Drug

Abarelix

As of the edition of 20 October 2026, Abarelix is a protein: marketed, first approved in 2003 (US); acts on GNRHR; no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2003
Kind
Protein
Brand name
Plenaxis
First approved
25 November 2003 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Speciality European Pharma
Registered trials
3, 0 stopped early
Disease areas
Cancer; Urinary and reproductive

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Abarelix.

Target

GeneProteinUniProt
GNRHRGonadotropin-releasing hormone receptorP30968

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 21100
Phase 31100
Phase 41000
All trials3

Who has held its approvals

CompanyRoleYears
Speciality European PharmaAcquired holder and Lead sponsor of trials1999 to now
PRAECIS PharmaceuticalsOriginator and Lead sponsor of trials2003 to now