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Suvecaltamide

Phase 2

Parkinson Disease | Small molecule | Neurology |Jazz Pharmaceuticals plc|Last Updated: Jan 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment169
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05642442A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's DiseasePHASE2 COMPLETED 169Dec 1, 2022Nov 11, 2024Jan 15, 202637 United States, Germany +2
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score
Baseline to Week 17

The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.

Secondary Endpoints
Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)
Baseline to Week 17
Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)
Baseline to Week 17
Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)
Baseline to Week 17
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORParticipants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.
SulvecaltamideEXPERIMENTALParticipants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.
Interventions
NameTypeDescription
PlaceboDRUGMatching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day.
SuvecaltamideDRUGSuvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day.
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Eligibility Criteria
Age Range40 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites37

KEY Inclusion Criteria: * Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria. * Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rig...

Countries:United StatesGermanyPolandSpain
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