At a glance
- Histrelin is an FDA-approved drug, marketed as Supprelin (first approval: May 3, 2007).
- PubMed lists 97 publications mentioning it, including 0 randomized controlled trials and 13 animal-only studies.
- ClinicalTrials.gov lists 15 registered studies testing it (5 active).
- FDA's adverse event system (FAERS) holds 903 reports mentioning it; 206 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 |
|---|---|---|---|---|
| NDA019836 | SUPPRELIN | Approved, discontinued | December 24, 1991 | SHIRE |
| NDA021732 | VANTAS | Approved, discontinued | October 12, 2004 | ENDO OPERATIONS |
| NDA022058 | SUPPRELIN LA | Approved, marketed | May 3, 2007 | ENDO OPERATIONS |
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
- Case Report: Sustained pubertal suppression for 68 months with a single histrelin acetate implant in central precocious puberty.
- Low-dose histrelin for ovulation induction in mares: a partially randomized crossover pilot study.
- Prolonged Pubertal Suppression due to Retained Histrelin Implant in Three Children with Central Precocious Puberty.
- FDA-approved drugs as potential covalent inhibitors of key SARS-CoV-2 proteins: an in silico approach.
- Adverse event profile differences among long-acting gonadotropin-releasing hormone analogs: A real-world, pharmacovigilance study.
- The US Supreme Court Joins the Debate Over Gender Dysphoria.
- Study of persistence and adherence to ADT in prostate cancer: relugolix, degarelix, and GnRH agonists in the US.
- Investigation and Treatment of Infertility in a Female Black Rhinoceros (Diceros bicornis).
- Periovulatory anticoagulant therapy enhances embryo recovery rates in superovulated mares.
- Comparative Cardiovascular Safety of Gonadotropin-releasing Hormone Antagonists and Agonists Among Patients Diagnosed with Prostate Cancer: A Systematic Review and Meta-analysis of Real-world Evidence Studies.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 15
- Active
- 5
- With posted results
- 2
Conditions studied
Show 5 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer | Completed | — | Jan 2011 |
| Vantas Implant Retrieval Study | Completed | — | Jul 2006 |
| Histrelin Subcutaneous Implant in Children With Central Precocious Puberty | Completed | Phase 3 | Sep 2004 |
| Study of Histrelin Subdermal Implant in Patients With Prostate Cancer | Completed | Phase 3 | May 2000 |
| Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer | Completed | Phase 3 | Apr 2000 |
All 15 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 903
- Serious
- 206
- With death outcome
- 30
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.