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hCG administration before embryo transfer
hCG administration before embryo transfer is a Small molecule drug developed by Istituto Clinico Humanitas. It is currently in Phase 2 development. Also known as: Gonasi HP 5000 UI or Ovitrelle 250mg.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | hCG administration before embryo transfer |
|---|---|
| Also known as | Gonasi HP 5000 UI or Ovitrelle 250mg |
| Sponsor | Istituto Clinico Humanitas |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study
- Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium (NA)
- Assessment of the Feasibility of Frozen Embryo Transfers in a Natural Cycle Among Obese Compared to Non-Obese Patients
- Intravenous Immunoglobulin and Prednisolone for RPL After ART. (PHASE2)
- Association Between Plasma Level of Mannose Binding Lectin and Human Reproduction
- Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium (EARLY_PHASE1)
- Optimal Stimulation of Hypo-responders Undergoing in Vitro Fertilization (IVF) (PHASE4)
- Natural Cycle vs Programmed Cycle Frozen Embryo Transfer (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:
- hCG administration before embryo transfer CI brief — competitive landscape report
- hCG administration before embryo transfer updates RSS · CI watch RSS
- Istituto Clinico Humanitas portfolio CI
Frequently asked questions about hCG administration before embryo transfer
What is hCG administration before embryo transfer?
Who makes hCG administration before embryo transfer?
Is hCG administration before embryo transfer also known as anything else?
What development phase is hCG administration before embryo transfer in?
Related
- Manufacturer: Istituto Clinico Humanitas — full pipeline
- Also known as: Gonasi HP 5000 UI or Ovitrelle 250mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing