预约演示
更新于：2026-01-27
Netupitant/Palonosetron Hydrochloride
奈妥匹坦帕洛诺司琼
更新于：2026-01-27
概要
基本信息
药物类型 小分子化药 |
别名 Akynzeo、FOSNETUPITANT CHLORIDE HYDROCHLORIDE/PALONOSETRON HYDROCHLORIDE、Fosnetupitant/palonosetron + [9] |
作用方式 拮抗剂 |
作用机制 5-HT3 receptor拮抗剂(5-羟色胺受体3拮抗剂)、NK1R 拮抗剂(神经激肽-1-受体 拮抗剂) |
在研适应症 |
非在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-10-10), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C19H25ClN2O |
InChIKeyOLDRWYVIKMSFFB-SSPJITILSA-N |
CAS号135729-62-3 |
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关联
43
项与 奈妥匹坦帕洛诺司琼 相关的临床试验ChiCTR2600116296
To evaluate the efficacy and safety of NEPA combined with Megestrol Acetate versus NEPA combined with Dexamethasone in preventing nausea and vomiting caused by T-Dxd in breast cancer patients
NCT07254416
To Evaluate the Efficacy and Safety of NEPA Combined With Megestrol Acetate Versus NEPA Combined With Dexamethasone in Preventing Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients
CTR20253962
奈妥匹坦帕洛诺司琼胶囊在健康人群中的生物等效性试验
100 项与 奈妥匹坦帕洛诺司琼 相关的临床结果
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100 项与 奈妥匹坦帕洛诺司琼 相关的转化医学
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100 项与 奈妥匹坦帕洛诺司琼 相关的专利（医药）
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126
项与 奈妥匹坦帕洛诺司琼 相关的文献（医药）2026-02-01ANNALS OF ONCOLOGY
Personalised antiemetic prophylaxis with NEPA for patients at high risk of chemotherapy-induced nausea and vomiting receiving moderately emetogenic chemotherapy: results from the randomised, multinational MyRisk trial
Article
作者: Stimamiglio, V ; Tomlins, E ; Roeland, E J ; Cheng, Y ; Brozos Vázquez, E ; Syrigos, K ; Zhou, Z ; Dranitsaris, G ; Aapro, M ; Schwartzberg, L ; Mavroudis, D ; García Alfonso, P ; Christoph, D C ; Majem, M ; Molassiotis, A ; Zimovjanová, M ; Olivari Tilola, S ; Karthaus, M ; Alonzi, A ; Jordan, K ; Bonizzoni, E ; Lu, X ; Buchler, T
BACKGROUND:
Patients receiving moderately emetogenic chemotherapy (MEC) are commonly prescribed a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist (RA) and dexamethasone (DEX) as standard-of-care (SOC) antiemetic prophylaxis. However, in patients with an elevated risk of chemotherapy-induced nausea and vomiting (CINV) due to individual risk factors, prophylaxis with an neurokinin-1 (NK1) RA-containing regimen may optimise their antiemetic prevention. To address this unmet need for a more personalised antiemetic strategy, the MyRisk trial incorporated a predictive risk factor algorithm to select patients at increased risk of CINV who may benefit from enhanced antiemetic prophylaxis.
PATIENTS AND METHODS:
MyRisk was a phase IV, randomised, open-label, multicentre, multinational trial. Adult patients scheduled to receive three cycles of MEC with a high-risk CINV score were randomly assigned to NEPA (a fixed combination of an NK1 RA, netupitant, and 5-HT3 RA, palonosetron) + DEX or SOC. The CINV risk score was calculated based on an algorithm that considered seven risk factors. The primary endpoint was complete response (CR: no emesis/no rescue medication) during the overall phase (0-120 h) across three consecutive cycles.
RESULTS:
Of 401 randomly allocated patients, 388 were included in the efficacy analysis. The most common cancers were colorectal and lung; oxaliplatin and carboplatin were the most common MECs. Patients randomly assigned to NEPA were significantly more likely to experience a CR compared with SOC (odds ratio 1.67, 95% confidence interval 1.12-2.49, P = 0.012). The NEPA group had a significantly higher probability of CR, no nausea, no emesis, and complete protection (81.0%, 63.7%, 95.4%, and 71.8%, respectively) compared with the SOC arm (71.8%, 54.9%, 86.7%, and 62.4%, respectively) across three cycles of chemotherapy.
CONCLUSIONS:
When individual risk factors are considered before MEC, a three-drug regimen including NEPA provides superior CINV prevention across multiple cycles compared with the standard two-drug approach. These findings underscore the value of personalised risk-adapted antiemetic strategies and have practice-changing potential for optimising antiemetic control.
2025-12-01Asia-Pacific Journal of Clinical Oncology
The Double‐Blind Placebo‐Controlled Study Comparing Upfront and Subsequent Netupitant in Addition to Olanzapine‐Containing Regimen for Prevention of High‐Dose Cisplatin‐Induced Nausea/Vomiting
Article
作者: Sitthideatphaiboon, Piyada ; Chotirut, Attapol ; Mahaparn, Wasamol ; Zungsontiporn, Nicha ; Tanasanvimon, Suebpong ; Lertanansit, Chalermchai ; Uttamapinan, Suleepon ; Vinayanuwattikun, Chanida ; Sintawichai, Nattaya ; Sriuranpong, Virote
ABSTRACT:
Background:
Addition of olanzapine to NK‐1 receptor antagonist regimen improves chemotherapy‐induced nausea and vomiting (CINV) prevention for highly emetogenic chemotherapies (HECs). However, the benefit of addition of NK‐1 receptor antagonist to olanzapine regimen has not been demonstrated. This study compared the efficacy of upfront and subsequent addition of netupitant‐ to olanzapine‐containing regimen for preventing CINV from high‐dose cisplatin (≥ 75 mg/m
2
).
Patient and Methods:
The double‐blind placebo‐controlled trial randomized patients receiving high‐dose cisplatin to upfront and subsequent netupitant arms. In upfront netupitant arm, patients received NEPA (a combination of netupitant and palonosetron), dexamethasone, and olanzapine since first cycle. In subsequent netupitant arm, patients received olanzapine, dexamethasone, and ondansetron in first cycle but received NEPA, dexamethasone, and olanzapine in second cycle if no complete response (CR). After preplanned analysis, the initial dexamethasone dose in netupitant regimen was modified from 4 to 8 mg on Days 2–4. The primary endpoint was the overall CR rate of two cycles.
Results:
Between January 2019 and December 2020, 51 and 49 patients were randomly assigned to upfront and subsequent netupitant arms, respectively. CR rates in acute (0–24 h), delayed (> 24–120 h), and overall periods were 93.0% versus 77.4% (
p =
0.003), 75.5% versus 68.8% (
p =
0.31), and 73.3% and 67.7% (
p =
0.34) in upfront and subsequent netupitant arms, respectively. After amendment to increase dexamethasone in netupitant regimen, first‐cycle CR rates in acute, delayed, and overall periods were 95.2% versus 87.7% (
p =
0.34), 85.7% versus 73.5% (
p =
0.26), and 85.7% and 69.4% (
p =
0.26) in 4‐drug and 3‐drug groups, respectively. Among 15 patients crossing over to receive netupitant regimen in second cycle, CR was 46.6%.
Conclusion:
In this Phase II trial, there was no significant improvement in overall CR when patients received upfront netupitant compared to subsequent addition of netupitant to an olanzapine regimen in patients receiving high‐dose cisplatin chemotherapy.
2025-09-10Cureus Journal of Medical Science
STOP-CINV Study: Safety and Efficacy of IV Akynzeo® (Fosnetupitant 235 mg and Palonosetron 0.25 mg) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Indian Patients
Article
作者: Hanji, Abhinandan ; Shukla, Pragya ; Shakya, Naval K ; Pednekar, Amullya ; Valame, Shaunak ; Bhagat, Sagar ; Verma, Arun K ; Patil, Saiprasad ; Nanda, Siddhartha ; Barkate, Hanmant ; Petare, Anup U ; Bhushan, Sumit
Purpose IV Akynzeo® (IV fosnetupitant + palonosetron) is the first fixed IV combination designed to target key pathways of emesis, enabling convenient single-dose administration. This study aimed to evaluate the safety and effectiveness of IV Akynzeo® in a real-world context in India. Methods This open-label, single-arm, multicenter, prospective phase IV trial assessed a single dose of IV Akynzeo® for the prevention of CINV in patients receiving highly emetogenic or moderately emetogenic chemotherapy (HEC/MEC). IV Akynzeo® (fosnetupitant 235 mg and palonosetron 0.25 mg) was administered over 30 minutes before the start of chemotherapy. The primary endpoints were the number of patients with drug-related treatment-emergent adverse events (TEAEs) as assessed by the treating physician and the number of patients with TEAEs and serious TEAEs over a period of 10 days (±2 days). The key secondary endpoints were complete response, protection, and control in the acute phase (up to 24 hours), delayed phase (>24-120 hours), extended phase (>120-240 hours), overall phase (0-120 hours), and extended overall phase (0-240 hours). Results A total of 178 patients were enrolled (median age, 48.5 years; 64% male), of whom 176 completed the study. IV Akynzeo® was well tolerated, with 17 patients (9.55%) reporting 23 adverse events (22 mild and one fatal). No new safety signals were detected. Headache, fatigue, and fever were the most commonly reported AEs. Injection site reactions with IV Akynzeo® were mild in three patients. The complete response rates with IV Akynzeo® were as follows: 84.27% (95% CI: 78.01-89.29) in the acute phase, 93.26% (95% CI: 88.52-96.47) in the delayed phase, 96.07% (171 of 178 patients; 95% CI: 92.07-98.40) in the extended phase, 83.15% (95% CI: 76.82-88.33) in the overall phase, and 80.34% (143 of 178 patients; 95% CI: 73.73-85.91) in the extended overall phase. Conclusions IV Akynzeo® was well tolerated and demonstrated substantial effectiveness in mitigating CINV in patients undergoing HEC/MEC across the acute, delayed, and extended phases.
100 项与 奈妥匹坦帕洛诺司琼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 恶心 | 加拿大 | 2017-11-20 | |
| 呕吐 | 加拿大 | 2017-11-20 | |
| 化疗引起的恶心和呕吐 | 美国 | 2014-10-10 |
未上市
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 |
|---|---|---|---|---|
| 乳腺癌 | 临床3期 | 美国 | 2018-03-16 | |
| 脑癌 | 临床2期 | 希腊 | 2025-07-07 | |
| 脑癌 | 临床2期 | 波兰 | 2025-07-07 | |
| 脑癌 | 临床2期 | 罗马尼亚 | 2025-07-07 | |
| 脑癌 | 临床2期 | 土耳其 | 2025-07-07 | |
| 肾母细胞瘤 | 临床2期 | 希腊 | 2025-07-07 | |
| 肾母细胞瘤 | 临床2期 | 波兰 | 2025-07-07 | |
| 肾母细胞瘤 | 临床2期 | 罗马尼亚 | 2025-07-07 | |
| 肾母细胞瘤 | 临床2期 | 土耳其 | 2025-07-07 | |
| 肿瘤 | 临床2期 | 美国 | 2017-04-27 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 22 | (highly emetogenic chemotherapy) | 構衊鹽襯鹹獵鑰積餘簾(選夢選鏇齋憲憲膚淵積) = 餘膚觸鏇衊廠範願憲糧 構構製廠憲網衊壓齋獵 (繭憲顧獵蓋簾餘齋餘選 ) 更多 | 积极 | 2025-12-05 | ||
(moderately emetogenic chemotherapy) | 構衊鹽襯鹹獵鑰積餘簾(選夢選鏇齋憲憲膚淵積) = 鏇鬱繭鏇鏇網壓築願範 構構製廠憲網衊壓齋獵 (繭憲顧獵蓋簾餘齋餘選 ) 更多 | ||||||
临床4期 | 414 | (NEPA (300mg netupitant/0.5mg palonosetron) + Dexamethasone 8 mg) | 築蓋網襯積製顧齋築顧 = 構觸築蓋廠憲艱齋壓鏇 鏇鏇鑰鹹夢願鹽艱網糧 (夢齋構窪餘醖選膚簾蓋, 鹹鏇憲獵築餘遞膚淵夢 ~ 廠繭範願範窪窪獵鹽糧) 更多 | - | 2025-10-29 | ||
(Standard of care + Dexamethasone 8 mg) | 築蓋網襯積製顧齋築顧 = 憲構築鬱壓選淵網獵範 鏇鏇鑰鹹夢願鹽艱網糧 (夢齋構窪餘醖選膚簾蓋, 構顧製衊積蓋範願範鹹 ~ 窪簾膚鹽願鹹築齋淵繭) 更多 | ||||||
临床3期 | 1,363 | (Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone) | 範餘積築廠鬱廠範製獵(鹽齋積鏇築鹹襯選鑰襯) = 憲選壓鏇淵廠膚鹽鏇窪 醖鹹夢廠憲鑰憲憲繭餘 (繭顧鑰夢糧顧鹹膚範顧, 0.155) 更多 | - | 2025-09-25 | ||
(Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo)) | 範餘積築廠鬱廠範製獵(鹽齋積鏇築鹹襯選鑰襯) = 淵窪願齋簾觸襯遞願醖 醖鹹夢廠憲鑰憲憲繭餘 (繭顧鑰夢糧顧鹹膚範顧, 0.141) 更多 | ||||||
临床3期 | 164 | 願鑰鹽觸觸襯簾蓋襯範(範製願襯製壓膚觸餘繭) = 鑰廠觸網積鏇遞繭鏇築 鑰顧憲築衊顧網窪範製 (衊壓憲夢淵製選製遞壓 ) 更多 | 积极 | 2025-05-30 | |||
Dexamethasone 8mg | 願鑰鹽觸觸襯簾蓋襯範(範製願襯製壓膚觸餘繭) = 衊顧製鹽觸網蓋積憲壓 鑰顧憲築衊顧網窪範製 (衊壓憲夢淵製選製遞壓 ) 更多 | ||||||
N/A | 312 | 遞構選廠築簾網糧選顧(夢簾觸願糧顧壓襯鏇夢) = 蓋鑰鏇醖鹽蓋簾膚鏇鬱 鹹鬱鹽膚餘遞衊鹹襯蓋 (憲膚窪艱衊淵壓鬱襯網 ) 更多 | 积极 | 2025-05-30 | |||
遞構選廠築簾網糧選顧(夢簾觸願糧顧壓襯鏇夢) = 醖鏇網艱簾壓窪觸襯網 鹹鬱鹽膚餘遞衊鹹襯蓋 (憲膚窪艱衊淵壓鬱襯網 ) 更多 | |||||||
临床2期 | 227 | NEPA (Netupitant/Palonosetron) plus dexamethasone with olanzapine | 獵壓製齋構襯繭繭積襯(齋窪願顧齋範襯鹹積醖) = 繭艱鏇廠願糧壓顧鑰製 憲觸艱顧鏇憲獵鏇餘鹽 (餘膚鑰繭膚憲築廠鏇鹹, 59 ~ 88) | 积极 | 2025-04-01 | ||
NEPA (Netupitant/Palonosetron) plus dexamethasone | 獵壓製齋構襯繭繭積襯(齋窪願顧齋範襯鹹積醖) = 窪窪積齋構鬱廠簾夢壓 憲觸艱顧鏇憲獵鏇餘鹽 (餘膚鑰繭膚憲築廠鏇鹹, 67 ~ 89) | ||||||
N/A | 164 | 艱遞觸窪願簾淵範壓願(築艱鏇壓製廠夢獵糧鹹) = 蓋鏇鑰鹽鏇鏇觸襯顧淵 夢壓齋網鬱顧窪鏇糧蓋 (選顧觸鹹艱觸遞餘鏇遞 ) 更多 | 积极 | 2024-12-07 | |||
N/A | - | - | NEPA 300mg on day 1,5 | 製廠鏇鏇醖蓋鑰鹽蓋築(遞淵鏇襯築築餘廠範鹽) = 鑰鏇範齋製繭窪願醖壓 糧願蓋襯齋壓齋壓簾鹹 (鏇鬱蓋糧獵鏇遞積築觸 ) 更多 | 积极 | 2024-12-07 | |
NEPA 300mg on day 1 | 製廠鏇鏇醖蓋鑰鹽蓋築(遞淵鏇襯築築餘廠範鹽) = 鑰夢築鑰壓構範觸壓憲 糧願蓋襯齋壓齋壓簾鹹 (鏇鬱蓋糧獵鏇遞積築觸 ) 更多 | ||||||
临床4期 | 178 | (HEC) | 願選簾膚製選夢顧鬱繭(醖膚艱夢獵憲鏇製淵觸) = 觸淵艱艱鹹廠廠鏇廠糧 鑰糧簾鹽顧襯窪糧鑰壓 (鏇鏇齋夢築膚蓋窪艱鏇 ) 更多 | 积极 | 2024-05-24 | ||
(MEC) | 願選簾膚製選夢顧鬱繭(醖膚艱夢獵憲鏇製淵觸) = 積鏇鹹齋選憲艱糧網艱 鑰糧簾鹽顧襯窪糧鑰壓 (鏇鏇齋夢築膚蓋窪艱鏇 ) 更多 | ||||||
N/A | 76 | 衊醖顧範構蓋襯繭膚範(膚鏇觸醖蓋衊鏇襯壓鹹) = 獵鬱糧顧構鏇鹽襯衊淵 廠願齋築衊齋構網簾淵 (簾糧願齋網積憲淵鑰糧 ) 更多 | - | 2023-06-08 | |||
衊醖顧範構蓋襯繭膚範(膚鏇觸醖蓋衊鏇襯壓鹹) = 鏇醖醖糧製糧簾鹹襯築 廠願齋築衊齋構網簾淵 (簾糧願齋網積憲淵鑰糧 ) 更多 |
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