At a glance
- Abarelix was approved by the FDA (Plenaxis, November 25, 2003), but the products are no longer marketed.
- PubMed lists 57 publications mentioning it, including 2 randomized controlled trials and 3 animal-only studies.
- ClinicalTrials.gov lists 5 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 55 reports mentioning it; 47 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 |
|---|---|---|---|---|
| NDA021320 | PLENAXIS | Approved, discontinued | November 25, 2003 | SPECIALITY EUROPEAN |
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
- GnRH Peptide Antagonist: Comparative Analysis of Chemistry and Formulation with Implications for Clinical Safety and Efficacy.
- Current and emerging gonadotropin-releasing hormone (GnRH) antagonists for the treatment of prostate cancer.
- Erythropoietin-producing hepatocellular receptor A7 restrains estrogen negative feedback of luteinizing hormone via ephrin A5 in the hypothalamus of female rats.
- Therapeutic outcomes of the LHRH antagonists.
- Utility of LHRH antagonists for advanced prostate cancer.
- Effects of GnRH antagonists vs agonists in domestic carnivores, a review.
- Gonadotropin-releasing hormone: an update review of the antagonists versus agonists.
- New treatment paradigm for prostate cancer: abarelix initiation therapy for immediate testosterone suppression followed by a luteinizing hormone-releasing hormone agonist.
- New treatment paradigm for prostate cancer: abarelix initiation therapy for immediate testosterone suppression followed by a luteinizing hormone-releasing hormone agonist.
- An update on the use of gonadotropin-releasing hormone antagonists in prostate cancer.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 5
- Active
- 2
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. | Active, not recruiting | Phase 1 | July 29, 2024 |
| Diagnosis of Pelvic Endometriosis in MRI | Not yet recruiting | N/A | December 20, 2023 |
| The Plenaxis® Experience Study | Suspended | Phase 4 | Jun 2004 |
| Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy | Completed | Phase 2 | May 2004 |
| Abarelix Versus Goserelin Plus Bicalutamide in Patients With Advanced or Metastatic Prostate Cancer | Completed | Phase 3 | Jan 1999 |
All 5 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 55
- Serious
- 47
- With death outcome
- 22
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
Change history
No changes since monitoring began on October 30, 2026.