Drug

Fondaparinux

As of the edition of 20 October 2026, Fondaparinux is an oligosaccharide: marketed, first approved in 2001 (US); acts on SERPINC1; no US protection is listed.

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

The drug

Status
Marketed; latest approval 2017
Kind
Oligosaccharide
Brand name
Arixtra
First approved
7 December 2001 (US)
Approvals on record
8 in 4 regions
Holder of the most recent approval
ASPEN PHARMA INDÚSTRIA FARMACÊUTICA LTDA; 4 holders in all
Withdrawn from market
11 March 2008 (in some regions)
Registered trials
49, 14 stopped early
Disease areas
Heart and blood vessels; Lungs and airways; Pregnancy and women's health; Urinary and reproductive; Cancer; Blood and lymph

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

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Fondaparinux.

Target

GeneProteinUniProt
SERPINC1Antithrombin-IIIP01008

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated151202
Phase 15302
Phase 25302
Phase 3161103
Phase 48305
All trials49

Who has held its approvals

CompanyRoleYears
GSKApplicant and Lead sponsor of trials2001 to now
ViatrisAcquired holder2002 to now