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Cetrotide Injectable Product
Cetrotide Injectable Product is a GnRH antagonist Small molecule drug developed by El Shatby University Hospital for Obstetrics and Gynecology. It is currently in Phase 3 development for Controlled ovarian hyperstimulation in assisted reproductive technology (ART) and in vitro fertilization (IVF) cycles.
Cetrotide is a gonadotropin-releasing hormone (GnRH) antagonist that blocks GnRH receptors to suppress luteinizing hormone and follicle-stimulating hormone secretion.
Cetrotide is a gonadotropin-releasing hormone (GnRH) antagonist that blocks GnRH receptors to suppress luteinizing hormone and follicle-stimulating hormone secretion. Used for Controlled ovarian hyperstimulation in assisted reproductive technology (ART) and in vitro fertilization (IVF) cycles.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Cetrotide Injectable Product |
|---|---|
| Sponsor | El Shatby University Hospital for Obstetrics and Gynecology |
| Drug class | GnRH antagonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Reproductive/Fertility |
| Phase | Phase 3 |
Mechanism of action
By antagonizing GnRH receptors in the pituitary gland, Cetrotide rapidly suppresses gonadotropin release without the initial flare effect seen with GnRH agonists. This leads to controlled suppression of ovarian steroid production, making it useful for controlled ovarian hyperstimulation in assisted reproductive technology cycles.
Approved indications
- Controlled ovarian hyperstimulation in assisted reproductive technology (ART) and in vitro fertilization (IVF) cycles
Common side effects
- Headache
- Ovarian hyperstimulation syndrome (OHSS)
- Injection site reactions
- Abdominal pain
- Nausea
Key clinical trials
- A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA) (PHASE3)
- Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?! (PHASE1, PHASE2)
- Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment (PHASE4)
- The LUTEAL Trial: Luteal Stimulation vs. Estrogen Priming Protocol (NA)
- Acupuncture in the Freeze-all IVF Cycle (NA)
- DEPO-Trigger Trial: GnRH Agonist DEPOt TRIGGER for Final Oocyte Maturation (PHASE1, PHASE2)
- Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders (PHASE3)
- An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cetrotide Injectable Product CI brief — competitive landscape report
- Cetrotide Injectable Product updates RSS · CI watch RSS
- El Shatby University Hospital for Obstetrics and Gynecology portfolio CI
Frequently asked questions about Cetrotide Injectable Product
What is Cetrotide Injectable Product?
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What drug class is Cetrotide Injectable Product in?
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What does Cetrotide Injectable Product target?
Related
- Drug class: All GnRH antagonist drugs
- Target: All drugs targeting GnRH receptor
- Manufacturer: El Shatby University Hospital for Obstetrics and Gynecology — full pipeline
- Therapeutic area: All drugs in Reproductive/Fertility
- Indication: Drugs for Controlled ovarian hyperstimulation in assisted reproductive technology (ART) and in vitro fertilization (IVF) cycles
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing