Current Clinical Trials

We are running a phase 2b clinical trial for Idiopathic Pulmonary Fibrosis (IPF) patients with chronic cough called CORAL (COugh Reduction in IPF with nALbuphine ER ). The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm study evaluating three doses of Haduvio (27mg, 54mg and 108mg twice daily) in IPF patients with chronic cough. 

Approximately 160 IPF patients with chronic cough are expected to be randomized 1:1:1:1 to one of three Haduvio doses or placebo for a period of 6-weeks, which includes a 2-week titration period followed by 4-weeks of fixed dose.

Primary Efficacy Endpoint:

Relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured via an objective cough monitor. 

Expected Timing:

• Topline data 2Q 2025

December 2024 – Positive sample size re-estimation outcome resulted in no change to the existing N=160.

Future Clinical Trials