阿巴帕肽(Abaloparatide) - 药物靶点：PTH1R_在研适应症：骨质疏松症，绝经期后骨质疏松_专利_临床

概要

基本信息

药物类型

合成多肽

别名

Abaloparatide (USAN/INN)、Abaloparatide Acetate、Abaloparatide patch

+ [16]

靶点

PTH1R

作用机制

PTH1R激动剂(甲状旁腺激素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Teijin Ltd.Theramex Ireland Ltd.

Radius Health, Inc.

+ [1]

非在研机构

Endo Ventures Ltd.

Radius Intelligence, Inc.

Radius International, Inc.

最高研发阶段批准上市

首次获批日期

美国 (2017-04-28),

绝经期后骨质疏松

最高研发阶段(中国)-

特殊审评-

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序列信息

Sequence Code 164795

来源: *****

关联

25

项与阿巴帕肽相关的临床试验

NCT04626141 / Withdrawn临床4期

Time to Healing, Loss of Fixation, and Loss of Alignment in Supracondylar Distal Femur Fractures Among a Geriatric Population Treated With Abaloparatide: A Double-Blind Placebo Controlled Study

Supracondylar femur fractures in the geriatric population present a unique challenge to the orthopaedic surgeon both in terms of fixation, healing, and final extremity axial alignment. Pulsed dosing of parathyroid hormone derivatives (Forteo) has been shown to increase bone mass, and several studies in Europe have demonstrated its benefit as an adjuvant for fracture healing. Abaloparatide represents a new compound which similarly offers great potential for accelerating fracture healing, especially healing associated with callous formation. This is a randomized, double blind placebo-controlled trial to compare a group of patients being treated for supracondylar distal femur fractures who receive abaloparatide (n=38) with a control group of patients who receive a placebo (n=38).

开始日期2024-06-01

申办/合作机构

Geisinger Ventures

[+1]

NCT06154187 / Not yet recruiting临床3期

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase III Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

This clinical trial was multicenter, randomized, double-blind, placebo-controlled, parallel, phase III bridge study.

开始日期2024-02-01

申办/合作机构

Pharmbio Korea Co., Ltd.

JPRN-UMIN000052340 / RecruitingN/AIIT

Searching study for comparative examination in Forteo and OSTABALO in a proximal femoral fracture patient - Forteo vs OSTABALO

开始日期2023-11-01

申办/合作机构-

100 项与阿巴帕肽相关的临床结果

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100 项与阿巴帕肽相关的转化医学

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100 项与阿巴帕肽相关的专利（医药）

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362

项与阿巴帕肽相关的文献（医药）

2024-12-01·ENDOCRINOLOGY AND METABOLISM CLINICS OF NORTH AMERICA

Latest on Anabolic Agents for Osteoporosis Treatment

Review

作者: di Filippo, Luigi ; Rosen, Clifford J. ; Rosen, Clifford J

In the last decades, novel therapeutics with anabolic bone properties have been developed and are currently used in the management of osteoporosis particularly in patients with high-risk of fragility fractures. These drugs include PTH-Related Analogues, teriparatide and abaloparatide, and the anti-sclerostin agent romosozumab, this latter drug currently approved only in female patients. Their efficacies in preventing fragility fractures are widely demonstrated and their potential serious side effects were progressively downgraded, including risk of malignancies in teriparatide- and cardiovascular events in romosozumab-users, respectively. Further data are warranted about their efficacy in glucocorticoids-induces osteoporosis and fracture healings.

2024-11-01·Bioactive Materials

Zinc finger-inspired peptide-metal-phenolic nanointerface enhances bone-implant integration under bacterial infection microenvironment through immune modulation and osteogenesis promotion

Article

作者: Yin, Yun ; Pan, Jiezhou ; Gan, Xueqi ; Fang, Jie ; He, Yunxiang ; Qi, Hexu ; Guo, Junling ; Xu, Lin ; Li, Yifei ; Li, Yu

Orthopedic and dental implantations under bacterial infection microenvironment face significant challenges in achieving high-quality bone-implant integration. Designing implant coatings that incorporate both immune defense and anti-inflammation is difficult in conventional single-functional coatings. We introduce a multifunctional nanointerface using a zinc finger-inspired peptide-metal-phenolic nanocoating, designed to enhance implant osseointegration under such conditions. Abaloparatide (ABL), a second-generation anabolic drug for treating osteoporosis, can be integrated into the design of a zinc-phenolic network constructed on the implant surface (ABL@ZnTA). Importantly, the phenolic-coordinated Zn²⁺ ions in ABL@ZnTA can act as zinc finger motif to co-stabilize the configuration of ABL through multiple molecular interactions, enabling high bioactivity, high loading capacity (1.36 times), and long-term release (>7 days) of ABL. Our results showed that ABL@ZnTA can modulate macrophage polarization from the pro-inflammatory M1 towards the anti-inflammatory M2 phenotype, promoting immune osteogenesis with increased OCN, ALP, and SOD 1 expression. Furthermore, the ABL@ZnTA significantly reduces inflammatory fibrous tissue encapsulation and enhances the long-term stability of the implants, indicated by enhanced binding strength (6 times) and functional connectivity (1.5-3 times) in the rat bone defect model infected by S. aureus. Overall, our research offers a nano-enabled synergistic strategy that balances infection defense and osteogenesis promotion in orthopedic and dental implantations.

2024-11-01·Endocrine Practice

Comparative Effectiveness of Abaloparatide and Teriparatide in Women 50 Years of Age and Older: Update of a Real-World Retrospective Analysis

Article

作者: Rizzoli, René ; Mitlak, Bruce H ; Reginster, Jean-Yves ; Wang, Yamei ; Chiodo, Joseph ; Curtis, Jeffrey R ; Mitlak, Bruce H. ; Cortet, Bernard ; DeSapri, Kristi T ; LaBaume, Clayton T. ; LaBaume, Clayton T ; Tabatabai, Laila ; Curtis, Jeffrey R. ; DeSapri, Kristi T. ; Cosman, Felicia

BACKGROUND:

Abaloparatide and teriparatide are osteoanabolic treatments indicated for postmenopausal women and men with osteoporosis at high risk of fracture. In the Abaloparatide Comparator Trial In Vertebral Endpoints study, bone mineral density improvements were significantly greater with abaloparatide compared to teriparatide at the total hip and femoral neck. We conducted a retrospective claims study to examine the incidences of hip and nonvertebral fractures and cardiovascular events in women aged ≥50 years initiating abaloparatide or teriparatide therapy, expanding on a previous retrospective claims study.

METHODS:

This retrospective observational study used anonymized claims data from ICON's Symphony Health, PatientSource for women aged ≥ 50 years with ≥ 1 prescription fill for abaloparatide or teriparatide. The index date was the date of the initial prescription dispensed. Times to first hip fracture, nonvertebral fracture, and serious cardiovascular event were compared between logistic regression-based propensity score-matched cohorts and in predefined subgroups by age, prior antiresorptive use, and prior fracture using Cox proportional hazards models.

RESULTS:

Patients (21 676 per cohort) were well matched on 73 baseline parameters. Forty-five percent of patients in the abaloparatide arm and 47% in the teriparatide arm were exposed to treatment for longer than 12 months. Over 18 months (+ 30 days follow-up), 245 (1.1%) and 296 (1.4%) women in the abaloparatide and teriparatide cohorts, respectively, had a hip fracture (HR [95% CI] 0.83 [0.70, 0.98]; P = .027); 947 (4.4%) and 1078 (5.0%) had a nonvertebral fracture (0.88 [0.80, 0.96]; P = .003). There were no significant treatment-subgroup interactions (P ≥ .2). Cardiovascular events were similar between groups.

CONCLUSIONS:

There were significantly lower rates of hip and nonvertebral fractures with abaloparatide compared to teriparatide, which were consistent across subgroups. No differences in cardiovascular safety were noted between cohorts.

71

项与阿巴帕肽相关的新闻（医药）

2024-12-09

·access wire

Radius Pharmaceuticals Expands Abaloparatide Licensing Agreement with Theramex Granting Additional Commercialization Rights Including Mexico, Canada, South Africa, Israel, and Russia

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties."Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options.""Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.About Theramex:Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]Edward Rees: Chief Corporate Development Officer, TheramexEmail: to [email protected]SOURCE: Radius Health

上市批准引进/卖出

2024-08-15

·PMLiVE

NICE recommends Theramex’s Eladynos to treat bone disease after menopause

The National Institute for Health Care and Research has recommended Theramex’s Eladynos (abaloparatide) as an option for treating bone disease after menopause. Available on the NHS in England in three months, the drug is set to benefit more than 14,000 people in the UK who are seeking treatment for osteoporosis after menopause, if there is a very high risk of fracture. Osteoporosis, a bone disease that affects 3.8 million people in the UK, develops when bone mineral density and bone mass decrease, or when the quality or structure of bone changes, leading to a decrease in bone strength that can increase the risk of broken bones or fractures. The disease particularly affects older women after menopause, as oestrogen, the hormone important for maintaining bone density and strength, decreases and bone density reduces, making broken bones more common. Other treatments for the disease include bisphosphonates such as alendronic acid and ibandronic acid, Eli Lilly’s selective oestrogen receptor modulator, Evista (raloxifene), parathyroid hormone treatments including teriparatide, and biological medicines including Amgen’s Prolia (denosumab) and Amgen/UCB’s Evenity (romosozumab). NICE’s decision was based on patients descriptions of how debilitating osteoporosis can be and how it all impacts day-to-day life, impairing mental and physical health. Theramex’s Eladynos is designed to increase bone density by stimulating the cells that produce new bone while also reducing the risk of fracture, providing an alternative for patients who have not responded to or cannot tolerate usual treatment options. Proven to be more clinically and cost-effective, the alternative treatment option comes as a pre-filled pen that is injected into the muscle through the skin. Prior to this, in March, Bayer shared positive long-term results from the late-stage OASIS 3 study, which supported the use of its investigational non-hormonal menopause drug, elinzanetant, to treat moderate-to-severe vasomotor symptoms (VMS), such as hot flashes, which are reported by up to 80% of women during the menopausal transition. In April, a Canadian study published in Neurology revealed that early menopause and a higher risk of cardiovascular disease could be linked to cognitive decline later in life.

临床结果临床3期上市批准

2024-08-09

·Pharmaceutical Technology

NICE supports Theramex’s Eladynos for post-menopause osteoporosis

Lower levels of oestrogen during menopause increases the risk of developing osteoporosis. Credit: Miss Ty via Shutterstock. Theramex’s Eladynos (abaloparatide) will be available for menopausal women with osteoporosis in England within three months, following positive guidance from The National Institute for Health and Care Excellence (NICE). The drug, which is marketed by Radius Health as Tymlos in the US, increases bone density by stimulating the cells that make new bone and this reduces the risk of fracture. It is an injection that comes as a pre-filled pen that people can self-administer at home once a day. Women’s health company Thermax acquired Eladynos through a March 2023 exclusive licensing agreement with Radius. Under the terms of the deal, Theramex can commercialise Eladynos in the European Economic Area, the UK, Australia, and Brazil. In April 2017, the injection was approved by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 for the treatment of men with osteoporosis at high risk for fracture. Menopause can accelerate bone loss and increase the risk of osteoporosis due to the decline in oestrogen levels, which are crucial for maintaining bone density. The usual treatment for osteoporosis after menopause in people with a very high risk of fracture includes UCB and Amgen ’s Evenity (romosozumab) or Eli Lilly’s Forsteo (teriparatide). See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Monoclonal antibody Evenity works by inhibiting sclerostin to increase bone formation and simultaneously reducing bone resorption. It was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2020. In April 2022, NICE reversed its previous decision from November 2021 and recommended Evenity, after its earlier concerns about cost were addressed. The drug pulled in $1.16m in 2023, as per Amgen’s financials. Despite the recommendation for Evenity, some patients cannot tolerate it due to side effects such as osteonecrosis, and they stop taking the drug. Forsteo works in a similar but not identical manner to Eladynos by acting as a synthetic form of parathyroid hormone (PTH), stimulating bone formation by activating osteoblasts. Eladynos, a synthetic peptide that is a PTH-related peptide analogue, offers a different binding profile and may provide greater efficacy according to some studies. NICE has said that Eladynos could benefit more than 14,000 people in England. According to GlobalData, the osteoporosis market is forecast to generate $17.9bn across the seven major markets (US, UK, France, Germany, Spain, Italy, and Japan) by 2033. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the recommendation, NICE’s chief medical officer Jonathan Benger said: “Our focus is on enabling access to care that improves quality of life while offering value to the taxpayer. Abaloparatide has been found by our independent committee to be clinically and cost-effective at reducing the risk of fracture, giving people more independence and therefore a better quality of life.”

上市批准引进/卖出并购

100 项与阿巴帕肽相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10885	阿巴帕肽	H05AA	DB05084

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
骨质疏松症	日本	Teijin Ltd.	2022-08-31
绝经期后骨质疏松	美国	Radius Health, Inc.	2017-04-28

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨质疏松性骨折	临床3期	美国	Radius Health, Inc.	2018-09-20
骨折	临床3期	美国	Radius Health, Inc.	2011-04-01
骨折	临床3期	阿根廷	Radius Health, Inc.	2011-04-01
骨折	临床3期	巴西	Radius Health, Inc.	2011-04-01
骨折	临床3期	捷克	Radius Health, Inc.	2011-04-01
骨折	临床3期	丹麦	Radius Health, Inc.	2011-04-01
骨折	临床3期	爱沙尼亚	Radius Health, Inc.	2011-04-01
骨折	临床3期	中国香港	Radius Health, Inc.	2011-04-01
骨折	临床3期	立陶宛	Radius Health, Inc.	2011-04-01
骨折	临床3期	波兰	Radius Health, Inc.	2011-04-01

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临床结果

适应症

分期

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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


NCT04760782 (CTgov)	临床2期	骨折	22	Hard collar immobilization+Abaloparatide (Treatment Group)	鑰憲襯製願廠壓觸網構(觸壓壓鹹窪鬱廠顧遞鹽) = 繭積夢醖簾壓艱蓋鬱築鹽範築餘憲蓋齋襯積餘 (獵憲壓糧選鹽構窪壓醖, 壓憲糧選艱鑰鹽遞鹽鬱 ~ 築餘構膚艱顧襯鬱構鹹) 更多	-	2024-09-19
				Hard collar immobilization (Historical Control Group)	鑰憲襯製願廠壓觸網構(觸壓壓鹹窪鬱廠顧遞鹽) = 觸製簾艱窪蓋製餘蓋憲鹽範築餘憲蓋齋襯積餘 (獵憲壓糧選鹽構窪壓醖, 簾艱願蓋鹽鹽繭範淵襯 ~ 壓衊窪獵憲淵齋醖齋餘) 更多
Biospace 人工标引	N/A	骨质疏松症	43,352	TYMLOS (abaloparatide)	積衊衊窪鹹艱鹽艱窪醖(襯鬱窪夢遞憲獵襯遞構) = 觸憲艱衊蓋糧餘壓鏇遞壓膚膚遞襯鑰膚鑰鹹醖 (襯憲壓夢選餘繭選鑰廠 ) 更多	积极	2024-04-16
				Teriparatide	積衊衊窪鹹艱鹽艱窪醖(襯鬱窪夢遞憲獵襯遞構) = 顧鏇積憲襯醖蓋鬱獵齋壓膚膚遞襯鑰膚鑰鹹醖 (襯憲壓夢選餘繭選鑰廠 ) 更多
NCT04366726 (CTgov)	临床1期	绝经期后骨质疏松	22	abaloparatide-sMTS	憲獵範鏇糧製鹹艱範廠(積繭膚蓋築餘願淵憲蓋) = 壓夢艱網遞築淵顧鹹製淵餘憲築繭願齋糧襯夢 (顧餘顧繭憲糧遞膚觸製, 艱遞鹽齋窪艱廠簾顧憲 ~ 遞構膚繭糧網簾製遞築) 更多	-	2023-11-22
NCT03512262 (ATOM, CTgov)	临床3期	骨质疏松症	228	Abaloparatide (Abaloparatide)	遞襯簾窪鏇膚齋衊鏇獵(夢網艱製廠鏇窪淵蓋範) = 繭憲膚範鬱壓糧遞餘顧艱淵淵獵繭襯鹽餘鹽艱 (遞艱築範鬱築艱蓋獵築, 遞築壓鹽構鑰範築糧衊 ~ 顧築獵醖衊鏇鹹繭獵繭) 更多	-	2023-04-07
				Placebo (Placebo)	遞襯簾窪鏇膚齋衊鏇獵(夢網艱製廠鏇窪淵蓋範) = 齋窪鏇齋網顧製構淵顧艱淵淵獵繭襯鹽餘鹽艱 (遞艱築範鬱築艱蓋獵築, 鬱憲繭淵範糧廠網壓簾 ~ 蓋製蓋窪窪願製壓鹹襯) 更多
NCT04064411 (CTgov)	临床3期	绝经期后骨质疏松	511	abaloparatide (Abaloparatide-SC)	憲夢齋網夢膚觸範選壓(襯蓋廠醖築餘鏇醖鑰廠) = 鹽齋廠窪蓋簾糧鏇顧醖鹽夢觸簾淵鏇壓網鏇選 (蓋淵醖糧築糧餘蓋顧簾, 範願構廠艱網廠衊獵壓 ~ 夢積築鹽鬱築鏇壓壓壓) 更多	-	2023-02-15
				abaloparatide solid microstructured transdermal system (Abaloparatide-sMTS)	憲夢齋網夢膚觸範選壓(襯蓋廠醖築餘鏇醖鑰廠) = 夢餘醖夢鑰鹽繭憲築積鹽夢觸簾淵鏇壓網鏇選 (蓋淵醖糧築糧餘蓋顧簾, 餘鑰製襯夢糧膚衊醖艱 ~ 繭膚窪觸夢構簾餘餘艱) 更多
NCT03512262 (ATOM, GlobeNewswire) 人工标引	临床3期	骨质疏松症	228	Abaloparatide	窪淵餘積蓋淵膚襯築築(積簾廠壓獵顧範範範餘) = 餘蓋範構鹹襯選願糧構簾選構夢網顧醖糧築簾 (醖範鑰鬱醖窪糧衊蓋簾 )	积极	2021-10-18
				Placebo	窪淵餘積蓋淵膚襯築築(積簾廠壓獵顧範範範餘) = 繭顧鑰願窪夢鬱鏇構獵簾選構夢網顧醖糧築簾 (醖範鑰鬱醖窪糧衊蓋簾 )
NCT03710889 (CTgov)	临床3期	骨质疏松性骨折 \| 绝经期后骨质疏松	23	Abaloparatide	廠遞齋齋夢觸淵築憲衊(築艱鏇築壓積鬱憲壓壓) = 繭餘膚願窪夢簾構壓壓鹹餘衊壓獵鹹憲觸願鹹 (繭鹹顧膚襯觸窪範鏇簾, 窪網鹹願鑰齋顧壓淵衊 ~ 淵餘鹹網選夢餘鑰構鹹) 更多	-	2021-10-15
NCT01343004 \| NCT01657162 (Pubmed \| J Clin Endocrinol Metab)	临床3期	绝经期后骨质疏松	-	Abaloparatide	鑰簾壓鹹鹽鬱鹹積衊鹹(襯衊壓齋鑰艱糧範艱壓) = 選築網廠艱齋窪齋醖衊餘獵積鑰鑰衊選壓壓簾 (憲壓構壓艱願築範鏇繭 )	-	2020-03-01
				Alendronate	鑰簾壓鹹鹽鬱鹹積衊鹹(襯衊壓齋鑰艱糧範艱壓) = 膚鬱網簾積鏇壓衊醖鏇餘獵積鑰鑰衊選壓壓簾 (憲壓構壓艱願築範鏇繭 )
ACR2017	N/A	糖皮质激素诱导的骨质疏松症	32	Abaloparatide 5 μg/kg	餘積糧壓鹹構網遞膚願(觸簾淵遞廠餘鹹糧蓋艱) = 艱顧窪鹹獵繭憲蓋繭憲鬱鬱獵網鑰壓範積膚遞 (遞蓋鬱艱積築鬱簾鹽願 )	积极	2017-11-07
NCT01343004 (ACTIVE, CTgov)	临床3期	绝经期后骨质疏松 \| 骨折	2,463	Placebo (Placebo)	觸獵積襯壓觸醖夢積壓(蓋淵憲簾淵衊齋蓋鑰醖) = 鹹鹹願積齋壓醖顧齋艱觸廠壓繭繭繭鹽憲製窪 (製窪積鹽齋蓋夢壓鏇簾, 鹽襯廠網構遞蓋網簾餘 ~ 憲觸夢範顧壓壓網襯顧) 更多	-	2017-03-01
				BA058 80 mcg (BA058 80 mcg (Abaloparatide))	觸獵積襯壓觸醖夢積壓(蓋淵憲簾淵衊齋蓋鑰醖) = 觸襯製憲網鹹壓鹹淵鏇觸廠壓繭繭繭鹽憲製窪 (製窪積鹽齋蓋夢壓鏇簾, 襯繭積構製蓋艱鑰衊獵 ~ 願蓋選顧積鏇糧獵襯選) 更多