Recurrent Pericarditis Drug Pipeline — PatSnap Eureka
Recurrent Pericarditis Drug Pipeline: IL-1 Inhibitors, Rilonacept & NLRP3 Approaches
The NLRP3 inflammasome and IL-1 signalling axis are driving a new wave of targeted biologics for recurrent pericarditis. Explore patent filings, clinical trial signals, and competitive intelligence — from rilonacept's Phase III RHAPSODY data to emerging NLRP3 small molecules.
From Viral Idiopathy to NLRP3-Driven Autoinflammation
Recurrent pericarditis (RP) has been repositioned from a "viral/idiopathic" entity to a disease with clear autoinflammatory underpinnings. The NIH-recognised NLRP3 inflammasome drives cyclical sterile pericardial inflammation, processing pro-IL-1β into its bioactive form via caspase-1 cleavage — making it the central upstream drug target in the field.
Both IL-1α (released by damaged pericardial mesothelial cells) and IL-1β (produced by infiltrating leukocytes after inflammasome activation) are pivotal cytokines. A naturally occurring endogenous antagonist, IL-1 receptor antagonist (IL-1Ra), normally mitigates these effects but is insufficient in RP patients. This dual-cytokine pathophysiology has critical therapeutic implications: agents that block both IL-1α and IL-1β demonstrate clinical superiority over selective IL-1β inhibition.
A genetic analysis from the National Amyloidosis Centre (London), examining 136 IRP patients alongside 1,910 patients with monogenic autoinflammatory diseases, formally linked RP pathogenesis to MEFV, MVK, NLRP3, and TNFRSF1A gene variants — establishing RP within the inflammasome-associated disease spectrum. This precision medicine angle remains an underexplored IP territory. Learn more about PatSnap's life sciences intelligence platform for drug target analysis.
Corticosteroid dependence is the principal unmet-need driver: conventional therapies (NSAIDs, colchicine, corticosteroids) consistently fail a meaningful subset of patients, with corticosteroids paradoxically associated with higher recurrence rates. This failure context motivates the entire IL-1 inhibitor development wave documented in this dataset.
Recurrent Pericarditis Drug Pipeline at a Glance
Seven therapeutic approaches identified across patent filings and peer-reviewed literature, ranked by clinical development stage.
| Agent / Approach | Mechanism | Key Targets | Development Stage | Lead Assignee |
|---|---|---|---|---|
| Rilonacept (IL-1 Trap) | Soluble IL-1R1/IL-1RAcP-Fc fusion decoy receptor; neutralises IL-1α & IL-1β | IL-1α, IL-1β | Phase III (RHAPSODY) | Regeneron Pharmaceuticals |
| Anakinra (IL-1Ra) | Recombinant IL-1 receptor antagonist; blocks IL-1α & IL-1β at IL-1R1 | IL-1R1, IL-1α, IL-1β | Phase II / RCT evidence | Academic (IRCCS Gaslini, Cleveland Clinic) |
| Canakinumab (anti-IL-1β mAb) | Fully human IgG1κ mAb; selective IL-1β neutralisation only | IL-1β | Case Reports | Novartis (academic evidence) |
| Direct NLRP3 Inhibitors (INF4E, OLT1177/dapansutrile) | Small molecule NLRP3 inflammasome blockade; upstream of IL-1β | NLRP3 | Preclinical (murine models) | VCU Pauley Heart Center (academic) |
| Cannabidiol (CBD) | NLRP3/IL-1β mRNA suppression; IL-6 attenuation; upstream pathway modulator | NLRP3, IL-1β, IL-6 | Preclinical (in vitro + in vivo) | Cardiol Therapeutics Inc. |
| Beta-Caryophyllene (BCP) | Bicyclic sesquiterpene; IL-1β/IL-6 attenuation; reduces pericardial effusion in vivo | NLRP3, IL-1β, IL-6 | Preclinical (in vitro + in vivo) | Cardiol Therapeutics Inc. |
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Patent Activity & Clinical Evidence Signals
Key data points from the PatSnap Eureka patent and literature dataset for recurrent pericarditis, 2019–2025.
Patent Filings by Assignee — Recurrent Pericarditis (2019–2025)
Regeneron dominates with 13+ filings across US, EP, CA, and WO jurisdictions; Cardiol Therapeutics and R-Pharm are emerging challengers.
IL-1 Target Coverage: Dual vs. Selective Blockade
Clinical evidence favours dual IL-1α+β blockade (anakinra, rilonacept) over selective IL-1β inhibition (canakinumab) in recurrent pericarditis.
Clinical Evidence Timeline — IL-1 Inhibitors in RP
From first paediatric anakinra case reports (2008) through Phase III RHAPSODY data (2022), showing the evidence build over 14 years.
NLRP3 Pathway: Drug Intervention Points in Recurrent Pericarditis
Five intervention points identified across retrieved patent and literature records, from upstream DAMP sensing to downstream cytokine signalling.
IL-1 Inhibitors: Mechanistic Differentiation & Clinical Evidence
Three primary IL-1 pathway agents — each with distinct mechanisms and evidence bases — define the current commercial and clinical landscape for recurrent pericarditis.
Rilonacept (IL-1 Trap) — Regeneron Pharmaceuticals
A soluble chimeric fusion protein combining IL-1R1 and IL-1RAcP extracellular domains linked to an Fc region. Acts as a high-affinity decoy receptor neutralising both IL-1α and IL-1β. Phase II data (Cleveland Clinic/Mayo Clinic) showed rapid CRP normalisation and pain resolution with 320 mg SC loading dose and 160 mg SC weekly maintenance. The pivotal Phase III RHAPSODY trial is referenced across multiple retrieved papers as demonstrating rapid pain and inflammation resolution with markedly reduced recurrence and a favourable safety profile. Regeneron holds 13+ active or pending patents across US, EP, CA, and WO jurisdictions (2019–2025), signalling aggressive IP lifecycle management. Explore PatSnap's IP analytics tools for competitive patent landscaping.
Dual IL-1α + IL-1β neutralisationAnakinra (IL-1Ra) — Recombinant IL-1 Receptor Antagonist
A recombinant human IL-1 receptor antagonist that competitively blocks both IL-1α and IL-1β signalling at IL-1R1. The most extensively documented agent in academic literature, with evidence spanning case reports, multicenter cohort analyses, and randomised controlled trials. A 2021 systematic review (California Institute of Behavioral Neurosciences) found 100 mg/day produced "remarkable improvement in patient outcomes" across 11 studies. Early paediatric use was documented as early as 2008 at IRCCS G. Gaslini (Genoa). Consistently described as rapidly acting, steroid-sparing, and safe. Multiple retrieved papers cite a completed RCT, distinguishing anakinra from canakinumab which has not been tested in a randomised RP trial. According to the EMA, IL-1 receptor antagonism is a validated mechanism in autoinflammatory conditions.
Steroid-sparing · Rapidly actingCanakinumab — Selective Anti-IL-1β Monoclonal Antibody
A fully human IgG1κ monoclonal antibody selectively neutralising IL-1β without affecting IL-1α. A critical 2020 paediatric case report from IRCCS Istituto Giannina Gaslini describes two children who responded well to anakinra but relapsed promptly upon switching to canakinumab — suggesting that simultaneous IL-1α and IL-1β blockade may be necessary for adequate RP disease control. This finding directly supports the mechanistic superiority of dual-targeting agents (rilonacept, anakinra) in RP. No randomised controlled trial data specifically in RP is available in retrieved results. The WHO essential medicines framework recognises IL-1 inhibition in autoinflammatory disease management.
IL-1β selective — insufficient in RPCannabidiol & Beta-Caryophyllene — Cardiol Therapeutics Inc.
Two distinct Cardiol Therapeutics patent families (WO 2024, US pending 2026, AU pending 2025) disclose cannabidiol (CBD) and beta-caryophyllene (BCP) for treating or preventing recurrent pericarditis. CBD patents claim attenuation of IL-1β and IL-6 levels, suppression of pro-IL-1β and NLRP3 mRNA transcription in vitro, and prevention of pericardial space increases in murine models. BCP (a bicyclic sesquiterpene) claims similar in vitro IL-1β/IL-6 attenuation and in vivo reduction of pericardial effusion and thickening. These represent the most recently dated patents (2024–2026) in this RP dataset and position natural compound-derived NLRP3 modulators as a potential oral/non-injectable alternative to injectable biologics. The PatSnap customer case studies include examples of early-stage biotech IP strategy in emerging therapeutic areas.
Oral/non-injectable NLRP3 modulationCompetitive & IP Landscape: Strategic Implications
Key strategic signals extracted from patent filings and clinical literature for biopharma teams, IP counsel, and investors evaluating the recurrent pericarditis space.
Regeneron's IP Position Is the Most Defensible
With 13+ patent filings across US, EP, CA, and WO jurisdictions spanning 2019–2025, Regeneron's IL-1R/IL-1RAcP-Fc fusion protein mechanism for pericarditis and PCIS creates substantial freedom-to-operate challenges for competitors seeking to enter with similar IL-1 trap molecules. US filings range from active granted patents to pending continuations as late as November 2025, indicating sustained portfolio extension activity.
Dual IL-1α+β Blockade Is the Mechanistic Standard
Retrieved results consistently frame rilonacept and anakinra as superior to canakinumab in RP due to dual-cytokine neutralisation. The canakinumab failure signal (paediatric relapses upon switch from anakinra) provides direct clinical evidence. Drug developers targeting RP should prioritise dual-blocking molecules or provide explicit mechanistic rationale if pursuing IL-1β-selective strategies.
Combination Approaches & Next-Generation Strategies
Biologic + corticosteroid weaning protocols are the dominant real-world translational model. Multiple retrieved papers describe clinical protocols where IL-1 inhibitors (anakinra or rilonacept) are introduced to enable tapering and cessation of corticosteroids in steroid-dependent patients. The Phase II rilonacept trial specifically included a corticosteroid-dependent cohort with a structured wean protocol.
NLRP3-targeted small molecules in cardiovascular disease are advancing in adjacent indications. Retrieved papers discuss direct NLRP3 inhibitors (INF4E, OLT1177/dapansutrile, IZD334) in cardiac ischaemia-reperfusion and heart failure models. VCU data demonstrates that NLRP3 blockers reduce pericardial inflammation in animal models alongside IL-1 biologics — suggesting upstream NLRP3 inhibition as a future oral RP strategy. PatSnap's patent analytics platform enables freedom-to-operate analysis for novel NLRP3 inhibitor chemical series.
Natural compound NLRP3 modulators from Cardiol Therapeutics Inc. (cannabidiol, BCP, filed 2024–2026) represent the most recently dated RP-specific patents in this dataset. These claim in vitro NLRP3 mRNA suppression and in vivo pericardial effusion reduction — positioning them as early preclinical bets on oral/non-injectable alternatives to injectable biologics. Investors should monitor NLRP3 mRNA suppression claims as a mechanistic validation endpoint.
Autoinflammatory genotyping to guide therapy is an emerging precision medicine direction. Genetic screening for MEFV, NLRP3, and related autoinflammatory variants may identify which patients are most likely to respond to IL-1 inhibition. The European Bioinformatics Institute maintains variant databases relevant to this stratification approach. This direction is not yet formalised in retrieved clinical trial protocols but is increasingly discussed in academic literature — and remains an underexplored IP territory. See how PatSnap's life sciences solutions support precision medicine IP strategy.
Recurrent Pericarditis Drug Pipeline — Key Questions Answered
Approximately 15–30% of patients with acute pericarditis experience recurrence, with a subset becoming colchicine-resistant and corticosteroid-dependent — a population representing the principal unmet medical need.
Rilonacept is a soluble chimeric fusion protein combining the extracellular domains of IL-1R1 and IL-1RAcP linked to an Fc region, acting as a high-affinity decoy receptor that neutralizes both IL-1α and IL-1β. This dual neutralization distinguishes rilonacept from anakinra (which blocks receptor signaling) and canakinumab (which targets IL-1β selectively).
A 2020 pediatric case report from IRCCS Istituto Giannina Gaslini describes two children who responded well to anakinra but relapsed promptly upon switching to canakinumab, suggesting that simultaneous IL-1α and IL-1β blockade (as achieved by anakinra or rilonacept) may be necessary for adequate disease control in at least some patients.
NLRP3 inflammasome activation drives cyclical sterile inflammation of the pericardium. The NLRP3 inflammasome functions as the macromolecular assembly that processes pro-IL-1β into its mature bioactive form via caspase-1 cleavage. Retrieved results from VCU demonstrate that inflammasome components are intensified in pericarditis tissue versus controls.
Regeneron Pharmaceuticals, Inc. holds at least 13 distinct patent filings across US, EP, CA, and WO jurisdictions, spanning 2019–2025, protecting methods of treating pericarditis and post-cardiac injury syndrome using an interleukin-1 receptor-Fc fusion protein — the molecular description of rilonacept.
Cardiol Therapeutics Inc. has filed patents (WO 2024, US pending 2026) for cannabidiol (CBD) and beta-caryophyllene (BCP) as NLRP3/IL-1β pathway modulators for recurrent pericarditis. These compounds claim to attenuate IL-1β and IL-6 levels, suppress pro-IL-1β and NLRP3 mRNA transcription in vitro, and reduce pericardial effusion in murine models.
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References
- Emerging Therapies for Recurrent Pericarditis: Interleukin-1 inhibitors — University Cardiology, A.O.U. Città della Salute e della Scienza di Torino, 2021
- Interleukin-1 Antagonists for the Treatment of Recurrent Pericarditis — Cleveland Clinic, 2022
- Novel Pharmacotherapies for Recurrent Pericarditis: Current Options in 2020 — Fatebefratelli Hospital, Milan, 2020
- Rilonacept and Anakinra in Recurrent Pericarditis: A Systematic Review and Meta-Analysis — Hawler Medical University, 2022
- Anti-interleukin-1 agents for pericarditis: a primer for cardiologists — Cleveland Clinic, 2021
- Interleukin-1 and the NLRP3 Inflammasome in Pericardial Disease — ASST Sette Laghi, Varese, 2021
- Recurrent Pericarditis: a Stubborn Opponent Meets New Treatments in 2022 — University of Vermont, 2022
- Rilonacept (Interleukin-1 Inhibition) for the Treatment of Pericarditis — Cleveland Clinic, 2022
- Efficacy of Anakinra in Pericarditis: A Systematic Review — California Institute of Behavioral Neurosciences & Psychology, 2022
- The Role of NLRP3 Inflammasome in Pericarditis — VCU Pauley Heart Center, 2021
- Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial — Mayo Clinic / Cleveland Clinic, 2020
- Treatment of inflammatory conditions by delivery of interleukin-1 receptor antagonist fusion protein — Regeneron Pharmaceuticals, Inc., 2022, US [Patent]
- Treatment of inflammatory conditions by delivery of interleukin-1 receptor antagonist fusion protein — Regeneron Pharmaceuticals, Inc., 2019, CA [Patent]
- Treatment of inflammatory conditions by delivery of interleukin-1 receptor antagonist fusion protein — Regeneron Pharmaceuticals, Inc., 2019, WO [Patent]
- Treatment of recurrent idiopathic pericarditis by delivery of interleukin-1 receptor antagonist fusion protein — Regeneron Pharmaceuticals, Inc., 2025, EP [Patent]
- Use of il1-r1 derived inhibitor of il-1b for the treatment of idiopathic recurrent pericarditis — R-Pharm Overseas, Inc., 2024, US [Patent]
- Cannabidiol for use in treating or preventing recurrent pericarditis — Cardiol Therapeutics Inc., 2024, WO [Patent]
- Beta-caryophyllene for use in treating or preventing pericarditis — Cardiol Therapeutics Inc., 2024, WO [Patent]
- IL-1 beta receptor antagonist efficacy in the treatment of idiopathic recurrent pericarditis — IRCCS G. Gaslini, 2008
- Failure of anti Interleukin-1β monoclonal antibody in the treatment of recurrent pericarditis in two children — IRCCS Istituto Giannina Gaslini, 2020
- National Institutes of Health (NIH) — Autoinflammatory Disease Research
- European Medicines Agency (EMA) — IL-1 Receptor Antagonism in Autoinflammatory Conditions
- World Health Organization (WHO) — Essential Medicines Framework: Autoinflammatory Disease Management
- European Bioinformatics Institute (EBI) — Autoinflammatory Gene Variant Databases (MEFV, NLRP3, MVK, TNFRSF1A)
All data and statistics on this page are sourced from the references above and from PatSnap's proprietary innovation intelligence platform. This report is derived from a limited set of patent and literature records retrieved across targeted searches and represents a snapshot of innovation signals within this dataset only — it should not be interpreted as a comprehensive view of the full field, clinical pipeline, or regulatory landscape.
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