Drugs / abarelix
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PLENAXIS | — | 2003-11-25 | fda.gov ↗ |
Trials 3 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00100243 | May 2004 → Sep 2005 | prostate cancer | PRAECIS Pharmaceuticals Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00841113 | Jan 1999 → Feb 2001 | prostate cancer | Speciality European Pharma Limited | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00103623 | Jun 2004 → Dec 2008 | prostate cancer | PRAECIS Pharmaceuticals Inc. | Suspended | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06379217 Background | Jul 2024 → Aug 2026 overdue | prostate neuroendocrine neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | abarelix | “Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).” NCT00100243 ↗ |
| Known as | Plenaxis | “Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks for 12 weeks (total dose of 600 mg).” NCT00100243 ↗ |
| Known as | PPI-149 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1252 ↗ |
| Known as | R-382 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1252 ↗ |
| Known as | R-3827 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1252 ↗ |
| Action | Inhibit | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1252 ↗ |
| Modality | Protein / enzyme biologic | — CHEMBL1252 ↗ |
| Route | Intramuscular | “100 mg intramuscularly (IM)” NCT00100243 ↗ |
| Target | GNRHR | “Gonadotropin-releasing hormone receptor antagonist” CHEMBL1252 ↗ |