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iloprost (CiVi 030 / CIVI030 / Civi 030)

✓ Approved

SERB Pharmaceuticals · PTGIR · 小分子

什么是 iloprost？

iloprost 是一种小分子，由SERB Pharmaceuticals研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intravenous (IV)。

药物档案

商品名CiVi 030, CIVI030, Civi 030
公司SERB Pharmaceuticals
药物类别小分子
分子靶点PTGIR
给药途径Injectable (Others), Intravenous (IV)
状态Approved
来源： ClinicalTrials.gov, SERB Pharmaceuticals

作用机制

分子靶点

iloprost 作用于 1 个分子靶点：

PTGIRprostaglandin I2 receptor (IP, PRIPR)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

iloprost 针对 3 个适应症，涉及 3 个治疗领域。

治疗领域疾病/病症分期
Injury, poisoning and procedural complicationsFrostbite✓ Approved
Vascular disordersRaynaud's phenomenonPhase III
Musculoskeletal and connective tissue disordersSclerodermaPhase III

相关研究文献

PubMedJournal of medicinal chemistry2026-07-27

Synthesis, Modeling, and Biological Properties of Fluoroprostacyclin Analogues: Potent Agonists for Prostanoid Receptors.

Jing Changcheng C, Perez-Powell Isabel I, Baars Hannah H, Mallah Shahida S et al.

Prostacyclin (PGI2, epoprostenol) and its more stable analogues iloprost and cicaprost are used in the treatment of pulmonary arterial hypertension (PAH) and other related diseases. Currently, PGI2 therapy is the most effective treatment for PAH, but is administered intravenously due to its instability under physiological conditions. We considered creating more chemically stable hybrids of PGI2 by merging essential features of iloprost/cicaprost with a more stable C-7 fluorinated PGI2, which maintained the cyclic enol ether. The synthesis employed our key bicyclic enal and furnished the required PGI2 analogues in just 7-8 steps, providing the most expedient route to this class of molecules. This led to the discovery of compound 9, a picomolar-potent, IP receptor-selective, and chemically stable PGI2 analogue that combined the ω-side chain of cicaprost with the C-7 difluorinated enol ether of PGI2. This compound provides the most potent PGI2 analogue tested to date.

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PubMedTherapeutic advances in hematology2026-07-27

Plain language summary: How safe and effective is long-term treatment with intravenous plasminogen concentrate for people with type 1 plasminogen deficiency?

Shapiro Amy D AD, McDaniel Heather H, Decker Robert W RW, Nakar Charles C et al.

What is this study about? Type 1 plasminogen deficiency (PLGD-1 for short) is a long-term, ultra-rare condition where the body does not make enough of a protein called plasminogen. This can cause thick layers made of a fibrous, insoluble protein called fibrin (known as lesions) to develop in different parts of the body. Intravenous plasminogen concentrate (IV PLG concentrate for short, also known as RYPLAZIM®) is the first medicine approved to treat this condition. It works by replacing plasminogen in the body. In this study, adults and children with PLGD-1 received long-term treatment with IV PLG concentrate. They had already received IV PLG concentrate before, as part of the clinical trial that led to the approval of the treatment, or through the expanded access programs. The researchers wanted to know how safe and effective long-term treatment with IV PLG concentrate was. They also wanted to explore whether giving IV PLG concentrate more or less often would affect how well the treatment worked. What were the results? Study participants had no new lesions associated with PLGD-1 or return of previous lesions when they received the treatment as prescribed. Some participants had previous lesions come back when they received the treatment less often than prescribed. These lesions rapidly improved or went away again when they started more frequent treatment, as originally prescribed. Most of the adverse events that participants experienced were classified as mild, and none were related to the study treatment. What do the results mean? Overall, long-term treatment with IV PLG concentrate is effective for people living with PLGD-1 and is well tolerated. Treatment with IV PLG concentrate can be personalized to meet people's individual needs. What is the purpose of this plain language summary? The purpose of this plain language summary is to help you understand the findings from recent research. Where can I find the original article on which this summary is based? You can read the original article titled 'Safety and efficacy of long-term treatment of type 1 plasminogen deficient patients with intravenous plasminogen replacement therapy' published in the journal Haemophilia for free at: https://doi.org/10.1111/hae.70019 Who sponsored the study and this summary? The study was sponsored by Prometic Biotherapeutics Inc., currently Kedrion Biopharma Inc. This summary was sponsored by Kedrion Biopharma Inc. Who is this summary for? This summary may be of interest to people living with PLGD-1, their families, and caregivers. Patient advocates, patient organizations, healthcare professionals, and funders of healthcare services may also find this summary useful.

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PubMedFrontiers in pharmacology2026-07-23

Pharmacovigilance assessment of gout: a real-world study using the FAERS database.

Ren Honghao H, Yao Nannan N, Ren Xiaodong X, Su Yani Y et al.

Drug intervention is a key method for preventing gout, various drugs have been implicated as potential risk factors in individual studies. This study aims to comprehensively identify drugs linked to the development of gout. Data were obtained from the FDA Adverse Event Reporting System (FAERS), and disproportionality analysis was employed to quantitatively assess the associations between drugs and gout. Four complementary signal detection methods-Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)-were utilized. To further delineate exposure-outcome relationships and identify influential predictors, least absolute shrinkage and selection operator (LASSO) logistic regression was implemented. Time-to-onset (TTO) analysis was conducted to examine the temporal dynamics between drug initiation and the occurrence of gout. Finally, a comprehensive assessment of the therapeutic indications of the drugs was performed. A total of 35 drugs were ultimately identified as potentially associated with the onset and progression of gout. Among these, several agents have been previously reported in the literature as having possible links to gout development. In addition, a number of novel candidates were detected for which evidence of an association with gout remains limited or has not been clearly established. These include Lenalidomide, Sacubitril valsartan, Ruxolitinib, Treprostinil, Octreotide, Selexipag, Rosuvastatin, Sitagliptin, Riociguat, Epoprostenol, Patiromer, Dasabuvir ombitasvir paritaprevir ritonavir, Tafamidis, Sparsentan, and Iloprost. Furthermore, TTO analysis suggested that approximately 75% of gout events occurred within 0.6 years following initiation of therapy. These pharmacotherapeutic agents are employed across diverse clinical settings, encompassing haematological malignancies, cardiovascular diseases, and pulmonary hypertension. These findings suggest the potential for targeted monitoring of drug-associated gout in clinical practice. When administering these medications, it may be crucial to regularly assess patients' uric acid levels and maintain heightened awareness for the possible onset of gout.

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PubMedmAbs2026-07-15

Setting expectations for current and future directions of native mass spectrometry in the biopharmaceutical industry.

Hecht Elizabeth E, Martin Esther E, Liko Idlir I, Mahan Andrew A et al.

While native mass spectrometry (native-MS) has been widely explored in academic laboratories, its practical role within biopharmaceutical research remains less clearly defined. In this perspective, we present an industry-driven view of how native-MS is currently applied, where it offers unique advantages over established analytical technologies, and where alternative methods remain more practical for routine characterization. Within biopharma workflows, characterization strategies traditionally rely on orthogonal techniques such as size-exclusion chromatography (SEC), ion-exchange chromatography (IEX), electrophoresis, light scattering, calorimetry, and denaturing liquid chromatography (LC) MS. Native-MS complements these methods by enabling direct assessment of intact molecular assemblies, including monoclonal antibodies (mAbs), multispecific antibodies, antibody-drug conjugates (ADCs), glycoproteins, and protein complexes. Applications include evaluation of higher-order assembly, ligand or cofactor binding, stoichiometry of target complexes, and heterogeneity that may be obscured under denaturing conditions. However, challenges related to throughput, sensitivity, automation, and accessibility have limited widespread adoption in industrial laboratories. Emerging developments, including chromatographic hyphenation, online buffer exchange (OBE), improved automation, and charge-detection MS (CDMS), are beginning to address these constraints. We argue that the future impact of native-MS in biopharma will depend on integrating these technological advances with platformed analytical workflows and software capable of supporting high-throughput characterization across therapeutic pipelines. We hope that the ideas raised in this article spur debate on when, how, and if native-MS would or should see increased adoption.

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Regulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.

Liebes-Peer Yael Y, Czeisler Shlomo S, Broderick Rachel R, Vecsler Manuela M et al.

Artificial intelligence (AI)-enabled software is increasingly integrated into digital and computational pathology, driving new regulatory and quality management requirements that extend beyond traditional laboratory practice and classical medical-device oversight. Practical, experience-based guidance on balancing development agility with global regulatory readiness remains limited for biomarker developers and translational pathologists navigating the convergence of AI governance, cybersecurity, and regulated clinical deployment. We reviewed our multi-year regulatory, quality, information security management program, and software lifecycle artifacts associated with AI-based diagnostic software development across multiple jurisdictions. Documentation, change control processes, and internal coordination mechanisms were analyzed to identify structural patterns supporting parallel progress in regulatory submissions, product releases, and assurance infrastructure. Our assessment consistently showed four transferable operational determinants to maintain iterative development while preserving regulatory readiness across jurisdictions: (1) Regulatory submissions and approvals (e.g., IVDR, FDA clearance); (2) product releases and lifecycle control; (3) quality and assurance infrastructure, including quality management system (QMS) certifications (e.g., ISO 13485, MDSAP); and (4) cybersecurity and information security certifications (e.g., ISO 27001, HITRUST, and C5). Together, these determinants enabled coordination of regulatory, release, and quality milestones in parallel, reducing friction at later submission stages and supporting synchronized readiness across jurisdictions. This technical note presents a transferable framework for managing AI-based pathology software development in regulated environments. High-quality deployment requires more than model performance alone; it depends on technical, regulatory, and operational maturity across many dimensions, including change control, documentation, security-aligned quality systems, post-market surveillance, technical support, and workflow integration. The presented framework is directly relevant to computational scientists, pathologists, and laboratory/medical directors tasked with evaluating AI systems by supporting informed evaluation and adoption decisions, including procurement considerations, in clinical and biopharma settings.

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PubMedJournal of burn care & research : official publication of the American Burn Association2026-07-08

A Protocolized Intravenous Epoprostenol Pathway for Frostbite: A Canadian Burn Centre Quality Improvement and Implementation Report.

Natanson Rimona R, Adibfar Alex A, Au Anita A, Tillman Bourke B et al.

Severe frostbite is a dynamic microvascular injury that can progress to delayed tissue loss despite appropriate initial care. Contemporary management emphasizes rapid rewarming, antithromboxane therapy, clinical grading, selective thrombolysis, and prostacyclin-based treatment. Iloprost is the prostacyclin analogue most often described, but access may be delayed in some Canadian settings. We developed and implemented a monitored intravenous epoprostenol pathway for Cauchy grade 2 to 4 frostbite and retrospectively evaluated 23 patients treated between December 2017 and November 2025. The pathway incorporated rapid rewarming, grading, topical and systemic antithromboxane therapy, eligibility criteria, dose titration, physiologic monitoring, dose modification, multidisciplinary care, and follow-up. Overall, 153 of 216 affected digits were preserved. Preservation varied by severity: 62 of 65 grade 2 digits, 74 of 100 grade 3 digits, and 7 of 41 grade 4 digits were preserved. Twelve patients avoided amputation altogether. Mean treatment duration was 3.8 days, and most patients reached 8 ng/kg/min at least once. Documented adverse effects or dose-limiting symptoms occurred in nine patients and were managed with dose reduction or temporary interruption. Available records did not identify thrombolytic therapy, permanent discontinuation for adverse reaction or grade 2 reassessment, or serious drug-attributed adverse events. Protocol-guided intravenous epoprostenol was feasible and generally well tolerated. Findings should be interpreted as descriptive and hypothesis-generating rather than evidence of treatment efficacy.

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