A Phase 3, Randomized, Double-mask, Placebo-controlled Study With Open-label Extension to Evaluate the Efficacy and Safety of Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)

The goal of this clinical trial is to evaluate the efficacy, safety, and tolerability of linsitinib in participants with moderate to severe Thyroid Eye Disease (TED).

开始日期2026-08-04

申办/合作机构

Sling Therapeutics, Inc.

NCT06112340

/ Recruiting临床2/3期

A Multicenter, Extension Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall study objective is to continue to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of linsitinib in subjects who were enrolled in the prior VGN-TED-301 through Week 24. These subjects include VGN-TED-301 Week 24 proptosis non-responders or subjects who relapse during the Follow-Up Period of VGN-TED-301.

开始日期2023-10-11

申办/合作机构

Sling Therapeutics, Inc.

NCT05276063

/ Completed临床2/3期

A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).

开始日期2022-07-01

申办/合作机构

Sling Therapeutics, Inc.

100 项与林西替尼相关的临床结果

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100 项与林西替尼相关的转化医学

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100 项与林西替尼相关的专利（医药）

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316

项与林西替尼相关的文献（医药）

2026-11-01·BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS

High glucose with insulin signalling blockade promotes cholesterol-sensitive, FAK-dependent UPEC invasion and blunts bladder antimicrobial defence

Article

作者: Thapa, Joythi ; Monika ; Gupta, Shishir K ; Maurya, Saumya

Diabetes increases susceptibility to urinary tract infection, but the epithelial mechanisms linking high glucose and insulin signalling blockade to UPEC invasion and weakened bladder defence remain incompletely defined. Here, we tested whether high glucose combined with insulin signalling blockade creates a bladder epithelial state that favours UPEC entry. In 5637 bladder epithelial cells, OSI-906 reduced AKT phosphorylation and, under high-glucose conditions, increased UPEC adhesion and intracellular recovery. This phenotype was associated with an increase in CTB/GM1-positive cells, consistent with membrane reorganisation toward more accessible GM1-enriched, cholesterol-sensitive domains that may provide permissive platforms for UPEC entry. Cholesterol perturbation with methyl-β-cyclodextrin reduced both the CTB/GM1 phenotype and UPEC invasion, whereas FAK inhibition with Y15 reduced invasion, supporting a cholesterol-sensitive membrane entry process that requires FAK activity. The relevance of these observations was examined in acute OSI-906-treated mice and chronically diabetic db/db mice. Acute OSI-906 treatment increased bladder UPEC burden and reduced selected antimicrobial-defence mediators. In db/db mice, increased bladder bacterial burden was accompanied by reduced early infection-associated host-defence responses compared with db/+ controls. Together, these findings suggest that high glucose, combined with insulin signalling blockade, reorganises the urothelial membrane toward a more accessible, cholesterol-sensitive state that favours FAK-dependent UPEC invasion while weakening bladder antimicrobial defence.

2026-09-01·ARCHIVES OF GERONTOLOGY AND GERIATRICS

Identification of MMP14 and FOS as key regulators of vascular smooth muscle cell senescence in diabetic kidney disease: A combined bioinformatics and experimental study

Article

作者: Wang, Bo ; Wang, Shanshan ; Qu, Bo ; He, Yuhua ; Zhou, Li ; Mao, Bing

OBJECTIVE:

Diabetic kidney disease (DKD) is a leading microvascular complication of diabetes in which vascular smooth muscle cell (VSMC) senescence plays a pivotal pathogenic role. This study aimed to identify key genes regulating VSMC senescence in DKD through integrated bioinformatics and machine learning analysis, construct a diagnostic nomogram prediction model, screen candidate therapeutic compounds, and validate findings experimentally.

METHODS:

Transcriptomic profiles for DKD (GSE30122, GSE96804, GSE142025) and a VSMC aging dataset (GSE198983) were retrieved from the GEO repository. Genes showing differential expression were determined using limma, succeeded by weighted gene co-expression network analysis (WGCNA) and functional annotation through Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG). Feature selection employed random forest, least absolute shrinkage and selection operator (LASSO), and support vector machine-recursive feature elimination (SVM-RFE) to isolate pivotal genes and develop diagnostic frameworks. Immune cell composition was analyzed via CIBERSORT, and competing endogenous RNA (ceRNA) plus transcription factor networks were assembled. Drug candidates were forecasted using the Connectivity Map platform. Human aortic smooth muscle cells (HASMCs), employed as a surrogate macrovascular smooth muscle cell model, and human renal artery smooth muscle cells (HRASMCs), employed as a kidney-proximal vascular model for cross-validation, underwent hyperglycemic exposure to recapitulate DKD conditions, with proliferation, programmed cell death, and senescence evaluated through CCK-8 assays, flow cytometry, and senescence-associated β-galactosidase (SA-β-gal) detection. Expression of p16, p21, osteopontin (OPN), and osteocalcin (OC) was quantified by Western blotting. Cell cycle distribution was additionally assessed by propidium iodide (PI)-based flow cytometry to elucidate the mechanism of proliferative suppression.

RESULTS:

A total of 43 candidate genes demonstrated enrichment predominantly in biological aging, cellular senescence, oxidative damage, insulin signaling cascades, and MAPK transduction pathways. MMP14 and FOS emerged consistently as pivotal genes exhibiting potential diagnostic capability. Immune infiltration disclosed marked changes across multiple immune populations, with MMP14 and FOS expression demonstrating associations with various immune cell subsets. The ceRNA architecture computationally predicted MMP14, FOS, NEAT1, and hsa-miR-181a-5p as critical regulatory nodes, with SRF computationally nominated as a shared transcriptional regulator. Five therapeutic candidates (neratinib, linsitinib, amlodipine, forskolin, piceatannol) were computationally identified. linsitinib demonstrated the most favorable in silico binding affinity in molecular docking simulations. This finding has not yet been validated experimentally and requires future in vitro and in vivo confirmation. Under hyperglycemic stress, HASMCs exhibited reduced proliferation, elevated apoptosis and senescence, alongside increased expression of p16, p21, OPN, and OC. Augmentation of MMP14 expression and suppression of FOS promoted cell proliferation while mitigating hyperglycemia-induced apoptosis and senescence. Cell cycle analysis revealed that high glucose induced G0/G1 phase arrest, which was relieved by MMP14 overexpression or FOS knockdown, and further exacerbated by MMP14 knockdown or FOS overexpression. All functional findings were consistently recapitulated in HRASMCs, confirming the conserved regulatory roles of MMP14 and FOS across VSMC subtypes.

CONCLUSION:

MMP14 and FOS function as crucial modulators of VSMC senescence in DKD, presenting diagnostic and therapeutic opportunities. The characterized regulatory circuits and identified pharmaceutical agents establish a foundation for precision interventions in DKD management.

2026-08-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Network pharmacology and in silico docking-based prediction of molecular targets of Pterospermum acerifolium in primary breast cancer and metastases to bones

Article

作者: Godbole, Mukul S ; Naik, Amruta ; Datt, Manish ; Kharade, Shutija

Breast cancer is known to metastasize to distinct organs, including bones. Dysregulation of cellular receptors-particularly estrogen and growth factor receptors-drives tumor progression, therapy resistance, and metastasis. Natural bioactive compounds have potential to modulate multiple molecular targets, with minimal side effects. Here, we applied a network pharmacology and molecular docking approach to investigate the therapeutic potential of Pterospermum acerifolium in primary breast cancer and bone metastasis. While Pterospermum acerifolium possesses pharmacological properties-antioxidant and anti-inflammatory effects-its potential impacts on breast cancer metastasis remain largely uninvestigated. Based on literature and pharmacokinetic profiles of Pterospermum acerifolium, we selected three compounds viz. kaempferol, luteolin and β-sitosterol. We identified predicted genomic targets of these compounds from databases, and compared their lists of genes with those associated with breast cancer and its metastasis to bones. Functional enrichment analyses of the overlapping genes suggested association of cellular pathways central to tumor progression and bone metastasis, including PI3K-Akt, MAPK, VEGF and estrogen signaling. Network construction further identified key receptor-based targets-ERα, ERβ, IGF1R and VEGFR2-as hub-genes based on degree of centrality and connectivity within the protein-protein interaction network. Further, we performed molecular docking analyses to evaluate compound-receptor binding affinities; analyses revealed strong binding affinities, particularly with β-sitosterol, suggesting the multi-target therapeutic action. Interestingly, the molecular docking analyses indicated β-sitosterol to have stronger affinity to ERα, ERβ, IGF1R and VEGFR2 than that of their known inhibitors (tamoxifen, diarylpropionitrile, linsitinib and sorafenib, respectively). The analyses also identified key amino acids involved in the interactions of bioactive compounds with binding pocket of the four native protein structures, some of which were similar to those involved in interactions with the known inhibitors. Finally, molecular dynamics simulations analyses confirmed strong molecular interactions of β-sitosterol with VEGFR2 and ERβ. Taken together, the findings highlight potential of phytoconstituents of Pterospermum acerifolium, especially β-sitosterol, kaempferol and luteolin, for clinical management of breast cancer and its metastasis to the bone.

项与林西替尼相关的新闻（医药）

2026-10-21

·Pharmaceutical Technology

Roche’s Enspryng nets a second indication on FDA eye disease approval

The US Food and Drug Administration (FDA) has granted Roche a label expansion for its ophthalmology therapy, Enspryng (satralizumab), in thyroid eye disease (TED), with the benefit of an at-home administration. This means that the interleukin 6 (IL-6) inhibitor is now greenlit for use in adults with TED – a condition where the body’s own cells attack the muscles, tear glands and connective tissues behind the eyes. Following its label expansion, healthcare providers can now prescribe Enspryng to either be self- or caregiver-administered once every four weeks during the maintenance phase of treatment. Currently, researchers estimate that TED, which is otherwise known as Graves’ ophthalmopathy, impacts around 155 to 250 people per 100,000 globally. The FDA gave Enspryng the TED green light based on the totality of data from the drug’s Phase III SatraGO programme (NCT05987423; NCT06106828). While the drug did not meet its pre-specified primary endpoints in SatraGO-1, patients with both active and chronic TED experienced significant improvements in both double vision and the degree to which their eyeballs bulge. Enspryng’s newfound approval expands the drug’s role from its original US approval in neuromyelitis optica spectrum disorder (NMOSD), which came back in 2020. It also makes it the first drug to get the FDA’s blessing as a subcutaneous treatment option in TED, as marketed options , Amgen’s Tepezza (teprotumumab-trbw) and Viridian Therapeutics’ recently greenlit therapy, Lumvoa (veligrotug-vvze), are intravenously administered. However, William Blair analysts note that, despite Enspryng’s place as a first-in-class, subcutaneous addition to the TED treatment paradigm, they do not view the drug as a “major competitive threat” to the anti-IGF-1R class – including drugs like Tepezza and Lumvoa. “We have seen limited excitement for the anti-IL-6 mechanism among doctors. The anti-IGF-1R class is still seen as the gold standard for treating TED, and the data from the SatraGO studies simply does not look particularly competitive,” they added. Though the analysts point to the importance of subcutaneous options in expanding the TED market, they do not believe that the current data will allow the IL-6 drug class to “supplant anti-IGF-1R therapies as the standard of care for a majority of patients”. There are currently several drugs in mid-to-late-stage development for TED, including Novartis-owned Tourmaline Bio’s rival anti-IL-6 therapy, pacibekitug, as well as Sling Therapeutics’ dual ATP-competitive kinase inhibitor pill, linsitinib. Currently, analysts at GlobalData, the parent company of Pharmaceutical Technology, estimate that Enspryng will generate $825m in sales in 2032. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准

2026-10-17

·NextSeq亦镁诺

甲状腺眼病：罗氏 IL-6R 单抗拿下首个居家皮下方案

甲状腺眼病：罗氏 IL-6R 单抗拿下首个居家皮下方案两项三期，只中了一项，FDA 还是批了。甲状腺眼病长期只有静脉输注一条路，患者得一次次跑输注中心。satralizumab 拿下首个可居家皮下注射的方案 [1]：SatraGO-2 突眼应答 52.9% 对 23.4% 达标，SatraGO-1 的 49.0% 对 31.2% 却没过线 [2]。一、两项三期只中一项仍获批首个能在家打的方案罗氏 10 月 16 日宣布，美国 FDA 批准 Enspryng（satralizumab）用于成人甲状腺眼病（TED）。这是一款抗 IL-6 受体单抗，走的是补充生物制品许可申请与优先审评通道[1][3]。它最特别的地方是给药方式：120 毫克皮下注射，第 0、2、4 周负荷给药，此后每 4 周一次，患者可居家自行完成[4]，也是首个且唯一可居家皮下的 TED 方案[1]。此前几款获批药物都得静脉输注，要一次次往返输注中心。 Enspryng 并不是新分子。它在 2020 年 8 月就已获批治疗视神经脊髓炎谱系疾病（NMOSD），积累了六年多的用药经验；如今拿下 TED，是它的第二个适应症[5]。一项落空，为什么还能批支撑这次批准的是两项设计相同的三期试验，合计 258 例、覆盖 19 个国家，两项试验同步推进[2]。入组的是中重度活动期患者，主要终点统一在第 24 周读取。SatraGO-2 达标：第 24 周突眼应答率 52.9%，安慰剂组 23.4%，差异显著（P=0.0011）；复视改善 60.7%，安慰剂组 25.8%[1]。所谓突眼应答，指眼球突出较基线至少回退 2 毫米，才算一例应答者，是阈值明确却依赖手工测量的硬指标[6]。另一项 SatraGO-1 却没中。同一个终点，应答率只有 49.0%，安慰剂组 31.2%，P=0.0715，没跨过显著性门槛[2]。两套研究的设计、入排标准与终点定义都对齐。差别主要来自人群、随访时点与自然病程的波动。研究方的解释是安慰剂组应答异常偏高，早在第 4 周就已显现，而且两组安慰剂之间 7.8 个百分点的差距，仍落在既往 TED 试验的波动范围里，他们因此把它归因于偏高的对照，而不是药物失效[2][7]。数字之外的争议两项三期只中一项，仍拿到优先审评放行，这让一些业内声音质疑注册证据够不够稳健[7]。我倾向于认为，监管看重的可能是疗效信号方向的一致性，而不是单点胜负。争议的另一半落在测量本身：突眼读数靠 Hertel 眼突计，检查者之间的变异历来偏大，学界因此呼吁推广标准化的影像测量[8]。SatraGO-1 的复视改善同样没做出来，44% 对 34%，裂口不止一处[2]。对患者来说，少跑几趟医院本身就是实在的好处[4]。说白了，这类试验的成败，有时就差在一个毫米的读数上。2 毫米的门槛卡在那里，量表松一格紧一格，结论就可能翻面，这也是突眼终点长期被学界挑剔的原因[8]。二、IL-6R 单抗的机制分野上游和受体，差在哪甲状腺眼病是器官特异性自身免疫炎症。TSH 受体（TSHR）与胰岛素样生长因子 1 受体（IGF-1R）在眼眶成纤维细胞上结成复合物，驱动眶内炎症、脂肪增生与纤维化，表现为突眼、复视与眼睑退缩。[9]现有抗体分成两条主线：一条直取 IGF-1R，代表是 teprotumumab 与 veligrotug；另一条绕到上游，掐住白介素 6 受体（IL-6R），代表是刚获批的 satralizumab。[2] 两者的差别，说白了是拦在哪一层。IGF-1R 单抗直接把 IGF-1R 这条受体信号按下去，抑制的是受体下游通路；IL-6 是炎症放大器，satralizumab 掐的是 IL-6 受体，等于从更上游的细胞因子信号处切断发炎回路。[9]它的抗体经过 pH 依赖改造：在偏酸的胞内环境里释放 IL-6R，自身循环使用，反复结合可溶型与膜结合型 IL-6R。这个设计拉长了半衰期，也撑起四周一次的皮下给药。[10]数字为什么不能直接比先看突眼应答这一栏。Tepezza 的 OPTIC 研究里，第 24 周突眼应答 83% 对安慰剂 10%[11]；veligrotug 的两项三期都达到主要终点，第 3 周起即见突眼改善[12]；satralizumab 的 SatraGO-2 则是 52.9% 对 23.4%[2]。信必敏在中国的 RESTORE-1 报告 85.8%[13]。同样看突眼，从 52.9% 到 85.8%，横跨三十多个百分点。安慰剂那一栏，也从 10% 到 23.4%[11][2]。几组数字的设计与人群都不同。OPTIC 与 THRIVE 只收活动期患者，SatraGO 则含慢性期[2]。我倾向于认为，不同试验、不同人群的数字不能直接比大小。终点与安全的两种读法疗效之外，终点本身也有争议。FDA 采纳的突眼应答门槛，是较基线改善至少 2 毫米；可这个数靠 Hertel 眼突计量出来，检查者之间的误差不小。[8]学界因此呼吁改用标准化的 MRI 或 CT 影像测量，把读数固定下来。更关键的是，2 毫米对患者未必等于有感觉。突眼轻了 2 毫米，复视可能照旧，外观的困扰也未必缓解。有综述直言，真正压着患者的是复视与外貌，而非影像上的那点变化。这得看你怎么定义改善。[8] 再看安全。IGF-1R 类带听力损伤警告[14]，Tepezza 吃官司；[15]SatraGO 24 周未见听力损失与高血糖。[16]IL-6R 类要防严重感染、肝酶升高与中性粒细胞减少，用药前先查乙肝、结核。[10]三、居家皮下改写给药与可及性给药方式，先看对决全球已获批的四款 TED 抗体，给药方式的分野比机制更直接。Tepezza、Lumvoa 与信必敏三款 IGF-1R 抗体都走静脉输注，要输 8 次、5 次或 8 次，都得跑输注中心[17][12]。Tepezza 一疗程约 23 瓶，得按周期一次次到院输注[18]。satralizumab 是 120 毫克皮下注射，第 0、2、4 周负荷后每 4 周一次，说明书明确患者本人或经培训照护者可在家完成[10]。少跑输注中心这一环，是它最实在的差异点。居家自注要打折看但“居家”得打折看。官方口径说 satralizumab 可由患者或经培训的照护者自行注射[4]，可皮下抗体受单次注射体积限制，剂量或暴露量可能存在折衷[19]。更值得留意的是安进的皮下 Tepezza——它的欧洲试验文件写明，所有剂量都由研究者或受训者注射[19]。有分析据此反问，患者能否在家自己用，眼下还是个问号。设备上叫居家，流程上未必。谁真能自己动手，我倾向于看试验的给药说明，而非宣传语。说白了，能不能自注是个流程问题，不是设备问题。厂商说居家，跟患者真能自己打，中间还隔着培训与随访两道关。真到用药那天，谁来下手、出了问题谁兜底，才是患者最该问的。这个价格，谁更划算皮下不再是 satralizumab 的独家。安进的皮下 Tepezza 在 III 期突眼应答做到76.7% 对 19.6%，突眼平均减 3.17 毫米，安慰剂 0.8 毫米[19]；Viridian 的皮下 elegrobart 每月给药应答 54%、每八周 63%，安慰剂 18%，拟 2027 年一季度申报[19][20]。居家皮下正从差异点变成入场券。可 Tepezza 自身增长停滞，2025 年约 19 亿美元、增速约 3%，四季度同比微降[21]。价格是另一道坎。Tepezza 疗程批发价约 34.3 万～44.7 万美元[18]，比 2020 年上市时贵了约十万美元[18]。输注中心除了药品，还占用场地、护理与患者半天时间，居家给药有望把这些负担一起压下来，省下的是时间与往返，不一定是药价本身。但省下来的成本会不会落到支付方和患者身上，眼下还没人给出答案。居家皮下真正的卖点，或许不在疗效，而在把治疗从医院挪到家里，替患者省下大半年里的来回奔波。市场规模这个数，我先搁着。各家机构给出的基数从十几亿到四十多亿美元都有，差得不是一星半点[22][23]。不写清机构与口径，单抛哪个数都站不住脚。宁可先不写，也别误导。四、中国患者与国产药分层四百多万患者，缺的是什么我国甲状腺眼病患者据报已达 400 多万[24]，且大多继发于 Graves 病——这类甲亢患者中，约 25%～40% 会合并甲状腺眼病[25]。这种病不算罕见，可真正能用的药一直很窄。过去国内以糖皮质激素为首选，它能压住炎症，却难以让已经突出的眼球退回去[26]，能逆转突眼的靶向药长期缺位。更棘手的是，约 3%～5% 的患者会发展至极重度，出现威胁视力的角膜溃疡或压迫性视神经病变[27]，对他们来说，能走的路就更少了。在信必敏出现之前，国内医生能真正改变突眼的武器并不多，选择实在有限。激素压得住炎症，却压不住眼球外突。很多患者只能等到手术这一步，这条路走得很勉强。一款国产药的两次闯关真正改变局面的，是信达生物的信必敏（替妥尤单抗 N01，IBI311）。2025 年 3 月，它正式获国家药监局批准用于甲状腺眼病，成为中国首个、也是全球第二款获批的 IGF-1R 抗体[13][26]。它瞄准的 IGF-1R 通路，正是驱动眶内炎症、脂肪增生与纤维化的关键开关[9]。中国的三期注册研究 RESTORE-1 显示，治疗 24 周时突眼回退至少 2 毫米的应答率达到 85.8%[13]，炎症、复视等症状也同步改善[26]。这里要先分清一件事：甲状腺眼病按活动度分成两拨人。临床活动性评分（CAS）≥3 分为活动期，<3 分为非活动期，严重度另按 EUGOGO 分级[25]，两者的用药逻辑并不相同。2026 年 10 月 8 日，信必敏的 RESTORE-3 研究在非活动性患者中达到主要终点：入组 116 例、平均病程 4.3 年，第 24 周突眼应答 60.4%，安慰剂组 23.5%[28][29]。非活动期约占患者的三分之二，这群人此前长期只有手术可选[29]。降价六成，够不够价格是国产替代最实在的一环，我觉得这一点不该被低估。按疗程费用算，Tepezza 完成一个疗程接近 300 万元人民币，信必敏只需它的十五分之一，加上中国患者体重更轻、给药剂量按体重算，实际支出还会更低[26]。2026 年 1 月 1 日起，信必敏正式进入国家医保目录，纳入医保后其价格较此前下降约 60%，按医保乙类支付，上海九院随即开出全国首张医保处方[24]。对原来只能靠激素和手术的患者，这条路终于能走下去了。说实话，satralizumab 还没在中国获批，它什么时候能进来，我拿不准。眼下国内真正在推进的，还是国产药的替代，以及按活动度和病程做的分层诊疗。结论这场批准真正的信号，是居家皮下正在从卖点变成入场券。安进的皮下 Tepezza 突眼应答冲到 76.7%，Viridian 也拟 2027 年一季度申报 [19]，谁还把患者按在医院里，谁就先掉队。中国这边，信必敏已入医保、降价约六成 [24]，satralizumab 能不能进来，还没定。关于 NextSeq 亦镁诺 NextSeq 亦镁诺（上海亦镁诺生物科技有限公司）专注组学数据分析与AI建模，携手美国合作伙伴 AmpSeq（实验室位于 Maryland、Boston 及 Connecticut），为科研机构与药企提供从快速测序到生信分析的端到端服务。在分析端，我们支持定制化生信Pipeline开发，并将AI建模能力拓展至肿瘤新抗原预测、mRNA/siRNA设计等药物开发场景；在CGT领域，具备面向长期安全性评估的NGS检测与解读能力。AmpSeq美国实验室同步提供Nanopore及NGS快速测序和交付服务，以灵活方案覆盖从深度分析到快速交付的多样化需求。如需了解，欢迎在公众号留言，或访问 nextseq.cn / ampseq.com。本文全部参考文献已汇总，点击底部「阅读原文」一键查看。资料来源 [1] Roche — FDA approves Roche's Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease（企业通稿, 2026-10-16）｜企业通稿：罗氏公布 FDA 批准 Enspryng（satralizumab）用于成人甲状腺眼病，维持期每四周一次皮下给药；SatraGO-2 第 24 周突眼应答 52.9% 对安慰剂 23.4%、复视改善 60.7% 对 25.8%，SatraGO-1 未达预设主要终点；并给出美国患病率约 155/10 万的口径。 https://assets.roche.com/f/176343/3f494a31f1/01-media-investor-release-enspryng-ted-fda-english.pdf [2] Ophthalmology（美国眼科学会期刊） — Efficacy and Safety of Satralizumab in Thyroid Eye Disease: Week 24 Results from Phase 3 SatraGO-1 and SatraGO-2（论文原文, 2026）｜论文原文：SatraGO-1 第 24 周突眼应答 49.0% 对安慰剂 31.2%（P=0.0715）未达预设主要终点，SatraGO-2 为 52.9% 对 23.4%（P=0.0011）；作者把 SatraGO-1 的落空归因于安慰剂组偏高的应答率，并讨论眼突测量的检查者间变异。 https://www.aaojournal.org/article/S0161-6420(26)00673-1/fulltext [3] Roche — FDA grants Priority Review to Roche's Enspryng for thyroid eye disease（企业公告, 2026-06-30）｜企业公告：罗氏披露 FDA 已受理 Enspryng 甲状腺眼病补充生物制品许可申请并授予优先审评资格，用于说明本次批准的审评通道。 https://www.roche.com/investors/updates/inv-update-2026-06-30 [4] MDspire — FDA approves first at-home therapy for thyroid eye disease（论文报道, 2026-10）｜论文报道：给出完整给药方案（第 0/2/4 周负荷后每四周维持）、乙肝与结核筛查与禁忌要求，并指出两项关键研究未与其他已获批治疗做头对头比较。 https://news.mdspire.com/ophthalmology/articles/fda-approves-first-athome-therapy-for-ted [5] 医药魔方 ByDrug — 首个且唯一！罗氏眼科新药新适应症获批上市（行业快讯, 2026-10-16）｜行业快讯：中文侧记录罗氏 Enspryng 获 FDA 批准用于成人甲状腺眼病，为首个居家皮下注射方案，并回顾其 2020 年首次获批用于视神经脊髓炎谱系疾病。 https://bydrug.pharmcube.com/news/detail/cbb2eeed00eab46d837752a8642a5e80 [6] Medscape — Satralizumab May Help Reduce Eye Bulging and Inflammation in Patients With TED（论文报道, 2026）｜论文报道：介绍 SatraGO 项目的研究设计与临床活动性评分口径，SatraGO-1 活动性评分下降达标率78.0% 对 54.9%，SatraGO-2 为 89.6% 对 63.3%。 https://www.medscape.com/viewarticle/satralizumab-may-help-reduce-eye-bulging-and-inflammation-2026a1000xsg [7] Pharmaceutical Executive — FDA Approves Enspryng (Satralizumab) for Thyroid Eye Disease（行业快讯, 2026-10）｜行业快讯：指出两项三期研究仅一项达到主要终点、FDA 仍以优先审评通过补充申请，并引用美国每 10 万人约 155 例的患病率口径。 https://www.pharmexec.com/view/fda-approves-enspryng-satralizumab-thyroid-eye-disease [8] European Thyroid Journal — What has changed in thyroid eye disease in the last five years (2020-2025)（论文原文, 2025）｜论文原文：系统梳理近五年甲状腺眼病诊疗变化，指出以突眼改善 2 毫米作为主要终点受检查者间变异影响，呼吁影像学标准化，并讨论复合终点与患者报告结局。 https://journals.bioscientifica.com/etj/article/15/1/ETJ250363/75593/What-has-changed-in-thyroid-eye-disease-in-the [9] StatPearls（美国国家生物技术信息中心） — Thyroid Eye Disease（论文索引页）｜论文索引页：综述甲状腺眼病病理机制，说明 TSH 受体与胰岛素样生长因子 1 受体在眼眶成纤维细胞形成功能性复合物，是眶内炎症与组织重塑的机制基础。 https://www.statpearls.com/ArticleLibrary/viewarticle/142674 [10] DailyMed（美国国家医学图书馆） — ENSPRYNG (satralizumab) prescribing information（监管披露文件）｜监管披露文件：说明书原文列出 120 毫克皮下给药、第 0/2/4 周负荷后每四周维持；给药前须筛查乙肝与结核并评估肝转氨酶，警告项包括严重感染、肝酶升高与中性粒细胞减少。 https://dailymed.nlm.nih.gov/dailymed/getFile.cfm?setid=64c156a4-9bad-4d45-a294-0733c141f47b [11] The New England Journal of Medicine — Teprotumumab for the Treatment of Active Thyroid Eye Disease（论文原文, 2020）｜论文原文：OPTIC 研究显示第 24 周突眼应答 83% 对安慰剂 10%，是 IGF-1R 抗体路线的里程碑证据，用于与 IL-6R 路线的疗效口径对照。 https://doi.org/10.1056/NEJMoa1910434 [12] Viridian Therapeutics — Viridian Therapeutics Announces U.S. FDA Approval and Launch of Lumvoa (veligrotug-vvze)（企业通稿, 2026-06）｜企业通稿：维瑞迪安宣布 IGF-1R 完全拮抗剂 Lumvoa 于 2026 年 6 月 26 日获 FDA 批准，标签覆盖活动期与慢性期，12 周完成给药；安全信息列输注相关反应约 9%、高血糖约 12% 与听力损伤警告，并披露皮下剂型 elegrobart 拟于 2027 年一季度申报。 https://www.viridiantherapeutics.com/press-release/viridian-therapeutics-announces-u-s-fda-approval-and-launch-of-lumvoa-veligrotug-vvze-for-the-treatment-of-thyroid-eye-disease [13] 信达生物（via PR Newswire 亚太） — 中国首个 IGF-1R 单抗：信必敏获 NMPA 批准治疗甲状腺眼病（企业通稿, 2025-03）｜企业通稿：信达生物宣布替妥尤单抗 N01（IBI311，商品名信必敏）获国家药监局批准，为中国首个、全球第二款获批的 IGF-1R 抗体，静脉给药每三周一次、共 8 次。 https://www.prnewswire.com/apac/news-releases/chinas-first-igf-1r-monoclonal-antibody-innovent-announces-nmpa-approval-of-sycume-for-the-treatment-of-thyroid-eye-disease-302401790.html [14] Ophthalmology Times — FDA approves veligrotug-vvze (Lumvoa) for thyroid eye disease（行业快讯, 2026-06）｜行业快讯：第二款 IGF-1R 抗体获批，静脉输注 5 次 12 周完成，安全信号包括输注相关反应与高血糖，并保留听力损伤警告。 https://www.ophthalmologytimes.com/view/fda-approves-veligrotug-vvze-lumvoa-for-thyroid-eye-disease-across-active-and-ch [15] Drugwatch — Tepezza: Side Effects, FDA Warnings and Hearing Loss Risks（媒体报道, 2025-11）｜媒体报道：汇总替妥尤单抗的听力损失风险与不良反应报告数据，并记录相关产品责任诉讼的进展，用于说明 IGF-1R 路线的安全争议。 https://www.drugwatch.com/drugs/tepezza [16] Review of Optometry — Satralizumab Shows Clinically Meaningful Improvements in TED（论文报道, 2026-08）｜论文报道：指出 SatraGO 项目二十四周内未见听力损失与高血糖事件，与 IGF-1R 路线的安全性谱形成对照。 https://www.reviewofoptometry.com/article/satralizumab-shows-clinically-meaningful-improvements-in-ted [17] Healio — FDA approves Enspryng for thyroid eye disease（论文报道, 2026-10-16）｜论文报道：确认 Enspryng 为甲状腺眼病首个可居家皮下注射方案，并把已获 FDA 批准的甲状腺眼病药物归纳为替妥尤单抗与 veligrotug 三款。 https://www.healio.com/news/ophthalmology/20261016/fda-approves-enspryng-for-thyroid-eye-disease [18] Analysis Atlas — Thyroid Eye Disease: The Six-Figure Drug Finally Gets a Rival（行业快讯, 2026）｜行业快讯：记录替妥尤单抗的定价路径，早期每瓶 1.49 万美元、疗程约 34.3 万美元，2026 年每瓶涨至约 1.95 万美元，并据此讨论疗程费用量级。 https://analysis-atlas.com/research/thyroid-eye-disease-drug-market [19] BioSpace — Amgen Seeks 'Return to Growth' for Tepezza as More Convenient Formulation Aces Phase 3（行业快讯, 2026）｜行业快讯：安进皮下剂型替妥尤单抗三期研究突眼应答 76.7% 对安慰剂 19.6%；并记录业内对皮下抗体能否真正由患者自行注射的疑问。 https://www.biospace.com/drug-development/amgen-seeks-return-to-growth-for-tepezza-as-more-convenient-formulation-aces-phase-3 [20] Prime Therapeutics — Quarterly Drug Pipeline: April 2026（行业报告, 2026-04）｜行业报告：梳理甲状腺眼病分阶段治疗路径与在研管线，包括皮下剂型替妥尤单抗、elegrobart 与 linsitinib 的推进节奏。 https://www.primetherapeutics.com/quarterly-drug-pipeline-april-2026 [21] Amgen — Amgen Reports Fourth Quarter and Full Year 2025 Financial Results（企业通稿, 2026-02）｜企业通稿：安进披露 Tepezza 2025 年第四季度收入 4.57 亿美元、同比约 −1%，全年约 19 亿美元，用于说明该药增长停滞。 https://amgen.com/newsroom/press-releases/2026/02/amgen-reports-fourth-quarter-and-full-year-2025-financial-results [22] BioReview — The Second Drug That Changed Thyroid Eye Disease: What Lumvoa's Approval Means（行业快讯, 2026）｜行业快讯：梳理 IGF-1R 路线竞争格局，并给出甲状腺眼病市场到 2034 年约 40 亿美元的预测口径，各机构基数差异较大。 https://www.bioreview.com/lumvoa-thyroid-eye-disease-approval [23] TheraRadar — IGF-1R: 20 Years of Cancer Failures, Then a 2 Billion Dollar Eye Drug（行业快讯, 2026）｜行业快讯：复盘 IGF-1R 靶点从肿瘤领域失败到眼科成功的路径，给出替妥尤单抗季度收入序列与累计治疗患者规模。 https://theraradar.com/briefs/igf1r-20-years-of-cancer-failures-then-a-2b-eye-drug [24] 光明网 — 无创靶向新疗法：给甲状腺眼病患者带来新希望（媒体报道, 2026-01-02）｜媒体报道：给出中国甲状腺眼病患者约 400 多万的规模口径，并说明信必敏已进入医保、患者负担相应下降。 https://health.gmw.cn/2026-01/02/content_38514187.htm [25] 中华医学会眼科学分会 — 中国甲状腺相关眼病诊断和治疗指南（2022 年）（行业协会发布, 2022）｜行业协会发布：给出临床活动性评分 3 分及以上判为活动期、以及按严重程度分级的诊断路径，是国内用药分层的依据。 https://www.gzzoc.org.cn/sites/zoc.live1.sysucloud2.sysu.edu.cn/files/2025-10/zhongguojiazhuangxianxiangguanyanbingzhenduanhezhiliaozhinan2022nian.pdf [26] 经济日报 — 填补甲状腺眼病治疗空白，中国首个 IGF-1R 抗体药物获批上市（媒体报道, 2025-03）｜媒体报道：记录信必敏 2025 年 3 月获批、填补国内空白，并给出其疗程费用约为同类进口药十五分之一的定价口径。 https://www.jingjiribao.cn/static/detail.jsp?id=575509 [27] 中国新闻网上海 — 甲亢突眼治疗有突破曜影成功开展替妥尤单抗精准治疗（媒体报道, 2025-04）｜媒体报道：记录信必敏在上海开出首批处方，并指出约 3% 至 5% 的甲状腺眼病患者会发展至极重度、面临视神经受压风险。 https://www.sh.chinanews.com/yljk/2025-04-18/134854.shtml [28] 信达生物（via PR Newswire） — 信必敏非活动性甲状腺眼病 III 期 RESTORE-3 达到主要终点（企业通稿, 2026-10-08）｜企业通稿：信达生物公布 RESTORE-3 研究第 24 周结果，非活动性甲状腺眼病突眼应答 60.4% 对安慰剂 23.5%，入组 116 例、基线平均病程 4.3 年。 https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html [29] Ophthalmology Times — SYCUME meets primary end point in inactive thyroid eye disease（行业快讯, 2026-10）｜行业快讯：信必敏在非活动性甲状腺眼病的三期研究中，研究眼突眼度较基线平均减少 1.88 毫米、安慰剂组减少 0.88 毫米，非活动期患者约占该病人群的三分之二。 https://www.ophthalmologytimes.com/view/sycume-meets-primary-end-point-in-inactive-thyroid-eye-disease 关注 NextSeq亦镁诺，每日获取基因测序与药物研发最新资讯。

2026-10-12

·BioSpace

Sling Therapeutics Presents Data from Phase 2b/3 LIDS Clinical Trial Demonstrating Durability of Linsitinib in Thyroid Eye Disease at ASOPRS 57th Annual Fall Scientific Symposium

Linsitinib achieved a statistically significant proptosis responder rate of 52% vs. 19% for placebo at Week 24 (p=0.010) 82% of Week 24 proptosis responders maintained their response through Week 72 (48 weeks after treatment completion), representing a highly favorable durability profile Low incidence of IGF-1R–associated adverse events of special interest; no treatment-related hearing impairment reported Confirmatory Phase 3 ORBIT pivotal trial currently enrolling moderate to severe active TED patients ANN ARBOR, Mich.--(BUSINESS WIRE)--Sling Therapeutics, Inc., a clinical-stage biopharmaceutical company developing the first and only late-stage oral small-molecule therapy for thyroid eye disease (TED), today announced the presentation of efficacy, safety and new durability results from its Phase 2b/3 LIDS trial of linsitinib in adults with moderate to severe active TED. The data were highlighted in an oral presentation and in a poster session at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) 57th Annual Fall Scientific Symposium. Linsitinib is the first and only oral IGF-1R inhibitor in Phase 3 development and only small molecule therapy to significantly reduce proptosis in TED, with more convenient oral dosing compared to currently available IV and injectable IGF-1R inhibitors. “Full LIDS results reinforce that linsitinib can deliver clinically meaningful proptosis reductions with a differentiated safety, delivery and durability profile,” said Ryan Zeidan, Ph.D., President and Chief Executive Officer of Sling Therapeutics. “Importantly, the data demonstrate that for the majority of proptosis responders in the trial, those improvements held for nearly a year after their last dose. This durability is particularly encouraging for patients, who are facing a disease that can remain active for years and often returns after treatment. With our confirmatory pivotal Phase 3 ORBIT trial now enrolling, we are focused on building the evidence to establish linsitinib as a convenient oral treatment that can deliver meaningful and durable benefit for people living with TED.” “For physicians, Clinical Activity Scores are an important measure in determining whether TED is active and at risk of flaring. Data from LIDS indicates treatment with linsitinib resulted in sustained suppression of disease activity after treatment ended, with further improvement over the follow-up period,” said Raymond Douglas, M.D., Ph.D., board-certified aesthetic and reconstructive oculoplastic surgeon. “Furthermore, quality of life scores among linsitinib responders continued to rise after treatment ended, alongside sustained proptosis improvement and low disease activity. For patients living with a visible, often distressing disease, that continued improvement off therapy is an important benefit." Presentation Highlights Week 24 Efficacy & Safety LIDS enrolled 90 adults with moderate to severe active TED, defined as onset within 12 months, proptosis ≥3 mm and Clinical Activity Scores (CAS) ≥4. Participants were randomized 1:1:1 to linsitinib 75 mg twice daily (BID), linsitinib 150 mg BID or placebo for 24 weeks. The primary endpoint was the proportion of proptosis responders at Week 24, defined as a reduction in proptosis of at least 2 mm from baseline. Linsitinib 150 mg BID achieved a statistically significant proptosis responder rate of 51.7%, compared with 18.8% for placebo (p=0.010). Linsitinib 75 mg BID achieved a proptosis responder rate of 38.9% (p=0.09 vs. placebo). The prespecified significance threshold for each dose was p10% in any arm) were: diarrhea, headache and nausea (each 20.7%), fatigue (17.2%), ALT increase and hyperhidrosis (each 13.8%), muscle spasms and AST increase (each 10.3%). Serious AEs occurred in 3.2% of placebo patients, 0% of 75 mg patients and 6.9% of 150 mg patients. Among IGF-1R–associated adverse events of special interest: No menstrual changes in any arm No encephalopathy Hyperglycemia occurred in one patient in each linsitinib arm One report of hypoacusis and one report of tinnitus in the 150 mg arm were assessed as unrelated to treatment Treatment discontinuations occurred in 16.7%, 20.0% and 33.3% of the placebo, 75 mg and 150 mg arms, respectively. Long-term Follow Up & Durability Twenty pooled linsitinib-treated patients who were proptosis responders at Week 24 entered a 48-week off-drug follow-up period. A post-hoc analysis of the durability of clinical response to linsitinib through Week 72 was assessed. Response was maintained in: 95% at Week 36, 48, and 60 82% at Week 72 Mean CAS remained low throughout follow-up, improving from 1.2 at Week 24 to 0.8 at Week 72. Mean overall Graves' Ophthalmopathy Quality of Life (GO-QoL) scores increased from 74.0 to 95.2 over the same period. During follow-up, no treatment-related AEs, serious AEs or AEs leading to discontinuation were reported. In September 2026 , Sling announced a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and the initiation and active enrollment of its confirmatory Phase 3 ORBIT pivotal trial in patients with moderate to severe active TED. About the Phase 2b/3 LIDS Trial The LIDS Trial (NCT05276063) was a Phase 2b/3, randomized, double-masked, placebo-controlled trial evaluating the efficacy, safety and pharmacokinetics of oral linsitinib in adults with moderate to severe active TED. A total of 90 patients were randomized 1:1:1 to linsitinib 75 mg BID, linsitinib 150 mg BID or placebo for 24 weeks. Week 24 responders then entered a 48-week off-drug extension period to assess durability. About Thyroid Eye Disease (TED) Thyroid Eye Disease (TED) is a serious, progressive, and vision-threatening rare autoimmune disease that is estimated to affect more than 200,000 people in the U.S. TED often occurs in people living with Graves’ disease and hyperthyroidism and is caused by dysfunction in the IGF-1R (insulin-like growth factor 1 receptor) signaling pathway, which results in fibrous tissue growth behind the eyes. This leads to several negative symptoms that may have long-term, irreversible damage as the tissue growth pushes the eyes forward or causes the eyes and eyelids to become red and swollen. As the disease progresses, it can lead to pain, eye bulging (proptosis), and vision loss in severe cases, thus dramatically impacting a patient’s quality of life. TED predominantly affects women, and most frequently affects people with hyperthyroidism due to Graves’ disease. The current standard of care typically involves either invasive orbital surgery or a lengthy series of infusions with potential adverse events like loss of hearing, hyperglycemia, or menstrual cycle changes. About Linsitinib Linsitinib is a convenient oral small molecule in clinical development for thyroid eye disease (TED). Linsitinib inhibits IGF-1R (insulin-like growth factor 1 receptor) intracellularly. IGF-1R is a validated target in TED and the only target for currently approved therapies. Activation of the IGF-1R drives the inflammation, tissue expansion, and proptosis seen in TED. By blocking this signaling, linsitinib is designed to reduce these effects. Linsitinib has an established safety pro treatment of more than 900 patients in 15 clinical trials in multiple diseases and has received Fast Track Designation from the U.S. FDA. About Sling Therapeutics Sling Therapeutics is a clinical-stage biopharmaceutical company focused on the late-stage advancement of an oral small molecule therapy for the treatment of thyroid eye disease (TED). Linsitinib, the first and only oral small-molecule intracellular IGF-1R (insulin-like growth factor 1 receptor) inhibitor in Phase 3 clinical development, is designed to provide TED patients with an effective, convenient oral treatment option while reducing the treatment burden on patients, physicians and healthcare systems. For more information, visit . Contacts Media Contact Amanda Lazaro, 1AB amanda@1abmedia.com

临床3期临床结果快速通道

100 项与林西替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09925	林西替尼	-	DB06075

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适应症	最高研发状态	国家/地区	公司	日期
格雷夫斯眼病	临床3期	加拿大	Sling Therapeutics, Inc.	2022-07-01
格雷夫斯眼病	临床3期	意大利	Sling Therapeutics, Inc.	2022-07-01
格雷夫斯眼病	临床3期	西班牙	Sling Therapeutics, Inc.	2022-07-01
格雷夫斯眼病	临床3期	英国	Sling Therapeutics, Inc.	2022-07-01
桥本病	临床3期	美国	Sling Therapeutics, Inc.	2022-07-01
桥本病	临床3期	加拿大	Sling Therapeutics, Inc.	2022-07-01
桥本病	临床3期	意大利	Sling Therapeutics, Inc.	2022-07-01
桥本病	临床3期	西班牙	Sling Therapeutics, Inc.	2022-07-01
桥本病	临床3期	英国	Sling Therapeutics, Inc.	2022-07-01
肾上腺皮质癌	临床3期	美国	Astellas Pharma, Inc.	2009-12-01

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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


NCT05276063 (LIDS, CTgov)	临床2/3期	桥本病 \| 格雷夫斯眼病	90	Placebo	鏇夢選積膚憲夢網選齋(蓋廠觸廠鏇簾夢衊廠窪) = 窪獵範醖壓觸網壓膚衊築蓋繭膚夢窪齋製繭顧 (範憲壓廠觸膚淵鹽餘窪, 憲鹽繭範壓餘顧願簾壓 ~ 築顧築糧壓艱鑰簾選遞) 更多	-	2026-08-26
NCT01560260 (SARC, Pubmed \| Clin Cancer Res) 人工标引	临床2期	胃肠道间质瘤	20	Linsitinib	廠鏇繭壓齋艱廠獵蓋範(醖願鑰鏇選網糧齋範鬱) = 築蓋鏇鏇構壓壓繭夢廠簾願鏇餘鹹廠鑰願膚範 (艱選繭廠築淵構夢淵醖 ) 更多	积极	2020-04-15
NCT02546544 (LINES, CTgov)	临床2期	复发性尤文肉瘤 \| 难治性尤文肉瘤	16	Linsitinib	餘顧觸壓齋窪襯製製製(襯範蓋艱窪願淵鏇蓋窪) = 範鹽膚襯鹽簾築壓襯鏇鏇淵築觸窪齋網選遞簾 (廠願壓壓選構鏇獵製憲, 顧醖願簾壓遞廠蓋夢鹽 ~ 鬱構廠襯遞醖選襯簾窪) 更多	-	2019-06-03
NCT01672736 (CTgov)	临床1/2期	复发性多发性骨髓瘤	19	Dexamethasone+Velcade+ASP7487	糧製顧獵壓網顧構簾獵 = 蓋襯構醖齋構遞繭醖構艱選齋觸憲範淵餘製構 (蓋築艱構鑰顧鹽遞醖壓, 築艱願鹽築衊壓醖襯艱 ~ 獵淵製夢淵觸網鹽糧繭) 更多	-	2018-09-13
NCT01186861 (Pubmed \| Med J Aust) 人工标引	临床2期	非小细胞肺癌维持	205	erlotinib+linsitinib	衊鏇築鏇簾網膚壓鑰憲(繭衊鏇範夢糧壓範積艱): P-Value = 0.601 更多	不佳	2017-09-05
				erlotinib+Placebo
NCT01560260 (SARC, CTgov)	临床2期	副神经节瘤 \| 软骨肉瘤 \| 胃肠道间质瘤 ... 更多	20	Pharmacological Study+Linsitinib	廠衊鬱鏇壓艱鹹憲夢鑰 = 構選壓鬱製糧壓窪顧夢製觸觸積繭夢鑰糧簾選 (鹹觸選襯膚齋構遞製廠, 襯膚壓鑰選艱鹽淵鑰餘 ~ 膚窪鹹糧觸觸積餘製鏇) 更多	-	2017-01-19
NCT01221077 (Pubmed \| Clin Lung Cancer) 人工标引	临床2期	非小细胞肺癌	88	erlotinib+Linsitinib	膚築醖鬱淵醖餘膚鏇壓(築憲簾鹹襯襯鹽廠衊構) = 蓋齋鏇簾壓襯範鏇淵憲蓋艱壓築遞簾糧願憲積 (願糧蓋製餘繭顧觸鏇獵 ) 更多	不佳	2017-01-01
				erlotinib+Placebo	膚築醖鬱淵醖餘膚鏇壓(築憲簾鹹襯襯鹽廠衊構) = 範繭醖鹹夢艱繭憲鏇窪蓋艱壓築遞簾糧願憲積 (願糧蓋製餘繭顧觸鏇獵 ) 更多
NCT01533181 (Pubmed \| Oncologist) 人工标引	临床2期	复发性小细胞肺癌	44	Topotecan Hydrochloride	遞膚獵繭遞顧構鹽獵製(衊憲淵壓壓鏇鏇構衊醖) = 齋蓋膚網範鏇襯糧膚選繭淵鏇築襯鹹餘網網遞 (積獵齋淵壓醖選蓋蓋衊, 1.5 ~ 3.6) 更多	不佳	2016-10-01
				Linsitinib	遞膚獵繭遞顧構鹽獵製(衊憲淵壓壓鏇鏇構衊醖) = 鬱構衊襯窪觸願觸觸廠繭淵鏇築襯鹹餘網網遞 (積獵齋淵壓醖選蓋蓋衊, 1.1 ~ 1.4) 更多
NCT01533181 (CTgov)	临床2期	复发性小细胞肺癌	44	Topotecan (Arm A: Topotecan)	築繭齋齋構築選選窪鬱(鏇齋獵鑰壓鑰製獵襯構) = 鏇窪顧範醖衊願獵衊衊壓鏇選顧築衊膚夢蓋艱 (鏇繭積衊夢廠觸觸襯遞, 鏇鑰淵鹽鏇醖夢糧願膚 ~ 襯顧網鏇蓋選夢艱積遞) 更多	-	2016-01-14
				OS-906 (Arm B: OS-906)	築繭齋齋構築選選窪鬱(鏇齋獵鑰壓鑰製獵襯構) = 願鑰積鹹鹽製鑰醖鬱壓壓鏇選顧築衊膚夢蓋艱 (鏇繭積衊夢廠觸觸襯遞, 鬱鏇齋鬱築積鹹襯衊衊 ~ 齋積糧衊衊鏇選觸繭願) 更多
NCT00924989 (Pubmed \| Lancet Oncol) 人工标引	临床3期	肾上腺皮质癌	139	Linsitinib	淵膚糧夢築蓋鹹壓選夢(窪餘積簾淵憲艱願鹽積) = 網憲蓋遞窪鏇壓夢齋遞衊選繭窪艱範鏇窪網糧 (築糧顧衊鬱艱艱範簾網 )	不佳	2015-04-01
				Placebo	淵膚糧夢築蓋鹹壓選夢(窪餘積簾淵憲艱願鹽積) = 窪鑰網夢鹽鬱遞鬱壓醖衊選繭窪艱範鏇窪網糧 (築糧顧衊鬱艱艱範簾網 ) 更多