ARISE · Phase 3 topline results

Improving how people with Parkinson's feel and function every day

In ARISE, once-daily oral solengepras was evaluated across everyday function, daytime alertness, and quality of life — the measures that reflect how people with Parkinson’s experience their day.

See the results How the study worked

experiences of daily living

1.91

points vs placebo

MDS-UPDRS Part II, solengepras 150 mg at Week 12. p=0.0008.

Functional and non-motor outcomeS

Meaningful impact across daily life, as reported by patients

Solengepras 150 mg

Placebo

Everyday motor tasks

MDS-UPDRS Part II

Secondary · significant

1.91

points better than placebo · p=0.0008

2.05

0.14

How much Parkinson’s gets in the way of speaking, eating, dressing, hygiene, handwriting, hobbies, turning in bed, getting up, and walking.

Daytime alertness

Epworth Sleepiness Scale

Secondary · nominal

0.98

points less sleepy than placebo · nominal p=0.009

1.39

0.41

How likely someone is to doze off in everyday situations, such as reading, watching TV, in conversation. Sleepiness is a common burden of Parkinson’s and of some dopaminergic treatments.

Quality of life

PDQ-39

Exploratory · nominal

2.87

points better than placebo · nominal p=0.012

3.73

0.86

Impact of Parkinson’s on mobility, emotional well-being, communication, and relationships.

Primary and key secondary endpoints

OFF time became good ON time

Participants entered ARISE with an average of 5.65 hours of daily OFF despite levodopa treatment; all were receiving levodopa, and nearly half were also on adjunctive therapies, including MAO-B and COMT inhibitors. With solengepras 150 mg, the hours taken out of OFF time came back almost one-for-one as ON time without troublesome dyskinesia — time when medication is working and movement isn’t disrupted by bothersome involuntary movements.

The reduction in OFF time was seen as early as Week 2, the first visit (0.75 h vs placebo; nominal p=0.0022), and at every visit through Week 12.

reduction in Daily OFF time · primary

−0.61 h

vs placebo at Week 12

p=0.0350 · 1.56 h vs 0.95 h from baseline

INCREASE IN Good ON time · key secondary

+0.60 h

vs placebo at Week 12

p=0.0468 · 1.58 h vs 0.98 h from baseline

Safety and tolerability

Generally well tolerated over 12 weeks

Most adverse events were mild or moderate. Solengepras does not act directly on dopamine receptors; the limited number of typical dopaminergic adverse events may be consistent with that mechanism.

discontinued, vs 10% with placebo

serious adverse events, vs 0.9% with placebo

4.4%

reported dyskinesia, vs 1.8% with placebo

Low incidence of treatment emergent adverse events

Event

Solengepras 150 mg

Placebo

Headache

9 (8.0%)

4 (3.5%)

Urinary tract infection

9 (8.0%)

7 (6.1%)

Insomnia

7 (6.2%)

1 (0.9%)

Nausea

7 (6.2%)

2 (1.8%)

Study design

About ARISE

Global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of solengepras as an add-on to levodopa and other Parkinson’s medications, in adults with motor fluctuations averaging at least 3 hours of OFF time a day.

341

participants randomized 1:1:1

12 weeks

once-daily oral dosing with no dose titration

91%

completed the trial (311 of 341)

A different mechanism

Non-dopaminergic, by design

Solengepras is a potential first-in-class inhibitor of GPR6, a receptor found on the cells of the striatal indirect pathway. Rather than replacing or mimicking dopamine, it aims to help rebalance the brain’s movement circuits — with the potential to address both motor and non-motor symptoms.

ClinicalTrials.gov: NCT06553027

Solengepras is an investigational therapy. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.

Current

October 7, 2026

Cerevance Announces Positive Phase 3 ARISE Results: Once-daily Oral Solengepras Meets Primary Endpoint and Demonstrates Motor and Non-motor Benefits in Parkinson's Disease

Solengepras 150 mg achieved a statistically significant reduction in daily OFF time, with benefit seen at Week 2
Statistically significant improvements in secondary endpoints of ON time without troublesome dyskinesia and motor experiences of daily living (MDS-UPDRS Part II)
Improvements in daytime sleepiness (Epworth Sleepiness Scale) and quality of life (PDQ-39, exploratory) point to broad motor and non-motor benefit
Generally well tolerated, with fewer adverse events than those typically associated with dopaminergic adjunctive therapies, and a discontinuation rate similar to placebo
Cerevance to meet with FDA to discuss the path to a potential New Drug Application