Triptorelin

Triptorelin is a GnRH agonist.

• TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.

• Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2) ] . Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1) ] .contraindicated

Must only be administered by a healthcare provider. ( 2.1 ) Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks. ( 2.1 ) Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose. ( 2.2 ) Measure height every 3-6 months and monitor bone age periodically. ( 2.2 ) See FPI for complete reconstitution and administration instructions. ( 2.3 ) Once TRIPTODUR is mixed, proceed to the next steps and administer without delay. ( 2.3 ) The injection of the suspension should be performed rapidly and in a steady and uninterrupted manner in order to avoid any potential blockage of the needle. ( 2.3 ) 2.1 Dosing Information TRIPTODUR must only be administered by a healthcare provider. The dosage of TRIPTODUR is 22.5 mg reconstituted with accompanying diluent (Sterile Water) 2 mL, and administered as a single intramuscular injection once every 24 weeks. TRIPTODUR treatment should be discontinued at the appropriate age of onset of puberty at the discretion of the physician. 2.2 Monitoring Monitor response to TRIPTODUR with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose.

Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. ( 5.1 ) Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. ( 5.2 ) Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.3 ) Severe Cutaneous Adverse Reactions (SCARs): Have been reported in patients receiving GnRH agonists, including triptorelin products. Interrupt TRIPTODUR if signs or symptoms of SCARs develop. Permanently discontinue TRIPTODUR if a SCAR is confirmed. ( 5.4 ) Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for headache, papilledema, and blurred vision. ( 5.5 ) 5.1 Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of initial therapy or after subsequent doses, gonadotropins and sex steroids may rise above baseline because of a transient stimulatory effect of the drug [see Clinical Pharmacology (12.2) ] .

The following serious adverse reactions are described here and elsewhere in the label: Initial Rise of Gonadotropins and Sex Steroid Levels [ see Warnings and Precautions ( 5.1 ) ] Psychiatric Events [ see Warnings and Precautions ( 5.2 ) ] Convulsions [ see Warnings and Precautions ( 5.3 ) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.4 ) ] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [ see Warnings and Precautions ( 5.5 ) ] In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months.

8.1 Pregnancy Risk Summary TRIPTODUR is contraindicated in women who are pregnant [ see Contraindications ( 4 ) ] since expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss. Available data with triptorelin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Based on mechanism of action in humans and findings of increased pregnancy loss in animal studies, TRIPTODUR may cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% -20%, respectively. Data Animal Data In pregnant rats administered triptorelin at doses of 2, 10, and 100 mcg/kg/day during the period of organogenesis, maternal toxicity (decrease in body weight) and embryo-fetal toxicities (pre-implantation loss, increased resorption, and reduced number of viable fetuses) were observed at 100 mcg/kg, approximately 4 times the clinical dose based on body surface area. No embryonic and fetal developmental toxicities were observed in mice at doses up to 4 times the clinical dose.

Metabolism

Absorption After an initial intramuscular TRIPTODUR 22.5 mg injection and a second 22.5 mg intramuscular injection 24 weeks later in children 2 to 9 years old with CPP, triptorelin peaked 4 hours postdose with a geometric mean C max of 39.9 and 36.5 ng/mL, respectively. No apparent accumulation of triptorelin occurred after the second injection.

There is no experience with overdosage in clinical trials of triptorelin. If overdosage occurs, therapy should be discontinued and appropriate supportive and symptomatic treatment administered.

• Jun 15, 2000NDANDA020715Verity
• Jun 29, 2001NDANDA021288Verity
• Mar 10, 2010NDANDA022437Verity
• Jun 29, 2017NDANDA208956Azurity

1. 1Death4357.7%
2. 2Off Label Use3836.8%
3. 3Needle Issue2274.0%
4. 4Disease Progression2093.7%
5. 5Fatigue2063.7%
6. 6Hot Flush1933.4%
7. 7Product Dose Omission Issue1893.4%
8. 8Drug Ineffective1843.3%
9. 9Asthenia1652.9%
10. 10Headache1582.8%
11. 11Inappropriate Schedule Of Product Administration1482.6%
12. 12Weight Increased1412.5%
13. 13Malignant Neoplasm Progression1402.5%
14. 14Nausea1292.3%
15. 15Ovarian Hyperstimulation Syndrome1262.2%

Recent PubMed references pinned to Triptorelin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• [Efficacy of the 3-month formulation of triptoreli in children with idiopathic central precocious puberty].
  Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2026 · Yu K, Bei YH, Deng SL, et al.
  PMID 42130352DOI 10.7499/j.issn.1008-8830.2508036
• The efficacy of deslorelin implants in neutered male dogs that sexually attract other male dogs: a randomized controlled trial.
  Theriogenology · 2026 · Leber J, Riege L, Fontaine C, et al.
  PMID 42119283DOI 10.1016/j.theriogenology.2026.117975
• Outcomes of GnRH agonist trigger in dydrogesterone-based PPOS versus GnRH antagonist cycles: a retrospective parallel cohort in freeze-all IVF treatment.
  European journal of obstetrics, gynecology, and reproductive biology · 2026 · Melado L, Ata B, Kalafat E, et al.
  PMID 41980430DOI 10.1016/j.ejogrb.2026.115101
• Diagnostic Usefulness of Subcutaneous Triptorelin Stimulation Testing in the Evaluation of Central Precocious Puberty in Girls.
  Hormone and metabolic research = Hormon- und Stoffwechselforschung = Hormones et metabolisme · 2026 · Cho MH, Kim J, Shim YS, et al.
  PMID 41956123DOI 10.1055/a-2844-9524
• Effect of 4.7-mg Deslorelin Acetate Implant on Blood Lipids and Steroid Hormones in Cockatiels (Nymphicus hollandicus).
  Journal of avian medicine and surgery · 2026 · Sosa-Higareda M, Guzman DS, Gomez-Ponce M, et al.
  PMID 41926275DOI 10.1647/AVIANMS-D-25-00015
• THE GONADOTROPIN RELEASING HORMONE AGONIST, DESLORELIN ACETATE, IS CONTRAINDICATED FOR MITIGATION OF AGGRESSION AND REPRODUCTIVE BEHAVIOR IN MALE COWNOSE RAYS (RHINOPTERA BONASUS).
  Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians · 2026 · Hyatt MW, Penfold LM, Mone AJ, et al.
  PMID 41926257DOI 10.1638/2025-0039
• Optimization of Triptorelin Administration in Children With Central Precocious Puberty and Short Stature.
  Clinical endocrinology · 2026 · Yao HB, Xie HX, Fan HP, et al.
  PMID 41841385DOI 10.1111/cen.70107
• [Efficacy and safety of triptorelin acetate microspheres for injection versus triptorelin acetate for injection in Chinese patients with endometriosis: a multicenter, randomized, double-blind, phase Ⅲ non-inferiority clinical trial].
  Zhonghua fu chan ke za zhi · 2026 · Zhao AM, Wang Y, Yang WW, et al.
  PMID 41611266DOI 10.3760/cma.j.cn112141-20250421-00161

The 10 most recently updated of 290 ClinicalTrials.gov registrations naming Triptorelin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
  Active not recruiting · Phase 2 · Interventional · 176 enrolled · Hoffmann-La Roche
  NCT04931342updated 2026-06-08
• A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
  Active not recruiting · Phase 3 · Interventional · 692 enrolled · Janssen Pharmaceutica N.V., Belgium
  NCT04557059updated 2026-06-05
• Intranasal Nafarelin For Triggering Oocyte Maturation
  Not yet recruiting · Phase 4 · Interventional · 154 enrolled · Fundacion Dexeus
  NCT06763926updated 2026-06-04
• Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
  Recruiting · Phase 3 · Interventional · 3,960 enrolled · NRG Oncology
  NCT05879926updated 2026-06-03
• Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment
  Active not recruiting · Observational · 450 enrolled · Ipsen
  NCT05377684updated 2026-06-01
• A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
  Active not recruiting · Phase 3 · Interventional · 56 enrolled · Debiopharm International SA
  NCT06129539updated 2026-05-28
• Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
  Active not recruiting · Phase 3 · Interventional · 372 enrolled · Sun Yat-sen University
  NCT07477626updated 2026-05-19
• Clinical Trial Evaluating the Biological Activity of a New Drug Identified as Prifetrastat (PF-07248144), Combined With Fulvestrant for the Treatment of Patients With Hormone Receptor Positive (HR+) and HER2 Negative (HER2-) Breast Cancer Extended to Other Organs.
  Not yet recruiting · Phase 2 · Interventional · 51 enrolled · UNICANCER
  NCT07340619updated 2026-05-19
• Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
  Recruiting · Phase 3 · Interventional · 804 enrolled · ECOG-ACRIN Cancer Research Group
  NCT04423211updated 2026-05-15
• A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer
  Active not recruiting · Phase 1 · Interventional · 181 enrolled · Genentech, Inc.
  NCT03332797updated 2026-05-15

Frequently asked questions

How does Triptorelin work?

Triptorelin is a GnRH agonist.

What is Triptorelin used for?

According to FDA labeling, Triptorelin carries indications including: TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Triptorelin?

Triptorelin is classified as Gonadotropin releasing hormone analogues, Gonadotropin Releasing Hormone Receptor Agonist, Gonadotropin Releasing Hormone Receptor Agonists, Hypothalamic Hormone Receptor Agonists, Decreased Follicle Stimulating Hormone Secretion, Decreased Luteinizing Hormone Secretion, Decreased Testosterone Secretion.

What are the brand names for Triptorelin?

Triptorelin is marketed under brand names including Trelstar, Triptodur.

What are the contraindications for Triptorelin?

Triptorelin labeling lists contraindications including: Hypersensitivity: TRIPTODUR is contraindicated in individuals with a known hypersensitivity to triptorelin, any other component of the product, or other GnRH agonists or GnRH [see Adverse Reactions (6.2) ] . Pregnancy: TRIPTODUR may cause fetal harm [see Use in Specific Populations (8.1) ] .. Always consult the full prescribing information and a clinician.