Zilebesiran History and Updates

17 events · 2021 – present

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

0
FDA Approvals
0
Label Revisions
17
Trial Milestones
0
Pivotal Publications
Zilebesiran — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2022202320242025202620272028202920302031Trial: NCT07553442 2026-04-27 → 2028-04-01 (primary completion)Trial: NCT07181109 2025-09-22 → 2030-09-30 (primary completion)Trial: NCT06423352 2024-06-05 → 2025-07-17 (primary completion)Trial: NCT06272487 2024-02-29 → 2025-06-19 (primary completion)Trial: NCT05103332 2021-11-05 → 2023-12-11 (primary completion)Results posted — 2025-07-09 Trial results posted: NCT05103332 Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARResults posted — 2026-04-30 Trial results posted: NCT06423352 A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertensiontoday (2026-05-15)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-15Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Zilebesiran since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (2)

2026
2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07553442
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07181109
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Card

Past events

2026
Results posted· ClinicalTrials.gov
Trial results posted: NCT06423352
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07553442
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07181109
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Card
Results posted· ClinicalTrials.gov
Trial results posted: NCT05103332
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KAR
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT06272487
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antih
2024
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06272487
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antih
2023
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05103332
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KAR
2021
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05103332
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KAR

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.