Drug

Nelarabine

As of the edition of 20 October 2026, Nelarabine is a small molecule: marketed, first approved in 2005 (US); no US protection is listed.

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

The drug

Status
Marketed; latest approval 2007
Kind
Small molecule
Brand name
Arranon
First approved
28 October 2005 (US)
Approvals on record
2 in 2 regions
Holder of the most recent approval
Sandoz
Registered trials
29, 7 stopped early
Disease areas
Cancer; Blood and lymph; Immune system; Heart and blood vessels; Digestive system; Infections

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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated5500
Phase 12200
Phase 217637
Phase 35130
All trials29

Who has held its approvals

CompanyRoleYears
GSKOriginator and Lead sponsor of trials1999 to now
SandozAcquired holder2023 to now