FDA · United States
cetrorelix acetate — FDA regulatory status
cetrorelix acetate (CETRORELIX ACETATE) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- CETRORELIX ACETATE
- Originator
- Teva Pharma GmbH
- Mechanism
- Gonadotropin-releasing hormone receptor antagonist
- Target
- Gonadotropin-releasing hormone receptor
- Structured fields
- 8
Sponsor / originator context: Teva Pharma GmbH. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Gonadotropin-releasing hormone receptor antagonist. Target: Gonadotropin-releasing hormone receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 3 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ICO-N-2013-03 | Phase 2 | CERo Therapeutics | 2024-516282-37-00 |
| Cetrorelix Acetate | Approved | United Therapeutics Europe | NCT03763786 |
| Generic cetrorelix acetate | Unknown | NORTHWEST BIOTHERAPEUTICS | NCT06023602 |
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Related hubs
FAQ
What is the FDA approval status of cetrorelix acetate?
cetrorelix acetate currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get cetrorelix acetate regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to cetrorelix acetate?
This spoke lists 3 published programs associated with cetrorelix acetate in our pipeline index.