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(rec)hCG
(rec)hCG is a Gonadotropin; hormone replacement Biologic drug developed by Organon and Co. It is currently in Phase 3 development for Induction of ovulation in anovulatory women, Support of luteal phase in assisted reproductive technology (ART), Treatment of hypogonadism in males.
Recombinant human chorionic gonadotropin (rec-hCG) mimics the natural hormone hCG to stimulate gonadal hormone production and support reproductive function.
Recombinant human chorionic gonadotropin (rec)hCG is used in fertility treatments, specifically in IVF patients, to stimulate embryonic development and pregnancy. It is often used as an alternative to urinary HCG, and can be administered in combination with recombinant FSH and LH.
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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 | (rec)hCG |
|---|---|
| Sponsor | Organon and Co |
| Drug class | Gonadotropin; hormone replacement |
| Target | Luteinizing hormone receptor (LH receptor) |
| Modality | Biologic |
| Therapeutic area | Reproductive endocrinology; Fertility |
| Phase | Phase 3 |
Mechanism of action
rec-hCG is a recombinant form of human chorionic gonadotropin, a glycoprotein hormone that acts on luteinizing hormone receptors in the testes and ovaries. In males, it stimulates testosterone production and spermatogenesis; in females, it supports corpus luteum function and progesterone production during the luteal phase. It is used clinically to induce ovulation, support luteal phase function, and treat hypogonadism.
Approved indications
- Induction of ovulation in anovulatory women
- Support of luteal phase in assisted reproductive technology (ART)
- Treatment of hypogonadism in males
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal discomfort
Key clinical trials
- Optimal Stimulation of Hypo-responders Undergoing in Vitro Fertilization (IVF) (PHASE4)
- Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells (PHASE1)
- Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715)
- Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714) (PHASE3)
- Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men (PHASE2)
- FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy (PHASE2, PHASE3)
- Endometrial Advancement After Rec or u-HCG Triggering (PHASE4)
- Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients (PHASE4)
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:
- (rec)hCG CI brief — competitive landscape report
- (rec)hCG updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about (rec)hCG
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Related
- Drug class: All Gonadotropin; hormone replacement drugs
- Target: All drugs targeting Luteinizing hormone receptor (LH receptor)
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Reproductive endocrinology; Fertility
- Indication: Drugs for Induction of ovulation in anovulatory women
- Indication: Drugs for Support of luteal phase in assisted reproductive technology (ART)
- Indication: Drugs for Treatment of hypogonadism in males
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing