

Valostat was approved in Japan in July 2020, and was approved by the US FDA in May 2023, and was launched in the United States in the third quarter of the same year. Its indication is the treatment of anemia in dialysis-dependent CKD patients.

Future Outlook

As China attaches great importance to the treatment of chronic kidney disease, vadostat may accelerate its entry into the Chinese market through the priority review channel, but the specific time still needs to wait for further official news.

The application of vadostat in China still needs to wait, and patients need to choose existing treatment options based on doctor’s recommendations.

Preparation for the use of vardostat

The use of vadostat requires strict assessment of the patient's condition and the development of an individualized plan.

Pre-treatment evaluation

Other causes of anemia, such as vitamin deficiency or chronic inflammation, need to be ruled out before starting treatment. At the same time, the iron status needs to be evaluated. If the serum ferritin is lower than 100mcg/L or the transferrin saturation is lower than 20%, iron supplements need to be supplemented first.

Liver function monitoring

Monthly monitoring of ALT, AST and bilirubin levels is required at baseline and in the first 6 months after treatment, and subsequent regular examinations based on clinical needs to avoid potential risks of hepatotoxicity.

Method of administration

Valadostat should be swallowed whole and should not be cut or chewed. If you miss a dose, you do not need to take it again. You can continue taking the medicine at the original time the next day. When combined with iron-containing medicines, the dose should be taken 1 hour apart.

Standard medication preparation is the basis for ensuring treatment effect, and patients must strictly follow the doctor's instructions.

Contraindications of Valostat

Valostat may bring serious risks in some cases, and the following groups of people need special attention.

Non-dialysis patients

Valadostat is only suitable for dialysis patients. Use in non-dialysis patients may increase the risk of death, stroke and acute kidney injury, and is an absolute contraindication.

Patients with severe liver disease

Valostat is contraindicated in patients with cirrhosis or acute liver disease. Although patients with Child-Pugh class B do not need to adjust the dose, their liver function needs to be closely monitored.

Patients with recent cardiovascular events

Patients who have had myocardial infarction, cerebrovascular events or acute coronary syndrome within 3 months should avoid use, as the drug may increase the risk of thrombosis.

Understanding the contraindications can help avoid potential risks. Patients must fully communicate with their doctors about their conditions before taking medication.