特立帕肽(Sawai Pharmaceutical)(Teriparatide Acetata(Sawai Pharmaceutical)) - 药物靶点：PTH1R_在研适应症：骨质疏松症_专利_临床

概要

基本信息

药物类型

合成多肽

别名-

靶点

PTH1R

作用方式

激动剂

作用机制

PTH1R激动剂(甲状旁腺激素受体激动剂)

治疗领域

内分泌与代谢疾病皮肤和肌肉骨骼疾病

在研适应症

骨质疏松症

非在研适应症-

原研机构

Sawai Pharmaceutical Co., Ltd.

在研机构

Sawai Pharmaceutical Co., Ltd.

非在研机构-

权益机构-

最高研发阶段批准上市

首次获批日期

日本 (2022-06-17),

骨质疏松症

最高研发阶段(中国)-

特殊审评-

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关联

6

项与特立帕肽(Sawai Pharmaceutical) 相关的临床试验

JPRN-UMIN000023344

/ CompletedN/AIIT

The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis - The efficacy of teriparatide for the bone strength of patients suffered proximal femoral fracture, evaluated by computed tomographic finite element analysis

开始日期2016-10-28

申办/合作机构-

JPRN-UMIN000022598

/ SuspendedN/AIIT

Study on inhibitory effect of teriparatide in knee osteoarthritis - Inhibitory effect of teriparatide in knee osteoarthritis

开始日期2016-08-01

申办/合作机构-

JPRN-UMIN000020584

/ CompletedN/AIIT

Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate on bone microarchitecture in patients with primary osteoporosis: A HR-pQCT study - Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate in patients with primary osteoporosis

开始日期2016-01-18

申办/合作机构-

100 项与特立帕肽(Sawai Pharmaceutical) 相关的临床结果

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100 项与特立帕肽(Sawai Pharmaceutical) 相关的转化医学

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100 项与特立帕肽(Sawai Pharmaceutical) 相关的专利（医药）

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1,269

项与特立帕肽(Sawai Pharmaceutical) 相关的文献（医药）

2025-06-01·Bone

Long-term impact of teriparatide on bone mineral density, trabecular bone score, and fracture risk relative to total hip T-score: A two-decade, registry-based cohort study

Article

作者: Häuselmann, HansJörg ; Guyer, Laura ; Ziswiler, Hans-Rudolf ; Everts-Graber, Judith ; Schmid, Gernot ; Oser, Sven ; Reichenbach, Stephan ; Wenger, Mathias ; Lehmann, Oliver ; Lehmann, Thomas ; Steiner, Christian ; Studer, Ueli

BACKGROUNDTeriparatide followed by antiresorptive therapy exhibits fracture reduction efficacy for up to 2 years, but it remains unclear if this leads to sustained increases in bone mineral density (BMD) and trabecular bone score (TBS), and if BMD correlates with fracture risk reduction.METHODSIn this multicenter cohort study, the effect of teriparatide administration for 18-24 months, followed by antiresorptive therapy, was assessed in patients partipicipating in a nationwide Swiss osteoporosis registry. BMD and TBS were measured up to 10 years before and after teriparatide initiation.RESULTSA total of 624 patients (87 % female, age 67 ± 13 years) were enrolled from May 2004 to December 2023. Among them, 198 (32 %) received no treatment prior to teriparatide, while 426 had received previous antiresorptive therapies (median duration 5.9 years [2.2, 8.0]). All patients underwent subsequent antiresorptive therapy, mainly with bisphosphonates and denosumab. The incidences of vertebral, hip, and any fractures were 0.96, 0.11, and 1.37, respectively, within 2 years prior to teriparatide initiation. The total hip T-score did not correlate with fracture reduction under teriparatide. After transitioning from teriparatide to an antiresorptive regimen, fracture incidence remained low and BMD was significantly higher for up to 5 years after teriparatide compared to the pre-treatment period (T-score + 0.876 for lumbar spine, p < 0.001; and + 0.112 for total hip, p < 0.005), while TBS increased by 0.047 (p < 0.001). Overall, significant improvement was observed in pretreated and treatment-naïve patients undergoing teriparatide treatment.CONCLUSIONTeriparatide led to sustained lower incidences of vertebral, hip, and other fractures for up to 8 years after switching to antiresorptive agents in both pretreated and treatment-naïve patients. Additionally, BMD and TBS levels were significantly higher than those before teriparatide treatment. During teriparatide treatment, the total hip T-score did not correlate with fracture risk.

2025-04-01·Journal of Controlled Release

Optimized suction patch design for enhanced transbuccal macromolecular drug delivery

Article

作者: Gao, Daniel ; Leroux, Jean-Christophe ; Krupke, Hanna ; Paunović, Nevena ; Klein Cerrejon, David ; Sachs, David

Peptides represent a rapidly expanding class of drugs with broad therapeutic potential. However, due to their large molecular weight and susceptibility to degradation in the gastrointestinal tract, most peptide drugs are administered via subcutaneous injections. Despite extensive research, a painless broad delivery platform for these drugs is still lacking. Recently, an octopus-inspired buccal patch has shown promise in addressing this challenge by leveraging a synergistic combination of mechanical stretching and permeation enhancers. In this study, the patch and the loaded formulation were optimized to improve ease of use, scalability, and efficacy. Through assessments of mechanical properties, finite element simulations, and ex vivo experiments, we evaluated the effects of patch design and material, as well as the drug matrix composition and the formulation preparation methods on the delivery performance. A patch with a > 9-fold larger effective surface area, produced via mold casting of medical-grade silicone (shore hardness 50) and loaded with a lyophilized drug matrix, emerged as the most promising system. In beagle dogs, 30-min application of this patch resulted in a 14.6 % bioavailability for teriparatide (4118 g mol^-1), while bioavailability of semaglutide (4114 g mol^-1) was 9.6 times higher than that of the commercial tablet. This work showcases how systematic optimization of this technology can improve and simplify the buccal administration of macromolecular drugs, facilitating the clinical translation of this non-invasive dosage form.

2025-04-01·Bone

Impact of prior teriparatide treatment on the effectiveness of romosozumab in patients with postmenopausal osteoporosis: A case-control study

Article

作者: Kashii, Masafumi ; Fukuda, Yuji ; Nakata, Ken ; Miyama, Akira ; Tsuboi, Hideki ; Kobayakawa, Tomonori ; Okada, Seiji ; Kurihara, Takuya ; Nagayama, Yoshio ; Okamura, Gensuke ; Noguchi, Takaaki ; Hirao, Makoto ; Sugimoto, Atsushi ; Ebina, Kosuke ; Etani, Yuki

PURPOSETo evaluate the impact of prior teriparatide (TPTD) treatment on the effectiveness of romosozumab (ROMO) in postmenopausal osteoporosis.METHODSIn this retrospective, case-controlled, multicenter study, 323 postmenopausal patients were initiated ROMO. Of these, 275 were treatment-naïve, and 48 were switched from TPTD, with uninterrupted ROMO treatment for 12 months. Propensity score matching was applied to ensure clinical comparability, yielding 44 patients in each group. Baseline characteristics included a mean age of 78.0 years, lumbar spine (LS) T-score of -3.6, and total hip (TH) T-score of -2.8. Bone mineral density (BMD) and serum bone turnover markers were evaluated over the 12-month period.RESULTSThe increasing rate in the bone formation marker PINP was significantly greater in the treatment-naïve group compared to the TPTD-switched group throughout the 1-12 month period. Conversely, the reduction in the bone resorption marker TRACP-5b was similar between the groups, indicating a diminished anabolic window in the TPTD-switched group. After 12 months, the TPTD-switched group showed lower BMD gains in the LS (10.3 % vs. 17.3 %; P = 0.002) and TH (3.1 % vs. 7.8 %; P = 0.002) compared to the treatment-naïve group. Multiple regression analysis revealed positive associations between the 12-month percentage BMD increases (LS; β = 0.30; 95 % CI = 0.85-11.61; P = 0.024 / TH; β = 0.32; 95 % CI = 0.51-8.56; P = 0.028) and being treatment-naïve compared to prior TPTD treatment.CONCLUSIONSPrior TPTD treatment may attenuate the effectiveness of ROMO, potentially due to diminished bone formation activation.

100 项与特立帕肽(Sawai Pharmaceutical) 相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
骨质疏松症	日本	Sawai Pharmaceutical Co., Ltd.	2022-06-17

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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


WCO_IOF_ESCEO2023	N/A	背痛 \| 脊柱骨折	200	Teriparatide 20 g	醖廠鹹遞鑰遞繭積餘憲(膚淵糧網窪齋襯簾鏇鹽) = Wedge type 遞淵憲繭遞衊壓淵網憲 (範蓋糧鏇夢觸壓獵積壓 )	积极	2023-05-04
WCO_IOF_ESCEO2023	N/A	骨质疏松性骨折	415	Teriparatide	築鑰壓鬱餘糧醖廠襯製(餘範繭襯範網憲構觸製) = 鑰繭顧餘壓壓憲餘鹽簾製餘襯蓋蓋夢淵衊顧憲 (獵鑰遞襯積窪鹹夢繭膚 )	积极	2023-05-04
				Placebo	築鑰壓鬱餘糧醖廠襯製(餘範繭襯範網憲構觸製) = 夢繭願餘簾淵鹽餘衊淵製餘襯蓋蓋夢淵衊顧憲 (獵鑰遞襯積窪鹹夢繭膚 )
ACTIVE (ENDO2020)	N/A	-	750	Abaloparatide	衊鑰淵製簾鏇遞鏇積觸(衊網網遞衊衊鹹築積範) = 艱願壓獵憲願簾鹽餘獵繭鬱醖醖蓋範醖夢蓋積 (鹽壓糧窪鹹廠壓齋壓鑰 )	积极	2020-05-08
				Teriparatide	衊鑰淵製簾鏇遞鏇積觸(衊網網遞衊衊鹹築積範) = 製淵艱製範鏇廠築鏇憲繭鬱醖醖蓋範醖夢蓋積 (鹽壓糧窪鹹廠壓齋壓鑰 )