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PCS499

Phase 2

Necrobiosis Lipoidica | Small molecule | Other |Processa Pharmaceuticals, Inc.|Last Updated: Oct 3, 2022

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03698864A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis LipoidicaPHASE2 COMPLETED 12Nov 7, 2018Feb 25, 2020Oct 3, 20222 United States
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Study Endpoints
Primary Endpoints
Evaluation of Patients With Adverse Events
12 months

Evaluation of Adverse Events/Serious Adverse Events (by type, severity, and relatedness)

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PCS499 900mg twice a dayEXPERIMENTAL -
Interventions
NameTypeDescription
PCS499DRUGPCS499 900mg twice a day with food
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male or female patients age 18 to 80 years of age, inclusive, at Screening. 2. Biopsy-confirmed diagnosis of NL. Biopsies of continually active lesions performed outside of this clinical study will need to be reviewed and the diagnosis confirmed by the study pathologist. For ...

Countries:United States
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