Pelacarsen History and Updates

32 events · 2018 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
32
Trial Milestones
0
Pivotal Publications
Pelacarsen — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2019202020212022202320242025202620272028202920302031Trial: NCT07625306 2026-08-31 → 2028-12-07 (primary completion)Trial: NCT07517263 2026-05-11 → 2030-01-09 (primary completion)Trial: NCT06875973 2025-05-19 → 2030-12-08 (primary completion)Trial: NCT06813911 2025-04-30 → 2028-02-03 (primary completion)Trial: NCT05646381 2024-03-07 → 2030-03-12 (primary completion)Trial: NCT05900141 2023-09-29 → 2028-08-24 (primary completion)Trial: NCT05305664 2022-08-19 → 2025-01-28 (primary completion)Trial: NCT05026996 2021-11-23 → 2022-10-19 (primary completion)Trial: NCT04993664 2021-10-01 → 2022-06-30 (primary completion)Trial: NCT05337878 2018-10-15 → 2019-12-18 (primary completion)Results posted — 2026-07-17 Trial results posted: NCT05305664 A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sestoday (2026-08-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-08-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Pelacarsen since 2018, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2026
2025

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07625306
Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06813911
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07625306
Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07517263
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05646381
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Ste

Past events

2026
Results posted· ClinicalTrials.gov
Trial results posted: NCT05305664
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Ses
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07517263
An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06813911
Lp(a) Lowering Study of Pelacarsen (TQJ230) With Background Inclisiran in Participants With Elevated Lp(a) and Established ASCVD
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05305664
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Ses
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05646381
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Ste
2023
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05900141
An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
2022
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05026996
Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Partici
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05305664
A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Ses
Primary completion· ClinicalTrials.gov
NA primary completion: NCT04993664
Influence of Pelacarsen on Patients After Myocardial Infarction With High Lp(a) Values (PEMILA)
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05026996
Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Partici
Trial started· ClinicalTrials.gov
NA trial started: NCT04993664
Influence of Pelacarsen on Patients After Myocardial Infarction With High Lp(a) Values (PEMILA)
2019
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05337878
A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants
2018
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05337878
A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.