Olpasiran History and Updates

27 events · 2020 – present

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

0
FDA Approvals
0
Label Revisions
27
Trial Milestones
0
Pivotal Publications
Olpasiran — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2020202120222023202420252026202720282029203020312032Trial: NCT07293260 2026-03-23 → 2028-06-15 (primary completion)Trial: NCT07136012 2025-08-22 → 2031-10-20 (primary completion)Trial: NCT06411860 2024-09-12 → 2024-11-29 (primary completion)Trial: NCT05581303 2022-12-14 → 2028-03-31 (primary completion)Trial: NCT05481411 2022-09-13 → 2023-04-05 (primary completion)Trial: NCT05489614 2022-09-13 → 2023-10-24 (primary completion)Trial: NCT04987320 2021-07-28 → 2021-11-12 (primary completion)Trial: NCT04270760 2020-07-28 → 2021-12-27 (primary completion)Results posted — 2023-08-23 Trial results posted: NCT04270760 Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding StudyResults posted — 2025-02-10 Trial results posted: NCT04987320 A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serumtoday (2026-06-08)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-08Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Olpasiran since 2020, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07293260
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07136012
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events

Past events

2026
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07293260
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07136012
OCEAN(a)-PreEvent - Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction to Prevent First Major Cardiovascular Events
Results posted· ClinicalTrials.gov
Trial results posted: NCT04987320
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum
2024
2023
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05489614
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participa
Results posted· ClinicalTrials.gov
Trial results posted: NCT04270760
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05481411
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairme
2022
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05581303
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05481411
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairme
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05489614
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Normal Renal Function and Participa
2021
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04987320
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04987320
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Participants With Elevated Serum
2020
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04270760
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

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.