Pelacarsen History and Updates

31 events · 2018 – present

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

0
FDA Approvals
0
Label Revisions
31
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)today (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download 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.

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
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.