Cerevance reports positive Phase 3 ARISE results for oral solengepras in Parkinson’s

Cerevance on 8 October 2026 reported topline positive Phase 3 ARISE results for once-daily oral solengepras as adjunctive therapy in Parkinson’s disease with motor fluctuations on levodopa or other medicines. The drug targets GPR6 in the striatal indirect pathway and has no direct dopamine-receptor effect. Results were presented at MDS 2026 in Seoul.

Key efficacy

• 341 participants randomised 1:1:1 to 75 mg (n=114), 150 mg (n=113) or placebo (n=114) for 12 weeks; baseline average 5.65 hours daily OFF; 311/341 (91%) completed.
• Primary: 150 mg reduced daily OFF by 0.61 hours versus placebo at Week 12 (p=0.0350; −1.56 h from baseline vs −0.95 h placebo). Benefit from Week 2.
• Secondary: ON without troublesome dyskinesia +0.60 h (p=0.0468); MDS-UPDRS Part II placebo-adjusted −1.91 (p=0.0008).
• Other: Epworth Sleepiness −0.98 vs placebo (nominal p=0.009); PDQ-39 exploratory −2.87 (nominal p=0.012).

Safety and limitations

• AE discontinuation 3.5% in all arms; no SAE with 150 mg; dyskinesia 4.4% vs 1.8% placebo; headache/UTI 8.0%; insomnia/nausea 6.2%.
• These are company topline results from one Phase 3, 12 weeks, adjunctive only; some endpoints are nominal; the drug is not yet approved. Cerevance plans FDA discussion for a potential NDA.
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