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urinary hCG (u-hCG)
urinary hCG (u-hCG) is a Small molecule drug developed by Merck KGaA, Darmstadt, Germany. It is currently in Phase 3 development for Pregnancy confirmation.
Urinary hCG is a diagnostic test that detects the presence of human chorionic gonadotropin in urine.
Urinary hCG is used as an ovulation trigger in IVF, with studies comparing its effectiveness to recombinant hCG. It is a small molecule that has been studied for its effects on embryonic development, pregnancy, and complications associated with artificial fertilization.
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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). -
Big-pharma sponsor
+3.0pp
Merck KGaA, Darmstadt, Germany is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | urinary hCG (u-hCG) |
|---|---|
| Sponsor | Merck KGaA, Darmstadt, Germany |
| Modality | Small molecule |
| Therapeutic area | Gynecology |
| Phase | Phase 3 |
Mechanism of action
The test works by detecting the presence of hCG, a hormone produced during pregnancy, in a urine sample. This hormone is produced by the placenta and can be detected in the urine of pregnant individuals. The test is used to confirm pregnancy and monitor fetal development.
Approved indications
- Pregnancy confirmation
Common side effects
Key clinical trials
- Delayed Start Versus Conventional Antagonist Protocol in Poor Responders Pretreated by Estradiol in Luteal Phase (PHASE3)
- Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women (PHASE3)
- Endometrial Advancement After Rec or u-HCG Triggering (PHASE4)
- Growth Hormone for Poor Responders in in Vitro Fertilization (IVF) (PHASE2)
- A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women (PHASE2)
- Pregnancy Rates in IVF After Ovulation Triggering With Recombinant or Urinary Human Chorionic Gonadotrophin (HCG) (PHASE3)
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:
- urinary hCG (u-hCG) CI brief — competitive landscape report
- urinary hCG (u-hCG) updates RSS · CI watch RSS
- Merck KGaA, Darmstadt, Germany portfolio CI
Frequently asked questions about urinary hCG (u-hCG)
What is urinary hCG (u-hCG)?
How does urinary hCG (u-hCG) work?
What is urinary hCG (u-hCG) used for?
Who makes urinary hCG (u-hCG)?
What development phase is urinary hCG (u-hCG) in?
Related
- Manufacturer: Merck KGaA, Darmstadt, Germany — full pipeline
- Therapeutic area: All drugs in Gynecology
- Indication: Drugs for Pregnancy confirmation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing