Pharvaris Sets 2026 Milestones for Oral Angioedema Drug Deucrictibant

ZUG, Switzerland – January 12, 2026 – Pharvaris N.V. today charted a decisive course for 2026, outlining a series of strategic milestones that position its novel oral drug, deucrictibant, to potentially transform the treatment landscape for hereditary angioedema (HAE) and related conditions. The late-stage biopharmaceutical company announced plans to file for U.S. regulatory approval for its on-demand HAE treatment in the first half of the year, while anticipating pivotal data for its prophylactic version in the third quarter. These developments signal a critical period for the company as it seeks to offer patients an injectable-free alternative in a multi-billion-dollar market.

For decades, individuals living with HAE—a rare, debilitating genetic disorder causing unpredictable, severe swelling attacks—have relied predominantly on injectable or infused therapies. Pharvaris aims to disrupt this paradigm with deucrictibant, a bradykinin B2 receptor antagonist designed for oral administration. The company is advancing two distinct formulations: an immediate-release capsule for acute attacks and an extended-release tablet for long-term prevention.

“The readout of Pharvaris’ first pivotal Phase 3 study, RAPIDe-3, in December was the culmination of a decade of scientific rigor, operational and financial diligence, executional excellence, and, most importantly, community engagement and commitment,” said Berndt Modig, Chief Executive Officer of Pharvaris. He emphasized that the recent data builds confidence for the drug's potential to become a new standard of care.

Redefining On-Demand Treatment

The most immediate catalyst for Pharvaris is the planned New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) for deucrictibant as an on-demand, or acute, treatment for HAE attacks. This submission, anticipated in the first half of 2026, will be anchored by compelling results from the pivotal RAPIDe-3 global Phase 3 study.

Data from RAPIDe-3 demonstrated that the 20 mg immediate-release capsule achieved its primary endpoint with high statistical significance. Patients taking deucrictibant experienced a median time to onset of symptom relief of just 1.28 hours, significantly faster than those on placebo. This rapid action is crucial for patients seeking to halt the progression of painful and potentially life-threatening swelling attacks.

Deucrictibant’s oral, rapid-acting profile places it in a competitive but evolving space. While the market for on-demand treatment has long been dominated by injectables like Icatibant (Firazyr), the recent approval of the first oral on-demand pill, sebetralstat (Ekterly), has validated the demand for non-injectable options. Pharvaris's positive Phase 3 data suggests deucrictibant could be a strong contender, offering a convenient pill that patients can take at the first sign of an attack, potentially improving response times and quality of life.

The Prophylactic Promise: A New Standard of Care?

While on-demand treatment is critical, the HAE market has seen a decisive shift towards prophylaxis, or long-term prevention, which now accounts for the majority of prescriptions. Pharvaris is squarely targeting this segment with its 40 mg extended-release tablet of deucrictibant, with topline data from its pivotal Phase 3 prophylactic study, CHAPTER-3, now expected in the third quarter of 2026.

The CHAPTER-3 study is a 24-week, randomized, placebo-controlled trial designed to evaluate the efficacy of a once-daily oral dose in preventing HAE attacks in approximately 81 participants. The confidence in this trial is bolstered by compelling long-term data from the earlier Phase 2 CHAPTER-1 study. Final results from CHAPTER-1, which followed patients for up to approximately three years, showed that deucrictibant was well-tolerated and highly effective. Participants experienced a mean monthly on-treatment attack rate of just 0.12, representing a significant and sustained reduction in attack frequency.

Success in CHAPTER-3 could position deucrictibant as a powerful oral prophylactic, competing with the established oral therapy berotralstat (Orladeyo) and injectable mainstays like lanadelumab (Takhzyro). The convenience of a once-daily pill, combined with a strong efficacy and safety profile, could prove to be a major draw for patients and clinicians alike.

Beyond HAE and into the Market

Pharvaris is also extending the potential application of deucrictibant beyond HAE. The company confirmed that recruitment is progressing as planned for CREAATE, a pivotal Phase 3 study evaluating the drug for both prophylactic and on-demand treatment of acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), a rarer but similarly debilitating condition. This program demonstrates the potential for deucrictibant to become a franchise therapy for multiple bradykinin-mediated diseases.

From a business perspective, Pharvaris appears to be on solid footing. The company reported an estimated cash runway extending into the first half of 2027, providing sufficient capital to see it through these critical clinical and regulatory milestones. This financial stability is complemented by growing market recognition, highlighted by its recent addition to the Nasdaq Biotechnology Index (NBI) in December 2025—an inclusion that reflects its increased market capitalization and trading volume.

The company is also preparing for a series of presentations at major medical and investor conferences in early 2026, including the Oppenheimer Healthcare Life Sciences Conference and the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. These events will provide a platform to disseminate more detailed data from its clinical programs to the scientific and financial communities, further building momentum ahead of its planned regulatory submissions.

The Patient Perspective: Overcoming the Burden of Injections

Behind the clinical data and market strategy lies a significant unmet need. Despite the availability of effective treatments, many HAE patients continue to face a substantial burden. The unpredictability of attacks fosters constant anxiety, and the reliance on injections or infusions presents its own set of challenges. Research indicates that issues like fear of needles (trypanophobia), difficulty with self-administration, and injection-site reactions can lead to treatment delays and reduced compliance.

According to one healthcare analyst focused on rare diseases, “Even with high satisfaction rates for current therapies, the desire for an easier, less invasive option is overwhelming. An effective oral drug isn't just an incremental improvement; for many patients, it represents a fundamental shift in how they manage their disease day-to-day.”

The potential of deucrictibant lies in this very shift. An oral pill that can rapidly stop an attack or be taken once daily to prevent them offers a level of freedom and normalcy that is difficult to achieve with injectables. This convenience could empower patients, reduce treatment-related anxiety, and ultimately improve overall health outcomes. As Pharvaris moves through a pivotal 2026, the prospect of delivering this long-awaited convenience is closer than ever, promising new hope for the entire angioedema community.