Chiesi Ends Tanimilast COPD Programme After Phase III Failure

Chiesi Group has discontinued development of its chronic obstructive pulmonary disease (COPD) and asthma candidate, tanimilast, after the Phase III PILASTER trial (NCT04636801) failed to meet its primary endpoint. The inhaled phosphodiesterase-4 (PDE4) inhibitor did not significantly reduce moderate-to-severe COPD exacerbations over 52 weeks, nor did it show improvement in secondary measures such as time to first exacerbation or annual exacerbation rate. Chiesi described the outcome as disappointing but reflective of the complexity of COPD drug development.

The decision is a setback for Chiesi’s respiratory portfolio, which currently includes two EU-approved combination therapies—BDP/FF/GB and BDP/FF—and ongoing global Phase III studies to expand approvals. The COPD market, meanwhile, is seeing renewed interest with emerging biologics like Sanofi and Regeneron’s Dupixent and GSK’s Nucala, both recently FDA-approved for COPD. Analysts predict strong long-term sales for these agents, reshaping the competitive landscape that Chiesi had aimed to join with tanimilast.

11-11-2025