Delving into the Latest Updates on Triptorelin acetate with Synapse

To investigate the pharmacokinetics of triprerelin acetate for injection and triprerelin acetate (Dufferin ®) for injection of reference preparation in patients with prostate cancer by single intramusculodynamic injection in fasting state, and to evaluate the bioequivalence of the two formulations in fasting state.

Start Date04 Dec 2024

Sponsor / Collaborator

The Affiliated Hospital of Qingdao University

[+8]

CTR20243425

/ RecruitingNot Applicable

注射用醋酸曲普瑞林人体生物等效性研究

[Translation] Study on the bioequivalence of triptorelin acetate for injection in healthy volunteers

研究空腹状态下单次肌肉注射受试制剂注射用醋酸曲普瑞林与参比制剂注射用醋酸曲普瑞林（达菲林®）在前列腺癌患者体内的药代动力学，评价空腹状态下两种制剂的生物等效性和安全性。

[Translation]

To study the pharmacokinetics of a single intramuscular injection of the test formulation triptorelin acetate for injection and the reference formulation triptorelin acetate for injection (Diphylline®) in patients with prostate cancer under fasting conditions and to evaluate the bioequivalence and safety of the two formulations under fasting conditions.

Start Date22 Oct 2024

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20240796

/ RecruitingPhase 3

一项多中心、开放、单臂 III 期临床试验：评估注射用醋酸曲普瑞林微球治疗儿童中枢性性早熟的有效性和安全性

[Translation] A multicenter, open-label, single-arm phase III clinical trial to evaluate the efficacy and safety of triptorelin acetate microspheres for injection in the treatment of central precocious puberty in children

评价注射用醋酸曲普瑞林微球治疗中枢性性早熟（CPP）受试者的临床疗效。

[Translation]

To evaluate the clinical efficacy of triptorelin acetate microspheres for injection in the treatment of subjects with central precocious puberty (CPP).

Start Date14 Jul 2024

Sponsor / Collaborator

Lizhu Group Lizhu Medicine Research Institute

[+1]

100 Clinical Results associated with Triptorelin acetate

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100 Translational Medicine associated with Triptorelin acetate

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100 Patents (Medical) associated with Triptorelin acetate

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926

Literatures (Medical) associated with Triptorelin acetate

01 Jan 2025·ESMO Open

Ten-year update of HOBOE phase III trial comparing triptorelin plus either tamoxifen or letrozole or zoledronic acid + letrozole in premenopausal hormone receptor-positive early breast cancer patients

Article

Author: Del Mastro, L ; Caputo, R ; Giuliano, M ; Perrone, F ; Riccardi, F ; Nuzzo, F ; Di Rella, F ; Cianniello, D ; Ribecco, A S ; Orlando, L ; Putzu, C ; Arenare, L ; Pacilio, C ; De Placido, S ; Ciardiello, F ; De Laurentiis, M ; Rossi, E ; Gallo, C ; Gargiulo, P ; Mocerino, C ; Forestieri, V ; Orditura, M ; Arpino, G ; Gravina, A ; Piccirillo, M C ; Cinieri, S ; Schettino, C

BACKGROUNDThe Hormonal Bone Effects (HOBOE) study tested whether adjuvant triptorelin plus either letrozole (L) or zoledronic acid (Z) plus L (ZL) was more effective than tamoxifen (T) in premenopausal patients with hormone receptor-positive (HR+) early breast cancer (BC). Here we report the long-term follow-up analysis.PATIENTS AND METHODSHOBOE (ClinicalTrials.gov number NCT00412022) is an open-label, three-arm, randomised, phase III trial that involved 16 centres in Italy. One thousand and sixty-five premenopausal patients with HR+ early BC receiving triptorelin were randomly assigned (1 : 1 : 1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis.RESULTSAs of 24 October 2024 at a median follow-up of 9.2 years, 199 DFS events and 79 deaths were reported. Both ZL and L improved DFS over T, with a hazard ratio (HR) of 0.58 [95% confidence interval (CI) 0.41-0.82; P = 0.002] for ZL versus T and 0.69 (95% CI 0.49-0.97, P = 0.030) for L versus T. No statistically significant difference in OS was reported (global log-rank P = 0.103). The previously reported statistically significant interaction with human epidermal growth factor receptor 2 (HER2) status was confirmed for ZL versus T comparison (P = 0.007).CONCLUSIONIn this updated analysis, L plus triptorelin, with or without Z, demonstrated a statistically significant DFS improvement over T plus triptorelin for the adjuvant treatment of early BC in premenopausal patients.

25 Dec 2024·Cureus

Optimizing Premenopausal Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer Management in India: Insights From Expert Consensus

Review

Author: Pagani, Olivia ; Prasad, Svss ; Gulia, Seema ; Dawer, Femina ; Wadhwa, Jyoti ; Kotak, Bhavesh P ; Biswas, Ghanashyam ; Desai, Rohit R ; Bharthuar, Anubha ; Vaid, Ashok K ; Agarwal, Vijay ; Sahoo, Tarini P ; Mohapatra, Prabrajya N ; Ramesh, Anita ; Desai, Chirag

This research aims to optimize adjuvant ovarian function suppression (OFS) for premenopausal Indian women with hormone receptor-positive (HR+) /human epidermal growth factor receptor 2-negative (HER2-) early breast cancer (eBC). To address specific challenges identified in clinical practice, a comprehensive questionnaire consisting of 21 statements was developed. These statements were reviewed and validated by a scientific committee, ensuring their accuracy and relevance to the study's objectives. A panel of 46 Indian experts and one global expert in the field of eBC were asked to rate their level of agreement/disagreement with each statement. Consensus was defined as achieving ≥80% agreement among participants. Following two rounds of the modified Delphi technique, a consensus was achieved on 19 out of 21 statements addressing critical aspects of premenopausal HR+ HER2- eBC management. The expert panel strongly recommended comprehensive risk stratification for premenopausal patients with HR+ HER2- eBC, highlighting age ≤40 as a high-risk factor and advising composite assessments for patients ≥40 years. For high-risk patients, OFS coupled with an aromatase inhibitor emerged as the recommended therapeutic strategy. The panel recommended a potential duration of up to five years for OFS, provided tolerability is maintained. For patients under 40, simultaneous OFS and chemotherapy is advised when needed. For those over 40, sequential initiation is acceptable. Triptorelin is preferred among luteinizing hormone-releasing hormone analogs, though all options have similar efficacies. The outcomes of this consensus offer valuable clinical guidance, enabling individualized and evidence-based approaches for OFS in Indian patients with HR+ HER2- eBC.

01 Dec 2024·Asia-Pacific Journal of Clinical Oncology

PRIORITI: Phase 4 study of triptorelin or active surveillance in high‐risk prostate cancer

Article

Author: Cabri, Patrick ; Gao, Xin ; Kopyltsov, Evgeny ; Wei, Qiang ; Houchard, Aude ; Ye, Dingwei ; Matveev, Vsevolod ; Luo, Jindan ; Xie, Li‐Ping ; Mahmood, Adnan ; Zhou, Fangjian

AbstractAimTo evaluate the efficacy and safety of triptorelin after radical prostatectomy (RP) in patients with negative lymph nodes.MethodsPRIORITI (NCT01753297) was a prospective, open‐label, randomized, controlled, phase 4 study conducted in China and Russia. Patients with high‐risk (Gleason score ≥ 8 and/or pre‐RP prostate‐specific antigen [PSA] ≥ 20 ng/mL and/or primary tumor stage 3a) prostate adenocarcinoma without evidence of lymph node or distant metastases were randomized to receive triptorelin 11.25 mg at baseline (≤ 8 weeks after RP) and at 3 and 6 months, or active surveillance. The primary endpoint was biochemical relapse‐free survival (BRFS), defined as the time from randomization to biochemical relapse (BR; increased PSA > 0.2 ng/mL). Patients were monitored every 3 months for at least 36 months; the study ended when 61 BRs were observed.ResultsThe intention‐to‐treat population comprised 226 patients (mean [standard deviation] age, 65.3 [6.4] years), of whom 109 and 117 were randomized to triptorelin or surveillance, respectively. The median BRFS was not reached. The 25th percentile time to BRFS (95% confidence interval) was 39.1 (29.9–not estimated) months with triptorelin and 30.0 (18.6–42.1) months with surveillance (p = 0.16). There was evidence of a lower risk of BR with triptorelin versus surveillance but this was not statistically significant at the 5% level (p = 0.10). Chemical castration was maintained at month 9 in 93.9% of patients who had received triptorelin. Overall, triptorelin was well tolerated and had an acceptable safety profile.ConclusionBRFS was observed to be longer with triptorelin than surveillance, but the difference was not statistically significant.Plain language summaryAfter a diagnosis of prostate cancer, one of the current treatments is surgical removal of the prostate and its cancer from the body. This is called radical prostatectomy. This may cure the person. Unfortunately, sometimes the tumor may have already spread into neighboring cells (lymph nodes). If this has happened, we know that giving people a chemical castration therapy to lower their levels of male sex hormones may reduce the risk of the cancer spreading further. This is achieved by giving people an androgen deprivation therapy (ADT), such as triptorelin (which is used in this study). What we do not yet know, and what we investigated in this study, is whether ADT can also benefit people who do not have signs that their cancer has already spread to the lymph nodes. Our study involved 226 men from China and Russia and investigated whether giving triptorelin for 9 months would lead to better outcomes compared with giving no additional treatment (active surveillance). All people in the study had radical prostatectomy but only half of them were given triptorelin in the following 8 weeks. The time frame of 8 weeks was used because this is the time needed to make sure that the surgery had gone well, and that no biological markers of cancer were still present in the person's blood (the marker is called prostate‐specific antigen [PSA]). High levels of PSA are a sign that the prostate cancer has returned. People were monitored for 3 years with regular checks of their castration status and levels of the cancer marker (PSA). At the end of the study, we saw that it took longer for PSA levels to increase for people who had taken triptorelin than it did for those who had not had additional treatment, but the difference was not statistically significant. There were no unexpected safety concerns seen among the people taking triptorelin. Our findings are promising but more studies are needed to confirm if starting triptorelin shortly after surgery can benefit this group of people who have had their prostate cancer treated by radical prostatectomy and have no signs that their cancer has spread to the lymph nodes.[Correction added on 31th July 2024, after first online publication: Plain language summary is added in this version.]

100 Deals associated with Triptorelin acetate

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Endometriosis	China	Livzon Pharmaceutical Group, Inc.	26 Sep 2024
Puberty, Precocious	Australia	Ferring Pharmaceuticals Pty Ltd.	04 Mar 2015
Prostatic Cancer	China	Changchun Genescience Pharmaceuticals Co., Ltd.	15 Sep 2004

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Puberty, Precocious	NDA/BLA	China	Changchun Genescience Pharmaceuticals Co., Ltd.	18 Apr 2024
Endometriosis	NDA/BLA	China	Shanghai Livzon Pharmaceutical Co. Ltd.	24 Aug 2023
Prostatic Cancer	Discovery	China	Shanghai Livzon Pharmaceutical Co. Ltd.	06 Apr 2020
HIV Infections	Discovery	Sweden	ISR Immune System Regulation AB	19 Sep 2018
HIV Infections	Discovery	Germany	ISR Immune System Regulation AB	19 Sep 2018

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESPE2023	Not Applicable	Puberty, Precocious	148	Subcutaneous Triptorelin Acetate	ouayvemvfr(nwtbjjmfxf) = gnrkqfedlp yphzxbnygf (hjapjqunmr )	-	21 Sep 2023
ESPE2018	Not Applicable	Puberty, Precocious	-	Leuprorelin Acetate	ybystehdyc(xaxfmlecyg) = zwqttqcqnf ljcxztenzr (anooocxlph ) View more	Positive	27 Sep 2018
				Triptorelin Acetate	ybystehdyc(xaxfmlecyg) = xmypscpppv ljcxztenzr (anooocxlph ) View more
ASCO2017	Phase 2	Breast Cancer Neoadjuvant	41	Letrozole 2.5mg daily	(jqreeozbqm) = ktfrjfildq rsvhfewsns (raeqkqioaf ) View more	Positive	30 May 2017
				Combined with triptorelin in premenopausal patients	(jqreeozbqm) = ewbrxueaeq rsvhfewsns (raeqkqioaf ) View more
ASCO_GU2016	Not Applicable	Prostatic Cancer Neoadjuvant \| Adjuvant	670	Buserelin	zbqatwaxij(xghmnxixih) = rlimxppned ywjeiuboar (emmtsqgjje )	-	10 Jan 2016
				Goserelin	zbqatwaxij(xghmnxixih) = mmjgwxqfsy ywjeiuboar (emmtsqgjje )
ESPE2014	Not Applicable	Puberty, Precocious	14	Triptorelin acetate	(gapynwktpc) = wlgmzoohbj aodncrliim (hokcqcyqmn )	-	18 Sep 2014
ASCO2008	Not Applicable	Breast Cancer Neoadjuvant	-	GnRH agonist (triptorelin)	mogmrvuuck(ehmgwvjwan) = bluzfdflyh czhdihuanu (uowpdgbbdx )	-	20 May 2008
				No triptorelin (control)	mogmrvuuck(ehmgwvjwan) = tiuuqyjqsv czhdihuanu (uowpdgbbdx )

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