FYREMADEL (ganirelix acetate) · Sun Pharma
Ganirelix acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-11-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FYREMADEL Approval History
What FYREMADEL Treats
1 indicationsFYREMADEL is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premature Luteinizing Hormone Surge
FYREMADEL 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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Sun Pharma's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06745466 V-RISES | 2207199 R21AG090810 | Ph 4 | recruiting | Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women |
| NCT05954962 PRO_NAT | IBMR43 | Ph 4 | completed | Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation. |
| NCT01614067 DOS/DOR results posted | UCSF 11-07259 | Ph 4 | terminated | Delayed Start to Ovarian Stimulation |
| NCT03051087 | LG-GNCL001 | Ph 4 | completed | To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran® |
| NCT00823004 | 1969yazdRCCI | Ph 1, Ph 2 | completed | Antagonist/Letrozole in Poor Responders |
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.
FYREMADEL FDA Label Details
Indications & Usage
Ganirelix acetate injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
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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