更新于：2024-10-16
Deucrictibant
更新于：2024-10-16
概要
基本信息
药物类型 小分子化药 |
别名 PHA 121、PHA-022121、PHVS-416 + [3] |
作用机制 B2 receptor拮抗剂(缓激肽B2受体拮抗剂) |
非在研适应症- |
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
结构
分子式C25H23ClF3N5O3 |
InChIKeyZTCLCSCHTACERP-SRSCGJFZSA-N |
CAS号2340111-58-0 |
关联
18
项与 Deucrictibant 相关的临床试验- PHA022121-C020
开始日期2024-06-18 |
申办/合作机构 |
A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults with Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE.
开始日期2024-02-26 |
申办/合作机构 |
An open-label, multiple dose study to compare the single-dose and steady-state pharmacokinetics of a 40 mg PHA-022121 extended-release (XR) tablet administered once daily between healthy Japanese, Chinese, and Caucasian volunteers.
开始日期2023-09-25 |
申办/合作机构 |
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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4
项与 Deucrictibant 相关的文献（医药）2024-09-01·Clinical and Translational Allergy
Advent of oral medications for the treatment of hereditary angioedema
Review
作者: Caballero, Teresa ; Frade, Joao P. ; Audhya, Paul K. ; Valerieva, Anna ; Magerl, Markus ; Craig, Timothy
Abstract:
Background:
Hereditary angioedema (HAE) is a rare genetic disorder characterized by unpredictable, debilitating episodes of submucosal and/or subcutaneous tissue swelling, which may be life‐threatening depending on anatomic location. The two primary management strategies for HAE are ready access to effective on‐demand treatment in all patients and the prevention of attacks (short‐term prophylaxis [STP] and long‐term prophylaxis [LTP]) in appropriate patients. All approved on‐demand and most LTP medications require subcutaneous or intravenous administration. Injection‐related challenges include trypanophobia (fear of needles), difficulty with self‐administration, injection‐site reactions (e.g., pain, erythema, bleeding, bruising), and anxiety—all contributing to poor compliance and administration delays. Oral HAE treatments may improve outcomes by reducing treatment barriers.
Aim:
To review oral therapies, approved or in development, for on‐demand treatment and/or prevention of HAE attacks.
Materials and Methods:
To provide a comprehensive review, data was obtained from publicly available resources through a targeted PubMed literature review and supplemented by information provided on company websites (search cutoff of May 31, 2024).
Results:
Berotralstat, an oral plasma kallikrein (PKa) inhibitor, is approved for LTP. Sebetralstat, another PKa inhibitor, is the investigational first oral on‐demand HAE treatment to complete a phase 3 trial. Deucrictibant, an oral bradykinin B2 receptor antagonist, has completed phase 2 trials for on‐demand therapy and LTP. Several other oral PKa inhibitors (ATN249, VE‐4666, and VE‐4062) are in early development for LTP.
Conclusion:
Substantial advances have been made in the development of oral treatments for HAE. These treatments have the potential to improve and optimize clinical outcomes, satisfaction, and quality of life among patients with HAE.
2024-07-01·The Journal of allergy and clinical immunology
Deucrictibant for angioedema due to acquired C1-inhibitor deficiency: A randomized-controlled trial
Article
作者: Kelder, Johannes P ; Petersen, Remy S ; Cohn, Danny M ; Fijen, Lauré M
BACKGROUND:
Angioedema due to acquired C1-inhibitor deficiency is a very rare but serious disease, with an estimated prevalence of 1 per 500,000 persons. There are no approved therapies to treat or prevent angioedema swelling in patients with this condition. Deucrictibant is a specific, orally bioavailable, competitive antagonist of the bradykinin B2 receptor currently under investigation for hereditary angioedema.
OBJECTIVE:
Our aim was to assess the efficacy and safety of deucrictibant as acute and prophylactic treatment for angioedema due to acquired C1-inhibitor deficiency.
METHODS:
A 2-part, randomized, double-blind, placebo-controlled crossover study was conducted. In Part 1, 4 consecutive angioedema attacks were treated with 3 doses of deucrictibant (10 mg, 20 mg, and 30 mg) or placebo. In Part 2, deucricibant, 20 mg, or placebo was administered twice daily for 2 treatment periods of 8 weeks.
RESULTS:
Three patients were enrolled; of those 3 patients, 1 completed both study parts and 2 completed only Part 2. In Part 1, a reduction in attack severity was observed in the 3 attacks treated with deucrictibant as opposed to an increase in severity of the attack treated with placebo. In Part 2, the individual mean monthly attack rates were 2.0, 0.6, and 1.0 during the placebo period and 0.0 across all patients during treatment with deucrictibant. There were no severe adverse events and 1 self-limiting treatment-emergent adverse event (abdominal pain).
CONCLUSIONS:
Deucrictibant has the potential to effectively and safely treat and prevent angioedema attacks due to acquired C1-inhibitor deficiency.
2022-04-01·International immunopharmacology2区 · 医学
In vitro pharmacological profile of PHA-022121, a small molecule bradykinin B2 receptor antagonist in clinical development
2区 · 医学
Article
作者: Pardali, Evangelia ; Gibson, Christoph ; Loenders, Brigitte ; Katzer, Werner ; Ambrosi, Horst-Dieter ; Lesage, Anne ; Saupe, Jörn ; Marceau, François ; Faussner, Alexander ; Knolle, Jochen
PHA-022121 is a novel small molecule bradykinin B2 receptor antagonist, in clinical development for the treatment and prevention of hereditary angioedema attacks. The present study describes the in vitro pharmacological characteristics of PHA-022121 and its active metabolite, PHA-022484 (M2-D). In mammalian cell lines, PHA-022121 and PHA-022484 show high affinity for the recombinant human bradykinin B2 receptor with Ki values of 0.47 and 0.70 nM, respectively, and potent antagonism of the human bradykinin B2 receptor with Kb values of 0.15 and 0.26 nM, respectively (calcium mobilization assay). Antagonist potency at the recombinant cynomolgus monkey bradykinin B2 receptor is similarly high (Kb values of 1.42 and 1.12 nM for PHA-022121 and PHA-022484, respectively), however, potency at rat, mouse, rabbit and dog bradykinin B2 receptors is at least 100-fold lower than the potency at the human receptor for both compounds. In the human umbilical vein contractility assay, both PHA-022121 and PHA-022484 show a potent, surmountable and reversible B2 antagonist activity with pA2 values of 0.35 and 0.47 nM, respectively. The in vitro off-target profile of PHA-022121 and PHA-022484 demonstrates a high degree of selectivity over a wide range of molecular targets, including the bradykinin B1 receptor. It is concluded that PHA-022121 is a novel, low-molecular weight, competitive antagonist of the human bradykinin B2 receptor with high affinity, high antagonist potency, and high selectivity. It is about 20-fold more potent than icatibant at the human bradykinin B2 receptor as assessed using recombinant or endogenously expressed receptors.
80
项与 Deucrictibant 相关的新闻（医药）2024-10-16
ZUG, Switzerland, Oct. 16, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced the acceptance of multiple abstracts at several upcoming scientific meetings. Presentation details are as follows: American College of Allergy, Asthma, & Immunology’s Annual Scientific Meeting (ACAAI), Boston, October 24-28, 2024. Seven abstracts have been accepted for e-Poster presentation: Poster: Long-Term Safety and Efficacy of Oral Deucrictibant for Hereditary Angioedema Prophylaxis: CHAPTER-1 Open-Label Extension StudySpeaker: John Anderson, M.D. Format: e-Poster (R102)Date, Time: Friday, Oct. 25, 2:00-2:15 p.m. EDTLocation: Monitor 21, Exhibit Hall A Poster: Long-Term Treatment of Hereditary Angioedema Attacks With Oral Deucrictibant: RAPIDe-2 Extension Study ResultsSpeaker: John Anderson, M.D. Format: e-Poster (R103)Date, Time: Friday, Oct. 25, 2:15-2:30 p.m. EDTLocation: Monitor 21, Exhibit Hall A Poster: Development Of A Novel Kinin Biomarker Assay For Characterization Of Bradykinin-Mediated DisordersSpeaker: Evangelia Pardali, Ph.D.Format: e-Poster (R088)Date, Time: Friday, Oct. 25, 2:30-2:45 p.m. EDTLocation: Monitor 20, Exhibit Hall A Poster: Development of a HMWK Capillary Immunoblotting Assay for Characterization of Bradykinin-Mediated DisordersSpeaker: Evangelia Pardali, Ph.D.Format: e-Poster (R090)Date, Time: Friday, Oct. 25, 3:00-3:15 p.m. EDTLocation: Monitor 20, Exhibit Hall A Poster: The Bradykinin Challenge Model In Non-Human Primates Successfully Predicted Efficacious Doses of Deucrictibant in HumansSpeaker: Juan Bravo, Ph.D.Format: e-Poster (R112)Date, Time: Friday, Oct. 25, 4:30-4:45 p.m. EDTLocation: Monitor 21, Exhibit Hall A Poster: CHAPTER-1 Phase 2 Trial of Oral Bradykinin B2 Receptor Antagonist Deucrictibant for Hereditary Angioedema Prophylaxis Speaker: H. James Wedner, M.D.Format: e-Poster (R100)Date, time: Friday, Oct. 25, 5:30-5:45 p.m. EDTLocation: Monitor 20, Exhibit Hall A Poster: Prophylactic Treatment With Oral Deucrictibant Improves Hereditary Angioedema Disease Control and Health-Related Quality of LifeSpeaker: H. James Wedner, M.D.Format: e-Poster (R101)Date, Time: Friday, Oct. 25, 5:45-6:00 p.m. EDTLocation: Monitor 20, Exhibit Hall A Canadian Society of Allergy and Clinical Immunology (CSACI), Banff, Alberta, Canada, November 6-9, 2024. Three abstracts have been accepted for poster presentation. Poster: Efficacy and Safety of Oral Deucrictibant, a Bradykinin B2 Receptor Antagonist, in Prophylaxis of HAE Attacks: Results of CHAPTER-1 Phase 2 Trial Speaker: William H. Yang, M.D., FRCPC, FAAAAIFormat: PosterDate, Time: Thursday, Nov. 7, 12:30-1:00 p.m. MST (2:30-3:00 p.m. EST) and Friday, Nov. 8, 1:30-2:00 p.m. MST (3:30-4:00 p.m. EST) Poster: Long-term safety and efficacy of oral deucrictibant, a bradykinin B2 receptor antagonist, for prophylaxis in HAE: CHAPTER-1 extension study results Speaker: William H. Yang, M.D., FRCPC, FAAAAIFormat: PosterDate, Time: Thursday, Nov. 7, 12:30-1:00 p.m. MST (2:30-3:00 p.m. EST) and Friday, Nov. 8, 1:30-2:00 p.m. MST (3:30-4:00 p.m. EST) Poster: Long-term efficacy and safety of oral bradykinin B2 receptor antagonist deucrictibant in treatment of HAE attacks: RAPIDe-2 extension study results Speaker: Hugo Chapdelaine, M.D., FRCPCFormat: PosterDate, Time: Thursday, Nov. 7, 12:30-1:00 p.m. MST (2:30-3:00 p.m. EST) and Friday, Nov. 8, 1:30-2:00 p.m. MST (3:30-4:00 p.m. EST) Japanese Society of Allergology (JSA), Kyoto, Japan, October 18-20, 2024. One abstract has been accepted for oral presentation. Presentation: Efficacy and safety of oral deucrictibant IR capsule in HAE: RAPIDe-3 phase 3 trial designSpeaker: Prof. Michihiro Hide, M.D., Ph.D.Format: Oral PresentationDate, Time: Sunday, Oct. 20, 13:30-14:45 JST (12:30 -1:45 a.m. EDT) The presentation slides and posters will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. About Pharvaris Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of bradykinin-mediated angioedema effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both prophylactically and on-demand. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks in the coming months. For more information, visit https://pharvaris.com/.
临床2期临床3期临床结果
2024-10-15
ZUG, Switzerland, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced it will host a virtual investor event to discuss the unmet need in both the prophylactic and on-demand treatment of HAE attacks, the potential of deucrictibant to address to needs, and the current HAE market dynamics, on Wednesday, October 23, 2024, at 10:00 a.m. ET/16:00 CET. To register, click here. Presenters of the event are: Michael E. Manning, M.D., Allergy, Asthma & Immunology Associates, LTDRaffi Tachdjian, M.D., MPH, David Geffen School of Medicine at the University of California, Los Angeles (UCLA)Berndt Modig, Chief Executive Officer of PharvarisPeng Lu, M.D., Ph.D., Chief Medical Officer of PharvarisWim Souverijns, Ph.D., Chief Commercial Officer of Pharvaris A live question and answer session will follow the formal presentations. Following the live event, an archived replay will be available for at least 30 days after the event. About PharvarisPharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of bradykinin-mediated angioedema effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both prophylactically and on-demand. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks in the coming months. For more information, visit https://pharvaris.com/.
临床3期临床2期
2024-10-03
ZUG, Switzerland, Oct. 03, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced the acceptance of six abstracts, two for oral presentation and four for poster presentation, at the 2024 Global Angioedema Forum – HAEi Global Leadership Workshop, taking place in Copenhagen, Denmark, from Oct. 4-5, 2024. Details are as follows: Title: Long-Term Safety and Efficacy of Oral Deucrictibant, a Bradykinin B2 Receptor Antagonist, for Prophylaxis in Hereditary Angioedema: Results of the CHAPTER-1 Open-Label Extension StudyPresenter: Marc A. Reidel, M.D., M.S.Format: Oral and PosterDate, time: Oral: Saturday, Oct. 5, Session 5, 9:59 CEST (3:59 a.m. EDT) | Poster: Friday, Oct. 4, 18:00-18:30 CEST (12:00-12:30 p.m. EDT), Poster Walk 1Title: Long-Term Efficacy and Safety of Oral Deucrictibant, a Bradykinin B2 Receptor Antagonist, in Treatment of Hereditary Angioedema Attacks: Results of the RAPIDe-2 Extension StudyPresenter: Anna Valerieva, M.D., Ph.D.Format: Oral and PosterDate, time: Oral: Saturday, Oct. 5, Session 5, 10:08 CEST (4:08 a.m. EDT) | Friday, Oct. 4, 18:30-19:00 CEST (12:30-1:00 p.m. EDT), Poster Walk 4Title: Efficacy and Safety of Oral Deucrictibant, a Bradykinin B2 Receptor Antagonist, in Prophylaxis of Hereditary Angioedema Attacks: Results of CHAPTER-1 Phase 2 TrialPresenter: Emel Aygören-Pursun, M.D.Format: Poster Date, time: Friday, Oct. 4, 18:00-18:30 CEST (12:00-12:30 p.m. EDT), Poster Walk 3Title: Prophylactic Treatment With Oral Deucrictibant Improves Health-Related Quality of Life of Patients with Hereditary AngioedemaPresenter: Andrea Zanichelli, M.D., Ph.D.Format: PosterDate, time: Friday, Oct. 4, 18:30-19:00 CEST (12:30-1:00 p.m. EDT), Poster Walk 2Title: Propensity Score-Matched Comparison of Outcomes for Deucrictibant vs. Standard of Care in People Living with Hereditary AngioedemaPresenter: Danny M. Cohn, M.D., Ph.D.Format: PosterDate, time: Friday, Oct. 4, 18:30-19:00 CEST (12:30-1:00 p.m. EDT), Poster Walk 2Title: Design of RAPIDe-3 Phase 3 Trial: Efficacy and Safety of the Oral Bradykinin B2 Receptor Antagonist Deucrictibant Immediate-Release Capsule in Treatment of Hereditary Angioedema AttacksPresenter: Phillip H. Li, MBBS, FRCPFormat: PosterDate, time: Friday, Oct. 4, 18:00-19:00 CEST (12:00-1:00 p.m. EDT), Poster Walk 1 The presentation slides and posters will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. In memory of Prof. Marcus Maurer, Professor of Dermatology and Allergy, Executive Director of the Institute of Allergology at the Charité – Universitätsmedizin Berlin, and Co-Director of Allergology and Immunology at the Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Pharvaris will make a donation to the Marcus Maurer Fellowship Program through GA2LEN, the Global Allergy and Asthma Excellence Network. About PharvarisPharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of bradykinin-mediated angioedema effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both prophylactically and on-demand. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks in the coming months. For more information, visit https://pharvaris.com/.
临床2期临床3期
100 项与 Deucrictibant 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| I型和II型遗传性血管性水肿 | 临床3期 | 法国 | 2022-12-28 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 以色列 | 2022-12-28 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 西班牙 | 2022-12-28 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 美国 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 保加利亚 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 加拿大 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 捷克 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 法国 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 德国 | 2021-02-03 | |
| 遗传性血管性水肿Ⅲ型 | 临床2期 | 匈牙利 | 2021-02-03 |
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临床结果
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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 |
|---|
N/A | - | 齋網獵襯遞壓築範衊網(廠積憲廠齋鬱衊醖鑰膚) = 糧繭鬱壓繭糧鏇窪蓋齋 積願鹹鬱網願網製獵衊 (觸醖顧窪襯夢製餘艱鹹 ) | 积极 | 2024-06-04 | |||
Placebo | 齋網獵襯遞壓築範衊網(廠積憲廠齋鬱衊醖鑰膚) = 廠簾願衊鹹糧鏇衊襯鑰 積願鹹鬱網願網製獵衊 (觸醖顧窪襯夢製餘艱鹹 ) | ||||||
临床2期 | 34 | deucrictibant 20mg | 蓋遞願蓋繭構蓋製蓋壓(簾網蓋鏇積鬱膚築觸襯) = 鏇襯遞繭壓積願觸遞糧 膚網齋蓋積鹽淵網選積 (淵衊艱醖製襯選憲顧築 ) 更多 | 积极 | 2023-12-06 | ||
deucrictibant 40mg | 蓋遞願蓋繭構蓋製蓋壓(簾網蓋鏇積鬱膚築觸襯) = 願壓觸齋鏇糧糧願艱獵 膚網齋蓋積鹽淵網選積 (淵衊艱醖製襯選憲顧築 ) 更多 | ||||||
临床2期 | - | Deucrictibant 10 mg | 鏇齋窪鏇鹹鬱繭簾觸鹹(顧簾獵積淵鹹餘艱鑰夢) = 範觸鬱遞鹹獵鹽醖夢範 廠膚齋壓製膚積範蓋鬱 (淵膚醖範鏇選選築選壓, 25 ~ 59) 更多 | 积极 | 2023-11-09 | ||
Deucrictibant 20 mg | 鏇齋窪鏇鹹鬱繭簾觸鹹(顧簾獵積淵鹹餘艱鑰夢) = 網淵鏇築憲網鏇鹽夢鑰 廠膚齋壓製膚積範蓋鬱 (淵膚醖範鏇選選築選壓, 25 ~ 26) 更多 | ||||||
临床1期 | - | (single ascending doses) | 鹹獵製憲遞壓鹹醖範醖(簾觸糧構顧艱艱鹽觸壓) = 蓋築齋醖遞網繭選鬱襯 窪蓋鑰築夢夢衊鹽觸齋 (簾積襯鏇襯鏇鏇觸獵襯 ) | 积极 | 2022-10-07 | ||
(multiple-ascending doses) | - | ||||||
N/A | - | 網鑰獵積繭網襯衊築選(鬱蓋淵網鏇鬱淵壓蓋觸) = 顧鑰餘願積淵壓鑰憲鹹 範窪顧鬱鏇蓋獵糧鑰鹹 (鏇齋蓋鹽艱觸糧淵艱鹹 ) | - | 2021-02-01 |
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