PTH134(Novartis)(PTH134(Novartis)) - 药物靶点：PTH1R_专利_临床

概要

基本信息

药物类型

多肽激素

别名

PTH1-34

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-

非在研适应症

绝经期后骨质疏松

原研机构

Novartis AG

在研机构-

非在研机构

Novartis AG

权益机构

Novartis Pharma AG

Emisphere Technologies, Inc.

最高研发阶段无进展临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

2

项与 PTH134(Novartis) 相关的临床试验

NCT01224717

/ Completed临床1期

A Phase I, Partially Blinded, Randomized, Placebo Controlled, Active Comparator Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Post-menopausal Women After Daily Oral Doses of PTH134

This study is designed to provide information about the bone-anabolic response of PTH134 when administered orally, in comparison to Forsteo®, the sub-cutaneous form of teriparatide, the active ingredient in PTH134.

开始日期2010-09-01

申办/合作机构

Novartis AG

NCT00676312

/ Completed临床1期

A Partially-Blinded, Randomized, Placebo and Active Controlled, Ascending Single-Dose Crossover Phase I Study to Explore the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of PTH134 Formulated With Different Concentrations of 5-CNAC in Healthy Postmenopausal Women

This study is designed to investigate the safety and tolerability of PTH134 in healthy subjects and to assess the exposure from PTH134.

开始日期2008-05-01

申办/合作机构

Novartis AG

100 项与 PTH134(Novartis) 相关的临床结果

登录后查看更多信息

100 项与 PTH134(Novartis) 相关的转化医学

登录后查看更多信息

100 项与 PTH134(Novartis) 相关的专利（医药）

登录后查看更多信息

138

项与 PTH134(Novartis) 相关的文献（医药）

2025-12-01·Nanomedicine-Nanotechnology Biology and Medicine

Smart polymersome carriers for osteoporosis treatment: Enhanced bone regeneration via targeted teriparatide delivery

Article

作者: Poorirani, Safoora ; Hashemnia, Mohammad ; Kamali, Ali N ; Mirian, Mina ; Alipour, Adel Mohammad ; Mostafavi, Sayed Abolfazl ; Hassanzadeh, Farshid

Targeted drug delivery improves therapeutic efficacy while minimizing off-target effects. In this study, PLGA-PEG-Su-Asp (PPSA) copolymers were synthesized to develop teriparatide-loaded nano-polymersomes (PPSA-PTH1-34 NP) for bone-targeted delivery. Nanoparticles were prepared by nanoprecipitation and optimized using a central composite design. The optimized nanoparticles had a size of 245.78 ± 8.2 nm, PDI of 0.352 ± 0.12, ZP of -18.89 ± 0.1 mV, and 72.20 ± 2.9 % drug entrapment efficiency. PPSA-PTH 1-34 exhibited strong affinity (64.86 %) to hydroxyapatite, enhancing targeting efficiency. In vitro assays in MG-63 cells confirmed time- and concentration-dependent proliferation, uptake efficiency, increased ALP activity, and mineralization. In vivo studies using an (ovariectomizd) OVX rat model showed that PPSA-PTH 1-34 significantly improved bone regeneration compared to free PTH1-34. These findings demonstrate that PPSA-based NP provide a promising platform for targeted and sustained PTH 1-34 delivery, potentially improving therapeutic outcomes in osteoporosis treatment.

2025-09-16·JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM

Bone Health and Linear Growth in Children With Familial Hypoparathyroidism Treated With Human Parathyroid Hormone 1-34

Article

作者: Winer, Karen K ; Kelly, Andrea ; Hans, Didier ; Zemel, Babette S ; Webb, Taura ; Reynolds, James C ; Lionakis, Michail S ; Kalkwarf, Heidi J ; Pechacek, Joseph

Abstract:

Context:

Our study explores the impact of human parathyroid hormone (PTH) 1-34 injections (PTH therapy) on growth, areal bone mineral density (BMD), and bone quality (measured by trabecular bone score, TBS) in hypoparathyroidism due to autoimmune polyendocrine syndrome type 1 (APS-1) or an activating variant of the calcium sensing receptor (CaR).

Objective:

To assess associations of (1) age and PTH therapy duration with age-standardized Z-scores for height (HAZ), BMD (BMD-Z), and TBS (TBS-Z) in CaR or APS-1, and (2) APS-1 disease severity with BMD-Z and TBS-Z.

Methods:

This secondary analysis pooled linear growth and lumbar spine (LS) dual-energy x-ray absorptiometry data from studies of hypoparathyroidism with mean baseline age of 13.7 ± 5.5 years. Comparing the 2 diagnostic etiologies (18 APS-1 and 9 CaR), we examined the impact of age and PTH duration on HAZ, LS-BMD-Z, and LS-TBS-Z using longitudinal mixed-effects modeling.

Results:

During PTH therapy, mean HAZ remained below 0 in the APS-1 group at all ages, whereas HAZ increased in the CaR group (age by group interaction P < .0001). Mean LS-BMD-Z were normal (BMD-Z: 0 ± 1) for both groups. Mean LS-TBS-Z were near or above 0 and differed by group; CaR showed an upward trajectory according to time on PTH whereas the APS-1 group maintained a LS-TBS-Z of approximately 0 (time by group interaction P = .02). The APS-1 group with greater disease severity (≥7 manifestations) had lower LS-BMD-Z and LS-TBS-Z than the less severe APS-1 or CaR groups.

Conclusion:

Our study highlights distinct growth and BMD patterns in APS-1 and CaR and underscores the need for careful monitoring and tailored treatment strategies to optimize growth and bone health.

2025-07-08·Journal of the Endocrine Society

Switch From rhPTH1-84 to TransCon PTH With Individual Dose Adjustment in Adult Hypoparathyroidism—4-Week Results

Article

作者: Hahner, Stefanie ; Hofbauer, Lorenz C ; Blaschke, Martina ; Lottspeich, Christian ; Berr, Christina M ; Peschke, Kim A ; Schmidmaier, Ralf ; Siggelkow, Heide ; Tsourdi, Elena

Abstract:

Background:

Replacement therapy with recombinant human PTH (rhPTH1-84) represents a causal treatment for patients with chronic hypoparathyroidism (HypoPT). Recently, palopegteriparatide (TransCon PTH), a novel long-acting drug with slow release of PTH1-34, was approved by the European Medicines Agency and Food and Drug Administration for treatment of HypoPT. To date, no data exist on the treatment switch from rhPTH1-84 to TransCon PTH.

Methods:

We retrospectively analyzed clinical data from 40 patients with chronic HypoPT during the switch from rhPTH1-84 to TransCon PTH. Independent of the last prior rhPTH1-84 dose, all patients were started on 18 µg of TransCon PTH as recommended by the manufacturer. TransCon PTH dose adjustments, changes in additional medication, and adverse events were documented during the treatment switch.

Results:

Within the first month after the treatment switch, 80% (n = 32) of patients needed individual adjustment of their TransCon PTH dose to achieve normocalcemia. Dose reduction (to 9-15 µg) was necessary in 38% (n = 15) and an increase (to 21-27 µg) in 43% (n = 17) of patients. Adjustments occurred predominantly (in 62% cases) according to serum calcium levels, partly dependent on symptoms. The prior applied rhPTH1-84 dose correlated significantly with the adjusted TransCon PTH dose (r = 0.4; P = .01). The treatment change was associated with moderate or mild adverse events in 24/40 patients.

Conclusion:

We hereby report the first clinical data on switching treatment from rhPTH1-84 to 18 µg TransCon PTH independent of the prior rhPTH1-84 dose. Our data support discrete adaptation of the starting dose depending on the prior rhPTH1-84 dosage.

1

项与 PTH134(Novartis) 相关的新闻（医药）

2008-10-27

·BioSpace

Zosano Pharma, Inc. Announces Positive Results of Phase 2 Osteoporosis Study

FREMONT, Calif.--(BUSINESS WIRE)--Zosano Pharma, Inc., a privately held pharmaceutical company developing a novel transdermal delivery technology, today announced positive results from its phase 2, randomized, multi-center, double-blind, multi-dose study designed to determine safety and efficacy of its ZP-PTH rapid delivery patch for the treatment of osteoporosis. The product delivers PTH 1-34, teriparatide (PTH), a compound that has been proven to stimulate formation of new bone and reduce the risk of fractures. The ZP-PTH patch uses a unique transdermal technology being developed as an alternative to daily injections.

100 项与 PTH134(Novartis) 相关的药物交易

登录后查看更多信息