CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Malik Lifesciences Pvt Ltd to submit a revised Phase III clinical trial protocol for its proposed Fixed Dose Combination (FDC) of Tamsulosin Hydrochloride IP 0.4 mg/0.4 mg (ER tablet), Dutasteride IP 0.5 mg/0.5 mg (film coated tablet), and Tadalafil IP 2.5 mg/5 mg (film coated hard gelatin capsule), intended for the management of Benign Prostatic Hyperplasia (BPH).
The matter was presented before the SEC at its meeting on 18 September 2025, in continuation of earlier recommendations dated 29 November 2023, 30 November 2023, and 21 August 2025. The firm submitted the bioequivalence (BE) study report along with the Phase III clinical trial protocol for review.
After detailed deliberation, the committee considered the BE study report and found it satisfactory. However, with regard to the Phase III protocol, the SEC noted specific requirements that must be incorporated into the revised design. These include:
Maximum urinary flow (Qmax) should range between 5 to 15 ml/sec with a minimum voided urine volume of more than 150 ml at screening.
Total serum prostate specific antigen (PSA) must be ≤6 ng/mL, and the prostate volume should be greater than 30 g.
All clinical trial investigators should be MCh-qualified Urologists to ensure appropriate expertise and specialized oversight during the study.
Based on these observations, the SEC recommended that Malik Lifesciences must submit the revised Phase III clinical trial protocol to CDSCO for further review and approval. Only after obtaining clearance from CDSCO can the firm initiate the trial. Furthermore, the committee directed that the Phase III clinical trial report must be submitted back to the SEC upon completion for its review.
The triple combination brings together Tamsulosin (an α1-blocker improving urinary flow), Dutasteride (a 5α-reductase inhibitor reducing prostate volume), and Tadalafil (a phosphodiesterase-5 inhibitor easing smooth muscle relaxation). The FDC is expected to provide a multi-mechanistic therapeutic approach to managing lower urinary tract symptoms (LUTS) in BPH patients.
