奈立膦酸(Neridronic acid) - 药物靶点：FDPS_在研适应症：成骨不全，高钙血症，畸形性骨炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

AHDP、AHHexBP、Attila

+ [1]

靶点

FDPS

作用机制

FDPS抑制剂(法呢基二磷酸合酶抑制剂)

治疗领域

遗传病与畸形内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

意大利 (2002-04-04),

成骨不全

最高研发阶段(中国)临床前

特殊审评-

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结构

分子式C6H17NO7P2

InChIKeyPUUSSSIBPPTKTP-UHFFFAOYSA-N

CAS号79778-41-9

关联

7

项与奈立膦酸相关的临床试验

NCT03560986 / Terminated临床3期

Placebo-controlled Efficacy and Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).
The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid 100 mg or placebo) over 10 days, and a Follow-up Period 1 until Week 26. At Week 26, participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52. Participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52.

开始日期2018-05-31

申办/合作机构

Grünenthal GmbH

NCT03530345 / Terminated临床3期

Randomized, Double-blind, Placebo-controlled Trial Investigating the Efficacy and Safety of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

The aim of this trial was to investigate the efficacy and safety of intravenous neridronic acid in subjects with Complex Regional Pain Syndrome (CRPS).
The trial consisted of an Enrollment Period lasting up to 60 days, Treatment Period A consisting of 4 infusions (neridronic acid or placebo) over 10 days, and a Follow-up Period 1 until Week 26.
At Week 26, participants not meeting the pre-specified criteria to continue into Treatment Period B continued in Follow-up Period 2 until Week 52. Participants meeting the pre-specified criteria entered the open-label Treatment Period B with 4 additional infusions (neridronic acid) over 10 days and follow-up visits until Week 52.

开始日期2018-05-30

申办/合作机构

Grünenthal GmbH

NCT02972359 / Completed临床3期

Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS)

The aim of this trial was to investigate the safety of intravenous neridronic acid in patients with complex regional pain syndrome (CRPS).
The trial was divided into 3 periods: a 60-day enrollment period, a treatment period consisting of 4 infusions over 10 days, and a follow-up period of approximately 50 weeks (with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).

开始日期2016-12-20

申办/合作机构

Grünenthal GmbH

100 项与奈立膦酸相关的临床结果

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100 项与奈立膦酸相关的转化医学

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100 项与奈立膦酸相关的专利（医药）

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14

项与奈立膦酸相关的文献（医药）

2020-07-01·Journal of Biomedical Materials Research Part A

Treatment with bisphosphonates to mitigate calcification of elastin‐containing bioprosthetic materials

Article

作者: Karpova, Elena V. ; Shatskaya, Svetlana S. ; Kuznetsova, Elena V. ; Timchenko, Tatyana P. ; Polienko, Yuliya F. ; Baratova, Ludmila A. ; Bogachev‐Prokophiev, Alexander V. ; Nichay, Nataliya R. ; Zhuravleva, Irina Y. ; Vasilieva, Maria B. ; Beshchasna, Natalia

AbstractThis study evaluated the ability of bisphosphonates (BPAs) of different molecular structures to mitigate the calcification of porcine aortic wall (PAW) and bovine jugular vein wall (BJVW). Tissues cross‐linked with glutaraldehyde (GA) or diepoxide (DE) were modified with pamidronic acid (PAM), alendronic acid (ALE), neridronic acid (NER) (type 1 BPAs); 2‐(2′‐carboxyethylamino)ethylidene‐1,1‐bisphosphonic acid (CEABA), 2‐(5‐carboxypentylamino)ethylidene‐1,1‐bisphosphonic acid (CPABA) (type 2); and zoledronic acid (ZOL) (type 3). After implanting the tissue samples subcutaneously in 100 rats, calcification was examined using atomic absorption spectrophotometry (60‐day explants) and light microscopy after von Kossa staining (10‐ and 30‐day explants). The calcium contents in GA‐BJVW and GA‐ and DE‐PAW increased up to 100–120 mg/g after 60 days, while being 3 times lower in DE‐BJVW. In modified and nonmodified PAW samples, calcium phosphates appeared by day 10 and were associated with elastic fibers and devitalized cellular elements. In all groups of BJVW samples, mineralization began in elastic fibers near the subendothelial layer. In addition, calcified collagen was found in the GA‐BJVW samples. Minimal calcification was found in GA‐PAW treated with type 1 BPAs and CEABA. For DE‐PAW and GA‐BJVW, the calcium level significantly decreased with PAM and CEABA. Meanwhile, ALE and NER were effective for DE‐BJVW.

2018-01-01·Archives of Neuropsychiatry4区 · 医学

New Indices from Polysomnographic Measures for the Severity of Obstructive Sleep Apnea Syndrome

4区 · 医学

Article

作者: Demır, Nurhak ; Öztura, İbrahim

INTRODUCTIONObstructive sleep apnea syndrome (OSAS) is characterized by recurrent abnormal respiratory events during sleep and causes oxidative stress which is reported as a major pathogenic mechanism for the development of various cardiovascular disorders. For the diagnosis and management of treatment, disease-related symptoms and the Apnea-Hypopnea Index (AHI) measured from polysomnographic (PSG) recordings are taken together. However, AHI do not sufficiently represent the total hypoxic load, and other indices related to apnea frequency, apnea duration, and desaturation degree should be investigated.METHODSIn this study, 317 polysomnographic recordings were retrospectively evaluated. Apart from the conventional AHI, apnea and/or hypopnea duration percentage (AHDP) and desaturation area (DesatArea) were calculated using PSG data.RESULTSAccording to the AHI, 21.8%, 32.8% and 45.4% of cases were grouped as mild, moderate and severe OSAS, respectively. When AHDP was taken into account, 10.4%, 22.1% and 67.5% of the cases were regrouped as mild, moderate or severe OSAS, respectively. When the DesatArea calculation was used, the grouping of cases as mild, moderate or severe OSAS changed in value to 10.7%, 21.1% and 68.1%, respectively. The total group change was found to be 58.4% for both the AHDP and DesatArea formulation. With the AHDP formulation, regrouping was made in 52.2% of the mild OSAS cases and 62.5% of the moderate OSAS cases; by using the DesatArea calculation, 50.7% of mild OSAS cases and 63% of moderate OSAS cases were regrouped.CONCLUSIONOur results show that when another parameters related to abnormal respiratory events are used, the same patients within the same group of disease severity are heterogeneously separated according to severity of hypoxia. It is suggested that grouping the patients based on AHI is insufficient and that using other polysomnographic measurements along with AHI should be considered to represent the severity of the disease.

2017-03-01·Joint Bone Spine3区 · 医学

First cases of calcium pyrophosphate deposition disease after zoledronic acid therapy

3区 · 医学

Article

作者: Couture, Guillaume ; Micallef, Joëlle ; Bagheri, Haleh ; Laroche, Michel ; Ruyssen-Witrand, Adeline ; Delzor, Faustine

A number of medications promote the development of calcium pyrophosphate deposition disease (CPDD). We report 2 cases of acute CPDD after intravenous zoledronic acid therapy. Case #1: a 63-year-old female was admitted for vertebroplasty at the site of an osteoporotic fracture. She received an intravenous infusion of zoledronic acid 5mg on the day after the procedure. Acute CPDD developed in her right knee 24hours later. Findings from joint aspiration and standard radiography confirmed the diagnosis. Case #2: this 79-year-old woman had a history of CPDD was on glucocorticoid and hydroxychloroquine therapy for lupus. She was given an intravenous infusion of zoledronic acid 5mg as prophylaxis of glucocorticoid-induced osteoporosis. Joint pain and a fever developed later on the same day. After 5 days, she had arthritis of the right wrist, laboratory evidence of systemic inflammation, and hypocalcemia. Radiographs showed evidence of CPDD. A Medline search identified 6 cases of bisphosphonate-related CPDD, including 2 due to pamidronate, 2 to etidronate, 1 to alendronic acid, and 1 to neridronic acid. The features were similar to those in our patients, with a short time to onset, systemic inflammation in many cases, a tendency toward hypocalcemia, and radiographs that often showed evidence of CPDD. Bisphosphonate-induced CPDD is a rare eventuality that should nevertheless be borne in mind by rheumatologists. Also, in patients with CPDD while taking bisphosphonate therapy, a role for the drug in the symptoms should be considered.

100 项与奈立膦酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	奈立膦酸	M05BA	DB11620

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
成骨不全	意大利	Abiogen Pharma SpA	2002-04-04
高钙血症	-	-	-
畸形性骨炎	-	-	-
骨质疏松症	-	-	-

未上市

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
复杂性局部疼痛综合征	临床1期	德国	Grunenthal SA	2016-12-20
成骨不全	临床前	中国	李氏大药厂控股有限公司	-

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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


NCT03560986 (CTgov)	临床3期	复杂性局部疼痛综合征	267	Neridronic Acid (Neridronic Acid - Treatment Period A)	鹹顧顧淵構蓋窪觸淵鏇(構鑰鏇齋醖顧蓋簾選願) = 襯構製選遞廠顧醖夢壓選遞蓋顧膚製夢鹽鬱艱 (顧襯餘鏇膚夢構獵願艱, 憲簾顧憲壓選壓鏇窪簾 ~ 窪鏇糧鏇製餘繭顧醖簾)	-	2020-08-05
				Placebo (Placebo - Treatment Period A)	鹹顧顧淵構蓋窪觸淵鏇(構鑰鏇齋醖顧蓋簾選願) = 鬱襯構選糧繭蓋鹹襯艱選遞蓋顧膚製夢鹽鬱艱 (顧襯餘鏇膚夢構獵願艱, 膚醖顧顧選鏇衊餘鏇獵 ~ 鬱簾觸膚網壓糧遞醖網)
NCT02972359 (CTgov)	临床3期	复杂性局部疼痛综合征	580	Neridronic acid	(鹹憲繭淵築築廠醖齋衊) = 獵觸積窪願糧淵築憲餘餘餘襯鬱鹽簾鹹簾窪獵 (蓋廠網築築醖鏇壓蓋糧, 膚膚鬱夢餘餘繭製網構 ~ 願鹹築獵遞積鹹網艱膚) 更多	-	2019-11-04
NCT03530345 (CTgov)	临床3期	复杂性局部疼痛综合征	182	Neridronic Acid (Neridronic Acid - Treatment Period A)	壓積鬱淵願窪鏇艱襯糧(顧襯範鏇鏇蓋獵膚憲鹹) = 廠夢網淵網獵醖製窪願願齋鏇鏇鹽觸鑰築鹹網 (窪窪餘窪築醖網艱蓋憲, 憲遞襯鬱糧鏇鏇鑰壓壓 ~ 蓋獵壓夢鑰艱醖築齋顧)	-	2020-08-06
				Placebo (Placebo - Treatment Period A)	壓積鬱淵願窪鏇艱襯糧(顧襯範鏇鏇蓋獵膚憲鹹) = 膚繭憲廠餘夢獵積遞衊願齋鏇鏇鹽觸鑰築鹹網 (窪窪餘窪築醖網艱蓋憲, 願範積齋壓鏇鏇鬱憲鑰 ~ 壓壓壓廠夢齋觸鑰蓋壓)