Abiogenesis Clinpharm To Conduct Phase III Trial of UTI Drug Phenazopyridine
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to Abiogenesis Clinpharm for conducting the phase III clinical study of Phenazopyridine Hydrochloride 200 mg Tablet.
However, this came with the condition that the firm shall submit the study's Case Report Form (CRF), which includes specific adverse drug reactions during treatment and immediate follow-up of study patients, in addition to any other (new) adverse drug reactions (ADRs).
This took place as the firm presented phase III clinical study Protocol No.: PHN-301-25 Version No. 1.0 dated 06-JUN-2025.
Phenazopyridine, also known as Pyridium, is a urinary tract analgesic used for the short-term management of urinary tract irritation and its associated unpleasant symptoms, such as burning and pain during urination.
Side effects of phenazopyridine hydrochloride administration can include nausea, interference with the oxygen-carrying capacity of red blood cells (methemoglobinemia), hemolytic anemia as well as renal and hepatic toxicity.
At the recent SEC meeting for analgesic and rheumatology held on 16th July 2025, the expert panel reviewed the phase III clinical study Protocol No.: PHN-301-25 Version No. 1.0 dated 06-JUN-2025 presented by the drug maker Abiogenesis Clinpharm.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm, with the condition that the firm shall submit the study CRF that should also include specific adverse drug reactions during treatment and immediate follow-up of study patients, in addition to any other (new) ADRs.
Additionally, it stated that it should incorporate known adverse events that were mentioned in their innovator molecule's summary basis approval and product information leaflet.
