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cP12

Phase 2

Thermal Burns | Small molecule | Other |United Therapeutics Corporation|Last Updated: Feb 18, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06814717A Safety, Tolerability and Pharmacokinetic Study of cP12 in Adults With Up To 10% Total Body Surface Area BurnsPHASE2 RECRUITING 6May 12, 2025Nov 1, 2026Feb 18, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events from dosing through follow-up
Day 1, Day 3 and Day 14

Clinical safety labs will be collected

Secondary Endpoints
Investigate pharmacokinetic profile
Predose, 2,5,15,30,60,120 and 240 minutes post dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Open-labelEXPERIMENTALSix adult male or female subjects will receive a single administration of 0.01mg/kg of cP12.
Interventions
NameTypeDescription
cP12DRUGcP12 is a novel fibronectin derived, 14-mer peptide
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * BMI between 18 kg/m2 (inclusive) and body weight \>/=50kg * TBSA thermal burns up to and including 10%. The selected burn must be superficial (epidermal), superficial partial-thickness, or deep partial-thickness * Able to be infused with cP12 within 2 to 24 hours post burn * A...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06814717studyFirstPostDate: changed