Drug

Rotigotine

As of the edition of 20 October 2026, Rotigotine is a small molecule: marketed, first approved in 2006 (EU); acts on DRD2, DRD3 and DRD4.

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

The drug

Status
Marketed; latest approval 2014
Kind
Small molecule
Brand name
Neupro
First approved
15 February 2006 (EU)
Approvals on record
9 in 4 regions
Holder of the most recent approval
UCB; 4 holders in all
Registered trials
79, 7 stopped early
Disease areas
Nervous system; Mental health; Bones, joints and muscles; Chemically induced; Heart and blood vessels; Nutrition and metabolism

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

5 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

5 company-target rows are on route B because of Rotigotine.

Targets

GeneProteinUniProt
DRD2Dopamine receptor D2P14416
DRD4Dopamine receptor D4P21917
DRD3Dopamine receptor D3P35462

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated6310
Phase 1141301
Phase 2171501
Phase 3322614
Phase 410901
All trials79

Who has held its approvals

CompanyRoleYears
UCBApplicant and Lead sponsor of trials2002 to now
OtsukaApplicant and Lead sponsor of trials2005 to now