The program has successfully completed Phase II clinical trials in virus-induced lung disease in India, with Phase III clinical studies submitted to the Drug Controller General of India (DCGI) and currently under regulatory review.
Building on this clinical foundation, RespiRAX Pharma is planning a US-aligned clinical bridging study in COPD and Lung Fibrosis caused by bacterial and fungal infections, to be conducted through a US FDA–approved Clinical Research Organization (CRO) in India, supporting future US market development.
The lead candidate has successfully completed Phase II clinical trials in India in patients with virus-induced lung disease. The study demonstrated a favourable safety profile and clinically meaningful signals of efficacy, forming a strong foundation for late-stage development and regulatory engagement.
Based on Phase II outcomes, the Phase III clinical trial protocol has been formally submitted to the Drug Controller General of India (DCGI) and is currently under regulatory review. Phase III development represents a key value inflection point for the program.
Successfully completed in India, demonstrating favourable safety and efficacy signals in patients with virus-induced lung disease. This milestone establishes the clinical foundation for further development.
Protocol formally submitted to the Drug Controller General of India (DCGI) and currently under regulatory review, marking a critical advancement toward late-stage clinical development.
Completed in India for virus-induced lung disease with favourable safety profile and efficacy signals.
Protocol submitted to DCGI and under regulatory review, representing key value inflection point.
Planning clinical bridging study in lung fibrosis (bacterial & fungal infections) through US FDA-approved CRO.
Strategic pathway supporting future US market development and global commercialization.
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