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Merional
Merional is a Small molecule drug developed by Cairo University. It is currently in Phase 3 development. Also known as: Decapeptyl ®.
Merional is a luteinizing hormone/Choriogonadotropin receptor agonist used in treatments for conditions such as Polycystic Ovary Syndrome, Ovarian Hyperstimulation Syndrome, Subfertility, and Infertility. It is administered as part of minimal ovarian stimulation protocols.
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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 | Merional |
|---|---|
| Also known as | Decapeptyl ® |
| Sponsor | Cairo University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- The Value of Addition of Human Menopausal Gonadotropin Drug Following Oocytes Retrieval in IVF Cycles (PHASE4)
- Effect of Ubiquinol Supplementation on Ovulation Induction in Clomiphene Citrate Resistance (PHASE2, PHASE3)
- The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome (NA)
- Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders (PHASE4)
- Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol (PHASE4)
- Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment (NA)
- Effect of Prolonged GnRh Agonists on Results of Intracytoplasmic Sperm Injection (ICSI ) in Endometrioma Patients (NA)
- The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles (NA)
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:
- Merional CI brief — competitive landscape report
- Merional updates RSS · CI watch RSS
- Cairo University portfolio CI
Frequently asked questions about Merional
What is Merional?
Who makes Merional?
Is Merional also known as anything else?
What development phase is Merional in?
Related
- Manufacturer: Cairo University — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Decapeptyl ®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing