Delving into the Latest Updates on Teriparatide(Hybio) with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Teriparatide(Hybio)

Target

PTH1R

Action

agonists, stimulants

Mechanism

PTH1R agonists(Parathyroid hormone receptor agonists), Osteogenesis stimulants, Parathyroid hormone replacements

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal Diseases

Active Indication

Osteoporosis, Postmenopausal

Inactive Indication-

Originator Organization

Hybio Pharmaceutical Co.. Ltd.

Active Organization

Hybio Pharmaceutical Co.. Ltd.

Inactive Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.

Start Date26 May 2023

Sponsor / Collaborator

Peking Union Medical College Hospital

CTR20222075

/ CompletedPhase 1

特立帕肽注射液在健康女性受试者中的随机、开放、单剂量、双周期、自身交叉空腹人体生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, self-crossover fasting human bioequivalence study of teriparatide injection in healthy female subjects

本研究以深圳翰宇药业股份有限公司生产的特立帕肽注射液（规格：20 μg：80 μL，2.4 mL/支）为受试制剂，Lilly France生产（Eli Lilly Nederland B.V.持证）的特立帕肽注射液（商品名：复泰奥®，规格：20 μg：80 μL，2.4 mL/支）为参比制剂，评估受试制剂和参比制剂在中国健康女性受试者中的生物等效性。并观察受试制剂和参比制剂在中国健康女性受试者中的安全性。

[Translation]

In this study, teriparatide injection (specification: 20 μg: 80 μL, 2.4 mL/vial) produced by Shenzhen Hanyu Pharmaceutical Co., Ltd. was used as the test preparation, and teriparatide injection (trade name: Futaio®, specification: 20 μg: 80 μL, 2.4 mL/vial) produced by Lilly France (licensed by Eli Lilly Nederland B.V.) was used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation in healthy Chinese female subjects. The safety of the test preparation and the reference preparation in healthy Chinese female subjects was also observed.

Start Date15 Aug 2022

Sponsor / Collaborator

Hybio Pharmaceutical Co.. Ltd.

100 Clinical Results associated with Teriparatide(Hybio)

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100 Translational Medicine associated with Teriparatide(Hybio)

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100 Patents (Medical) associated with Teriparatide(Hybio)

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5

Literatures (Medical) associated with Teriparatide(Hybio)

01 Aug 2024·European Spine Journal

Teriparatide alone versus vertebroplasty on pain control and radiographic outcomes after osteoporotic vertebral compression fracture

Article

Author: Niu, Chi-Chien ; Kao, Fu-Cheng ; Hsieh, Ming-Kai ; Fu, Tsai-Sheng ; Chiu, Ping-Yeh ; Chen, Po-An ; Tsai, Tsung-Ting ; Lai, Po-Liang

PURPOSETo investigate efficacy of 3-month teriparatide(TPD) and compare this treatment with vertebroplasty in terms of clinical and radiographic outcomes after osteoporotic vertebral compression fractures (OVCFs).METHODSThis is a retrospective matched cohort study. Patients who received conservative treatment with at least 3-month TPD treatment for acute OVCF with at least 6 months follow-up were included. Each enrolled TPD case was matched with 2 vertebroplasty cases using age and gender. 30 TPD cases and 60 vertebroplasty cases were enrolled. Patient-reported pain scores were obtained at diagnosis and 1, 3, 6 months after diagnosis. Radiographic parameters including middle body height, posterior body height, wedge angle and kyphotic angle were measured at diagnosis and 6 months after diagnosis. Fracture non-union and subsequent vertebral fracture were evaluated.RESULTSTPD treatment showed inferior pain relief to vertebroplasty group at 1 month, but did not show difference at 3 and 6 months after diagnosis. In TPD cases, progression of vertebral body collapse was noted in terms of middle body height and wedge angle at final follow up. Instead, both middle body height and wedge angle increased significantly after operation in the vertebroplasty group. Fracture non-union was confirmed via MRI and 4 TPD patients were diagnosed with non-union (4/30, 13.3%). Subsequent compression fracture within 6 months was significant higher in vertebroplasty group (12/60, 20%) than in TPD group (1/30, 3.3%).CONCLUSIONIn acute OVCFs, 3-month TPD treatment alone showed comparable pain improvement and less subsequent spine fracture than vertebroplasty.

01 May 2011·The Journal of Clinical Endocrinology & MetabolismQ2 · MEDICINE

The Waning of Teriparatide Effect on Bone Formation Markers in Postmenopausal Osteoporosis Is Associated with Increasing Serum Levels of DKK1

Q2 · MEDICINE

Article

Author: Silvano Adami ; Maurizio Rossini ; Luca Idolazzi ; Ombretta Viapiana ; Davide Gatti ; Elena Fracassi

CONTEXTThe effect of teriparatide (TPD) on bone turnover is initially exuberant but then diminishes. TPD is thought to stimulate bone formation by down-regulating the expression of specific Wnt antagonists, such as of sclerostin and Dickkopf-1 (DKK1).OBJECTIVEOur objective was to determine whether long-term treatment with TPD is associated with increasing serum levels of either sclerostin or DKK1.DESIGN AND SETTINGAncillary observation was made of patients participating in a randomized clinical trial. PATIENTS, INTERVENTION, AND OUTCOMES: Fifty-five women with postmenopausal osteoporosis were randomly allocated to treatment for 18 months with either TPD 20 μg daily or placebo.RESULTSIn the TPD group, both N-propeptide of type I collagen and C-terminal telopeptide of type I collagen rose significantly by 108 and 175% within the first 6 months. At month 18, the mean values decreased significantly compared with month 12 (-10 and -12%, respectively), but they were still significantly higher than baseline (+84 and 152%, respectively). Sclerostin remained stable over the entire study period in both groups. DKK1 did not change during the first 6 month of treatment, but only in the active group, it rose significantly at month 12 (median change +26.9%) and remained elevated at month 18 (+29.7%), at the time when the pharmacological effect of treatment with TPD appeared to be declining.CONCLUSIONLong-term (>12 months) treatment with TPD is associated with an increase in serum levels of DKK1 that might be associated with the appearance of declining effect on bone formation markers.

01 Jan 2010·SpineQ2 · MEDICINE

Effect of Teriparatide [rhPTH(1,34)] and Calcitonin on Intertransverse Process Fusion in a Rabbit Model

Q2 · MEDICINE

Article

Author: Helgeson, Melvin D ; Dmitriev, Anton E ; Riew, K Daniel ; Christensen, Christine L ; Lehman, Ronald A ; Eckel, Tobin T ; Raymond, JoLynne W ; Cardoso, Mario J

STUDY DESIGNRandomized, double-blinded, placebo controlled animal study.OBJECTIVETo evaluate the effect of teriparatide and calcitonin after an intertransverse process spinal fusion in a rabbit model.SUMMARY OF BACKGROUND DATAIt is widely recognized that some osteoporosis medications, including bisphosphonates, can interfere with bone healing. Although prescribed frequently in the treatment of osteoporosis, the effect of teriparatide and calcitonin on spinal fusion has not been fully elucidated. We hypothesized that teriparatide, being the only anabolic medication for osteoporosis treatment, would have a beneficial effect on spine fusion.METHODSFifty-one New Zealand white rabbits underwent a posterolateral L5-L6 intertransverse process arthrodesis using autogenous iliac crest bone graft. The rabbits were randomly divided into 3 groups. All animals received daily subcutaneous injections of group I (n = 17) 1 mL of saline placebo; group II (n = 17) 10 microg/kg/day of teriparatide; group III (n = 17) 14 IU/animal of calcitonin during the 8-week postoperative period. Postmortem analyses included manual palpation, radiographic, biomechanical, and histologic assessment. Three random 10x fields were examined/graded within the cephalad, middle, and caudal regions of each section (810 fields). Fusion quality was graded using the Emery histologic scale (0-7 based on fibrous/bone content of the fusion mass).RESULTSHistologic fusion rates for teriparatide averaged 86.7% and was significantly greater than the autograft control group (50%) (P = 0.033). Radiographically, there was a strong trend towards teriparatide being superior to the calcitonin group (85.7% vs. 56.3%, respectively; P = 0.07). The average Emery grading score was 5.99 +/- 1.46 SD for the autologous group and 6.26 +/- 0.93 SD for the teriparatide group (P = 0.031). Although not significant, the teriparatide group showed less motion in flexion/extension, lateral bending, and axial rotation.CONCLUSIONOur results suggest that teriparatide enhances spinal fusion while calcitonin has a neutral effect. The teriparatide group had the best histologic fusion rate and Emery scores, while the calcitonin group was similar to the saline controls. Although not significant, the teriparatide group had a strong trend towards superior radiographic fusion over the calcitonin group.

100 Deals associated with Teriparatide(Hybio)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	NDA/BLA	China	Hybio Pharmaceutical Co.. Ltd.	28 Apr 2014

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENDO2024	Not Applicable	Hypoparathyroidism PTH mutation	-	Teriparatide 20 mcg SC daily	(zhvvkjjzog) = kwoldkacet scmjmroxeo (qgsesgjkos ) View more	Positive	01 Jun 2024
				Calcitriol and calcium carbonate	(zhvvkjjzog) = ujuahdpvgn scmjmroxeo (qgsesgjkos ) View more
THU441 (ENDO2023)	Not Applicable	Osteoporosis	4	Teriparatide 20 mcg daily	(tczihmqujn) = buyscfhaog lsprntwrvb (inmpptbdrl, 2 - 14)	Positive	05 Oct 2023
NCT04026256 (CTgov)	Phase 4	Osteoporosis, Postmenopausal	37	Teriparatide (Teriparatide Only)	wjvbiyrxjj(qzfojuxfoo) = zwixwlejrq jzgdfsfkmb (tncubaphzt, xcdfxlrwjm - usduphzjzq) View more	-	02 Aug 2023
				Denosumab (Denosumab Only)	wjvbiyrxjj(qzfojuxfoo) = fiqsivogvv jzgdfsfkmb (tncubaphzt, jplvvqnmey - hwzzikylaf) View more
BONE-RELATED OUTCOMES (WCO_IOF_ESCEO2023)	Not Applicable	Osteoporosis, Postmenopausal Add-on	-	Denosumab + Teriparatide	(docanwtisi) = yauepsdvyc zagfzzwces (uaublggytw ) View more	Negative	04 May 2023
				Denosumab	(docanwtisi) = hewebkuwkb zagfzzwces (uaublggytw, 19.4) View more
WCO_IOF_ESCEO2023	Not Applicable	Chronic Kidney Diseases	-	Teriparatide	(oetisfhbzt) = no significant changes in bone density feomjojwqp (wrxyyuemnq ) View more	Positive	04 May 2023
				Denosumab
WCO_IOF_ESCEO2022	Phase 3	Glucocorticoid-induced osteoporosis	214	Alendronate 10 mg	mfywzhygzr(csvqcbwudx) = vmtbrbhgxu ogdykcurpq (figdzwbfts )	Positive	24 Mar 2022
				Teriparatide 20 g	mfywzhygzr(csvqcbwudx) = yaspxrrgse ogdykcurpq (figdzwbfts )
NCT02176382 (DATA-HD, CTgov)	Phase 4	Osteoporosis, Postmenopausal	76	zoledronic acid+teriparatide+denosumab (Standard Dose Teriparatide)	phteovrpig(negogbipvi) = nvghrwlbhg jcwqwddnai (rdxxqffnfc, dtbxmxgfwl - cnkiyygdoy) View more	-	22 Jan 2021
				zoledronic acid+teriparatide+denosumab (High Dose Teriparatide)	phteovrpig(negogbipvi) = xedljecxdl jcwqwddnai (rdxxqffnfc, cjihtswivd - qnbbupwlox) View more
SAT-LB64 (ENDO2020)	Not Applicable	PTH	-	Teriparatide	pqlqruxvog(clbfoyyawu) = 3.3% bone loss on the left femoral head xusvnlciqy (ofouibjiwj ) View more	Positive	08 May 2020
				Ibandronate
MON-358 (ENDO2020)	Not Applicable	Hypercalcemia	2	Teriparatide	xmgyaurgvl(wqhubuteyu) = 1-3% of patients may have mild hypercalcemia after administration rojpjnuqww (hnlxeepsci )	Positive	08 May 2020
				Raloxifene
SUN-517 (ENDO2019)	Not Applicable	Hypoparathyroidism \| Celiac Disease	1	Teriparatide	iigjwhbyxx(egznrlqfgu) = wxvtqrihce zkrwygegeh (gqxayabate ) View more	-	30 Apr 2019

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