GenSci144, a Novel SLC6A19 Inhibitor, Receives IND Approval from NMPA

Recently, GenSci144 tablets received IND approval from the National Medical Products Administration (NMPA) for the treatment of chronic kidney disease (CKD), following its previous trials for phenylketonuria(PKU).

As an oral small-molecule inhibitor targeting the neutral amino acid transporter SLC6A19, GenSci144 is designed to inhibit the re-absorption of neutral amino acids in both renal tubules and the intestine. Therefore, it has the potential to alleviate the metabolic burden on the kidneys, ameliorate intrarenal metabolic disorders, and mitigate renal inflammation and fibrosis, thereby slowing kidney function decline. It is potentially beneficial to patients across all types of CKD if the primary endpoint is achieved in clinical trials.

CKD is defined by persistent abnormalities of kidney structure or function resulting from various underlying causes. Globally, the prevalence of CKD is estimated to be approximately 674 million cases, accounting for 8.0% of the global population[1]. In China, the prevalence of CKD among adults is approximately 8.16%, affecting nearly 156 million patients[2]. CKD is frequently associated with comorbidities such as type 2 diabetes and cardiovascular disease, with complex underlying mechanisms that often require combination treatment approaches.

The existing therapies are still limited by safety concerns and patients may discontinue treatment due to intolerable adverse reactions. These challenges underscore a significant unmet medical need for innovative therapies with novel mechanisms of action.

The approval of GenSci144 for clinical trials in CKD marks an important milestone in GenSci’s kidney disease portfolio development. GenSci will continue to advance the development of its innovative pipeline and deliver more treatment options for patients with kidney diseases.

Disclosure Notice

1. Innovative drug development entails high risks, and the outcome of clinical trials remains uncertain.

2. This press release is provided as a medical information source for healthcare experts only and is not used for commercial purposes.

3. GenSci does not recommend the use of any unapproved drugs or indications.