What is the New Pill for COPD? Exploring Recent Advancements

October 5, 2025 •

3 min read

In 2024 and 2025, two significant new medications were approved by the FDA for chronic obstructive pulmonary disease (COPD), representing the first novel treatments in over a decade. However, to answer the question, "What is the new pill for COPD?", it's important to clarify that these major advances are actually an injectable biologic and a nebulized therapy, rather than traditional oral pills.

Quick Summary

Several groundbreaking treatments for COPD have recently received FDA approval, including Dupixent, an injectable biologic, and Ohtuvayre, a nebulized therapy, which target specific inflammatory pathways to reduce flare-ups.

Key Points

New treatments are not pills: Recent breakthroughs are injectable (Dupixent) and nebulized (Ohtuvayre) therapies, not oral pills, despite headlines.
Dupixent is a biologic: Approved in September 2024, Dupixent (dupilumab) is an injectable biologic for adults with inadequately controlled COPD and an eosinophilic phenotype.
Ohtuvayre is a nebulized therapy: Approved in June 2024, Ohtuvayre (ensifentrine) is a nebulized drug with dual bronchodilator and anti-inflammatory properties, a first of its kind.
Targeted treatment is key: New therapies focus on specific inflammatory pathways, offering more personalized medicine for patients who have not responded sufficiently to traditional inhalers.
Older oral options exist: While not new, some oral medications like roflumilast and azithromycin are sometimes used, but often have tolerability issues that limit widespread use.
Look beyond the pill: Advances in COPD treatment extend beyond pills, with significant progress seen in biologics, nebulizers, and even medical devices like endobronchial valves.

Major Breakthroughs Are Not Pills

While recent advancements have generated excitement about new COPD treatments, these major developments are not oral pills. Instead, they represent novel therapies, such as biologic agents and nebulized treatments, that address the disease differently from traditional inhalers and older oral medications.

The New Biologic: Dupixent (dupilumab)

Approved by the FDA in September 2024, Dupixent is an injectable biologic used as an add-on maintenance treatment for certain adults with inadequately controlled COPD. Administered every two weeks via subcutaneous injection, Dupixent is a monoclonal antibody that targets specific inflammatory proteins.

How Dupixent Works

Dupixent is indicated for patients with an "eosinophilic phenotype," a type of inflammation driven by interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. By blocking the signaling of these proteins, Dupixent can improve lung function and reduce COPD exacerbations. Clinical trials demonstrated a significant reduction in moderate or severe exacerbations and improvements in FEV1 and quality of life.

The New Nebulized Treatment: Ohtuvayre (ensifentrine)

Ohtuvayre, a nebulized inhaled therapy, received FDA approval in June 2024, marking the first novel inhaled maintenance treatment for COPD in over two decades.

The Dual-Action Mechanism of Ohtuvayre

Ohtuvayre acts as a selective dual inhibitor of PDE3 and PDE4 enzymes, providing both bronchodilator and non-steroidal anti-inflammatory effects. This helps to open airways and reduce inflammation, decreasing exacerbations without the pneumonia risk associated with inhaled corticosteroids.

Comparing Recent COPD Medications


Feature	Ohtuvayre (ensifentrine)	Dupixent (dupilumab)	Older Oral Treatments (e.g., Roflumilast)
Administration	Nebulized inhalation, typically twice daily.	Subcutaneous injection every two weeks.	Oral pill, typically once daily.
Mechanism	Dual PDE3/PDE4 inhibitor, acting as a bronchodilator and non-steroidal anti-inflammatory.	Monoclonal antibody that blocks IL-4 and IL-13, targeting type 2 inflammation.	PDE4 inhibitor, primarily acting as an anti-inflammatory.
Patient Profile	Approved for adults with moderate to severe COPD.	For adults with inadequately controlled COPD and an eosinophilic phenotype (high eosinophil levels).	For patients with severe COPD, chronic bronchitis, and a history of exacerbations.
Exacerbation Reduction	Reduced exacerbations by up to 43% in clinical trials.	Reduced exacerbations by up to 34% in clinical trials.	Can reduce exacerbations, but systemic side effects often limit its use.
Side Effects	Found to have a favorable safety profile, comparable to placebo in trials.	Common side effects include injection site reactions and viral infections.	Gastrointestinal issues and weight loss are common, limiting its widespread use.

The Importance of Personalized Treatment

The availability of Dupixent and Ohtuvayre represents a move towards personalized COPD treatment, allowing therapies to be tailored to a patient's specific inflammatory profile. This precision medicine approach is particularly beneficial for patients with uncontrolled disease despite standard care, offering improved outcomes and better management of flare-ups.

Other Notable Advancements

Beyond these two major approvals, the COPD treatment landscape includes other potential therapies in development, such as additional biologics and procedural interventions like endobronchial valves. These developments, though not pills, expand the range of options available for managing COPD.

Conclusion

Although there isn't a new oral pill for COPD, the recent FDA approvals of Dupixent and Ohtuvayre mark significant progress in treating the disease. These injectable and nebulized therapies offer new mechanisms to target inflammation and improve lung function, providing valuable options for patients, particularly those with specific inflammatory subtypes or those not adequately controlled by existing treatments. These advancements highlight a promising future for more individualized and effective COPD management.

Frequently Asked Questions

No, there is no new oral pill for COPD that has been recently approved. The most significant new treatments, Dupixent and Ohtuvayre, are administered as an injection and a nebulized inhalation, respectively.

Dupixent (dupilumab) is an injectable biologic medication approved in September 2024 for adults with inadequately controlled COPD and an eosinophilic phenotype. It works by blocking inflammatory proteins to reduce flare-ups and improve lung function.

Dupixent is for adult patients with moderate-to-severe COPD whose disease is not well-controlled with existing inhalers, and who have a specific type of inflammation indicated by high levels of eosinophils in their blood.

Ohtuvayre (ensifentrine) is a nebulized inhaled therapy approved in June 2024. It is the first maintenance treatment for COPD in over a decade with a new mechanism of action, acting as both a bronchodilator and a non-steroidal anti-inflammatory agent.

Unlike traditional inhalers, Ohtuvayre has a dual mechanism of action, inhibiting both PDE3 and PDE4 enzymes. This allows it to simultaneously widen airways and reduce inflammation without the risks associated with inhaled corticosteroids.

Yes, older oral medications like roflumilast (Daliresp) are still used for specific patient populations, particularly those with chronic bronchitis and a history of exacerbations. However, side effects often limit their use compared to newer, more targeted therapies.

Eosinophilic COPD is a subtype of the disease characterized by higher levels of a specific white blood cell, the eosinophil, which drives a type of airway inflammation. Patients with this phenotype may respond particularly well to targeted therapies like Dupixent.