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更新于：2026-10-24
SHR-7280
更新于：2026-10-24
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评- |
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关联
11
项与 SHR-7280 相关的临床试验NCT06969664
A Phase I Clinical Study to Evaluate Effect of High-Fat Diet on Pharmacokinetics of a Single Oral Dose of SHR7280 Tablets and to Assess the Effect of SHR7280 on QT Interval in Healthy Subjects
NCT06949124
A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of SHR7280 and Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects
NCT06408948
Phase I Clinical Trial of Mass Balance of [14C]SHR7280 in Healthy Chinese Subjects
100 项与 SHR-7280 相关的临床结果
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100 项与 SHR-7280 相关的转化医学
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100 项与 SHR-7280 相关的专利（医药）
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5
项与 SHR-7280 相关的文献（医药）2025-09-01Clinical Drug Investigation
Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers
Article
作者: Li, Lanping ; Qin, Ruzhai ; Peng, Jiao ; Shu, Chang ; Huang, Dongxiang ; Duan, Lian ; Shen, Kai ; Li, Xi ; Li, Xiaomei ; Ma, Lingyu ; Ye, Lika ; Liu, Xian ; Xie, Zhihong ; Chen, Sihan
BACKGROUND:
SHR7280 is an oral small-molecule gonadotropin-releasing hormone (GnRH) antagonist that can be developed as therapeutic agent for the treatment of hormone-dependent pathologies, including prostate, breast, and ovarian cancers. SHR7280 dry suspension formulation is being developed to provide an alternative mode of administration for order patients, those using nutritional tubes, and those unable to swallow solid dosage forms.
OBJECTIVE:
This study evaluated the relative bioavailability, pharmacokinetics (PK), and safety of SHR7280 dry suspension and tablets administered in a single dose in healthy Chinese volunteers.
METHODS:
A randomized, open, two-preparation, two-sequence, two-cycle, double-crossover design was used in this study. The plasma drug concentration was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The main PK parameters of the two formulations of SHR7280 were calculated by noncompartmental analysis using Phoenix WinNonlin (version 8.3.4) software. A total of 16 healthy participants were randomized to receive SHR7280 (200 mg) as tablets (n = 8) or dry suspension (n = 8) formulation.
RESULTS:
The geometric least squares mean ratio (90% confidence interval [CI]) for maximum concentration of drug in blood plasma (Cmax) and area under the plasma concentration-time curve from time 0 to t (AUC0-t) and from time 0 to infinity (AUC0-∞) between the dry suspension of SHR7280 and its tablets were calculated as follows: Cmax-101.90% (90% CI 79.50-130.62), AUC0-t-111.58% (90% CI 91.71-135.76), and AUC0-∞-111.44% (90% CI 91.70-135.43). A total of nine (56.3%) subjects experienced treatment-emergent adverse events (TEAEs).
CONCLUSIONS:
The bioavailability of SHR7280 tablets was found to be comparable to that of dry suspension. The safety profile of two formulations was favorable. No serious adverse events or adverse drug reactions were reported.
TRIAL REGISTRATION:
ClinicalTrials.gov (NCT05868057; 22 May 2023).
2025-07-01HUMAN REPRODUCTION
SHR7280, an oral gonadotropin-releasing hormone antagonist, for the prevention of premature luteinizing hormone surge in controlled ovarian hyperstimulation: a dose-finding, phase 2 trial
Article
作者: Tan, Jichun ; Guan, Yichun ; Song, Ying ; Chi, Hongbin ; Chen, Hong ; Sun, Yuqi ; Cao, Yunxia ; Li, Yanping ; Li, Zeli ; Jin, Lei ; Wang, Xiaohong ; Song, Xueru ; Diao, Feiyang ; Qiao, Jie ; Liang, Xiaoyan ; Shu, Chang ; Ma, Qianhong ; Shen, Kai
Abstract:
STUDY QUESTION:
What is the minimum effective dose of SHR7280, a novel oral GnRH antagonist, to prevent a premature LH surge in women undergoing controlled ovarian hyperstimulation for ART?
SUMMARY ANSWER:
SHR7280 at 200 mg once every 12 h (Q12h) was the minimal effective dose to suppress an LH surge and was associated with high-quality embryos, and a high clinical pregnancy rate. SHR7280 was well-tolerated and safe.
WHAT IS KNOWN ALREADY:
Currently, all approved GnRH antagonists for preventing a premature LH surge are injectable, peptide-based formulations, which can cause inconvenience and injection site reactions. There is a significant unmet need for an orally available GnRH antagonist to address this issue. SHR7280 has previously demonstrated effective suppression of LH levels in healthy volunteers in phase 1 trials.
STUDY DESIGN, SIZE, DURATION:
This multi-center, open-label, dosing-finding phase 2 trial was conducted between 26 January 2022 and 3 August 2023 in 85 infertile women.
PARTICIPANTS/MATERIALS, SETTING, METHODS:
The starting dose of SHR7280 was 300 mg Q12h, followed by dose exploration in two lower dose groups (200 mg Q12h and 200 mg Q24h) sequentially. Dose exploration was terminated if an LH surge occurred. SHR7280 was administrated orally starting on Day 5 of recombinant human FSH stimulation until hCG administration. The primary endpoint was the rate of premature LH surge inhibition during SHR7280 treatment.
MAIN RESULTS AND THE ROLE OF CHANCE:
Eighty-five patients received SHR7280: 300 mg Q12h, n = 40; 200 mg Q12h, n = 42; 200 mg Q24h, n = 3. The mean ( ± SD) duration of SHR7280 treatment was 5.7 ± 1.2, 5.7 ± 1.3, and 3.7 ± 0.6 days, respectively. The rate of LH surge inhibition was 99% (95% CI 94–100) in all patients, 100% (95% CI 91–100) in the 300 mg Q12h group, 100% (95% CI 92–100) in the 200 mg Q12h group, and 67% (95% CI 9–99) in the 200 mg Q24h group. Two hundred milligrams Q12h was established as the minimal effective dose. Embryological and pregnancy outcomes were comparable in the 300 and 200 mg Q12h groups. In the 200 mg Q12h group, the mean ( ± SD) number of oocytes retrieved per patient, two-pronucleate zygotes, and high-quality embryos was 10.7 ± 4.6, 6.9 ± 3.2, and 3.9 ± 2.6, respectively; among patients receiving fresh embryo transfer, 62% (95% CI 44–78) were tested positive for serum β-hCG and 53% (95% CI 35–70) were confirmed to be clinically pregnant per transfer. No spontaneous ovulation occurred on the day of oocyte retrieval. In all 85 patients, treatment-related adverse events were reported in 1 (1%; mild in severity) patient.
LIMITATIONS, REASONS FOR CAUTION:
The sample size was moderate and there was no standard peptide-based GnRH antagonist as a control group. Additionally, the performance of SHR7280 in specific populations, such as patients with diminished ovarian reserve and at high risk of OHSS, remains to be established. Further research is also needed to determine the recommended dose in patients with high BMI, intending for frozen embryo transfer, and using a GnRH agonist as trigger. Moreover, the study included only Chinese patients and allowed up to 2 embryos per transfer. The efficacy and safety of SHR7280 in other racial groups and regions require further investigation.
WIDER IMPLICATIONS OF THE FINDINGS:
Findings from this phase 2 trial suggest that an oral GnRH antagonist could be an effective alternative for preventing a premature LH surge in ART.
STUDY FUNDING/COMPETING INTEREST(S):
This study was funded by Jiangsu Hengrui Pharmaceuticals. Z.L., Yu.S., C.S., Hong.C., and K.S. were employees of Jiangsu Hengrui Pharmaceuticals at the time of study. All other authors have no conflicts of interests to declare.
TRIAL REGISTRATION NUMBER:
NCT05082233.
2023-12-01Clinical pharmacokinetics
Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Article
作者: Li, Yuan ; Yu, Qin ; Xu, Bing ; Feng, Sheng ; Zhu, Zhenyi ; Guo, Hongyan ; Cai, Linrui ; Liu, Yiming ; Zheng, Ying
BACKGROUND:
Oral gonadotropin-releasing hormone (GnRH) antagonists are promising agents in the treatment of endometriosis-related pain. Here we assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR7280, an oral non-peptide GnRH antagonist in premenopausal women with endometriosis.
METHODS:
In the Phase 1 part of the randomized, double-blinded, placebo-controlled, dose-ascending, Phase 1/2 trial, premenopausal women with endometriosis were randomized (4:1) to receive SHR7280 or placebo treatment for 21 consecutive days. The treatment dose started from 200 mg QD, and then increased to 300 mg QD and 200 mg BID. Safety, PK, and PD parameters were assessed.
RESULTS:
In total, 30 patients received assigned treatment, 24 with SHR7280 and 6 with placebo. SHR7280 was well tolerated. Adverse events (AEs) were reported in 19 (79.2%, 19/24) patients in the SHR7280 group and 5 (83.3%, 5/6) patients in the placebo group. Most AEs were mild and no severe AEs occurred. SHR7280 showed a rapid absorption, with a time to maximum plasma concentration (Tmax) of 1.0 h, 1.0 h, and 0.8 h for the 200 mg QD, 300 mg QD, and 200 mg BID regimens, respectively. Plasma concentration of SHR7280 was dose dependent. The mean half-life (t1/2) at steady state was 6.9 h, 7.4 h, and 2.8 h, respectively, and little or no accumulation was observed. Pharmacodynamic analysis showed that SHR7280 could effectively suppress estradiol and luteinizing hormone concentrations and prevent progesterone increase in a dose-dependent manner. SHR7280 at doses of 300 mg QD and 200 mg BID could suppress estradiol levels within the desired therapeutic window of 20-50 pg/mL throughout the treatment period.
CONCLUSIONS:
SHR7280 showed favorable safety, PK, and PD profiles in the doses of 200 mg QD, 300 mg QD, and 200 mg BID. The results of this study provide evidence to support the further development of SHR7280 as a GnRH antagonist for the treatment of endometriosis-related pain in the subsequent Phase 2 trial.
TRIAL REGISTRY:
Trial registration number: Clinicaltrials.gov, identifier: NCT04417972. Trial registration date: 5 June 2020.
100 项与 SHR-7280 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 |
|---|---|---|---|---|
| 卵巢刺激 | 申请上市 | 中国 | 2025-09-23 | |
| 女性不孕症 | 临床3期 | 中国 | 2023-08-29 | |
| 月经过多 | 临床3期 | 中国 | 2022-09-10 | |
| 子宫肌瘤 | 临床3期 | 中国 | 2022-09-10 | |
| 卵巢过度刺激综合征 | 临床2期 | 中国 | 2022-03-06 | |
| 子宫内膜异位症 | 临床2期 | 中国 | 2020-07-29 | |
| 去势敏感前列腺癌 | 临床1期 | 中国 | 2021-09-24 | |
| 去势抵抗性前列腺癌 | 临床1期 | 中国 | 2021-09-14 | |
| 多内分泌代谢卵巢综合征 | 临床1期 | 中国 | 2020-09-11 | |
| 性早熟 | 临床1期 | 中国 | 2020-09-11 |
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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1期 | - | 16 | 網糧鑰製繭餘獵鏇夢範(簾鏇憲壓顧築糧衊築艱): ratio = 111.58 (90.0% CI, 91.71 ~ 135.76) 更多 | 积极 | 2025-08-08 | ||
临床3期 | 315 | 築築齋膚窪顧遞醖鏇夢(壓簾襯廠網繭鹹淵窪鹹) = 構積壓糧壓繭觸製遞構 壓獵窪簾衊衊醖願衊廠 (觸淵鏇壓鑰鹽窪鹽觸壓 ) 达到 更多 | 非劣 | 2025-07-25 | |||
築築齋膚窪顧遞醖鏇夢(壓簾襯廠網繭鹹淵窪鹹) = 範壓鬱範蓋襯憲壓窪積 壓獵窪簾衊衊醖願衊廠 (觸淵鏇壓鑰鹽窪鹽觸壓 ) 达到 更多 | |||||||
临床2期 | 85 | SHR7280 300 mg Q12h | 齋選膚壓齋窪繭網憲膚(餘選築餘夢選選顧築網) = 蓋鹹鬱鏇網簾範築壓蓋 觸糧願醖遞鹽艱網蓋夢 (簾廠壓淵鑰夢廠願淵壓, 94 ~ 100) 更多 | 积极 | 2025-07-01 | ||
SHR7280 200 mg Q12h | 齋選膚壓齋窪繭網憲膚(餘選築餘夢選選顧築網) = 鏇壓簾鬱壓壓簾簾獵餘 觸糧願醖遞鹽艱網蓋夢 (簾廠壓淵鑰夢廠願淵壓, 92 ~ 100) 更多 | ||||||
临床1期 | 30 | 構繭襯蓋膚範鏇獵襯遞(鹹糧網繭餘鏇夢蓋鹹襯) = 淵廠網獵簾繭觸蓋簾壓 襯鹹壓餘獵窪蓋蓋蓋遞 (憲簾構鏇製醖觸壓觸憲 ) | 积极 | 2023-10-14 | |||
Placebo | 構繭襯蓋膚範鏇獵襯遞(鹹糧網繭餘鏇夢蓋鹹襯) = 觸鹹蓋鑰襯夢積壓簾願 襯鹹壓餘獵窪蓋蓋蓋遞 (憲簾構鏇製醖觸壓觸憲 ) | ||||||
临床1期 | - | 70 | 餘鏇繭鑰簾製蓋夢鏇廠(鹽窪網範窪壓廠憲鹹鑰) = 鹹鬱襯蓋衊鬱蓋憲糧獵 廠齋構窪築繭廠餘願膚 (觸選衊製鏇齋鹹窪積觸 ) 更多 | - | 2023-04-03 | ||
Placebo | 餘鏇繭鑰簾製蓋夢鏇廠(鹽窪網範窪壓廠憲鹹鑰) = 顧積餘衊衊製壓鬱鑰鏇 廠齋構窪築繭廠餘願膚 (觸選衊製鏇齋鹹窪積觸 ) 更多 | ||||||
临床1期 | - | 118 | 窪蓋繭壓築獵窪觸積襯(蓋鏇鏇齋網繭鹽鏇餘顧) = 選製餘鬱簾窪鑰顧齋製 襯襯醖獵糧鬱艱壓齋顧 (觸餘繭繭鹽廠糧鏇網齋 ) | - | 2022-01-01 | ||
窪蓋繭壓築獵窪觸積襯(蓋鏇鏇齋網繭鹽鏇餘顧) = 窪鏇製鑰餘膚鹹鏇齋繭 襯襯醖獵糧鬱艱壓齋顧 (觸餘繭繭鹽廠糧鏇網齋 ) |
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