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Pelacarsen

Phase 3

Hyperlipoproteinemia (a) | Small molecule | Other |Novartis AG|Last Updated: Aug 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05900141An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)PHASE3 ACTIVE NOT_RECRUITING 41 — — Sep 29, 2023Aug 24, 2028Aug 6, 20259 Germany
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Study Endpoints
Primary Endpoints
Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
60 months

Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study

Duration of drug exposure
60 months

Duration of drug exposure will be collected

Secondary Endpoints
Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
60 months
Absolute change in Lp(a) compared to baseline of the parent study.
month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
Percentage change in Lp(a) compared to baseline of the parent study.
month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pelacarsen (TQJ230)EXPERIMENTALopen-label pelacarsen 80 mg
Interventions
NameTypeDescription
PelacarsenDRUGPelacarsen 80mg s.c. monthly
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Signed informed consent * Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement. Exclusion Criteria: * Any medical condition(s) that may put the participant at risk in the investigator's opinion * P...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05900141primaryCompletionDate: changed
LOWMay 24, 2026NCT05900141studyFirstPostDate: changed