Chiesi Group has dropped its late-stage clinical programme for its chronic obstructive pulmonary disease (COPD) and asthma candidate, tanimilast.
This comes after the Phase III PILASTER study (NCT04636801), in which the inhaled phosphodiesterase-4 (PDE4) inhibitor failed to reduce the number of moderate-to-severe COPD flareups during the 52-week treatment window.
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Tanimilast also fell short at its secondary endpoints, triggering no significant impact on a patient’s time to first moderate or severe exacerbation, as well as no notable reduction in the annual rate of severe exacerbations experienced.
In a 3 November statement, the Italian pharmaceutical company noted that while the outcome of the Phase III PILASTER trial was “disappointing”, it reflects the complexities of respiratory disease and the associated challenges of developing COPD drugs.
This will be a blow to Chiesi’s respiratory portfolio, which currently comprises two combination COPD and asthma treatments, BDP, FF and GB [beclomethasone dipropionate / formoterol fumarate / glycopyrronium bromide], and BDP and FF alone. Both these formulations are currently only approved for use in the EU.
However, the company is also exploring the efficacy and safety of both BDP/FF/GB and BDP/FF alone in two global Phase III studies, which could see the combinations gain approval across the US and other key global markets.
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By GlobalDataCOPD market heats up
While the COPD indication has traditionally been a tough nut to crack, a range of targeted therapies have recently become available to patients.
This includes Sanofi’s blockbuster seller, Dupixent (dupilumab), which became the first-ever biologic to get the US Food and Drug Administration (FDA) green light in COPD in 2024.
Since its approval, analysts at GlobalData forecast that Dupixent’s sales will go from strength to strength, as it is estimated to rake in $6.57bn for Sanofi and Regeneron in COPD alone during 2033. This is a 600% increase from the $928m the drug is forecast to generate in COPD in 2025.
GlobalData is the parent company of Clinical Trials Arena.
At the time of Dupixent’s FDA approval in COPD, key opinion leaders (KOLs) interviewed by GlobalData analysts also had high hopes for the drug, with the general consensus being that it could dominate the COPD market moving forward.
However, Asiyah Nawab, healthcare analyst at GlobalData, noted that GSK’s top-selling asthma drug, Nucala (mepolizumab) could offer Dupixent some healthy competition. The therapy, which has been available to severe asthma patients since its FDA approval in 2015, also got the FDA green light for COPD in May 2025.
When speaking with key opinion leaders (KOLs), Nawab said that they “indicated confidence” in the drug’s potential in severe asthma, which signifies “a level of trust” with the therapy, which will likely translate through to other indications.
A patient-based forecast from GlobalData for Nucala’s performance in the COPD market predicts that Nucala will bring in $3.45bn in 2033.
