A Phase 2 trial of rotigotine for ADPKD (NCT06291116) has been registered on ClinicalTrials.gov with an estimated start date of March 2026. Rotigotine is a dopamine agonist currently approved for Parkinson's disease and restless legs syndrome, delivered via transdermal patch.
The rationale for testing rotigotine in PKD is based on the discovery that dopamine receptors (particularly D1 and D5) are expressed in kidney tubular cells. Activation of these receptors reduces cyclic AMP (cAMP) levels — the same signaling pathway targeted by tolvaptan. Since elevated cAMP is a key driver of cyst growth and fluid secretion in ADPKD, dopamine agonists represent a potentially complementary approach.
The transdermal patch delivery system offers convenience advantages over tolvaptan's oral dosing and associated water balance challenges. However, dopamine agonists carry their own side effect profile including potential nausea, dizziness, and impulse control issues.
This trial represents yet another novel mechanism entering the PKD pipeline, further diversifying the range of approaches being explored. The trial is currently listed as not yet recruiting, and limited details about trial design, endpoints, and enrollment targets are available.