At a glance
- Triptorelin is an FDA-approved drug, marketed as Trelstar, Triptodur (first approval: June 15, 2000).
- PubMed lists 1,176 publications mentioning it, including 188 randomized controlled trials and 87 animal-only studies.
- ClinicalTrials.gov lists 313 registered studies testing it (75 active).
- FDA's adverse event system (FAERS) holds 8,403 reports mentioning it; 6,176 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA020715 | TRELSTAR | Approved, marketed | June 15, 2000 | VERITY |
| NDA021288 | TRELSTAR | Approved, marketed | June 29, 2001 | VERITY |
| NDA022437 | TRELSTAR | Approved, marketed | March 10, 2010 | VERITY |
| NDA208956 | TRIPTODUR KIT | Approved, marketed | June 29, 2017 | AZURITY |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Proposed Method for Mass Spectrometric Measurement of the Gonadotropin-Releasing Hormone Agonist Deslorelin.
- Comparison of cardiovascular events in patients with metastatic hormone sensitive prostate cancer treated with LHRH agonists to LHRH antagonists in the US: A retrospective cohort study.
- Is there a difference in ovarian hyperstimulation syndrome rates in freeze-all treatment cycles in high-risk patients treated with different GnRH agonist triggers?
- Optimizing ovarian stimulation in oocyte donation: exploratory comparison of rhFSH (2:1) versus hp-hMG under PPOS protocols.
- The two-shot protocol. A randomized controlled trial of a novel two-injection ovarian stimulation strategy.
- Pubertal Triptorelin Exposure Alters Hypothalamic Reproductive-Metabolic Integration in a Sex-Specific Manner.
- Evaluation of triplet therapy combined with robot-assisted cytoreductive prostatectomy for high-volume metastatic prostate cancer: a multicentre randomised controlled trial protocol.
- Development of a parsimonious predictive model for height gain outcome in children with central precocious puberty following gonadotropin-releasing hormone agonist therapy.
- Central Precocious Puberty and Sjogren-Larsson Syndrome in a Child: A Rare Case Report.
- In vitro fertilization-frozen embryo transfer in a patient with gonadotroph adenoma: Exacerbation of ovarian hyperstimulation by triptorelin: a case report.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 313
- Active
- 75
- With posted results
- 49
Conditions studied
Show 40 more studies
All 313 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 8,403
- Serious
- 6,176
- With death outcome
- 909
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.