What is the new medication for PE? An overview of recent advances in pulmonary embolism treatment

October 11, 2025 •

4 min read

According to the CDC, pulmonary embolism (PE) affects up to 900,000 Americans each year, with approximately one-third of these events resulting in death. While well-established treatments exist, recent innovations are pushing boundaries for safer and more effective care, which begs the question: What is the new medication for PE?

Quick Summary

Recent advances in pulmonary embolism (PE) treatment include new drug classes like Factor XIa inhibitors in clinical trials and device-drug combinations for thrombectomy, alongside generic versions of established anticoagulants, all aiming for improved efficacy and reduced bleeding risk.

Key Points

Factor XIa Inhibitors: A promising new class of anticoagulants, currently in clinical trials, that may offer a lower bleeding risk compared to existing options by targeting only the pathological clotting process.
Device-Drug Combinations: New FDA-cleared systems like Imperative Care's Symphony Thrombectomy and Boston Scientific's EKOS combine mechanical clot removal with targeted drug delivery, offering rapid relief for high-risk PE patients.
Generic Rivaroxaban: The recent FDA approval of generic versions of the DOAC rivaroxaban improves patient access and affordability for a well-established PE treatment.
Improved Safety Profiles: The central goal of many new PE treatment strategies is to reduce the risk of major bleeding associated with potent anticoagulants and thrombolytics.
Patient Risk Stratification: Recent guidelines and technological advances are enabling more precise risk assessment, allowing for individualized treatment plans, from standard anticoagulation to interventional therapies.
Pipeline Innovations: Beyond FXIa inhibitors, the PE treatment pipeline includes various novel anticoagulants, device enhancements, and even RNA-based therapies under development.

Understanding the Landscape of Pulmonary Embolism Treatment

Pulmonary embolism (PE) is a life-threatening condition caused by blood clots, most often originating in the deep veins of the legs, that travel to and block arteries in the lungs. The standard of care has long involved anticoagulants, or blood thinners, to prevent further clot formation, and in severe cases, thrombolytics or “clot-busting” drugs to dissolve existing clots. However, these treatments are associated with a significant risk of bleeding. The search for safer and more effective therapies is driving innovation in several key areas of medicine.

The Rise of Factor XIa Inhibitors

One of the most promising new frontiers in anticoagulant pharmacology is the development of Factor XIa (FXIa) inhibitors. Unlike traditional anticoagulants that target key factors involved in both blood clotting and the body's essential wound-healing process (hemostasis), FXIa inhibitors are designed to specifically target the coagulation pathway primarily responsible for pathologic clot formation, leaving hemostasis largely intact. This targeted approach aims to reduce the risk of thromboembolic events with a lower risk of bleeding complications.

Targeted Action: Factor XIa plays a larger role in clot formation under pathological conditions, suggesting that its inhibition can prevent harmful clots without disrupting normal bleeding control.
Clinical Trials: Numerous FXIa inhibitors, such as asundexian, are currently in Phase 3 clinical trials for various thrombotic disorders, including venous thromboembolism (VTE), which encompasses PE.
High Hopes: Clinical trials have shown promising data for efficacy while demonstrating a significantly lower bleeding risk compared to existing treatments.

Advancements in Anticoagulants and Device-Drug Combinations

Beyond entirely new drug classes, advancements are also occurring with existing medication categories and novel delivery systems. The market has seen generic versions of existing anticoagulants introduced, increasing access and affordability. Concurrently, interventional technologies are being refined to combine drug delivery with mechanical clot removal.

Generic Anticoagulants

In March 2025, the FDA approved the first generic versions of rivaroxaban (Xarelto) 2.5 mg tablets. While not a new chemical entity, the availability of generic direct oral anticoagulants (DOACs) is a significant development for patient access and cost reduction. Rivaroxaban is widely used to treat and prevent PE.

Device-Drug Innovations

For patients with higher-risk PE, traditional systemic thrombolysis carries a high bleeding risk. Newer catheter-based therapies (CBTs) combine mechanical clot removal with lower-dose, targeted drug delivery.

The EKOS System: Uses ultrasonic waves to help break up the clot, allowing for better penetration of clot-dissolving drugs. Clinical trials have shown it can improve right ventricular function and reduce clot burden with a lower risk of bleeding compared to systemic thrombolysis.
The Symphony Thrombectomy System: In September 2025, Imperative Care announced FDA clearance for its Symphony Thrombectomy System to treat PE. This device combines large-bore power with precise vacuum control for efficient mechanical clot removal. It represents a new option for physicians to remove clots quickly and effectively, with supportive data from the SYMPHONY-PE study.

Comparison of PE Treatments: Established vs. Emerging Therapies


Feature	Standard Anticoagulation (e.g., Warfarin, DOACs like Eliquis/Xarelto)	Factor XIa (FXIa) Inhibitors (e.g., Asundexian, in trials)	Catheter-Based Therapies (e.g., EKOS, Symphony)
Primary Mechanism	Inhibits key factors in the clotting cascade to prevent new clot formation.	Selectively inhibits Factor XIa to disrupt pathological clot formation while preserving hemostasis.	Mechanical removal of clot, often combined with targeted, low-dose thrombolytic drugs.
Patient Profile	Most PE patients, especially those with stable hemodynamics.	Future standard for many PE patients if trials confirm lower bleeding risk across various patient groups.	Intermediate- to high-risk PE patients with evidence of right ventricular strain or hemodynamic instability.
Bleeding Risk	Present and well-documented, especially with warfarin.	Potentially lower risk of bleeding compared to existing anticoagulants, based on phase 2 trials.	Risk of bleeding exists but is often localized and may be lower than with systemic thrombolysis.
Speed of Action	Days for warfarin to take full effect; rapid for DOACs.	Rapid action, similar to DOACs.	Rapid, immediate clot reduction with mechanical devices.
Application	Oral administration (DOACs, warfarin) after initial parenteral therapy.	Oral administration.	Interventional procedure requiring specialized expertise and hospital stay.

Conclusion: Looking Ahead to Improved Care

The treatment landscape for pulmonary embolism is evolving rapidly, driven by the dual goals of enhancing efficacy and, critically, reducing bleeding complications. The most compelling development in pharmacology is the advancement of Factor XIa inhibitors, which promise a new generation of anticoagulants with a more favorable safety profile. Simultaneously, the refinement of catheter-based thrombectomy devices like Imperative Care's Symphony system is expanding options for rapid clot removal in higher-risk patients. The arrival of generic options for established drugs also plays a vital role in broadening access to care. Together, these innovations are paving the way for more individualized and safer treatment strategies for patients suffering from this dangerous condition, underscoring a new era in the management of thromboembolic diseases.

Potential Future Directions in PE Treatment

Future research and clinical practice are likely to focus on several areas to further refine PE management:

AI and Risk Stratification: Integrating artificial intelligence and advanced imaging for more precise and rapid patient risk stratification, enabling tailored treatment decisions.
Long-Term Outcomes: Continued evaluation of long-term outcomes for patients treated with catheter-based therapies to ensure sustained benefits.
Head-to-Head Trials: Conducting direct comparison studies between different types of DOACs and novel anticoagulants to inform best-practice guidelines.

The Future of Pulmonary Embolism Care

While established treatments like DOACs, including the recently available generic rivaroxaban, remain the cornerstone of care for most patients, new therapeutic avenues are opening up. The potential of Factor XIa inhibitors to deliver superior safety with comparable efficacy is an exciting prospect. For severe cases, sophisticated device-drug combinations are providing safer and more effective mechanical solutions. As these innovations move from clinical trials to standard practice, they promise to significantly improve outcomes for patients affected by pulmonary embolism.

This article is for informational purposes only and does not constitute medical advice. Consult with a healthcare professional for diagnosis and treatment.

Frequently Asked Questions

The most notable new class of medications for Pulmonary Embolism (PE) are Factor XIa (FXIa) inhibitors, which are currently undergoing Phase 3 clinical trials. They are designed to prevent clots with a reduced risk of bleeding compared to existing anticoagulants.

While no entirely new drug classes for PE received FDA approval in 2025, the year saw the approval of generic rivaroxaban (a DOAC) for broader access. A significant development was the FDA clearance of Imperative Care's Symphony Thrombectomy System, a device used to treat PE.

Factor XIa inhibitors are a new class of anticoagulants that work by targeting Factor XIa, a protein mainly involved in pathological clot formation. This is different from older anticoagulants that affect a broader part of the clotting cascade, and therefore carries a potentially lower risk of serious bleeding complications.

The Symphony Thrombectomy System is an FDA-cleared device for the treatment of pulmonary embolism. It uses large-bore vacuum technology to mechanically remove blood clots from the pulmonary arteries, offering a fast and precise option for physicians.

Technology is central to new PE treatments through catheter-based therapies (CBTs). Devices like the EKOS system use ultrasound to enhance drug delivery, while systems like Symphony provide a mechanical means of clot removal, often used in conjunction with medication.

The development and wider use of Direct Oral Anticoagulants (DOACs) like rivaroxaban and apixaban have facilitated the outpatient treatment of low-risk pulmonary embolism for suitable patients. However, risk stratification is crucial to determine who can be safely managed outside of a hospital setting.

The duration of anticoagulation for PE varies based on the individual patient's risk factors and recurrence risk. Newer guidelines emphasize reassessing treatment duration after an initial period, typically 3 to 6 months.