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FTC-146

Phase 1

Chronic Pain | Small molecule | Neurology |GE HealthCare Technologies Inc.|Last Updated: Jun 6, 2025

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
UNCONTROLLED
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04435821PET/MRI in the Diagnosis of Pediatric Chronic PainPHASE1 COMPLETED 5Nov 19, 2020Oct 31, 2024Jun 6, 20251 United States
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Study Endpoints
Primary Endpoints
[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients
3 hours

Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
Pediatric Chronic Pain PatientsEXPERIMENTALIndividuals 11-18 years old, with chronic pain (lasting at least 2 months).
Interventions
NameTypeDescription
[18F]FTC-146DRUGParticipants will be injected with 0.08 mCi/kg \[18F\]FTC-146. A whole-body PET/MRI scan will be performed after injection.
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Eligibility Criteria
Age Range11 Years — 18 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 11-18 years old. * Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months. * Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of screening). * Covid Vaccination status: Vaccinated or unvaccinated subjects who received a ne...

Countries:United States
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