Triptorelin

Overview

Triptorelin is a synthetic decapeptide agonist analog of luteinizing hormone releasing hormone (LHRH). Possessing greater potency than endogenous LHRH, triptorelin reversibly represses gonadotropin secretion. After chronic, continuous administration, this agent effects sustained decreases in LH and FSH production and testicular and ovarian steroidogenesis. Serum testosterone concentrations may fall to levels typically observed in surgically castrated men.

Background

Indication

Triptorelin is indicated for the palliative treatment of advanced prostate cancer.

Associated Conditions

Advanced Prostate Cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on Human Bioequivalence of Triprerelin Acetate for Injection	2024/11/11	NCT06683066	Phase 1	Recruiting	The Affiliated Hospital of Qingdao University
Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer	2024/09/03	NCT06581679	Not Applicable	Completed	Zagazig University
Effect GnRH Agonist Administration in Endometriosis Cyst Patients	2024/07/29	NCT06525155	Phase 3	Recruiting	Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer	2024/07/22	NCT06513962	Phase 3	Recruiting	Children's Oncology Group
Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP	2024/07/05	NCT06487143	Phase 4	Not yet recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients	2024/06/25	NCT06473259	N/A	Recruiting	Santa Chiara Hospital
Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial	2024/04/23	NCT06378866	Phase 2	Recruiting	Mayo Clinic
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers	2024/02/28	NCT06282588	Phase 2	Recruiting	Cancer Research Antwerp
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)	2023/11/13	NCT06129539	Phase 3	Recruiting	Debiopharm International SA
Elacestrant With/Without Triptorelin in Premenopausal Women With Luminal Breast Cancer	2023/08/08	NCT05982093	Phase 2	Active, not recruiting	SOLTI Breast Cancer Research Group

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DECAPEPTYL INJECTION 0.1 mg/ml	FERRING GMBH	SIN08697P	INJECTION	100 mcg/ml	5/6/1996
DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 3.75 mg/vial	IPSEN PHARMA BIOTECH (Lyophilisate manufacturer), CENEXI (Solvent manufacturer), Ipsen Pharma Biotech (Gamma irradiation site of lyophilisate), Sterigenics Italy S.P.A (Gamma irradiation site of lyophilisate), Sterigenics Belgium (Gamma irradiation site of lyophilisate)	SIN14634P	INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE	3.75 mg/vial	9/25/2014
Pamorelin Powder for Suspension for Injection 11.25 mg per vial	Debiopharm Research & Manufacturing SA, Synergy Health Daniken AG (Contract Sterilization Facility)	SIN14324P	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	11.25 mg	3/11/2013
Pamorelin Powder for Suspension for Injection 22.5 mg per vial	Debiopharm Research & Manufacturing SA, Synergy Health Daniken AG (Contract Sterilization Facility)	SIN14325P	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	22.5 mg	3/11/2013
Pamorelin Powder for Suspension for Injection 3.75 mg per vial	Debiopharm Research & Manufacturing SA, Synergy Health Daniken AG (Contract Sterilization Facility)	SIN14323P	INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION	3.75 mg	3/11/2013
DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 mg/vial	IPSEN PHARMA BIOTECH (Lyophilisate manufacturer), CENEXI (Solvent manufacturer), Ipsen Pharma Biotech (Gamma Irradiation site of lyophilisate), Sterigenics Italy S.P.A (Gamma Irradiation site of lyophilisate), Sterigenics Belgium (Fleurus) SA (Gamma irradiation site of lyophilisate)	SIN14635P	INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE	11.25 mg/vial	9/25/2014
DECAPEPTYL CR FOR INJECTION 3.75 mg/syringe	FERRING GMBH	SIN09105P	INJECTION, POWDER, FOR SOLUTION	3.75 mg/syringe	12/28/1996

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Triptorelin Acetate for Injection	IPSEN PHARMA	国药准字HJ20130797	化学药品	注射剂	5/16/2023
Triptorelin Acetate for Injection	IPSEN PHARMA	国药准字HJ20140298	化学药品	注射剂	6/7/2023
Triptorelin Pamoate for Injection	IPSEN PHARMA	国药准字HJ20230075	化学药品	注射剂	6/21/2023
Triptorelin Pamoate for Injection	IPSEN PHARMA	国药准字HJ20130842	化学药品	注射剂	5/16/2023
Triptorelin Acetate Microspheres for Injection	丽珠医药集团股份有限公司	国药准字H20230009	化学药品	注射剂	5/6/2023
Triptorelin Acetate Injection	华夏生生药业（北京）有限公司	国药准字H20244791	化学药品	注射剂	9/3/2024
Triptorelin Acetate Injection	长春金赛药业有限责任公司	国药准字H20044922	化学药品	注射剂	8/10/2020
Triptorelin Acetate Injection	重庆莱美药业股份有限公司	国药准字H20223597	化学药品	注射剂	3/7/2023
Triptorelin Acetate Injection	Ferring AG	国药准字HJ20160237	化学药品	注射剂	10/30/2020
Triptorelin Acetate Injection	成都天台山制药股份有限公司	国药准字H20058648	化学药品	注射剂(注射液)	6/17/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DIPHERELINE triptorelin {as embonate} 11.25mg powder for suspension vial and water for injections ampoule	109856	Ipsen Pty Ltd	Medicine	A	8/28/2006
DIPHERELINE triptorelin (as embonate) 3.75 mg powder for suspension vial and water for injections ampoule	109854	Ipsen Pty Ltd	Medicine	A	8/28/2006
DIPHERELINE triptorelin (as embonate) 22.5 mg powder for suspension vial and water for injections ampoule	159173	Ipsen Pty Ltd	Medicine	A	7/27/2010
DECAPEPTYL triptorelin acetate 100 micrograms/1 mL solution for injection in 1mL pre-filled syringe with integrated needle	219857	Ferring Pharmaceuticals Pty Ltd	Medicine	A	3/4/2015

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