A Phase 3, Randomized, Double-blind, Placebo-controlled, 3-Part Study to Evaluate the Efficacy and Safety of Orally Administered Deucrictibant Extended-release (XR) Tablet for Prophylaxis and Deucrictibant Immediate-release (IR) Capsule for On-demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor Deficiency

This is a Phase 3, multicenter, 3-part study, with 2 randomized, double-blind, placebo-controlled parts and an open-label extension part, to evaluate the efficacy and safety of orally administered deucrictibant XR tablet for prophylaxis, and deucrictibant IR capsule for on-demand treatment of angioedema attacks in adult participants aged ≥ 18 years with AAE-C1INH.

开始日期2025-10-16

申办/合作机构

Pharvaris Netherlands BV

NCT07046806

/ Recruiting临床1/2期

Oral Deucrictibant for the Prophylactic and Acute Treatment in Patients With Bradykinin Mediated Angioedema With Normal C1 Inhibitor (BK-AE-nC1INH)

To assess the efficacy of prophylactic treatment with deucrictibant extended release (XR) tablet versus placebo in preventing angioedema attacks, and to also assess the efficacy of deucrictibant soft capsules as on-demand treatment versus placebo in achieving angioedema symptom relief during acute attacks.

开始日期2025-03-10

申办/合作机构

Institute For Asthma & Allergy, PC

NCT06679881

/ Recruiting临床3期

A Long-term, Open-label Study to Evaluate the Safety and Efficacy of Orally Administered Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

This is a Phase 3, multicenter, long-term, open-label study to evaluate the safety and efficacy of once-daily orally administered deucrictibant extended-release tablet for prophylaxis to prevent angioedema attacks in participants aged ≥12 years with Hereditary Angioedema

开始日期2025-02-01

申办/合作机构

Pharvaris Netherlands BV

100 项与 Deucrictibant 相关的临床结果

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100 项与 Deucrictibant 相关的转化医学

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100 项与 Deucrictibant 相关的专利（医药）

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项与 Deucrictibant 相关的文献（医药）

2026-04-01·Lancet Haematology

Oral deucrictibant for on-demand treatment of hereditary angioedema attacks (RAPIDe-1): a randomised, double-blind, placebo-controlled, phase 2 trial

Article

作者: van Leeuwen, Simone ; Hakl, Roman ; Tarzi, Michael D ; Maurer, Marcus ; Spadaro, Giuseppe ; Lu, Peng ; Anderson, John ; Guilarte, Mar ; Lesage, Anne ; Chen, Huaihou ; Králíčková, Pavlína ; Hagin, David ; Jouvin, Marie-Helene ; Li, H Henry ; Sussman, Gordon L ; Cohn, Danny M ; Lleonart, Ramon ; Kiani-Alikhan, Sorena ; Farkas, Henriette ; Manning, Michael E ; Baeza, Maria Luisa ; Magerl, Markus ; Zhu, Li ; Kessel, Aharon ; Crabbé, Rafael ; Greve, Jens ; Chapdelaine, Hugo ; Riedl, Marc A ; Fain, Olivier ; Staevska, Maria T ; Reshef, Avner ; Bouillet, Laurence ; Valerieva, Anna ; Knolle, Jochen ; Aygören-Pürsün, Emel ; Du-Thanh, Aurélie ; Ritchie, Bruce ; Stobiecki, Marcin ; Yang, William H ; Jacobs, Joshua S ; Staubach, Petra

BACKGROUND:

Hereditary angioedema is a bradykinin-mediated disorder characterised by recurrent painful swelling attacks. Treatment relies on medications to prevent attacks and on-demand therapies for attack manifestations. Parenteral administration associated with most available on-demand therapies often leads to treatment being delayed or forgone. Deucrictibant is an orally bioavailable bradykinin B2 receptor antagonist under development for prophylaxis and on-demand treatment of hereditary angioedema attacks. We aimed to investigate the efficacy and safety of deucrictibant for the on-demand treatment of hereditary angioedema attacks.

METHODS:

RAPIDe-1 was a double-blind, randomised, placebo-controlled, crossover, dose-ranging, phase 2 trial that recruited adults aged 18-75 years with hereditary angioedema type 1 or 2 from 38 sites (eg, university hospitals and accredited angioedema centres) across North America, Europe, and Israel. Participants were required to have experienced two or more attacks within the past 2 months or three or more attacks within the past 4 months before screening. An interactive response technology system randomly assigned eligible patients (1:1:1) to receive a blinded dose of oral deucrictibant (immediate-release capsule) 10 mg, 20 mg, or 30 mg during an attack-free period to assess pharmacokinetics and safety in the part 1 of the study; and, subsequently, to receive a crossover treatment sequence of two administrations of the same deucrictibant dose (10 mg, 20 mg, or 30 mg) and one of placebo to treat three investigator-confirmed angioedema attacks in the part 2. Randomisation was stratified by whether the participant was willing to participate in full pharmacokinetic sampling. Participants, investigators, site personnel, and the sponsor were masked to treatment assignment and capsules of deucrictibant and placebo were identical. For each attack, patients self-administered the oral study drug within 3 h after at least one symptom (skin pain, skin swelling, or abdominal pain) reached a visual analog scale (VAS) individual score of 30 or more out of 100 and within 6 h from symptom onset. The primary endpoint was change in the patient-reported composite VAS-3 score measuring severity of attack manifestations from before treatment to 4 h post-treatment and assessed in the modified intention-to-treat and per-protocol populations. Safety was assessed in all patients who received any dose of study drug. RAPIDe-1 is registered with ClinicalTrials.gov (NCT04618211) and is completed.

FINDINGS:

Between Feb 3, 2021, and June 23, 2022, 89 patients were screened, of whom 74 were randomly assigned between Feb 23, 2021, and July 26, 2022. For the primary analysis set, the median follow-up was 130·0 (IQR 92·5 to 212·5) days for the deucrictibant 10 mg group, 166·5 (80·0 to 275·0) days for the deucrictibant 20 mg group, and 172·0 (65·0 to 242·0) days for the deucrictibant 30 mg group. The primary efficacy analysis included 147 attacks in 62 patients, of whom 42 (68%) were female and 60 (97%) were White. Least squares mean differences of change in VAS-3 score between deucrictibant and placebo was -16·75 (95% CI -21·52 to -11·97) for 10 mg, -15·02 (-20·22 to -9·81; p<0·0001) for 20 mg, and -16·28 (-21·27 to -11·29; p<0·0001) for 30 mg. In part 1, all treatment-emergent adverse events were grades 1-2, with the most common in two or more patients being headache (two [8%] of 25) and nasopharyngitis (two [8%] of 25) in the deucrictibant 30 mg group. In part 2, no single treatment-emergent adverse event was reported by two or more patients in any treatment group. Most adverse events were considered unrelated to the study drug and there were no grade 3 or worse adverse events.

INTERPRETATION:

Deucrictibant significantly reduced the severity of hereditary angioedema attacks compared with placebo; these results support continued investigation of antagonism of the bradykinin B2 receptor with an orally available agent as a potentially effective approach, with a safety profile similar to placebo, for on-demand treatment.

FUNDING:

Pharvaris.

2026-04-01·Lancet Haematology

Oral deucrictibant for prophylaxis of hereditary angioedema attacks (CHAPTER-1): primary analysis of a randomised, double-blind, placebo-controlled, phase 2 trial

Article

作者: Cancian, Mauro ; Eren, Efrem ; Zhu, Li ; Crabbé, Rafael ; Tarzi, Michael D ; Chapdelaine, Hugo ; Mulders, Susan ; Arcoleo, Francesco ; Knolle, Jochen ; Conlon, Niall ; Manning, Michael E ; Kiani-Alikhan, Sorena ; Lu, Peng ; Guarino, Maria D ; Anderson, John ; Grigoriadou, Sofia ; Kinaciyan, Tamar ; Wedner, H James ; Gurugama, Padmalal ; Aygören-Pürsün, Emel ; Gompels, Mark ; Levy, Jonathan ; Lesage, Anne ; Valerieva, Anna ; Zanichelli, Andrea ; Riedl, Marc A ; Yang, William H ; Stobiecki, Marcin ; Magerl, Markus

BACKGROUND:

Hereditary angioedema is a bradykinin-mediated, rare condition characterised by recurrent and potentially life-threatening attacks of subcutaneous and submucosal swelling. Bradykinin B2 receptor antagonism is a proven mechanism for on-demand treatment of attacks, but no evidence exists on its effects when used prophylactically. Deucrictibant is an investigational orally bioavailable bradykinin B2 receptor antagonist. We aimed to evaluate the efficacy, safety, and tolerability of two dose regimens of oral deucrictibant administered as prophylaxis against hereditary angioedema attacks.

METHODS:

CHAPTER-1 was a multicentre, double-blind, placebo-controlled, randomised, phase 2 trial conducted in two parts, a double-blind placebo controlled first part and an open-label second part, with only part 1 reported here. Part 1 recruited adults (aged 18-75 years) with hereditary angioedema type 1 or 2 from 37 sites (university hospitals and accredited angioedema centres) across North America, Europe, and Israel. Patients required a documented history of three or more attacks within the last 3 consecutive months before screening or two or more during the screening period (up to 8 weeks) to be eligible. An interactive response technology system randomised eligible patients 1:1:1 to receive oral deucrictibant 20 mg daily, 40 mg daily, or matching placebo for 12 weeks. Randomisation to treatment groups was stratified by the baseline attack rate. Patients, investigators, site personnel, and the sponsor were blinded to treatment assignment. Masking was achieved with identically appearing deucrictibant and placebo capsules. The primary endpoint was the time-normalised number of investigator-confirmed attacks per 4 weeks (monthly attack rate) from weeks 1 to 12 and was assessed using the intention-to-treat set. The endpoint was analysed by comparing each deucrictibant group with the placebo group using a Poisson generalised linear model with a log link function and Pearson's χ² scaling of SEs to account for potential dispersion. The safety analysis set included all patients who were randomly assigned and who received one or more doses of study drug (deucrictibant or placebo). CHAPTER-1 is registered with ClinicalTrials.gov (NCT05047185) and is now complete.

FINDINGS:

Between March 9, 2022, and June 19, 2023, 44 patients were screened. Of 34 patients who were randomly assigned, 11 patients received deucrictibant 20 mg, 12 patients received deucrictibant 40 mg, and 11 patients received the placebo, with a median follow-up of 85·0 days (IQR 84·0-86·0). 21 (62%) patients were female, 13 (38%) were male, and 34 (100%) patients were White. The least squares mean monthly attack rate (primary analysis) was 0·40 (95% CI 0·18-0·92) for deucrictibant 20 mg, 0·30 (0·11-0·81) for deucrictibant 40 mg, and 1·93 (1·30-2·88) for placebo; percent reduction in attack rate compared with placebo was 79·2% (95% CI 47·2-91·8) for deucrictibant 20 mg (p=0·0010) and 84·5% (95% CI 53·8-94·8) for deucrictibant 40 mg (p=0·0008). Treatment-related treatment-emergent adverse events were experienced by two (18%) patients receiving deucrictibant 20 mg, one (8%) patient receiving deucrictibant 40 mg, and one (9%) patient receiving the placebo; all were mild in severity (grade 1) and did not require dosing modification of the study drug. There were no serious adverse events or deaths in any treatment group.

INTERPRETATION:

To the best of our knowledge, this trial provides the first clinical evidence and proof-of-concept for bradykinin B2 receptor antagonism as a therapeutic approach for the prevention of hereditary angioedema attacks and supports further investigation of oral deucrictibant for bradykinin-mediated angioedema.

FUNDING:

Pharvaris.

2026-01-01·PEPTIDES

Non-peptide bradykinin B2 receptor ligands possessing the substituted quinolinyl moiety: Pharmacological properties and prospective clinical uses

Review

作者: Sahli, Ahmed ; Marceau, François ; C-Gaudreault, René

Bradykinin is a nonapeptide derived from the cleavage of circulating kininogens by plasma or tissue kallikreins and is endowed with powerful pharmacologic actions, such as the production of protein-rich exudates and vasodilation. The widely expressed B2 receptor for bradykinin (a G protein-coupled receptor) has been the focus of intense drug development efforts for more than 4 decades, with marked differences in affinities and competitiveness for synthetic antagonists across mammalian species. Many non-peptide ligands of the human B2 receptor have been developed by various industrial organizations. A recurring substituted 8-[(2,6-dichlorophenyl)methoxy]-2-methylquinolinyl ("quinolyl") moiety, or variants thereof, was explored by several pharmaceutical organizations. FR173657, fasitibant, anatibant, deucrictibant and Compound 3 (the non-deuterated version of deucrictibant) are examples of competitive antagonists of the human B2 receptor, some of which having reached the stage of clinical trials. Other compounds structurally related to the common moiety, such as FR190997 and Compound 47a, are partial or nearly full agonists of the B2 receptor. The ongoing clinical development of deucrictibant for the treatment of hereditary angioedema is a first step in clarifying the therapeutic potential of orally bioavailable B2 receptor antagonists.

133

项与 Deucrictibant 相关的新闻（医药）

2026-05-06

·BioSpace

Chiesi snaps up KalVista for $1.9B, betting big on rare disease med Ekterly

Chiesi Group is taking KalVista Pharmaceuticals under its wing, paying $1.9 billion for the biotech’s oral therapy Ekterly to treat severe swelling episodes caused by the rare genetic disorder hereditary angioedema. Chiesi Group is acquiring KalVista Pharmaceuticals and its hereditary angioedema treatment Ekterly, which secured FDA approval last summer and has since enjoyed a highly successful launch. taly-based Chiesi’s rare disease group spearheaded the deal, paying the Massachusetts biotech $27 per share in cash for an estimated total value of $1.9 billion, according to a Wednesday release. The deal terms represent a 36% premium on KalVista’s 30-day average share price. The acquisition is expected to close in the third quarter of this year and is “Chiesi’s most substantial acquisition to date in value terms,” according to the Italian drugmaker. Back in 2023, the company penned a takeover of rare disease–focused Amryt Pharma and the now approved Filsuvez topical gel for up to $1.25 billion upfront. Once today’s deal is complete, Chiesi will gain access to KalVista’s Ekterly, the first oral, on-demand, plasma kallikrein inhibitor to be marketed for acute hereditary angioedema (HAE) attacks among patients 12 years and older. The genetic condition causes days-long swelling attacks that can be extremely painful and even life-threatening. While patients with HAE can receive Ionis’ Dawnzera or CSL’s Andembry—both injectable prophylactic drugs administered regularly to prevent occurrences—Ekterly is the only drug among the three that can be taken on-demand to quell attacks as they pop up. “Chiesi’s $1.9B acquisition of KALV and its oral on-demand treatment for HAE attacks reflects strong strategic interest in the oral HAE space,” analysts with RBC Capital Markets wrote in a Wednesday note. After securing an FDA greenlight last July, KalVista’s therapy hit $49.1 million in 2025 sales. With approvals in the U.S., E.U. and other regions already under its belt, KalVista is currently conducting studies evaluating Ekterly for patients younger than 12 years. Chiesi expects Ekterly to “meaningfully contribute” to its 2030 strategic revenue target of €6 billion” ($7 billion), while also bolstering the drugmaker’s commercial infrastructure and market presence in the U.S., according to today’s release. “In HAE, patients continue to face significant unmet needs, and KalVista’s innovation meaningfully expands our presence in rare immunology by adding a differentiated, on-demand treatment option that can bring meaningful advancement in how the disease can be managed,” Giacomo Chiesi, executive vice president for Chiesi Global Rare Diseases, said in a Wednesday statement. Once KalVista is acquired, Pharvaris and BioCryst Pharmaceuticals will be the only smaller public biotechs working on HAE therapies, “likely adding an incremental layer of M&A optionality to both names,” RBC analysts noted. In particular, Pharvaris is developing deucrictibant, an immediate-release drug that RBC said has a superior clinical pro Ekterly across key efficacy endpoints. “Although deucrictibant IR will likely be second to market, we believe that lower switching barriers between oral agents could enable PHVS to capture meaningful share,” the analysts wrote. Meanwhile, analysts at Stifel called the acquisition “a very solid outcome for Kalvista given the likely more narrow pool of potential buyers for the company, which secures an exit while not taking on the risk of competitor PHVS’ prophy readout/near-term launch in HAE.” The content above comes from the network. if any infringement, please contact us to modify.

上市批准并购

2026-04-20

·久谦中台丨海外生科

口服B2受体拮抗剂的终局之战：已验证的机制能否经得起临床与市场的双重考验？

Pharvaris的核心资产deucrictibant，其研发基础是已获临床验证的缓激肽B2受体拮抗机制，创新点在于提供了口服给药的选择。然而，公司的成功并非既定事实，完全取决于几个尚未得到完整验证的关键变量。这些变量构成了评估其商业潜力的核心框架：急性治疗III期数据的稳健性与监管接受度、预防治疗关键数据在更大规模试验中的可重复性、在已获批口服疗法竞争下的实际临床价值，以及一系列即将到来的监管与临床节点。本文将基于现有数据与竞争格局，逐一分析这些变量带来的确定性与不确定性。急性治疗数据初具优势，但临床价值的根基尚待监管背书 Deucrictibant在急性发作治疗领域已展现出有竞争力的III期顶线数据，但其宣称的优势尚未经过完整监管审查，且面临与已获批口服药物EKTERLY的直接比较压力。其临床价值的最终确立，不仅取决于数据本身的强度，还取决于与现有标准疗法的差异化程度以及监管机构的最终审评结论。已获验证的机制是研发的起点，但并非成功的保证。 Deucrictibant是一种口服小分子缓激肽B2受体拮抗剂，其作用核心是阻断缓激肽与B2受体的结合，从而从信号通路末端阻止血管性水肿的发生。皮下注射B2受体拮抗剂Icatibant（Firazyr）的获批已历史性验证了此机制的有效性。Pharvaris的策略是将此注射验证的机制转化为口服制剂（速释胶囊PHVS416），旨在提供相当的疗效并提升给药便利性，这是一种剂型改良与给药途径创新。关键III期RAPIDe-3研究的顶线数据表现强劲，但存在固有局限性。2025年12月公布的RAPIDe-3研究（全球/随机/双盲/安慰剂对照，样本量134人）数据显示，deucrictibant在主要终点和所有11项次要终点上均达到统计学显著性。具体数据包括：症状缓解起效时间为1.28小时。进展停止时间为17.47分钟。完全症状消退时间为11.95小时。此外，83.0%的发作通过单次给药得到控制，93.2%的发作无需使用挽救药物，研究期间未报告治疗相关严重不良事件。这些数据为药物的疗效和初步安全性提供了支持。然而，上述数据在转化为临床价值前，存在必须澄清的局限性。所有数据均为公司报告的顶线数据，尚未经过美国食品药品监督管理局或欧洲药品管理局的完整监管审查，也未在同行评审期刊上完整发表。其次，尽管公司声称该研究完全符合AURORA共识核心结局集，但这可能导致其终点定义与竞争对手的临床试验存在差异，增加了间接比较的难度。预防治疗的高应答率能否在III期重复，是确立市场优势的生死线 Deucrictibant在预防治疗领域的II期数据极具吸引力，但这建立在一个小样本量研究之上。预计于2026年第三季度公布的CHAPTER-3关键III期数据能否成功复制高效力，将直接决定该药物能否在口服预防市场获得一席之地，甚至挑战现有口服疗法标准。 II期CHAPTER-1研究的数据为III期试验设定了极高的期望门槛。在CHAPTER-1研究中，deucrictibant缓释片剂（40mg每日一次）将HAE患者的月发作率降低了84.5%，这一降幅具有统计学显著性（p=0.0008）。其长期开放标签扩展数据显示，经过约34个月的治疗，患者平均发作率从基线2.18次/月降至0.12次/月，降幅达92.4%。这些数据为deucrictibant作为预防性药物的潜力提供了强有力的初步证据。 II期数据的局限性要求我们必须以审慎态度看待III期结果。 CHAPTER-1研究的样本量较小，deucrictibant 40mg组仅纳入约12名患者。小样本量研究的结果波动性更大，其观察到的效应值在更大规模的人群中可能无法完全复现。因此，将II期84.5%的降幅直接视为III期的预期标准是不稳健的。在获批口服药物的竞争中，寻找不可替代的临床定位随着EKTERLY的上市，deucrictibant在急性治疗领域已失去“首个口服疗法”的先发优势。其商业前景将取决于能否在起效速度/作用持久性及预防治疗能力等方面，构建起足以支撑市场渗透的差异化临床价值。这种差异化必须得到头对头研究或真实世界数据的最终验证。监管审评与长期数据：决定商业可行性的最后关卡 Pharvaris的商业化之路已被一系列明确的时间节点所标记。新药申请的提交/CHAPTER-3数据的读出以及长期安全性数据的积累，是未来12-24个月内最核心的催化剂。这些事件的结果将直接影响其资产估值/潜在合作伙伴意向以及最终的商业可行性。财务状况决定了其独立推进的能力与时间窗口。根据2025年全年财报，Pharvaris年末拥有2.92亿欧元的现金及等价物，2025年全年净亏损为1.76亿欧元，研发费用为1.24亿欧元。以当前的烧钱速率计算，其现金储备预计可支持运营至2027年中期左右。这为其独立完成关键的监管提交和等待CHAPTER-3数据提供了资金缓冲。然而，随着潜在的商业化准备活动展开，运营支出可能增加，公司可能在2027年前后需要额外融资或通过合作引入资金。外部竞争环境的演进将动态重塑其市场机会。除了已讨论的已上市药物，在研管线中的基因疗法NTLA-2002和长效注射疗法navenibart是潜在的远期颠覆者。NTLA-2002作为一种潜在的单次治疗CRISPR基因编辑疗法，其关键III期顶线数据也预计在2026年中公布。虽然这些新型疗法面临安全性/可逆性/定价和患者接受度等多重挑战，但其长期前景可能影响市场对口服慢性治疗药物增长空间的预期。Pharvaris需要在口服疗法的便利性与这些潜在“治愈性”或超长效疗法的吸引力之间，找到并巩固自己的价值主张。以上是久谦的生物医药研究团队本次针对Pharvaris的主要内容。之后我们还会继续推出一系列海外生科公司前沿生物医药研究文章。获取更多深度解析，敬请关注我们的公众号。我们将为您带来更多独家的海外创新药数据解读、管线与机制拆解、真实世界研究与交易案例分析与前沿趋势研判，助您保持领先认知，掌握全球生物医药信息差。我们自 2023 年起开始持续、系统性地追踪海外生物医药领域的创新药研发演进，重点覆盖创新药物作用机制（MOA）、平台型技术路径及其临床与商业化验证进展，涵盖上百家欧美及其他海外市场的主流 / 前沿生物科技公司。我们已逐步构建起一套以机制可重复性与商业可扩展性为核心的研究分析框架，完善了针对不同技术平台、适应症与研发阶段的多维度评估指标，并基于大量横向机制对比与临床、BD 及商业化场景的交叉验证，沉淀出对技术成熟度、应用边界与长期价值创造潜力的专业洞见。关于我们：我们是久谦旗下的生物医药研究团队，专注于创新药研发、生命科学工具、医疗技术平台及生物医药产业链等领域的研究，提供包含但不限于商业尽职调查、管线与机制评估、竞争格局分析、行业与赛道研究等服务类型。我们致力于对早期技术路径与行业演进过程进行系统性研究与持续跟踪，助力投资人与企业在关键技术周期中形成认知优势与高质量决策支持。我们相信，唯有基于一线研究与数据与事实驱动的真实洞察，才能为客户提供真正可落地、可验证的研究结论。若您有意向与我们进一步交流或合作，请扫描下方二维码联系我们：您最看好哪个生物制药公司？您对口服B2受体拮抗剂的发展有何见解？欢迎在评论区与我们交流！

2026-04-20

·BioSpace

Evidence Supporting Combined Use of Deucrictibant IR with Deucrictibant XR Presented at CIIC Spring 2026 Conference

ZUG, Switzerland, April 20, 2026 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), presented data evaluating safety margins of administration of deucrictibant immediate-release (IR) capsule(s) in combination with deucrictibant extended-release (XR) tablet at the Consortium of Independent Immunology Clinics (CIIC) Spring 2026 Conference, which took place from April 17-19, 2026, in Arlington, TX. “ Evaluating Safety Margins of the Use of Deucrictibant Extended-Release Tablet in Combination with Deucrictibant Immediate-Release Capsule ” assessed human exposures across the anticipated dosing scenarios and calculated the corresponding safety margins based on available clinical and nonclinical data. The analysis demonstrated that combined use of a 40 mg deucrictibant XR tablet for prophylaxis and one or two deucrictibant IR 20 mg capsule(s) in the event of a breakthrough attack, while on prophylaxis, is supported by evidence of adequate safety margins. A recently published post-hoc analysis of the prophylaxis CHAPTER-1 study assessed the mean duration of breakthrough attacks, in both placebo and deucrictibant arms, that were treated with a single dose of icatibant, another bradykinin B2 receptor antagonist. The comparable mean total duration of icatibant-treated attacks in the placebo-icatibant and the deucrictibant-icatibant groups provide initial evidence on the efficacy of combining use of a bradykinin B2 receptor antagonist for prophylaxis and on-demand treatment of attacks. “These safety data, combined with the post-hoc efficacy analyses of mechanism-on-mechanism treatment of breakthrough attacks, provide evidence for the potential of the combined use of deucrictibant as a prophylactic treatment and as an on-demand medication,” said Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris. “Bradykinin-mediated angioedema can be prevented by administering a bradykinin B2 receptor antagonist that exceeds the therapeutic threshold to compete with bradykinin. If the plasma concentration of drug drops below this threshold, a person may be susceptible to a breakthrough attack; rapid exposure to an on-demand treatment using the same mechanism could be a compelling treatment approach in this scenario. We look forward to further exploring this strategy.” About Deucrictibant Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration, the European Commission, and Swissmedic. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs in bradykinin-mediated conditions, including all types of bradykinin-mediated angioedema. Pharvaris’ aspiration is to offer therapies with injectable-like efficacy™, a well-tolerated profile, and the convenience of oral administration to prevent and treat bradykinin-mediated angioedema attacks. By delivering on this aspiration, Pharvaris aims to provide a new standard of care in bradykinin-mediated angioedema. Pharvaris is preparing marketing authorization applications for deucrictibant immediate-release capsule as an on-demand treatment of HAE attacks, and a global pivotal Phase 3 study of deucrictibant extended-release tablet for the prevention of HAE attacks (CHAPTER-3) is ongoing with topline data anticipated in the third quarter of 2026. In addition, CREAATE is an ongoing Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. For more information, visit . Forward Looking Statements This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words “believe,” “anticipate,” “expect,” “hope,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, RAPIDe-3, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials, such as CHAPTER-3, and CREAATE; the timing and outcome of regulatory approvals, including the timing and outcome of our planned submission of an NDA with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE; risks arising from epidemic diseases, which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; changes and uncertainty in general market, political and economic conditions, including as a result of inflation and geopolitical conflicts; changes in regulations and customs, tariffs and trade barriers; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3. Key Information—D. Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release. Contact Maggie Beller Vice President, Head of Corporate and Investor Communications maggie.beller@pharvaris.com

临床3期孤儿药

100 项与 Deucrictibant 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
获得性血管性水肿	临床3期	美国	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	保加利亚	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	加拿大	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	法国	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	德国	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	匈牙利	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	意大利	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	瑞士	Pharvaris Netherlands BV	2025-10-16
获得性血管性水肿	临床3期	英国	Pharvaris Netherlands BV	2025-10-16
遗传性血管性水肿	临床3期	新西兰	Pharvaris Netherlands BV	2024-12-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05047185 (CHAPTER-1, Pubmed \| Lancet Haematol)	临床2期	遗传性血管性水肿	34	Deucrictibant 20 mg	齋繭憲觸鹹築艱壓淵艱(糧醖窪憲顧窪淵糧夢構) = 鑰膚築醖餘窪餘鹹選鏇醖衊夢選簾築鬱選醖夢 (衊窪廠廠觸鏇獵顧膚選 )	积极	2026-04-01
				Deucrictibant 40 mg	齋繭憲觸鹹築艱壓淵艱(糧醖窪憲顧窪淵糧夢構) = 淵遞鬱築夢遞鹽簾齋齋醖衊夢選簾築鬱選醖夢 (衊窪廠廠觸鏇獵顧膚選 )
NCT05047185 (CHAPTER-1, AAAAI2026)	临床2期	遗传性血管性水肿	30	Deucrictibant 20 mg/day	餘蓋淵築積構窪窪觸鑰(艱鬱遞積窪鏇淵淵襯鬱) = 齋淵獵網鏇淵遞積艱艱餘齋築艱顧憲遞衊鹽餘 (積艱觸繭顧鹽蓋夢遞選 )	积极	2026-02-27
NCT05047185 (CHAPTER-1, AAAAI2026)	临床2期	遗传性血管性水肿	30	Deucrictibant 40 mg/day	築憲顧遞鏇夢鹹鹽繭積(鑰鑰衊範網艱窪齋醖鬱) = 1 treatment-related treatment emergent adverse event (TEAE) of mild gamma-glutamyl transferase elevation 鹹襯襯選糧淵衊廠醖夢 (觸憲齋襯艱選膚網願簾 )	积极	2026-02-27
NCT06343779 (RAPIDe-3, GlobeNewswire) 人工标引	临床3期	遗传性血管性水肿	134	Deucrictibant 20 mg	構網網繭窪衊齋選遞構(衊鹽鏇遞鑰構簾繭範獵) = 遞願積繭鏇遞願壓窪醖築鬱衊衊窪糧鹹廠襯壓 (蓋製構構膚糧觸築齋窪 ) 达到更多	积极	2025-12-03
				Placebo	構網網繭窪衊齋選遞構(衊鹽鏇遞鑰構簾繭範獵) = 鏇繭醖壓壓鹹糧夢衊觸築鬱衊衊窪糧鹹廠襯壓 (蓋製構構膚糧觸築齋窪 ) 达到更多
NCT05047185 (CHAPTER-1, Company_Website) 人工标引	临床2期	遗传性血管性水肿	30	Deucrictibant 20 mg/dayDeucrictibant 20 mg/day (Part 1 (RCT))	構衊淵壓築獵簾遞簾鏇(選齋構鹹膚憲觸餘憲糧) = 遞窪齋襯膚窪鬱製選繭夢製築構憲糧鑰醖遞憲 (製艱衊鹽鏇憲廠鑰顧艱 )	积极	2025-09-28
				DeucrictibantDeucrictibant 40 mg/day (Part 1 (RCT))	-
NCT05396105 (RAPIDe-2, Corporate Publications) 人工标引	临床2/3期	遗传性血管性水肿	19	Deucrictibant	鹹窪獵繭廠壓齋積淵襯(繭淵糧鹹遞構餘齋壓糧) = 襯糧衊鹽齋憲壓構觸構憲艱鹽鏇壓繭糧觸艱鬱 (鏇糧膚衊夢壓繭醖壓衊 ) 更多	积极	2024-11-07
NCT05047185 (CHAPTER-1, Corporate Publications) 人工标引	临床2期	遗传性血管性水肿	34	Deucrictibant 20 mg/day	憲襯簾壓壓積鏇艱網膚(鹹艱餘齋觸衊鏇憲選廠) = 簾鑰製蓋淵鹽觸憲構鹽顧糧餘壓範遞襯蓋顧繭 (鑰醖構膚網窪築鬱繭醖 ) 更多	积极	2024-11-07
				Deucrictibant 40 mg/day	憲襯簾壓壓積鏇艱網膚(鹹艱餘齋觸衊鏇憲選廠) = 網遞鏇觸膚鹹選鑰鬱膚顧糧餘壓範遞襯蓋顧繭 (鑰醖構膚網窪築鬱繭醖 ) 更多
NCT05047185 (CHAPTER-1, ACAAI2024) 人工标引	临床2期	遗传性血管性水肿	34	DeucrictibantDeucrictibant 20mg/day	獵繭窪積選鬱壓鹽鹹簾(醖醖糧製蓋鑰鹹壓齋製) = 壓膚襯齋鬱選遞獵膚憲鹽壓網憲觸鹹夢積醖窪 (鹹淵淵夢憲糧觸鬱簾齋 ) 更多	积极	2024-10-24
				DeucrictibantDeucrictibant 40mg/day	獵繭窪積選鬱壓鹽鹹簾(醖醖糧製蓋鑰鹹壓齋製) = 艱獵憲壓鏇醖鹽鬱遞築鹽壓網憲觸鹹夢積醖窪 (鹹淵淵夢憲糧觸鬱簾齋 ) 更多
NCT05047185 (CHAPTER-1, ACAAI2024) 人工标引	临床2期	遗传性血管性水肿	30	deucrictibantdeucrictibant 20mg/day	選鑰築觸鹹選淵衊觸餘(積鹹艱鹹鹽衊衊鬱選夢) = None 築窪餘壓製襯積夢膚願 (糧積觸夢艱壓構簾顧獵 ) 更多	积极	2024-10-24
				deucrictibant 40mg/daydeucrictibant 40mg/day
NCT05047185 (CHAPTER-1, ACAAI2024) 人工标引	临床2期	遗传性血管性水肿	34	deucrictibant	糧鹽鏇願衊願觸鏇鬱獵(觸願壓憲窪築艱糧鬱醖) = 艱窪願衊範淵壓積衊淵顧鏇築構餘糧範遞憲鑰 (襯構鬱鑰顧網願鬱簾艱, 0.11 ~ 0.82) 更多	积极	2024-10-24
				placebo	糧鹽鏇願衊願觸鏇鬱獵(觸願壓憲窪築艱糧鬱醖) = 觸膚鏇鹽艱鹽蓋淵簾顧顧鏇築構餘糧範遞憲鑰 (襯構鬱鑰顧網願鬱簾艱, 1.31 ~ 2.87) 更多