Drugs / RBD4059
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05653037 | Mar 2023 → Dec 2025 overdue | — | Suzhou Ribo Life Science Co. Ltd. | Active not recruiting | Met primary |
| Phase 21 trial | ||||||
| Phase 2 | NCT06717074 | Aug 2024 → Apr 2026 | coronary artery disorder | Ribocure Pharmaceuticals AB | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Suzhou Ribo Life Science Co. Ltd. | Results 瑞博生物披露全球首个靶向FXI的siRNA药物vortosiran的 IIa 期临床积极数据 ribolia.com ↗
研究结果显示，vortosiran总体耐受性良好，可显著、剂量依赖且持久地抑制 FXI 活性。 |
| 2026-07-22 | Ribocure Pharmaceuticals AB | Results Ribo Discloses Positive Data from Vortosiran Phase 2a Trial – World’s First Clinical Data on siRNA-Mediated FXI Inhibition Following Multiple Dosing in Patients with Coronary Artery Disease ribocure.com ↗ |
| 2026-05-11 | Suzhou Ribo Life Science Co. Ltd. | Regulatory 瑞博生物递交全球首创靶向FXI的siRNA新药vortosiranⅡb临床申请，剑指又一大适应症——静脉血栓栓塞 ribolia.com ↗
今日宣布，公司自主研发的全球首创靶向凝血因子XI(FXI)的siRNA药物vortosiran(RBD4059)已向欧洲药品管理局（EMA）成功递交针对静脉血栓栓塞症（VTE）的Ⅱb期临床试验申请（CTA），申报代号为ORBIT-XI-VTE。 |
| 2026-05-11 | Ribocure Pharmaceuticals AB | Regulatory Ribo Advances Clinical Development of FXI siRNA vortosiran with EMA Phase 2b CTA Submission in Venous Thromboembolism, ORBIT-XI-VTE ribocure.com ↗
Ribo is thereby expanding their anti-thrombotic clinical development of its lead siRNA asset, vortosiran (RBD4059), into the prevention of venous thromboembolism (VTE). |
| 2026-04-14 | Suzhou Ribo Life Science Co. Ltd. | Regulatory 瑞博生物递交全球首创靶向FXI的siRNA新药vortosiran针对房颤的IIb临床试验申请 ribolia.com ↗
苏州瑞博生物技术股份有限公司(6938.HK)及其子公司Ribocure Pharmaceuticals(合称“瑞博生物”)今日宣布，公司自主研发的全球首创靶向凝血因子XI(FXI)的siRNA药物vortosiran(RBD4059)，已成功递交针对心房颤动患者卒中预防(SPAF)的IIb期临床试验申请(CTA)。 |
| 2026-04-14 | Ribocure Pharmaceuticals AB | Regulatory Ribo Submits Phase 2b Clinical Trial Application for world’s first siRNA FXI inhibitor in atrial fibrillation ribocure.com ↗
The submission marks an important milestone in the clinical development of siRNA-based approaches to anticoagulation. |
| 2026-02-09 | Suzhou Ribo Life Science Co. Ltd. | Results 凝血因子XI抑制剂突破性进展推动抗凝治疗革新，瑞博生物siRNA疗法彰显卓越的临床潜力与全球竞争力 ribolia.com ↗ |
| 2026-02-09 | Ribocure Pharmaceuticals AB | Results Recent advances in factor XI (FXI) inhibition are reshaping the landscape of anticoagulation therapy ribocure.com ↗
The results show a robust, dose‑dependent, and durable suppression of FXI activity exceeding 90%. |
| 2025-09-01 | Ribocure Pharmaceuticals AB | Results Ribo showcases new clinical data from its leading siRNA programs at ESC 2025, underscoring significant progress and achievements in advancing cardiovascular therapies ribocure.com ↗
Using deep-phenotyping data in high-risk coronary artery disease patients undergoing percutaneous coronary intervention, Ribo showed that high FXI levels were associated with elevated endothelial activation biomarkers and impaired endothelial function during follow-up after the index event. |
| 2025-02-21 | Ribocure Pharmaceuticals AB | Results Ribo announces the publication of a scientific paper of our liver-targeted siRNA against Factor XI, which is being developed as a potential breakthrough treatment for thrombosis ribocure.com ↗
The results of the current preclinical study show that RBD4059 exhibits potent and long-lasting FXI inhibition in mice and cynomolgus monkeys measured by reduced FXI activity and prolonged aPTT (activated partial thromboplastin time). |
| 2025-02-20 | Suzhou Ribo Life Science Co. Ltd. | Results 瑞博生物靶向Factor XI的抗血栓小核酸药物RBD4059的临床前研究数据在心血管权威期刊发表 ribolia.com ↗
在动脉和静脉血栓模型中，RBD4059能有效抑制血栓引起的血流速降低，表现出显著的抗血栓药效。 |
| 2024-09-02 | Ribocure Pharmaceuticals AB | Results Ribo presented the first clinical data from our completed Ph1 study of the world’s first and most advanced hemostasis-sparing antithrombotic Factor XI (FXI) targeting siRNA asset, RBD4059, based on our RIBO-GalSTAR™ technology. ribocure.com ↗
RBD4059 demonstrated dose-dependent, predictable PK, and pronounced (>90%) and durable FXI activity and protein reduction in in the dose range of 50 mg – 600 mg. |
| 2024-05-29 | Ribocure Pharmaceuticals AB | Regulatory Ribocure Pharmaceuticals AB announces authorization to start a Phase II clinical trial in Sweden for the world’s first siRNA drug targeting Factor XI: RBD4059 ribocure.com ↗ |
| 2023-09-04 | Ribocure Pharmaceuticals AB | Results Ribo announces the latest research news for three siRNA therapeutic drugs at the European Society of Cardiology Congress 2023 ribocure.com ↗
Using RNAi approach targeting FXI, Ribo presented the key safety and efficacy data from its preclinical IND-enabling data package, showing the high potency and long duration of its FXI gene silencer. |
| 2023-02-09 | Ribocure Pharmaceuticals AB | Regulatory World’s first siRNA-based FXI silencing agent ribocure.com ↗
On February 6 th , 2023, Suzhou Ribo Life Science Co., Ltd. (hereinafter referred to as “Ribo”), a leading innovative oligonucleotide therapeutics company in China, announced that the first FXI (coagulation factor XI) targeting anti-thrombotic siRNA agent (RBD4059) had received HREC approval for its Phase 1 first-in-human clinical trial in Australia. |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RBD4059 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05653037 ↗ |
| Known as | vortosiran | “RNA interference therapy targeting coagulation factor XI: a first-in-human trial of RBD4059 (vortosiran).” PMID 41512172 ↗ Apr 2026 |
| Action | Inhibit | “via inhibition of FXI activity” NCT05653037 ↗ |
| Modality | Small interfering RNA (siRNA) | “an N-acetylgalactosamine-conjugated small interfering RNA (siRNA), RBD4059, targeting FXI” PMID 41512172 ↗ Apr 2026 |
| Route | Subcutaneous | “administered subcutaneously” PMID 41512172 ↗ Apr 2026 |