At a glance
- Cetrorelix is an FDA-approved drug, marketed as Cetrotide, Cetrorelix (first approval: August 11, 2000).
- PubMed lists 607 publications mentioning it, including 86 randomized controlled trials and 148 animal-only studies.
- ClinicalTrials.gov lists 140 registered studies testing it (14 active).
- FDA's adverse event system (FAERS) holds 736 reports mentioning it; 539 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 |
|---|---|---|---|---|
| NDA021197 | CETROTIDE | Approved, marketed | August 11, 2000 | EMD SERONO INC |
| ANDA215737 | CETRORELIX ACETATE | Approved, discontinued | August 12, 2022 | TEVA PHARMS INC |
| ANDA217776 | CETRORELIX ACETATE | Approved, marketed | April 16, 2024 | QILU |
| ANDA214540 | CETRORELIX ACETATE | Approved, marketed | April 24, 2024 | LIVZON GRP |
| ANDA218150 | CETRORELIX ACETATE | Approved, marketed | April 25, 2024 | GLAND |
| ANDA218061 | CETRORELIX ACETATE | Approved, marketed | June 3, 2025 | XIROMED |
| ANDA218740 | CETRORELIX ACETATE | Approved, marketed | April 29, 2026 | EPIC PHARMA LLC |
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
- Oral gonadotropin-releasing hormone antagonists versus injectable cetrorelix for luteinizing hormone surge prevention in donor in vitro fertilization cycles: A retrospective cohort study of efficacy, embryology, and stimulation dynamics.
- Radix Bupleuri Chinensis Extract Ameliorates Doxorubicin-Induced Spermatogenic Dysfunction: Involvement of the GnRHR Signaling Pathway and Taurine Biosynthesis.
- Evaluating progestin-primed and GnRH antagonist ovarian stimulation protocols in PGT-A cycles: implications for clinical practice.
- Efficacy and safety of different cetrorelix doses in the luteal phase for preventing ovarian hyperstimulation syndrome: A cross-sectional study.
- Comparison of Chitosan-Poloxamer Nanoparticles and Poloxamer-based In-Situ Forming Gel for Nose-to-Brain Delivery of Cetrorelix: In Vitro and Pharmacokinetic Studies in Rats.
- GnRH Agonists and Antagonists in IVF/ICSI Cycles of PCOS Women: A Network Meta-Analysis.
- Medroxyprogesterone acetate vs. GnRH antagonist for preventing premature LH surge during ovarian stimulation in assisted reproductive technology: a retrospective cohort study.
- The Stimulating Effect of Low-Molecular-Weight Luteinizing Hormone Receptor Agonist on Steroidogenesis and Ovulation in Female Rats with Dehydroepiandrosterone-Induced Polycystic Ovary Syndrome.
- A new cetrorelix-based estrogen-free ovarian synchronization protocol for fixed-time artificial insemination in beef cattle.
- Hydrogel and oleogel formulation of the decapeptide cetrorelix acetate for nasal administration.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 140
- Active
- 14
- With posted results
- 16
Conditions studied
Show 40 more studies
All 140 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 736
- Serious
- 539
- With death outcome
- 9
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.