Single Centre Open-label, Non-randomised, 3-treatment, 2-period, Pharmacokinetic Drug Interaction Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan in Healthy Male Participants

To assess Drug drug interactions between Acoziborole and Dextromethorphan and Midazolam in healthy male volunteers.

开始日期2023-02-09

申办/合作机构

Drugs for Neglected Diseases initiative

NCT05433350

/ Active, not recruiting临床2/3期IIT

Pharmacokinetic, Efficacy, Safety, and Tolerability Study of a Single Dose of Acoziborole Under Fasting Conditions in Paediatric Patients From 1 to 14 Years of Age and With g-HAT: a Multicentre, Open-label Study

Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper. This decrease, coupled with the loss of diagnostic skills and disease management expertise, will lead to a weak and less specialised HAT technical environment. The history of g-HAT has shown that outbreaks or re-emergence of the disease have already happened under different circumstances when surveillance was relaxed or simply because the populations at risk live in areas of political instability, limiting access to specialised care. Even with a steady decrease of reported incidence, no model can currently predict that HAT could not re-emerge.
Although g-HAT is predominantly a disease of adults, children are also affected at diverse rates depending on the geographical and behavioural characteristics in the different areas of disease transmission. Hence efforts are needed to develop a paediatric formulation from a new generation of oral HAT treatments.

开始日期2022-07-09

申办/合作机构

Drugs for Neglected Diseases initiative

NCT05256017

/ Completed临床2/3期IIT

Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Non-parasitologically Confirmed Subjects: a Multicentre Randomised Double-blind Placebo-controlled Study

Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b. gambiense), which is transmitted by the bite of the tsetse fly. HAT can be fatal without diagnosis and treatment. Several treatment options are currently available to treat HAT caused by the T.b. gambiense parasite (g-HAT), but these treatments can be administered only after demonstrating via microscopy the presence of the parasite in a body fluid. However, there are factors such as low parasitaemia and the complexity and low sensitivity of parasitological methods that make such demonstration difficult. It has been demonstrated that a variable proportion (mainly depending on the prevalence) of such g-HAT "sero-suspects" are confirmed cases and, therefore, remain potential reservoirs of the parasite and a source of new infections hindering the efforts to eliminate the disease.
The drug acoziborole was evaluated in a study called "DNDi-OXA-02-HAT". During this study, patients with g-HAT from the DRC and Guinea took a single dose of acoziborole. This study showed that acoziborole has a high efficacy and is safe for treating patients with confirmed g-HAT .
The present study is called "DNDi-OXA-04-HAT". It included seropositive participants from the DRC and Guinea who did not have parasites detected via microscopy in a body fluid. Its objective was to collect data on the safety and tolerability of a single dose of acoziborole compared to a placebo (i.e. a dummy treatment). The results of this study would help decide if acoziborole can be used in the population of g-HAT seropositive individuals and help eliminate the HAT disease.

开始日期2021-12-30

申办/合作机构

Drugs for Neglected Diseases initiative

100 项与 Acoziborole 相关的临床结果

登录后查看更多信息

100 项与 Acoziborole 相关的转化医学

登录后查看更多信息

100 项与 Acoziborole 相关的专利（医药）

登录后查看更多信息

项与 Acoziborole 相关的文献（医药）

2025-11-05·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Mass balance, pharmacokinetics, metabolism, and excretion of radiolabeled acoziborole, a potential novel treatment for human African trypanosomiasis, following single microtracer oral dose to humans

Article

作者: Launay, Delphine ; Pelay-Gimeno, Marta ; Wauthier, Valérie ; Tarral, Antoine ; Gillon, Jean-Yves ; Loyau, Sabrina ; Andel, Lotte van ; Sidhu, Sharan ; Louis, Mathieu ; Rembry, Sandra ; Weinling, Estelle ; Simon, François

ABSTRACT:

Acoziborole is an oxaborole 6-carboxamide active against Trypanosoma brucei gambiense and rhodesiense , the parasites responsible for human African trypanosomiasis. This open-label, phase I study in six healthy male participants evaluated the mass balance, pharmacokinetics, metabolism pathways, and excretion of a single oral 960 mg dose of [ 14 C]-acoziborole. Blood, plasma, and feces were collected for 120 days and urine for 16 days. The excretion balance and systemic exposure of total circulating radioactivity were determined using accelerator mass spectrometry. Metabolism profiling was performed in pools of plasma, urine, and feces. Liquid chromatography coupled with tandem mass spectrometry quantified acoziborole and its metabolite SCYX-3109 in plasma and urine. By Day 60, 87.3% of the total radioactivity had been recovered (10.9% and 74.2% of the total dose in urine and in feces, respectively), with an excretion increment of <1% between Days 59 and 61. Mean ratios of total radioactivity indicated an equivalent distribution between blood cells and plasma. The concentration-time profiles of total radioactivity and acoziborole in plasma were similar. In plasma, acoziborole accounted for 95.1%, an oxidized form of acoziborole for 2.3% of the total radioactivity, while SCYX-3109 was not detected. Seven metabolites (oxidative deboronation, glucuronidation, and mono-oxidation) were detected in urine with individual abundances relative to the dose of 0.1–2.1%; unchanged acoziborole accounted for 0.6%. In feces, acoziborole, SCYX-3109, and two other oxidized or deboronated forms of acoziborole represented 33.6%, 12.3%, and 2.3% of the dose, respectively. Acoziborole showed good absorption, limited metabolism, minimal urinary elimination, and predominant but slow biliary-fecal elimination.

2025-06-01·COMBINATORIAL CHEMISTRY & HIGH THROUGHPUT SCREENING

To Explore Potential Inhibitors against Various Enzymatic Targets of Human African Trypanosomiasis

Review

作者: Bagchi, Soumya Ranjan ; Brahma, Sayandeep ; Samadder, Asmita ; Moitra, Susmita ; Nandi, Sisir

Synthetic drugs currently prescribed for the treatment of Human African Trypanosomiasis (HAT) are non-specific, toxic, demand extended therapeutic regimes and are of varying efficacy. Along with the challenging demographic and socio-economic hurdles, the everincreasing risk of drug resistance is another major problem to be addressed. Cysteine protease, Heat shock proteins (HSP-90), Trypanothione reductase (TR), Farnesyl diphosphate synthase, Glucose-6-phosphate dehydrogenase, UP-4-galactose epimerase, and Cytidine triphosphate synthetase are potential enzymatic targets for the development of novel inhibitors against HAT which are the main focus of this review. The potential enzymatic targets of Trypanosoma brucei, especially small molecules like cysteine proteases and heat shock proteins are identified as major candidates for the sustenance of the parasite, their proliferation, infection, and spread of the disease. The development of new compounds to combat the disease by thorough ligand modification has been explored in the current review. Extracting these compounds and studying their efficacy, toxicity, and target mechanism extensively, this review has proposed a list of different compounds, including some synthetic and natural compounds along with multi-target inhibitors such as acoziborole, fexinidazole, etc. Potential inhibitors against these enzymatic targets of the T. brucei are important candidates for designing novel therapeutics against HAT. Multi-target inhibitors have also been identified as crucial molecules because of their potential advantage against the development of drug resistance.

2024-09-01·TRENDS IN PARASITOLOGY

Pass the boron: benzoxaboroles as antiparasite drugs

Review

作者: Horn, David ; Zoltner, Martin ; Field, Mark C

The development of new drug modalities has been facilitated recently by the introduction of boron as a component of organic compounds, and specifically within a benzoxaborale scaffold. This has enabled exploration of new chemical space and the development of effective compounds targeting a broad range of morbidities, including infections by protozoa, fungi, worms, and bacteria. Most notable is the recent demonstration of a single oral dose cure using acoziborole against African trypanosomiasis. Common and species-/structure-specific interactions between benzoxaboroles and parasite species have emerged and provide vital insights into the mechanisms of cidality, as well as potential challenges in terms of resistance and/or side effects. Here, we discuss the literature specific to benzoxaborole studies in parasitic protists and consider unanswered questions concerning this important new drug class.

项与 Acoziborole 相关的新闻（医药）

2026-03-03

·中山生物医药科技融投产业园

全球生物医药企业动态

欧洲医学管理局建议在欧盟（EU）授予mCombriax的上市许可，这是一种用于保护50岁及以上人群免受COVID-19和季节性流感（流感）感染的信使RNA疫苗。根据世界卫生组织发布的数据，截至2026年2月1日，欧洲报告的新冠病例为281,728,062例。季节性流感也带来了重大负担，欧洲经济区（EEA）每年约有5000万例有症状病例。 mCombriax 的作用机制与其他疫苗类似，通过准备身体防御感染。它含有信使RNA，指示用于制造SARS-CoV-2及以下季节性流感病毒上的蛋白质：维多利亚谱系的A-H1N1型流感、A-H3N2型流感和B型流感。作为首个联合新冠/流感疫苗，mCombriax为患者提供单针疫苗的选择，以预防两种疾病。疫苗针对的SARS-CoV-2株基于EMA在2023/2024年度的建议，而针对流感的病毒株则基于世卫组织2023/2024年的建议。与针对COVID-19和流感的现有病毒一样，mCombriax的成分预计将定期更新，以匹配社区中流行的病毒株。此外，一项仅含有mCombriax流感成分的mRNA疫苗研究显示，它能预防流感并激发适当的免疫反应。 EMA人类药物委员会（CHMP）已对Acoziborole Winthrop在治疗由布鲁氏甘比恩斯锥虫（g-HAT）引起的人类非洲锥虫病（HAT）方面获得积极的科学意见。 Acoziborole Winthrop 旨在欧盟（EU）以外使用，并根据 EU-M4all 计划进行了评估。EU-M4all旨在促进低收入和中等收入国家的患者获得旨在预防或治疗重大公共卫生疾病所需的基本药物。阿科齐博罗尔·温斯罗普适用于体重至少40公斤的12岁以上成人和青少年，用于治疗第一期和第二期（包括重度第二期）的g-HAT患者。目前针对g-HAT的治疗包括多次剂量、静脉输注或肌肉注射，以及住院治疗。他们根据疾病阶段进行选择，该阶段通过腰椎穿刺（腰椎穿刺）确定。阿可齐博罗尔温斯罗普口服一次，适用于g-HAT的所有阶段，无需腰椎穿刺和住院治疗。这简化了患者的治疗，促进了依从性和可及性。 EMA的积极科学意见将简化世卫组织的预资格审查流程，并促进阿科齐博罗尔·温斯罗普在该疾病流行国家的公共卫生项目中进行全国注册。科学意见的申请在加速时间表下评估，以便患者更快获得该药物。 EMA人类药物委员会（CHMP）在2026年2月的会议上推荐了12种药物待审批。委员会建议授予mCombriax（流感和COVID-19 mRNA疫苗）的上市许可，这是首个用于保护50岁及以上人群免受COVID-19和季节性流感（flu）感染的联合信使RNA疫苗。 CHMP建议授予Ojemda（托沃拉非尼）有条件上市许可，用于治疗六个月及以上的儿童低级别胶质瘤患者，这是一种非癌性脑肿瘤。目前的治疗选项包括手术和化疗。 CHMP对Onerji（左旋多巴/卡比多巴）给予了积极评价，用于治疗晚期帕金森病，这是一种神经系统进展性疾病，导致颤抖、僵硬、动作迟缓和平衡困难。 Palsonify（巴尔图索汀）获得了CHMP对肢端肥大症的积极评价，这是一种罕见的激素疾病，通常发生在中年人，由垂体产生过多生长激素引起。委员会通过了对Rhapsido（雷米布替尼）治疗慢性自发性荨麻疹（一种长期瘙痒皮疹）的积极意见。 Xolremdi（马沃利沙福）在特殊情况下获得了CHMP对WHIM综合征的积极评价，这是一种极为罕见的遗传性疾病，该病中免疫系统（身体的自然防御系统）功能失常，使患者更容易感染细菌和病毒。委员会对六种生物类似药采取了积极意见：Bysumlog （胰岛素lispro）和Dazparda（胰岛素亚非特里），用于糖尿病治疗。Fubelv （依他诺普），用于治疗类风湿关节炎、青少年特发性关节炎、银屑病关节炎、轴向脊柱关节炎、斑块银屑病和儿童斑块银屑病。波赫迪（派妥祖单抗），用于乳腺癌治疗。Tuyory （托西珠单抗），用于治疗类风湿关节炎、COVID-19、系统性青少年特发性关节炎、多关节性青少年特发性关节炎、CAR-T细胞诱导的严重或危及生命的细胞因子释放综合征以及巨细胞动脉炎。Zandoriah （teriparatide），用于治疗骨质疏松症。 EMA建议在欧盟（EU）授予Ojemda（托沃拉非尼）有条件的上市许可，用于治疗6个月及以上患有儿科低级别胶质瘤（一种非癌性脑瘤）患者。目前的治疗选择包括手术和化疗。虽然化疗对部分患者有效，但其益处通常有限，且可能引发显著副作用。此外，靶向治疗仅适用于肿瘤中带有BRAF V600E突变的患者。但对于治疗后病情恶化的患者，目前无其他治疗选择。Ojemda是一种新的每周一次口服靶向治疗，面向更广泛的儿童低级别胶质瘤患者。 Ojemda的活性物质托沃拉非尼通过阻断参与肿瘤生长的RAF蛋白起作用。通过靶向这些蛋白，托沃拉非尼有助于减缓或阻止导致某些BRAF基因变化的肿瘤细胞（包括BRAF V600突变和BRAF融合）的生长和繁殖信号。 Ojemda被推荐申请有条件上市授权，这是欧盟促进早期获得满足未满足医疗需求的药物的监管机制之一。这种批准允许机构在药物即时可获得的利益大于尚未所有数据尚未公开的风险时，以较少完整数据推荐药品进行上市授权。 2026年2月25日，专注于皮肤及黏膜疾病领域的综合型中医药企业山东汉方制药股份有限公司（以下简称“汉方制药”）向港交所主板递交上市申请，中泰国际担任独家保荐人，拟登陆港股市场。本次IPO募资计划主要用于候选产品研发与商业化、生产基地建设及补充运营资金。招股书显示，汉方制药的核心旗舰产品——复方黄柏液涂剂是目前国内中成药领域唯一获批的处方涂剂，为国家二级中药保护品种，享有独家市场地位。值得注意的是，汉方制药的收入几乎完全依赖复方黄柏液涂剂，招股书显示，2023年、2024年及2025年前三季度，该产品销售额分别占总收入的99.8%、99.8%和99.7%，显示出该公司对单一产品的深度依赖。汉方制药此次赴港上市，其高壁垒的独家产品与高度依赖单一业务的双面性需要关注。该公司能否成功应对上述风险，突破多元化瓶颈，布局新的增长曲线，值得重点关注。 2025年10月底上市的禾元生物发布上市后首份年度业绩快报，2025年实现营业总收入4786.14万元，同比增长89.80%，主要得益于核心产品奥福民®获批上市，但归母净利润与扣非净利润分别亏损1.58亿元、1.76亿元，亏损同比扩大。该公司2022至2024年已累计亏损4.8亿元，当前仍处产能爬坡期且研发投入高。奥福民®是全球首创植物源重组人白蛋白产品，目前仅获批肝硬化低白蛋白血症一项适应证，市场空间萎缩，且终端价高于传统血浆源产品。公司正推进技术迭代降本、适应证拓展及医保谈判。此外，禾元生物与美国Ventria公司的跨国专利诉讼持续5年，产生高额专业服务费，进一步加重财务负担。免责声明：本文部分内容根据网络信息整理，推送旨在积善利他，如涉及作品内容、版权和其它问题，请跟我们联系删

2026-03-02

·drugs

New Drug, Acoziborole, Could Boost Efforts to Wipe Out Sleeping Sickness

MONDAY, March 2, 2026 — A new treatment for sleeping sickness could make it much easier to treat and possibly eliminate the deadly disease. On Friday, a committee of the European Medicines Agency (EMA) recommended approval of acoziborole, a drug made by Sanofi . The decision is a key step to making the medicine available in Congo, where most cases occur, and in other African countries. Unlike current treatments, which can take up to 10 days and require difficult trips from remote areas to the hospital, acoziborole is taken as three pills swallowed in a single dose. Supporters say that could make a major difference. “This disease is on the brink of elimination," Dr. Junior Matangila of the Drugs for Neglected Diseases initiative told The Associated Press . He said the new drug could help “accelerate progress toward finishing the job.” Sleeping sickness, also called human African trypanosomiasis (HAT), is spread by tsetse flies in rural parts of sub-Saharan Africa. The flies carry a parasite that infects people through their bite, according to the U.S. Centers for Disease Control and Prevention (CDC). Early symptoms can look like the flu. But as the infection spreads, the parasite can reach the brain, according to the CDC . People may develop confusion, personality changes and a reverse sleep pattern: Awake at night and sleepy during the day. Without treatment, the disease can lead to coma and death. “It’s a disease of poverty,” Matangila said, who is based in Congo. Older medicines were painful and sometimes toxic. While treatments improved in the early 2000s, they still involve hospital stays and spinal taps to determine how far along the infection is. Acoziborole could change that. The new drug works for both early and advanced stages of the most common form of sleeping sickness. It can be used in patients ages 12 and older, and it removes the need for spinal taps. In a 2023 study of about 200 patients in Congo and Guinea, more than 95% were considered cured 18 months after treatment. Sanofi has pledged to donate the drug to the World Health Organization (WHO), meaning it would be free for patients. Sleeping sickness surged in the 1970s and 1990s during times of political unrest in Africa. But better treatments and efforts to control tsetse flies have helped bring cases down. Reported infections dropped below 10,000 in 2009 for the first time in 50 years. In 2024, fewer than 600 cases of the most common form were reported. The WHO aims to stop the spread of this form of sleeping sickness by 2030. “This isn’t solved yet,” Monica Mugnier , a sleeping sickness researcher at Johns Hopkins University, told The AP . She noted that scientists still do not fully understand where the parasite may be hiding. If eliminated, sleeping sickness could become the first infectious disease controlled without a vaccine, Sanofi officials said. Sources The Associated Press, Feb. 27, 2026

上市批准

2026-03-01

·雪球

动态：第9周全球创新药

核心观察：四大技术路线同步爆发本周见证了生物医药领域罕见的技术集群效应——CAR-T跨界、mRNA癌症疫苗、基因疗法新机制、GLP-1口服竞争同时在关键节点取得突破。一、FDA批准：四大重磅上市1.度普利尤单抗（Dupixent）——自免药王的第10+适应症·批准时间：2026年2月24日·新适应症：变应性真菌性鼻窦炎（AFRS），用于有鼻窦手术史的6岁及以上患者·核心数据：III期LIBERTY-AFRS-AIMS研究显示，治疗52周时：§鼻窦混浊评分改善：50.0%vs安慰剂9.8%§鼻塞症状改善：81%vs11%§嗅觉丧失改善：67%vs19%§鼻息肉体积缩小：64%vs4%§手术/激素需求降低：92%（p=0.0010）·意义：全球首个且唯一获批的AFRS靶向治疗，填补术后高复发患者空白2.宗艾替尼——HER2突变肺癌一线治疗新标准·批准时间：2026年2月26日（FDA加速批准）·商品名：Hernexeos·适应症：HER2激活突变的不可切除或转移性非鳞状非小细胞肺癌（NSCLC）成人患者，首次扩展至初治人群·关键数据：§初治患者客观缓解率（ORR）：76%§64%缓解者持续缓解≥6个月，44%≥12个月§显著优于标准治疗预期（30%-45%）·技术优势：不与野生型EGFR结合，毒性更低·监管路径：2023年快速通道→2024年突破性疗法认定→2025年8月经治获批→2026年2月一线拓展二、NMPA批准：国产创新药加速崛起1.贝莫苏拜单抗——国产PD-L1肺癌巩固治疗·批准时间：2026年2月·适应症：不可切除III期非小细胞肺癌放化疗后巩固治疗·关键数据：§疾病控制率：87.3%§中位PFS：9.69个月§进展/死亡风险降低：47%§≥3级TRAE发生率：29.4%·意义：实打实中国原创，全程国内标准2.奥妥珠单抗β——视神经脊髓炎谱系疾病颠覆性突破·批准时间：2026年2月·适应症：视神经脊髓炎谱系疾病（NMOSD）·核心数据：o复发风险降低：97.5%o年化复发率：从1.3人/年降至0.028人/年·意义：基于中国人群高等级循证医学证据，高复发/高致残困局破解3.济乐美（硫酸索西美雷塞）——KRASG12C国产四强格局形成·批准时间：2026年2月28日·开发商：济民可信/杭煜制药·适应症：KRASG12C突变型晚期NSCLC（至少接受过一种系统性治疗）·关键数据：关键II期研究（n=145）§ORR：52.4%§DCR：87.6%§中位PFS：7.2个月·差异化优势：§较强脑通透性§无心脏毒性§无明显药物相互作用风险·市场格局：国内KRASG12C抑制剂增至4款（氟泽雷塞、格索雷塞、戈来雷塞、济乐美），全部进入医保三、临床试验突破：三大技术路线历史性进展1.mRNA癌症疫苗——6年无复发的"死刑反转"《自然》2026年2月24日重磅研究·研究团队：BioNTech（U.Sahin、Ö.Türeci）·适应症：早期三阴性乳腺癌（TNBC）术后高危患者·TNBC-MERITI期试验核心数据：§纳入患者：15人知情同意，14人完成治疗纳入评估§无病生存率（78.6%）：11人随访最长超6年无复发§免疫持久性：所有患者产生抗癌T细胞，9人对至少5种新抗原产生应答，效果维持1-6年§复发患者转机：3名复发者中，免疫反应最弱者使用PD-1治疗后再次完全缓解§安全性：仅轻度流感样症状（发热、乏力、寒战）·机制突破："一人一方"个体化定制§第一步：基因测序找到癌细胞专属新抗原§第二步：mRNA技术制备疫苗，最多针对20个突变靶点§第三步：8针疫苗接种§第四步：诱导两种"超级T细胞"——细胞毒性效应T细胞+干细胞样记忆T细胞，实现长期监控·对比传统治疗：国内早期TNBC术后标准化疗3年无病生存率最高约93.1%，仍有复发风险；mRNA疫苗将无复发时间拉长至6年+2.CAR-T跨界——自身免疫病"深度缓解+器官逆转+长期停药"成人患者大规模数据（83名患者）·公布会议：2026年2月Transplantation&CellularTherapyTandemMeetings·覆盖疾病：系统性红斑狼疮、系统性硬化症、特发性炎性肌病、多发性硬化、重症肌无力·疗效：o91.6%患者约18个月随访期实现深度缓解oB细胞重建后仍保持临床缓解，成功实现长期停用所有免疫抑制剂·安全性：oCRS多为1级，无严重病例，3天内自行缓解oICANS发生率仅12%，症状轻微通用型CAR-T首例给药——科济药业KJ-C2219·突破：2026年2月完成系统性红斑狼疮患者首次给药·意义：从"一人一批"到"现货供应"跨越o传统自体CAR-T：制备周期2-4周，成本高昂（12-15万元/次）o通用型CAR-T：健康供者规模化生产，冷冻保存现货供应，大幅缩短等待时间+降低成本3.基因疗法——两大里程碑突破雷特综合征基因疗法NGN-401获FDA突破性疗法认定·宣布时间：2026年2月26日（Neurogene）·疗法：AAV9基因疗法，递送全长人类MECP2基因·核心技术：Exact™转基因调控技术o实现逐个细胞级别一致且严格控制的MECP2蛋白表达o从源头规避过表达毒性·临床数据：1/2期试验o患者在雷特综合征多个核心领域实现具有临床意义且持久的功能性改善o能够随时间推移持续获得新技能·给药途径：脑室注射（ICV），直接靶向大脑和神经系统区域·监管进展：o已获FDA突破性疗法+再生医学先进疗法+孤儿药+快速通道+罕见儿科疾病认定oEMA：PRIME+孤儿药+先进治疗药物产品认定o英国：ILAP认定·下一步：Embolden™注册试验预计2026年Q2完成全部给药，计划年中公布1/2期数据四、GLP-1赛道：口服+超长效双线竞争白热化1.礼来Orforglipron——头对头击败口服司美格鲁肽·公布时间：2026年2月26日（发表于《柳叶刀》）·试验：ACHIEVE-3III期头对头研究（vs口服司美格鲁肽）·患者：1,698名，52周·核心数据：oA1c降低：2.2%vs司美格鲁肽1.4%（36mg剂量）o减重：19.7磅（9.2%）vs11.0磅（5.3%），相对减重提升73.6%o起效快：4周即出现改善，持续52周·优势：无食物/水摄入限制，任意时间服用·监管状态：已向40+国家提交，预计美国肥胖适应症Q22026行动2.诺和诺德Wegovy口服片——上市首月70%+医生开方·上市时间：2025年12月FDA批准，2026年1月商业化·首月数据（2026年2月20日Spherix报告）：o70%+医生报告已处方（PCPs73%，内分泌科78%）o未处方医生意向：98%PCPs、88%内分泌科6个月内处方o品牌认知：2月60%PCPs、78%内分泌科列为"top-of-mind"（vs2025年11月14%、11%）·意义：口服GLP-1扩展整体市场而非简单蚕食注射剂型五、EMA批准：欧洲市场同步推进1.mCombriax——全球首款新冠+流感联合疫苗·推荐时间：2026年2月27日（CHMP推荐）·开发商：Moderna·适用人群：50岁及以上·意义：单一疫苗保护两种病毒，简化接种流程2.Ojemda——儿童低级别胶质瘤新选择·推荐时间：2026年2月27日·药物：tovorafenib·适应症：6个月及以上儿科脑肿瘤伴BRAF改变·优势：每周一次口服治疗，覆盖更广泛患者群体3.Acoziborole——单剂量口服治疗非洲人类锥虫病（睡眠病）·推荐时间：2026年2月27日·意义：简化第一、第二阶段疾病治疗4.类器官芯片新药——监管范式革命·批准时间：2026年2月24日（EMA）·药物：ORG-2026-X（罕见遗传性代谢肝病）·技术核心：人源肝脏类器官芯片模型o预测准确度>92%vs传统动物模型60%-70%o更真实反映人类个体差异·颠覆意义：o终结"动物实验依赖"开端：未来药企可大幅减少/免除部分动物实验，缩短研发周期1-2年，降低数亿美元成本o解决罕见病难题：患者细胞构建芯片，体外大规模"虚拟临床试验"o推动精准医疗：患者细胞制作"个人专属芯片"，术前测试多种药物方案·全球影响：o美国、中国NMPA预计2026年下半年发布类似指导草案o类器官芯片概念股盘后大涨六、IPO与资本市场：生物科技市场回暖信号1.EikonTherapeutics——3.81亿美元，2024年来最大生物科技IPO·上市时间：2026年2月中旬（纳斯达克）·发行价：18美元/股（发行区间上限）·核心管线：oEIK1001（TLR-7/8双重激动剂）：II/III期临床，联合K药治疗晚期黑色素瘤/NSCLC，中期数据2026H2公布oPARP抑制剂（eik1003、eik1004）：I/II期，卵巢癌/乳腺癌（eik1004具血脑屏障穿透能力）oWRN解旋酶抑制剂（eik1005）：I/II期，实体瘤oHDAC6抑制剂：阿尔茨海默病/肌萎缩侧索硬化症·技术护城：诺奖级超分辨率显微+单分子追踪（SMT）技术，实时可视化细胞内药物-靶点相互作用·募资用途：约1亿美元专项用于EIK1001临床推进·团队：前默沙东研发总裁RogerPerlmutter博士领衔2.GenerateBiomedicine——4亿美元募资·上市时间：2026年2月27日·募资分配：o3亿美元→重度哮喘药GB-0985（抗TSLP抗体）后期临床o1亿美元→慢阻肺早期试验o1500万美元→两款I期抗癌药3.Innovacell——9200万美元，东京证交所首家药物研发企业·上市时间：2026年2月24日·核心产品：ICEF15（再生医学药物，急迫性大便失禁）·技术：局部注射患者自身骨骼肌成肌细胞再生肌肉组织·临床阶段：全球多中心III期·意义：打破东京生物科技板块长达一年IPO沉寂4.MiniMed——美敦力糖尿病子公司分拆上市·计划上市：2026年2月24日·发行：2800万股，定价25-28美元，募资7-9亿美元·代码：MMED·预计市值：90亿美元·意义：释放估值+聚焦主业，医械巨头分拆趋势七、其他关键进展1.瑞银下调美股配置至"基准"·宣布时间：2026年2月27日·判断：美国资本市场相对全球市场"回撤"幅度达近15年最高水平·维持：新兴市场"超配"·数据支撑：追踪美国以外市场的ACWXETF年初以来涨幅超9%vs标普500仅0.3%八、总结：五大趋势判断1.CAR-T从抗癌向自身免疫跨界加速：成人深度缓解+器官逆转+长期停药+通用型降本+生育能力恢复，"免疫系统重置"范式确立2.mRNA技术从疫苗向癌症疫苗突破：个体化新抗原疫苗实现6年无复发，"一次接种，长期护航"从概念走向现实3.基因疗法递送技术重大突破：AAVLINK解决长基因递送难题，Exact™技术规避过表达毒性，NGN-401获多重监管认定4.GLP-1从注射向口服+超长效双向进化：Orforglipron头对头击败口服司美格鲁肽，PF-08653944每月一针12.3%减重，依从性改善成竞争关键5.监管范式从动物实验向类器官芯片革命：EMA批准首款基于类器官芯片数据新药，预测准确度>92%vs动物模型60%-70%，研发周期缩短1-2年6.国产创新药从跟随走向引领：GV-971全球同步上市、KRASG12C国产四强格局、芦康沙妥珠单抗TROP2ADC、奥妥珠单抗βNMOSD突破、贝莫苏拜单抗肺癌巩固治疗7.资本寒冬结束信号：3.81亿美元+4亿美元+9200万美元IPO扎堆2月，成熟管线受追捧生物医药创新已经进入多技术路线并行、中美欧三地同步、资本与临床双重驱动的新阶段。对投资者而言，CAR-T跨界、mRNA癌症疫苗、基因疗法新递送技术是值得重点跟踪的长期赛道；对患者而言，CAR-T自身免疫病深度缓解、mRNA癌症疫苗6年无复发、GV-971阿尔茨海默病全球同步上市，标志着从"缓解症状"向"治本"的历史性跨越。

上市批准免疫疗法临床3期基因疗法突破性疗法

100 项与 Acoziborole 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	Acoziborole	-	DB13086

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
布氏锥虫感染	申请上市	欧盟	DNDi Japan	2026-02-27
布氏锥虫感染	申请上市	欧盟	Sanofi	2026-02-27
肝素诱导血小板减少	临床3期	几内亚	Drugs for Neglected Diseases initiative	2021-12-30
肝素诱导血小板减少	临床3期	刚果共和国	Drugs for Neglected Diseases initiative	2021-12-30
非洲锥虫病	临床3期	刚果民主共和国	Drugs for Neglected Diseases initiative	2016-10-11
非洲锥虫病	临床3期	几内亚	Drugs for Neglected Diseases initiative	2016-10-11

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03087955 (OXA002, CTgov)	临床2/3期	非洲锥虫病	208	Acoziborole (Late-stage HAT)	夢簾衊膚餘鏇鑰醖壓齋 = 糧醖鏇衊齋構艱蓋獵淵鹹鏇簾遞壓夢鏇獵壓網 (壓艱餘網鬱蓋齋願夢鏇, 鹹繭蓋顧膚憲繭醖積構 ~ 鹹壓簾積餘製淵鑰鑰構) 更多	-	2025-09-17
NCT03087955 (OXA002, CTgov)	临床2/3期	非洲锥虫病	208	Acoziborole (Early- and Intermediate-stage HAT)	願廠築網繭餘壓獵範醖 = 糧廠鹽膚壓願鬱蓋願餘壓夢齋鏇構艱觸憲膚願 (齋襯觸觸選壓淵簾觸觸, 繭鑰糧構繭遞網衊獵鏇 ~ 遞餘衊觸築願鑰選願製) 更多	-	2025-09-17
NCT05256017 (OXA004, CTgov)	临床2/3期	布氏锥虫感染 \| 非洲锥虫病 \| 肝素诱导血小板减少	1,208	Acoziborole (Acoziborole)	鏇齋鏇淵膚範鑰壓顧積 = 製廠壓淵鏇構繭製壓蓋選獵壓簾鹽鏇膚築觸壓 (衊艱醖遞網襯簾醖獵膚, 製艱壓壓願獵築構顧壓 ~ 簾窪選觸選鬱鬱遞窪積) 更多	-	2025-03-20
NCT05256017 (OXA004, CTgov)	临床2/3期	布氏锥虫感染 \| 非洲锥虫病 \| 肝素诱导血小板减少	1,208	Placebo (Placebo)	鏇齋鏇淵膚範鑰壓顧積 = 壓鏇獵鹹窪糧廠築鏇繭選獵壓簾鹽鏇膚築觸壓 (衊艱醖遞網襯簾醖獵膚, 願窪廠窪餘淵範構醖選 ~ 襯醖鬱顧蓋顧醖製膚積) 更多	-	2025-03-20
NCT01533961 (Pubmed \| Clin Pharmacokinet)	临床1期	非洲锥虫病	128	Acoziborole 960mg	製蓋鏇鏇壓鏇鹹壓繭鹹(窪構構壓繭網鑰觸鹽簾) = appeared rapidly in plasma (at 1 h), reached tmax between 24 and 72 h, and remained stable for up to 96 h, after which a slow decrease was quantifiable until 14 weeks after dosing 衊鹽獵齋範顧鬱鹽糧鹽 (艱襯醖襯衊積醖壓網構 ) 更多	积极	2023-03-01
NCT03087955 (Pubmed) 人工标引	临床2/3期	非洲锥虫病	208	Acoziborole	淵獵壓製積構蓋範獵積(醖鬱窪壓壓鬱範壓觸簾) = 齋積蓋淵鹽憲鏇願壓獵蓋鹽鏇糧齋襯觸齋構齋 (鹽鹽膚構築積鏇築齋衊, 91.2 ~ 97.7) 更多	积极	2022-11-29