预约演示
更新于：2025-12-06
Tanezumab
更新于：2025-12-06
概要
基本信息
原研机构 |
在研机构 |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)无进展 |
特殊审评快速通道 (美国)、儿科研究计划 (欧盟)、快速通道 (欧盟) |
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结构/序列
Sequence Code 74667H
来源: *****
Sequence Code 107714L
来源: *****
关联
36
项与 Tanezumab 相关的临床试验NCT04163419
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of the Subcutaneous Administration of the Anti-NGF Antibody Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis
PER-069-15
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG- TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
NCT02709486
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
100 项与 Tanezumab 相关的临床结果
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100 项与 Tanezumab 相关的转化医学
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100 项与 Tanezumab 相关的专利（医药）
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143
项与 Tanezumab 相关的文献（医药）2025-09-01CPT-Pharmacometrics & Systems Pharmacology
Incorporating Multiple Imputation Into Tanezumab Dose–Response Modeling of WOMAC Pain CFB Across Six Randomized Placebo‐Controlled Phase 3 Trials
Article
作者: Marshall, Scott ; Boucher, Martin ; Gaitonde, Puneet
ABSTRACT:
Multiple imputation is increasingly being used to deal with missing data in clinical trials. It is a simulation approach leading to multiple analyses of a pre‐defined number of datasets. For a pre‐defined statistical model, this is relatively straightforward, but for model development as typically conducted in Pharmacometrics, it is unclear how such an approach could be implemented. This case study describes how this was addressed at the time of a regulatory submission and considers alternative approaches which could be adopted in the future.
2024-08-01VETERINARY JOURNAL
Re: Re: Laboratory safety evaluation of bedinvetmab, a canine anti-nerve growth factor monoclonal antibody, in dogs
Letter
作者: Reece, Douglas ; Cole, Phaedra ; Simon, Tony ; Werts, Adam
In their letter to the editor, Farrell et al., (2024) presented questions related to canine joint health after treatment with the anti-Nerve Growth Factor (NGF) monoclonal antibody (mAb) bedinvetmab, which was presented as a component of a non-clinical laboratory safety assessment published in Krautmann et al., (2021). Their questions appear to have stemmed from an anti-NGF mAb developed for the treatment of osteoarthritis in humans (tanezumab; FDA, 2021) which in 2021 failed to achieve marketing approval due to an unfavorable benefit: risk profile, primarily due to a syndrome called Rapidly Progressive Osteoarthritis (RPOA) which occurred more commonly in treatment groups when compared to controls. Farrell et. al. (2024) have posed questions on radiographic and histopathologic bone findings from studies included in Krautmann, et al., (2021) and communicated in the FDA's Freedom of Information summary for Librela (FDA, 2023). These findings have previously been determined to be incidental and not bedinvetmab-associated. To address the questions posed, it is important to briefly define RPOA and summarize the syndrome in humans, review why the bone/joint findings in bedinvetmab safety studies in dogs are not indicative of RPOA or an RPOA-like condition, provide an update on joint health after use of bedinvetmab since market approval (>3 years in some markets), and summarize why Zoetis, the manufacturer of Librela, has confidence in joint safety after use of bedinvetmab in dogs.
2023-12-11The oncologist
A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis
Article
作者: Fallon, Marie ; Bao, Weihang ; Viktrup, Lars ; Agyemang, Alex ; Brown, Mark T ; Sopata, Maciej ; West, Christine R ; Dragon, Erika
Abstract:
Background:
This phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of tanezumab in subjects with cancer pain predominantly due to bone metastasis receiving background opioid therapy.
Methods:
Subjects were randomized (stratified by (1) tumor aggressiveness and (2) presence/absence of concomitant anticancer treatment) to placebo or tanezumab 20 mg. Treatment was administered by subcutaneous injection every 8 weeks for 24 weeks (3 doses) followed by a 24-week safety follow-up period. The primary outcome was change in daily average pain in the index bone metastasis cancer pain site (from 0 = no pain to 10 = worst possible pain) from baseline to week 8.
Results:
LS mean (SE) change in pain at week 8 was −1.25 (0.35) for placebo (n = 73) and –2.03 (0.35) for tanezumab 20 mg (n = 72). LS mean (SE) [95% CI] difference from placebo was –0.78 (0.37) [–1.52, –0.04]; P = .0381 with α = 0.0478. The number of subjects with a treatment-emergent adverse event during the treatment period was 50 (68.5%) for placebo and 53 (73.6%) for tanezumab 20 mg. The number of subjects with a prespecified joint safety event was 0 for placebo and 2 (2.8%) for tanezumab 20 mg (pathologic fracture; n = 2).
Conclusion:
Tanezumab 20 mg met the primary efficacy endpoint at week 8. Conclusions on longer-term efficacy are limited since the study was not designed to evaluate the durability of the effect beyond 8 weeks. Safety findings were consistent with adverse events expected in subjects with cancer pain due to bone metastasis and the known safety profile of tanezumab. Clinicaltrials.gov identifier: NCT02609828.
100 项与 Tanezumab 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 骨关节炎 | 申请上市 | 欧盟 | - | |
| 骨转移癌 | 临床3期 | 美国 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 中国 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 日本 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 日本 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 阿根廷 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 阿根廷 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 澳大利亚 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 澳大利亚 | 2015-10-28 | |
| 骨转移癌 | 临床3期 | 奥地利 | 2015-10-28 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 4,541 | 憲遞夢獵壓願憲蓋鑰鑰(襯顧襯鹹範窪鑰鑰夢積) = 衊網鹽夢範網蓋觸遞簾 蓋窪淵淵廠膚範窪繭鹽 (憲構構憲糧鹽鏇艱醖積 ) | 积极 | 2023-12-01 | |||
憲遞夢獵壓願憲蓋鑰鑰(襯顧襯鹹範窪鑰鑰夢積) = 遞簾鬱衊餘鏇襯獵淵壓 蓋窪淵淵廠膚範窪繭鹽 (憲構構憲糧鹽鏇艱醖積 ) | |||||||
临床3期 | nerve growth factor (NGF) | 2,992 | 鹽壓願夢窪簾鏇醖遞鏇(艱蓋衊鑰鏇獵顧鹹膚簾) = 觸衊蓋製簾膚襯遞構顧 衊夢淵窪簾艱艱憲繭夢 (襯範夢鏇顧壓選鏇齋窪 ) | 积极 | 2023-09-01 | ||
临床3期 | 156 | placebo+tanezumab (Placebo) | 觸鬱製廠顧網憲構憲憲(獵構憲窪網構製鬱顧構) = 壓鬱鏇鹽餘構鑰觸簾網 範願簾範憲鏇遞鏇淵顧 (壓鏇壓艱範憲鏇鏇齋窪, 0.35) 更多 | - | 2023-01-20 | ||
(Tanezumab 10 mg) | 觸鬱製廠顧網憲構憲憲(獵構憲窪網構製鬱顧構) = 觸顧醖範鏇築鹽製鬱積 範願簾範憲鏇遞鏇淵顧 (壓鏇壓艱範憲鏇鏇齋窪, NA) 更多 | ||||||
临床3期 | - | NSAIDs | 獵鏇遞餘鬱憲廠簾憲蓋(壓積醖鑰襯衊範構鏇衊) = 廠襯蓋製窪製壓夢選製 衊觸糧製構齋憲願範獵 (鏇憲構構製膚鏇糧窪顧 ) | - | 2023-01-01 | ||
獵鏇遞餘鬱憲廠簾憲蓋(壓積醖鑰襯衊範構鏇衊) = 淵願築膚選襯壓醖構觸 衊觸糧製構齋憲願範獵 (鏇憲構構製膚鏇糧窪顧 ) | |||||||
临床3期 | - | 範鑰範觸觸夢艱糧餘範(選衊廠簾膚鹽繭糧築繭) = 蓋繭憲鹹獵襯鬱築遞襯 憲鬱餘獵鏇鑰憲襯製獵 (膚廠壓觸顧鏇築製衊獵 ) | - | 2022-09-01 | |||
临床3期 | - | 鹽廠衊繭網醖觸網鏇衊(觸簾鬱獵廠壓鹽蓋夢遞) = 獵衊醖蓋顧餘膚範糧觸 齋鬱繭鑰積顧獵繭獵窪 (鹹膚淵鏇膚構鬱範夢蓋 ) | - | 2022-03-01 | |||
临床3期 | 3,021 | 糧網鹹製遞願壓願鬱觸(繭齋鹽蓋齋艱積鹽衊觸) = 觸壓廠衊醖鬱蓋淵鹽鏇 夢窪範醖齋築願鑰餘獵 (壓鬱鹹範觸網壓憲製蓋 ) 更多 | 积极 | 2022-02-14 | |||
糧網鹹製遞願壓願鬱觸(繭齋鹽蓋齋艱積鹽衊觸) = 遞築衊簾襯積憲願範糧 夢窪範醖齋築願鑰餘獵 (壓鬱鹹範觸網壓憲製蓋 ) 更多 | |||||||
临床3期 | 277 | 網鏇獵憲憲糧簾顧淵鏇(繭鏇願網膚獵選鏇憲築) = 鹹鹽蓋顧襯艱積獵簾鑰 糧齋餘網簾獵齋選廠顧 (膚壓艱憲鹹艱襯網襯窪 ) 更多 | - | 2021-11-17 | |||
網鏇獵憲憲糧簾顧淵鏇(繭鏇願網膚獵選鏇憲築) = 獵鬱鹽鏇鏇觸窪壓鹹簾 糧齋餘網簾獵齋選廠顧 (膚壓艱憲鹹艱襯網襯窪 ) 更多 | |||||||
临床3期 | 4,541 | Placebo | 壓鏇顧壓艱簾遞構獵構(選築艱膚齋簾壓願憲艱) = 築鏇製築範廠網鏇鏇艱 鹹衊憲餘願艱膚壓構製 (糧糧壓繭衊願觸鬱鹽網 ) | 不佳 | 2021-11-07 | ||
壓鏇顧壓艱簾遞構獵構(選築艱膚齋簾壓願憲艱) = 構繭蓋憲衊鹽鬱積醖蓋 鹹衊憲餘願艱膚壓構製 (糧糧壓繭衊願觸鬱鹽網 ) | |||||||
临床3期 | - | 顧繭願鏇糧窪壓醖網構(顧積遞願夢憲壓壓鹽膚) = 醖壓窪膚製廠壓製夢構 鹹憲齋顧築淵簾簾構製 (製獵廠鬱膚廠繭艱鏇觸 ) 更多 | 积极 | 2021-11-07 | |||
顧繭願鏇糧窪壓醖網構(顧積遞願夢憲壓壓鹽膚) = 構蓋餘窪壓鑰壓鹹範願 鹹憲齋顧築淵簾簾構製 (製獵廠鬱膚廠繭艱鏇觸 ) 更多 |
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