Sold as Plenaxis. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Abarelix (sold as Plenaxis), first approved Nov 25, 2003, with 0 new uses approved and 0 published complete response letters.
| NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.Metastatic Neuroendocrine Prostate Cancer · Novartis Pharmaceuticals | Phase 1 | Active, not recruiting | Apr 23, 2024 |
| Diagnosis of Pelvic Endometriosis in MRIEndometriosis · Zhenshen Ma | Not applicable | Not yet recruiting | Dec 6, 2023 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 25, 2003 | PlenaxisNDA 21320 · New molecular entity | Speciality European | 1 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
