奥芬达唑(Oxfendazole) - 在研适应症：神经系统囊虫病，片形吸虫病，鞭虫病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

(5-(phenylsulfinyl)-1H-benzimidazol-2-yl)carbamic acid methyl ester、5-(phenylsulfinyl)-2-benzimidazolecarbamic acid methyl ester、5-phenylsulfinyl-2-carbomethoxyaminobenzimidazole

+ [8]

靶点-

作用方式-

作用机制-

治疗领域

感染神经系统疾病其他疾病+ [3]

在研适应症

神经系统囊虫病片形吸虫病鞭虫病+ [2]

非在研适应症-

原研机构

National Institute of Allergy & Infectious Diseases

在研机构

Drugs for Neglected Diseases initiative

Universidad Peruana Cayetano HerediaThe Oxfendazole Development Group

非在研机构

National Institute of Allergy & Infectious Diseases

权益机构-

最高研发阶段临床2/3期

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)

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结构/序列

分子式C15H13N3O3S

InChIKeyBEZZFPOZAYTVHN-UHFFFAOYSA-N

CAS号53716-50-0

关联

12

项与奥芬达唑相关的临床试验

NCT06367361

/ Not yet recruiting临床2期IIT

Non-inferiority, Controlled, Randomized, Single-blind Study for Compare Regimens of One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole to Treat Chronic Fascioliasis

Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.

开始日期2025-08-30

申办/合作机构

Universidad Peruana Cayetano Heredia

[+2]

CTRI/2025/04/084620

/ Not yet recruiting临床2期IIT

A phase IIa, proof-of-concept, placebo controlled, randomised trial to investigate the efficacy and safety of oxfendazole as a macrofilaricidal drug in adults harbouring Lymphatic Filarial worms. - NIL

开始日期2025-05-15

申办/合作机构-

PACTR202412611774752

/ Suspended临床2期IIT

A phase IIa, multi-country, randomized, placebo-controlled, double-blinded, adaptive, basket trial to assess the efficacy and safety of oxfendazole in adults with trichuriasis, and /or mansonellosis, and/or onchocerciasis and/or loiasis

开始日期2025-01-31

申办/合作机构

University Of Buea

100 项与奥芬达唑相关的临床结果

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100 项与奥芬达唑相关的转化医学

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100 项与奥芬达唑相关的专利（医药）

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857

项与奥芬达唑相关的文献（医药）

2026-04-01·VETERINARY PARASITOLOGY

Some further insights into oxfendazole broad anthelmintic spectrum: Flukicidal efficacy at a high dose in sheep

Article

作者: Ceballos, L ; Alvarez, L ; Soler, P ; Moreno, L ; Larroza, M ; Lanusse, C ; Lirón, J P ; Canton, C ; Herrera, R

Although oxfendazole (OFZ) has been traditionally used as a nematodicidal compound, its potential as a flukicidal compound has been explored. The goal of the current trials was to assess the flukicidal efficacy of OFZ administered as a single oral dose (30 mg/kg) to sheep naturally parasitized with Fasciola hepatica, using both the faecal egg count reduction test (FECRT) and the controlled efficacy test (CET). Two independent trials were performed in different farms of Patagonian region of Argentina to assess oxfendazole flukicidal activity in comparison to that of albendazole (ABZ), a well established trematodicidal benzimidazole compound. In Farm I, the efficacy was evaluated by the FECRT. F. hepatica infected sheep were allocated into three (3) experimental groups: Group ABZ_7.5 (n = 15), treated with ABZ at 7.5 mg/kg), Group OFZ₅ (n = 11), and Group OFZ₃₀ (n = 10) orally treated with OFZ at 5 and 30 mg/kg, respectively. FECRT results demonstrated a clear dose-response pattern for OFZ, with flukicidal efficacies of 4.1 % and 67.9 % for the 5 and 30 mg/kg doses, respectively, while ABZ achieved 87 % efficacy. In Farm II, OFZ efficacy was evaluated through both a CET and the FECRT. F. hepatica infected sheep were allocated in two experimental groups: Untreated Control (n = 4) and OFZ₃₀ (n = 5). The FECRT (estimated at 10 days after treatment) indicated high oxfendazole flukicidal efficacy (92 %), whereas the CET revealed substantial inter-animal variability, largely influenced by one sheep carrying a high parasite burden before treatment. The combined findings from the trials reported here indicate that OFZ exhibits dose-dependent flukicidal activity in sheep. Although, its pharmacological potency against liver flukes remains lower than that of ABZ, the obtained results confirms that OFZ have flukicidal activity.

2026-02-01·CPT-Pharmacometrics & Systems Pharmacology

Repurposing Oxfendazole for Onchocerciasis: Population Pharmacokinetics of a Tablet Formulation in Healthy African Adults

Article

作者: Hoglund, Richard M. ; Jongo, Said ; Specht, Sabine ; Adehin, Ayorinde ; Nyaulingo, Gloria ; Tarning, Joel ; Assmus, Frauke ; Reus, Elisabeth ; Ackermann, Eveline ; Keiser, Jennifer ; Scandale, Ivan ; Rocha, Fabiana Barreira Da Silva ; Mbarak, Hussein

ABSTRACT:

Global efforts to eliminate onchocerciasis are hampered by the lack of a macrofilaricidal drug capable of killing adult parasites. Oxfendazole, a veterinary anthelminthic, exhibits macrofilaricidal activity and holds promise to shorten treatment durations. Phase 1 studies in healthy Caucasian adults demonstrated favorable pharmacokinetics and safety using a veterinary oral liquid formulation. More recently, a Phase 1 bioavailability trial (NCT04920292) evaluated a field‐applicable tablet formulation in healthy African adults. This study presents a secondary analysis to (i) characterize the population pharmacokinetics of oxfendazole and its major metabolites in healthy African adults receiving the tablet formulation and (ii) propose a dosing regimen for Phase 2 evaluation in patients with onchocerciasis. Thirty healthy African adults were enrolled, and plasma concentration–time profiles of oxfendazole, fenbendazole, and oxfendazole sulfone were obtained from 24 participants who received oxfendazole (8 per dose group: 100 mg single dose, 400 mg single dose, 400 mg once daily for 5 days). All cohorts were pooled and analyzed using nonlinear mixed effects modeling. Oxfendazole absorption was best described by first‐order kinetics with first‐pass metabolism. Dose‐limited bioavailability was evident. Disposition was best described by one‐compartment models with linear elimination. Simulations suggested that 400 mg once daily (or 50 mg twice daily) for 5 days is required to achieve putative exposure targets (> 200 ng/mL for 5 days), with low risk of safety concerns. The population pharmacokinetic model adequately described oxfendazole pharmacokinetics in healthy African adults and supports dosing selection for future clinical trials.Trial Registration:ClinicalTrials.gov Identifier: NCT04920292

2025-12-01·International Journal for Parasitology-Drugs and Drug Resistance

In vitro screening of the open-access Pandemic Response Box reveals ESI-09 as a compound with activity against Echinococcus multilocularis

Article

作者: Kaethner, Marc ; Preza, Matías ; Laleu, Benoît ; Bartetzko, Anissa ; Vetter, Laura ; Zumkehr, Trix ; Hemphill, Andrew ; Zumstein, Pascal ; Lundström-Stadelmann, Britta

Alveolar echinococcosis (AE) is a life-threatening disease caused by the metacestode stage of the fox tapeworm Echinococcus multilocularis, primarily in the liver. Current drug treatments rely on benzimidazoles, which are not parasiticidal, requiring life-long therapy with significant side effects. Therefore, novel drug treatments are urgently needed. Drug repurposing offers a strategy to identify novel therapies against the neglected disease AE. We report on the in vitro screening of the Pandemic Response Box, an open-access compound library composed of 400 drug-like molecules assembled by Medicines for Malaria Venture (MMV) and the Drugs for Neglected Disease Initiative (DNDi), against E. multilocularis. An overview screen at 10 μM using the metacestode vesicle damage-marker release assay (based on release of phosphoglucose isomerase, PGI) and metacestode vesicle viability assay (based on ATP measurement) identified 37 active compounds. Reassessment in triplicates resulted in five active compounds (alexidine, carbendazim, ESI-09, MMV1581545, oxfendazole) displaying anti-metacestode activity. The parasiticidal activity of these five compounds was evaluated by ATP measurement in germinal layer cells. One compound, ESI-09, acted specifically against E. multilocularis (IC₅₀ on metacestode vesicles 6.06 ± 3.18 μM by PGI release assay and 2.09 ± 0.56 μM by metacestode vesicle viability assay as well as an IC₅₀ of 2.45 ± 0.86 μM on germinal layer cells) with a broad therapeutic window when compared to mammalian cell toxicity. Further experiments applying Seahorse technology and tetramethylrhodamine ethyl ester (TMRE) assay revealed that ESI-09 acts as a mitochondrial uncoupler in parasite cells. However, transmission electron microscopy showed no significant ultrastructural changes in parasite mitochondria, though increased secretion of extracellular vesicle-like structures between the tegument and the laminated layer was observed. In summary, screening of the Pandemic Response Box identified ESI-09 as a potential drug candidate for the treatment of AE. Further experiments are needed to evaluate the efficacy of ESI-09 in vivo.

2

项与奥芬达唑相关的新闻（医药）

2025-05-21

·ETPharma

196 Drug Samples Fail CDSCO Quality Test; One Deca-Durabolin Sample Flagged as Spurious

New Delhi: Drug regulators, during their monthly quality review, have identified around 196 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” The drug alert issued by the Central Drugs Standard Control Organization ( CDSCO ) states that out of the 196 NSQ samples, 60 were identified by central drug laboratories, while the remaining 136 were flagged by state laboratories. In addition, one drug sample identified as spurious is a “ Nandrolone Decanoate Injection,” marketed as Deca-Durabolin —an anabolic steroid used for various medical conditions, including osteoporosis and anemia. According to a note from the Union Health Ministry , the spurious sample was picked from Bihar and “is manufactured by an unauthorized manufacturer using the brand name owned by another company.” In its alert, the CDSCO specified that the tested sample failed due to issues with the “Identification and Assay of Nandrolone Decanoate .” In India, “Deca-Durabolin 50 mg” is marketed by Ahmedabad-based Zydus Healthcare, following its acquisition of the brand from MSD (Merck Sharp & Dohme) in December 2016. The matter is currently under investigation, and the purported spurious drug is subject to the outcome of the inquiry. A drug is deemed spurious if it resembles another drug in a manner likely to deceive, or if it bears upon its label or container the name of another drug—among several other conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Among the 60 NSQ samples flagged by central laboratories are Nimesulide and Paracetamol tablets manufactured by Pro-Pharma Care; Cefpodoxime Proxetil tablets by Sunvij Drugs; Ciprofloxacin tablets by Cadila Pharmaceuticals; and 57 other samples. The 136 NSQ samples identified by state laboratories include Glimepiride 1 mg and Metformin HCl 500 mg tablets manufactured by Surge Pharmaceuticals; Albendazole tablets by Samkem; and Oxfendazole and Ivermectin Bolus by Argon Remedies, among 133 other samples. The identification of drug samples as NSQ is based on the failure of the sample to meet one or more specified quality parameters. The term NSQ is defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “the failure is specific to the drug products of the batch tested by the Government Laboratory and does not warrant concerns about other drug products available in the market.” The ministry added that the identification of NSQ and spurious medicines is undertaken regularly (monthly), in collaboration with state regulators, to ensure such drugs are detected and removed from the market. By Online Bureau ,

并购上市批准

2025-05-21

·ETPharma

196 Drug Samples Fail CDSCO Quality Test; One Deca-Durabolin Sample Flagged as Spurious

New Delhi: Drug regulators, during their monthly quality review, have identified around 196 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” The drug alert issued by the Central Drugs Standard Control Organization ( CDSCO ) states that out of the 196 NSQ samples, 60 were identified by central drug laboratories, while the remaining 136 were flagged by state laboratories. In addition, one drug sample identified as spurious is a “ Nandrolone Decanoate Injection,” marketed as Deca-Durabolin —an anabolic steroid used for various medical conditions, including osteoporosis and anemia. According to a note from the Union Health Ministry , the spurious sample was picked from Bihar and “is manufactured by an unauthorized manufacturer using the brand name owned by another company.” In its alert, the CDSCO specified that the tested sample failed due to issues with the “Identification and Assay of Nandrolone Decanoate .” In India, “Deca-Durabolin 50 mg” is marketed by Ahmedabad-based Zydus Healthcare, following its acquisition of the brand from MSD (Merck Sharp & Dohme) in December 2016. The matter is currently under investigation, and the purported spurious drug is subject to the outcome of the inquiry. A drug is deemed spurious if it resembles another drug in a manner likely to deceive, or if it bears upon its label or container the name of another drug—among several other conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Among the 60 NSQ samples flagged by central laboratories are Nimesulide and Paracetamol tablets manufactured by Pro-Pharma Care; Cefpodoxime Proxetil tablets by Sunvij Drugs; Ciprofloxacin tablets by Cadila Pharmaceuticals; and 57 other samples. The 136 NSQ samples identified by state laboratories include Glimepiride 1 mg and Metformin HCl 500 mg tablets manufactured by Surge Pharmaceuticals; Albendazole tablets by Samkem; and Oxfendazole and Ivermectin Bolus by Argon Remedies, among 133 other samples. The identification of drug samples as NSQ is based on the failure of the sample to meet one or more specified quality parameters. The term NSQ is defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “the failure is specific to the drug products of the batch tested by the Government Laboratory and does not warrant concerns about other drug products available in the market.” The ministry added that the identification of NSQ and spurious medicines is undertaken regularly (monthly), in collaboration with state regulators, to ensure such drugs are detected and removed from the market. By Online Bureau ,

并购上市批准

100 项与奥芬达唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05291	奥芬达唑	-	DB11446

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
神经系统囊虫病	临床3期	-	Universidad Peruana Cayetano Heredia	2024-12-15
神经系统囊虫病	临床3期	-	The Oxfendazole Development Group	2024-12-15
片形吸虫病	临床2期	-	Universidad Peruana Cayetano Heredia	2025-08-30
鞭虫病	临床2期	-	The Oxfendazole Development Group	2024-07-01
丝虫病	临床1期	坦桑尼亚	Drugs for Neglected Diseases initiative	2022-04-21
眼盘尾丝虫病	临床1期	瑞士	Drugs for Neglected Diseases initiative	2022-01-30
蠕虫病	临床1期	美国	The Oxfendazole Development Group	-

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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


NCT03035760 (CTgov)	临床1期	蠕虫病	36	Oxfendazole (Arm 1: 3 mg/kg Oxfendazole for 5 Days)	艱衊築膚獵憲餘網夢築 = 壓鏇觸蓋壓鑰網網膚繭鏇鑰繭糧鬱顧鬱觸顧窪 (餘鹹蓋繭鹽選繭獵夢積, 顧願艱衊齋餘襯壓鏇願 ~ 襯餘餘鑰鏇淵範窪鬱餘) 更多	-	2019-12-17
				Oxfendazole (Arm 2: 7.5 mg/kg Oxfendazole for 5 Days)	艱衊築膚獵憲餘網夢築 = 顧網糧簾蓋糧鏇夢餘膚鏇鑰繭糧鬱顧鬱觸顧窪 (餘鹹蓋繭鹽選繭獵夢積, 簾獵簾鏇選鏇鬱積膚鏇 ~ 鏇鑰構鬱範觸醖選簾製) 更多
NCT02234570 (CTgov)	临床1期	神经系统囊虫病	70	Oxfendazole (0.5 mg/kg Oxfendazole)	選鏇憲蓋艱齋衊廠齋鑰 = 築壓窪遞觸壓窪憲窪簾憲網鹹鹽夢壓鏇築鑰蓋 (壓願鹹餘範膚遞範憲鹽, 窪觸醖網網醖繭選糧鑰 ~ 觸鏇膚艱窪壓鑰齋鑰憲) 更多	-	2019-11-26
				Oxfendazole (1 mg/kg Oxfendazole)	選鏇憲蓋艱齋衊廠齋鑰 = 壓齋積顧鑰蓋膚選積艱憲網鹹鹽夢壓鏇築鑰蓋 (壓願鹹餘範膚遞範憲鹽, 製築艱淵製積遞遞選製 ~ 範鬱製糧醖鹽製廠範觸) 更多
NCT02234570 (Pubmed \| Antimicrob Agents Chemother)	临床1期	-	70	Oxfendazole	窪窪憲選餘齋艱願鏇鑰(顧鹽範膚蓋窪齋蓋選遞) = dose-dependent decrease 積鏇糧膚繭構觸簾鹽鬱 (襯憲觸憲網積淵齋鬱積 ) 更多	-	2019-04-01