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

NCT06565507

/ Not yet recruiting临床2/3期IIT

A Double-blind Multicenter, Randomized Controlled Trial of Single and Multiple Dose Regimens of Oxfendazole for Mild (One or Two Lesions) Parenchymal Brain Cysticercosis, With an Open Comparison Group

The goal of this clinical trial is to compare a single and multiple dose regimens of oxfendazole with the standard treatment in patients with mild (one or two lesions) parenchymal brain cysticercosis. The main question it aims to answer is if OXF will enhance clearance of brain parasites and therefore provide greater cysticidal efficacy, with the potential to provide a single-dose therapy for this type of NCC.
The study cohort will also allow us to identify early imaging markers that predict lesion resolution, as well as factors associated with residual calcification or focal gliosis after lesion resolution. This study will also provide additional information on the safety of the study interventions.

开始日期2026-12-01

申办/合作机构

Universidad Peruana Cayetano Heredia

[+1]

NCT06367361

/ Not yet recruiting临床2期IIT

A Non-Inferiority, Randomized, Blind Laboratory Analysis, Controlled Trial Comparing One and Two Doses Regimes of Oxfendazole Versus a Two Dose Regime 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2026-08-15

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-

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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875

项与奥芬达唑相关的文献（医药）

2026-04-01·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Pharmacokinetics, safety, and tolerability of an oxfendazole tablet formulation: a phase 1, randomized, placebo-controlled trial in healthy African volunteers

Article

作者: Satam, Vijay ; Mbaraka, Hussein ; Robinson, Stephen ; Jongo, Said ; Nyaulingo, Gloria ; Cicconi, Silvia ; Specht, Sabine ; Keiser, Jennifer ; Saxena, Meera ; Tumbo, Anneth ; Kassim, Kamaka ; Scandale, Ivan ; Rocha, Fabiana Barreira Da Silva ; Assmus, Frauke ; Louis, Mathieu ; Reus, Elisabeth ; Ackermann, Eveline ; Rashid, Mohammed Ally

ABSTRACT:

Oxfendazole, a registered veterinary drug, has demonstrated broad-spectrum activity against multiple nematode species. First-in-human studies in healthy, predominantly Caucasian adults receiving a liquid formulation of oxfendazole demonstrated a favorable pharmacokinetic and safety profile, supporting its potential as a drug candidate for treating human helminth infections. To further advance its clinical development, we conducted a phase I bioavailability study using a field-applicable, immediate-release oxfendazole tablet. This trial investigated the pharmacokinetics, safety, and tolerability of the tablet formulation in healthy African adults residing in a filariasis-endemic country. Oxfendazole was administered as a single dose (100 or 400 mg) or as multiple doses (400 mg for 5 consecutive days) to 30 participants, randomized 8:2 to oxfendazole or placebo per cohort. Plasma concentrations of oxfendazole were measured using a validated high-performance liquid chromatography tandem mass spectrometry method, and pharmacokinetics were assessed using non-compartmental analysis. Peak plasma concentrations were reached after ~2.5–3 h. The median elimination half-life ranged from 11.6 to 13.9 h and was consistent across cohorts. Non-linear pharmacokinetics was observed, with exposure (AUC ∞ , Cmax ) increasing less than dose-proportionally and showing high variability. Oxfendazole was well tolerated, with no adverse events reported and no clinically significant abnormalities in laboratory tests, vital signs, physical examinations, or electrocardiograms. These findings support the further development of oxfendazole in early proof-of-concept studies. Formulation optimization is suggested to reduce variability in exposure and improve the reliability of exposure-response assessments in future clinical trials. The study is registered with ClinicalTrials.gov as NCT04920292 .

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.

2026-04-01·International Journal for Parasitology-Drugs and Drug Resistance

Pharmacokinetics of fenbendazole and its bioactive metabolite oxfendazole in northern bobwhite administered an anthelmintic feed

Article

作者: Kinsey, Kaya ; Kaskocsak, Ashley ; Kendall, Ronald J ; Valencia, Henry ; Suber, Hannah N ; Patel, Dhavalkumar ; Robinson, Will R ; Arlowe, Timothy B

The northern bobwhite (Colinus virginianus) has experienced significant population declines across its native range. Parasitic nematodes are increasingly being recognized as contributing factors. QuailGuard®, an anthelmintic feed that uses fenbendazole (FBZ) as the active ingredient, has shown promise in field studies for reducing parasite loads in wild quail. However, little is known about the pharmacokinetics of FBZ in bobwhite, limiting accurate assessments of therapeutic exposure. This study investigated the pharmacokinetic profile of FBZ and its bioactive metabolite, oxfendazole (OFZ), in bobwhite fed QuailGuard®. Plasma concentrations were measured at multiple time points during (1, 2, 4, 8, and 24 h) and after (2, 4, 8, 24, and 32 h) feed administration using LC/MS-MS. Key pharmacokinetic parameters, including estimated area under the curve (AUC), apparent elimination rate, half-life, and mean residence time (MRT) were calculated using composite sampling. Peak average plasma concentrations of FBZ (2.3701 μg/mL) and OFZ (0.5526 μg/mL) occurred at 8 h post-ingestion. Estimated AUCs were 47.782 μg h/mL for FBZ and 12.783 μg h/mL for OFZ, with respective half-lives of 3.83 and 4.03 h. Combined drug exposure approached levels associated with the lethality of Oxyspirura petrowi in prior studies, indicating that intake over multiple weeks may achieve therapeutic efficacy. While sex did not affect analyte accumulation during treatment, females exhibited faster OFZ apparent elimination than males. FBZ and OFZ were rapidly absorbed and eliminated, which supports the safety of QuailGuard® for use in wild populations. These findings establish foundational pharmacokinetic data necessary for optimizing field treatment regimens and improving parasite control strategies in declining bobwhite populations.

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	2026-12-01
神经系统囊虫病	临床3期	-	The Oxfendazole Development Group	2026-12-01
片形吸虫病	临床2期	-	Universidad Peruana Cayetano Heredia	2026-08-15
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

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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


NCT03035760 (CTgov)	临床1期	蠕虫病	36	Oxfendazole (Arm 1: 3 mg/kg Oxfendazole for 5 Days)	廠繭顧遞遞壓鬱選構簾 = 壓顧繭鹽膚鹽糧艱膚壓廠衊簾選襯鹽鬱夢鹹憲 (顧壓憲壓餘繭壓淵夢範, 淵繭齋繭鏇鏇淵醖淵鏇 ~ 顧艱廠鑰廠壓衊糧網襯) 更多	-	2019-12-17
				Oxfendazole (Arm 2: 7.5 mg/kg Oxfendazole for 5 Days)	廠繭顧遞遞壓鬱選構簾 = 顧繭網齋蓋範網蓋鬱齋廠衊簾選襯鹽鬱夢鹹憲 (顧壓憲壓餘繭壓淵夢範, 壓繭淵廠糧衊鹹壓製觸 ~ 糧糧簾艱築構獵構網淵) 更多
NCT02234570 (CTgov)	临床1期	神经系统囊虫病	70	Oxfendazole (0.5 mg/kg Oxfendazole)	積齋鑰衊憲願壓鹹顧廠 = 鬱鏇餘選網鑰構淵鹹廠顧遞觸繭壓壓製艱築遞 (鬱遞網繭衊醖憲鏇選製, 簾衊壓淵憲積鹹夢製願 ~ 鑰繭遞積鏇鏇艱夢艱襯) 更多	-	2019-11-26
				Oxfendazole (1 mg/kg Oxfendazole)	積齋鑰衊憲願壓鹹顧廠 = 鹽選構窪簾觸遞製窪選顧遞觸繭壓壓製艱築遞 (鬱遞網繭衊醖憲鏇選製, 築選範遞衊憲糧製願簾 ~ 獵獵鹹選網鑰範網鏇範) 更多
NCT02234570 (Pubmed \| Antimicrob Agents Chemother)	临床1期	-	70	Oxfendazole	鬱糧繭鬱鹹顧夢鏇選艱(鹹膚衊衊鹽觸觸壓窪鑰) = dose-dependent decrease 壓積襯壓餘觸範顧餘衊 (選選廠廠鏇鹽獵顧鹽範 ) 更多	-	2019-04-01