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RAP-219

Phase 3

Focal Seizure | Small molecule | Neurology |Rapport Therapeutics, Inc.|Last Updated: Sep 2, 2026

Target and mechanism

Molecular targetRAP
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment645

FDA Designations

No designations recorded

Clinical trial landscape

RAP-219 · 5 trials · 8 indications

Phase 3 2Phase 2 3
NCT07594119Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal SeizuresFocal Seizure
RECRUITING312 Analytics
NCT07563881Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1Focal Seizure
RECRUITING333 Analytics
PHASE3RECRUITING
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal SeizureUnlock trial analytics
PHASE3RECRUITING
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal SeizureUnlock trial analytics

Study Endpoints

Primary Endpoints

Median Percent Change in Seizure Frequency
End of double-blind treatment period (end of week 14) vs Baseline

Median percent change in seizure frequency and ≥ 50% seizure frequency reduction responder rates

Incidence of treatment-emergent adverse events (TEAEs)
From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112
Young Mania Rating Scale (YMRS)
Baseline to End of Treatment at Week 3

The YMRS is a clinician administered scale that consists of 11 items used to assess the severity of manic symptoms (total scores range from 0 to 60). The higher the YMRS score, the more severe the subject's symptoms of mania.

Change in long episode frequency during the treatment period compared to pre-treatment baseline: Responder proportion, Percent Change Percent change
Screening until 5 months after enrollment

Change in long episode frequency per 28-day period during the treatment period compared to baseline

Secondary Endpoints

≥50% seizure frequency reduction responder rates
End of double-blind treatment period (end of week 14) vs Baseline.
Longest Seizure Free Interval
Across the entire 14-week double-blind treatment period
Percent change in clinical seizure frequency
Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active Arm- Medium DoseEXPERIMENTALRAP-219 daily tablets administered orally
Active Arm-Low DoseEXPERIMENTALRAP-219 daily tablets administered orally
PlaceboPLACEBO_COMPARATORInert comparator matching the active treatment
Active Arm- High DoseEXPERIMENTALRAP-219 daily tablets administered orally
RAP-219EXPERIMENTAL -
Active ArmEXPERIMENTALTreatment with RAP-219

Interventions

NameTypeDescription
RAP-219DRUGRAP-219 medium dose tablets administered orally daily
PlaceboOTHERMatching placebo tablets administered orally
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Age 18 - 75 2. BMI 18-45 kg/m2 3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1 4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis 5. Concomitant use of betwee...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 2, 2026NCT07594119startDate: changed
LOWSep 2, 2026NCT07594119startDate: changed
LOWSep 2, 2026NCT07594119startDate: changed
LOWSep 1, 2026NCT07563881lastUpdatePostDate: changed
LOWSep 1, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 14, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 14, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 14, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 12, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 12, 2026NCT07563881lastUpdatePostDate: changed
MEDIUMAug 11, 2026NCT07046494Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 11, 2026NCT07046494Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMAug 11, 2026NCT07046494Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWAug 5, 2026NCT07594119startDate: changed
LOWAug 5, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 4, 2026NCT07563881lastUpdatePostDate: changed
LOWAug 4, 2026NCT07563881lastUpdatePostDate: changed
LOWJul 31, 2026NCT07563881lastUpdatePostDate: changed
LOWJul 31, 2026NCT07563881lastUpdatePostDate: changed
LOWJul 24, 2026NCT07563881lastUpdatePostDate: changed

Frequently asked questions about RAP-219

What is RAP-219 used for?

RAP-219 is an investigational small molecule being developed for focal seizures, focal epilepsy, refractory focal epilepsy, and bipolar 1 disorder. It is currently in Phase 2 and Phase 3 clinical trials for focal onset seizures in adults.

What does RAP-219 target?

RAP-219 targets the RAP receptor. It is a small molecule being studied for its potential to treat focal seizures and related epilepsy conditions.

Who makes RAP-219?

RAP-219 is being developed by Rapport Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol RAPP.

What phase is RAP-219 in?

RAP-219 is in Phase 2 and Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing for focal onset seizures.

What clinical trials is RAP-219 in?

RAP-219 is being studied in several clinical trials. NCT06377930 is a completed Phase 2 study in refractory focal epilepsy. NCT07219407 is a recruiting long-term Phase 2 study. NCT07563881 and NCT07594119 are recruiting Phase 3 studies in focal seizures.

Is RAP-219 the same as RAP-219?

RAP-219 is the drug name used in clinical trials. No other names for this drug have been mentioned in the trial records.