drugset

Drugs / Zilebesiran

Follow last change Apr 2026 re-read 2 minutes ago

Zilebesiran

also known as ALN-AGT01 · AD-85481 · ALN-85481

Developed for: hypertensive disorder · atherosclerotic cardiovascular disease · essential hypertension
Investigated by: Alnylam Pharmaceuticals · Hoffmann-La Roche

Trials 6 · a red edge is where a trial was stopped

today NCT07181109 · Ph 3 NCT06423352 · Ph 1/2 NCT06272487 · Ph 2 NCT05103332 · Ph 2 NCT04936035 · Ph 2 NCT03934307 · Ph 1

2019202020212022202320242025202620272028202920302031

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 11 trial
Phase 1	NCT03934307	May 2019 → Apr 2022	hypertensive disorder	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT06423352	Jun 2024 → Jul 2025	hypertensive disorder	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 23 trials
Phase 2	NCT06272487	Feb 2024 → Jun 2025	hypertensive disorder	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT05103332	Nov 2021 → Dec 2023	essential hypertension	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT04936035	Jul 2021 → Apr 2023	hypertensive disorder	Alnylam Pharmaceuticals	Completed	No outcome recorded
Phase 31 trial
Phase 3	NCT07181109	Sep 2025 → Sep 2030 expected	atherosclerotic cardiovascular disease, hypertensive disorder	Alnylam Pharmaceuticals	Recruiting	No outcome recorded

Also used as a comparator or background therapy in 1 trial

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2	NCT07553442 Background	Apr 2026 → Apr 2028 expected	hypertensive disorder	Alnylam Pharmaceuticals	Recruiting	No outcome recorded

Press releases naming this drug 15 releases

Date	Issuer	Release
2026-03-30	Alnylam Pharmaceuticals	New Data Presented at ACC.26 Further Support Benefits of Vutrisiran in ATTR-CM and Potential of Zilebesiran for Hypertension Management alnylam.com ↗
2025-10-01	Alnylam Pharmaceuticals	Alnylam Announces First Patient Dosed in ZENITH Global Phase 3 Cardiovascular Outcomes Trial of Zilebesiran alnylam.com ↗
2025-08-30	Roche Global Development	Roche and Alnylam advance zilebesiran into global phase III cardiovascular outcomes trial for people with uncontrolled hypertension roche.com ↗
2025-08-30	Alnylam Pharmaceuticals	Alnylam to Advance Zilebesiran into Global Phase 3 Cardiovascular Outcomes Trial alnylam.com ↗
2024-04-07	Alnylam Pharmaceuticals	Alnylam Presents Positive Results from the KARDIA-2 Phase 2 Study of Zilebesiran Added to Standard of Care Antihypertensives in Patients with Inadequately Controlled Hypertension alnylam.com ↗
2024-03-20	Alnylam Pharmaceuticals	Alnylam to Webcast Investor Event to Discuss Results from KARDIA-2 Phase 2 Study of Zilebesiran at American College of Cardiology Scientific Session alnylam.com ↗
2024-03-05	Roche Global Development	Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care roche.com ↗
2024-03-05	Alnylam Pharmaceuticals	Alnylam Reports Positive KARDIA-2 Topline Study Results Demonstrating Clinically Significant Blood Pressure Reductions When Zilebesiran is Added to Standard of Care Antihypertensives alnylam.com ↗
2023-11-11	Alnylam Pharmaceuticals	Alnylam Presents Positive Results from the KARDIA-1 Phase 2 Dose-Ranging Study of Zilebesiran, an Investigational RNAi Therapeutic in Development for the Treatment of Hypertension in Patients at High Cardiovascular Risk alnylam.com ↗
2023-09-07	Alnylam Pharmaceuticals	Alnylam Reports Positive Topline Results from KARDIA-1 Phase 2 Dose-Ranging Study of Zilebesiran, an Investigational RNAi Therapeutic in Development to Treat Hypertension in Patients at High Cardiovascular Risk alnylam.com ↗
2023-07-24	Alnylam Pharmaceuticals	Alnylam Announces Partnership with Roche to Co-Develop and Co-Commercialize Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension in Patients with High Cardiovascular Risk alnylam.com ↗
2023-07-19	Alnylam Pharmaceuticals	Alnylam Announces Publication of Phase 1 Study Results for Zilebesiran in the New England Journal of Medicine alnylam.com ↗
2021-11-13	Alnylam Pharmaceuticals	Alnylam Presents New Data for Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension, at the American Heart Association Scientific Sessions 2021 alnylam.com ↗
2021-11-08	Alnylam Pharmaceuticals	Alnylam Initiates KARDIA-2 Phase 2 Study of Investigational Zilebesiran (ALN-AGT) in Patients with Inadequately Controlled Hypertension alnylam.com ↗
2021-06-30	Alnylam Pharmaceuticals	Alnylam Initiates KARDIA-1 Phase 2 Study of Zilebesiran (ALN-AGT) in Patients with Mild-to-Moderate Hypertension alnylam.com ↗

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

Field	Value	Cited text
Known as	Zilebesiran	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07553442 ↗ 4 NCT07181109 ↗ NCT06272487 ↗ NCT05103332 ↗ NCT06423352 ↗
Known as	AD-85481	ChEMBL registry synonym — accepted as the source's own label CHEMBL5095298 ↗
Known as	ALN-85481	ChEMBL registry synonym — accepted as the source's own label CHEMBL5095298 ↗
Known as	ALN-AGT01	ClinicalTrials.gov intervention name — accepted as the source's own label NCT04936035 ↗ 1 NCT03934307 ↗
Action	Inhibit	“inhibits hepatic angiotensinogen synthesis” PMID 37467498 ↗ Jul 2023
Modality	Small interfering RNA (siRNA)	“Zilebesiran, an investigational RNA interference therapeutic agent with a prolonged duration of action, inhibits hepatic angiotensinogen synthesis.” PMID 37467498 ↗ Jul 2023
Route	Subcutaneous	“ALN-AGT01 will be administered by subcutaneous (SC) injection.” NCT03934307 ↗