AP303 has shown promise in improving renal survival in an ADPKD mice model. Credit: mi_viri/Shutterstock.com.

Alebund Pharmaceuticals has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its investigational drug AP303.

This designation is intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

AP303 is an internally developed drug candidate that has shown promise in improving renal survival in an ADPKD mice model.

The drug has successfully completed a first-in-human study in healthy subjects in Australia and is poised to enter Phase II trials.

ADPKD has a prevalence of between one in 400 and one in 1,000 live births and is a significant cause of end-stage kidney disease (ESKD), which often necessitates renal replacement therapy.

See Also:

Alebund co-founder, chairman, and CEO Dr Gavin Xia said: “We are very excited that AP303 has been granted orphan drug designation by the FDA.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“It is an important milestone for Alebund as well as our efforts to address the significant unmet medical needs with ADPKD. We look forward to advancing AP303 to improve future treatment options for patients in need.”

The FDA’s ODD supports the development of drugs for rare diseases or disorders that affect fewer than 200,000 US people.

This status comes with several benefits, including marketing exclusivity upon approval, tax credits for clinical testing, and exemption from certain FDA fees, which can accelerate the drug’s development and review process.

Biopharmaceutical company, Alebund is engaged in the discovery and development of new therapies primarily for kidney diseases and their complications, as well as other chronic conditions.