PREGNYL (gonadotropin, chorionic)
PREGNYL is indicated for the treatment of Cryptorchidism; Hypogonadotropic Hypogonadism; Anovulation; Infertility.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1976-10-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PREGNYL Approval History
What PREGNYL Treats
4 indicationsPREGNYL is approved for 4 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cryptorchidism
- Hypogonadotropic Hypogonadism
- Anovulation
- Infertility
PREGNYL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02703584 | 03012016 | Ph 4 | completed | Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation |
| NCT01607203 results posted | Dr. Decleer Wim | Ph 4 | completed | Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist |
| NCT00627406 results posted | N-VN-2002-0046MCH | Ph 4 | completed | Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PREGNYL FDA Label Details
Indications & Usage
FDA Label (PDF)PREGNYL is indicated for the treatment of Cryptorchidism; Hypogonadotropic Hypogonadism; Anovulation; Infertility.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment