Abbott Denied Nod for UDCA Dengue Trial as CDSCO Panel Flags Clinical, Scientific Gaps
New Delhi: Raising key scientific and clinical concerns, the Subject Experts Committee (SEC) has declined to recommend the Phase III clinical trial proposal submitted by Abbott India Limited for Ursodeoxycholic Acid Tablets I.P 450 mg and 600 mg, filed under SND/MA/25/000108.
The review was conducted during the committee meeting held on 08.10.2025, where the firm presented its revised trial protocol and supporting data.
In light of the earlier SEC recommendation dated 24.07.2025, the firm presented a revised protocol for the Phase III clinical trial along with a proof of concept (Published retrospective observational study) in support of the new indication applied for.
Abbott India Limited, a major pharmaceutical company known for its gastroenterology and hepatology portfolio, sought approval to evaluate ursodeoxycholic acid for a new use related to liver injury associated with dengue virus infection.
Ursodeoxycholic acid (UDCA), widely used for treating cholestatic liver diseases, gallstone dissolution and certain hepatobiliary disorders, was proposed to be repurposed for managing liver enzyme elevation noted in dengue-affected patients.
After detailed deliberation, the committee opined that:
1. The proposed effect size for the primary endpoint, defined as a difference of 25 IU/L in mean ALT levels between the treated and placebo groups, is not clinically relevant. This concern was amplified by the very broad ALT range at enrolment (~120 to 1000 IU/L), which, according to the committee, would make the proposed difference insufficiently meaningful from a clinical standpoint.
2. The rationale for treating liver injury observed in dengue virus infection was deemed unclear. The committee observed that the elevation of liver enzymes in dengue patients—particularly in the absence of any clinical symptoms or bilirubin increase—is well recognized to improve spontaneously within a short period. Further, the firm did not provide any mechanistic or clinical justification for why ursodeoxycholic acid would be expected to ameliorate such transient enzyme elevations in dengue cases.
Given these reasons, the committee did not recommend the proposed Phase III clinical study. Instead, it advised the firm to first conduct a proof-of-concept study specifically in the indication applied for, to generate robust preliminary evidence before seeking further clinical trial approval.
