A randomized, open-label, single dose, 2-sequence, 2-period crossover study to explore the safety and pharmacokinetic characteristics of Teribone injection 56.5ug and Rap18001 in postmenopausal female volunteers

Start Date24 Jun 2019

Sponsor / Collaborator

Jeonbuk National University Hospital

JPRN-UMIN000022345 / RecruitingIIT

A study on the effect of teriparatide acetate injections in the rotator cuff tear repair. - A study on the effects of teriparatide in the ARCR.

Start Date01 Jun 2016

Sponsor / Collaborator-

100 Clinical Results associated with Teriparatide Acetate( Asahi Kasei Pharma)

100 Translational Medicine associated with Teriparatide Acetate( Asahi Kasei Pharma)

100 Patents (Medical) associated with Teriparatide Acetate( Asahi Kasei Pharma)

Literatures (Medical) associated with Teriparatide Acetate( Asahi Kasei Pharma)

01 Aug 2022·Disease Models & Mechanisms

Pharmacological intervention of the FGF–PTH axis as a potential therapeutic for craniofacial ciliopathies

Article

Author: Kristeková, Daniela ; Chang, Ching-Fang ; Bonatto Paese, Christian Louis ; Brugmann, Samantha A.

ABSTRACTCiliopathies represent a disease class characterized by a broad range of phenotypes including polycystic kidneys and skeletal anomalies. Ciliopathic skeletal phenotypes are among the most common and most difficult to treat due to a poor understanding of the pathological mechanisms leading to disease. Using an avian model (talpid2) for a human ciliopathy with both kidney and skeletal anomalies (orofaciodigital syndrome 14), we identified disruptions in the FGF23–PTH axis that resulted in reduced calcium uptake in the developing mandible and subsequent micrognathia. Although pharmacological intervention with the U.S. Food and Drug Administration (FDA)-approved pan-FGFR inhibitor AZD4547 alone rescued expression of the FGF target SPRY2, it did not significantly rescue micrognathia. In contrast, treatment with a cocktail of AZD4547 and teriparatide acetate, a PTH agonist and FDA-approved treatment for osteoporosis, resulted in molecular, cellular and phenotypic rescue of ciliopathic micrognathia in talpid2 mutants. Together, these data provide novel insight into pathological molecular mechanisms associated with ciliopathic skeletal phenotypes and a potential therapeutic strategy for a pleiotropic disease class with limited to no treatment options.

01 Dec 2021·Journal of Medical Case Reports

Bilateral stress fracture of the femoral neck in association with simultaneously developing osteonecrosis of the femoral head: a case report

Article

Author: Nishino, Tomofumi ; Watanabe, Yu ; Yamazaki, Masashi ; Mishima, Hajime ; Sugaya, Hisashi ; Kikuchi, Naoya

AbstractBackgroundFemoral neck stress fractures are rare and often recognized as overuse injuries that occur in young athletes or military personnel. A case following osteonecrosis of the femoral head is quite rare; even more uncommon is its occurrence in the bilateral hips. Magnetic resonance imaging has been established as the preferred tool for diagnosing nondisplaced femoral neck stress fracture due to overuse injury. Magnetic resonance imaging was also useful to detect the initial lesion even in this case, although the etiology was different between overuse injury and insufficiency fracture.Case presentationA 41-year-old Japanese woman diagnosed with bilateral early stage idiopathic osteonecrosis of the femoral head was observed non-weight-bearing as much as possible using a stick. However, her pain and difficulty in walking progressed. Bilateral femoral neck stress fractures were subsequently detected by magnetic resonance imaging. The fracture initially appeared as a spot of bone marrow edema at the medial site of the femoral neck, and then developed into a fracture line. The patient underwent internal fixation of both hips with sliding hip screws to stabilize the stress fractures. In addition, the preparatory reaming served as core decompression of the femoral heads, as well as being treatment for osteonecrosis. Her bone mineral density and 25-hydroxy vitamin D values were low for her age. We administered eldecalcitol and teriparatide acetate. Her symptoms mostly improved, and the fracture lines and necrotic lesions on magnetic resonance imaging reduced at 5 months after the surgery.ConclusionsBilateral femoral neck stress fractures are a very rare condition and are often missed. It is important to listen to the patient’s complaints and perform an appropriate examination. We encountered a case of bilateral femoral neck stress fracture that occurred in a patient with early stage osteonecrosis of the femoral head, and were able to observe progression of stress fracture since before fracture occurred. This is considered to be the first report to capture imaging changes before and after the onset.

12 Oct 2021·Evidence-Based Complementary and Alternative MedicineQ4 · MEDICINE

Correlation Analysis of Adverse Reactions of Antiosteoporosis Drugs by Different Mechanisms with Bone Turnover and Vitamin D

Q4 · MEDICINE

ArticleOA

Author: Wei, Tingting ; Zhou, Xiaoling ; Li, Xin ; Xu, Ying ; Lei, Chen

Objective. The risk factors for the most common adverse reactions of two types of antiosteoporosis drugs in the first treatment of postmenopausal osteoporosis were analyzed to investigate the relationship between the occurrence of adverse reactions and different bone transition states and vitamin D levels. Methods. A total of 381 postmenopausal women who were diagnosed with osteoporosis in the Osteoporosis Clinic of Ningxia Medical University General Hospital from January 2017 to June 2020 were enrolled. A telephone follow-up survey was conducted on the mentioned subjects. According to the survey results, the mentioned subjects were selected according to their first use of antiosteoporosis drugs. They were divided into zoledronic acid and teriparatide acetate groups. The subjects in the two groups were divided into two groups according to the presence or absence of adverse reactions after medication and according to vitamin D level and P1NP level, and the correlation between the two factors and the occurrence of adverse reactions was analyzed. Results. Among the 307 patients treated with zoledronic acid for antiosteoporosis, 99 patients developed acute phase adverse reactions (APR+), accounting for 32.2% of the total subjects. 56.7 percent of the subjects had vitamin D deficiency. The 25(OH)D level of the APR + subjects was 16.75 ± 9.20 ng/mL, significantly lower than that of the APR− patients (23.68 ± 10.67 ng/mL). Serological P1NP level in APR+ patients was 73.95 ± 34.50 ng/ml, significantly higher than that of APR− patients with 55.80 ± 36.91 ng/ml. Musculoskeletal symptoms were observed in 14 of the 74 subjects treated with teriparatide acetate, accounting for 18.9% of the total subjects. The 25(OH)D level was deficient in 59.5% of the subjects. The 25(OH)D level of the subjects with musculoskeletal symptoms was 15.96 ± 8.17 ng/ml, while that of the subjects without musculoskeletal symptoms was 20.86 ± 8.52 ng/ml, which showed no statistical significance. The reason was considered to be related to the small sample size included in the study. The P1NP level of subjects with musculoskeletal symptoms was 96.85 ± 58.52 ng/ml, significantly higher than the P1NP level of subjects without musculoskeletal symptoms (55.28 ± 27.87 ng/ml). Conclusions. The 25(OH)D level in vivo was negatively correlated with the acute phase adverse reactions after the first infusion of zoledronic acid. When the rate of bone formation is increased and osteoblasts are active, the risk of acute phase adverse reactions is increased with the use of zoledronic acid as antiosteoporosis therapy. There was no significant correlation between 25(OH)D levels and musculoskeletal symptoms after teriparatide acetate treatment of osteoporosis. When the rate of bone formation is increased and osteoblasts are active, the risk of adverse reactions to musculoskeletal symptoms is increased with antiosteoporosis treatment with teriparatide acetate.

News (Medical) associated with Teriparatide Acetate( Asahi Kasei Pharma)

11 Nov 2022

·www.ema.europa.eu

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022

Four new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended four medicines for approval at its November 2022 meeting. The CHMP recommended authorising the COVID-19 vaccine VidPrevtynBeta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below. The committee adopted a positive opinion for a biosimilar medicine , Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break. A generic medicine , Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult. The CHMP adopted a positive opinion for a generic medicine , Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant. Recommendations on extensions of therapeutic indication for 11 medicines The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin , Comirnaty , DuoPlavin , Dupixent , Enhertu , Eylea , Imfinzi , Iscover , Lynparza , Plavix and Xofluza . Withdrawals of applications Two applications for marketing authorisation were withdrawn: Orepaxam * for the treatment of pulmonary arterial hypertension, and Febseltiq * for the treatment of cholangiocarcinoma (cancer of the bile ducts). Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes. Question-and-answer documents on the withdrawals are available in the grid below. COVID-19 update The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. Safety update The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee ( PRAC ) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case ofquality, safety or efficacy issues. A public health communication on this referral is available in the grid below. Agenda and minutes The agenda of the November 2022 CHMP meeting is published on EMA's website. Minutes of the October 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the November 2022 CHMP meeting are represented in the graphic below. *This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendation on new medicines Name of medicine VidPrevtyn Beta International non-proprietary name (INN) COVID-19 vaccine (recombinant, adjuvanted) Marketing-authorisation applicant Sanofi Pasteur Therapeutic indication VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral vector COVID-19 vaccine More information VidPrevtyn Beta: Pending EC decision News announcement: EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine Positive recommendation on new biosimilar medicine Name of medicine Kauliv INN teriparatide Marketing-authorisation applicant Strides Pharma Cyprus Therapeutic indication Treatment of osteoporosis More information Kauliv: Pending EC decision Positive recommendations on new generic medicines Name of medicine Pirfenidone Viatris INN pirfenidone Marketing-authorisation applicant Viatris Limited Therapeutic indication Treatment of idiopathic pulmonary fibrosis More information Pirfenidone Viatris: Pending EC decision Name of medicine Sugammadex Amomed INN sugammadex Marketing-authorisation applicant AOP Orphan Pharmaceuticals GmbH Therapeutic indication Reversal of neuromuscular blockade induced by rocuronium or vecuronium More information Sugammadex Amomed: Pending EC decision Positive recommendations on extensions of indications Name of medicine Ceprotin INN human protein C Marketing-authorisation holder Takeda Manufacturing Austria AG More information Ceprotin: Pending EC decision Name of medicine Comirnaty INN tozinameran Marketing-authorisation holder BioNTech Manufacturing GmbH More information Comirnaty: Pending EC decision Name of medicine DuoPlavin INN clopidogrel / acetylsalicylic acid Marketing-authorisationholder Sanofi-aventis groupe More information DuoPlavin: Pending EC decision Name of medicine Dupixent INN dupilumab Marketing-authorisation holder Sanofi-aventis groupe More information Dupixent: Pending EC decision Name of medicine Enhertu INN trastuzumab deruxtecan Marketing-authorisation holder Daiichi Sankyo Europe GmbH More information Enhertu: Pending EC decision Name of medicine Eylea INN aflibercept Marketing-authorisation holder Bayer AG More information Eylea: Pending EC decision Name of medicine Imfinzi INN durvalumab Marketing-authorisation holder AstraZeneca AB More information Imfinzi: Pending EC decision Name of medicine Iscover INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Iscover: Pending EC decision Name of medicine Lynparza INN olaparib Marketing-authorisationholder AstraZeneca AB More information Lynparza: Pending EC decision Name of medicine Plavix INN clopidogrel Marketing-authorisationholder Sanofi-aventis groupe More information Plavix: Pending EC decision Name of medicine Xofluza INN baloxavir marboxil Marketing-authorisationholder Roche Registration GmbH More information Xofluza: Pending EC decision Withdrawal of initial marketing authorisation application Name of medicine Febseltiq INN infigratinib Marketing-authorisation applicant Helsinn Birex Pharmaceuticals Limited More information Febseltiq: Withdrawn application Name of medicine Orepaxam INN treprostinil diolamine Marketing-authorisationapplicant Ferrer Internacional S.A. More information Orepaxam: Withdrawn application Withdrawals of post-authorisation marketing authorisation applications Name of medicine Gavreto INN pralsetinib More information Gavreto: Withdrawn application Name of medicine Ilaris INN canakinumab More information Ilaris: Withdrawn application Conclusion of referral Name of medicine Janus kinase (JAK) inhibitors More information Janus Kinase inhibitors (JAKi) Other updates List item Scientific advice and protocol assistance adopted during the CHMP meeting 7-10 November 2022 (PDF/246.92 KB) (new) Adopted First published: 11/11/2022 EMA/CHMP/SAWP/872304/2022 List item Start of Union reviews adopted during the CHMP meeting of 7-10 November 2022 (PDF/106.5 KB) (new) Adopted First published: 11/11/2022 EMA/846051/2022

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Osteoporosis	JP	Asahi Kasei Pharma Corp.	26 Sep 2011

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