Drugs / Zilebesiran
Zilebesiran
Trials 6
| 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 · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT06272487 | Feb 2024 → Jun 2025 | hypertensive disorder | Alnylam Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT05103332 | Nov 2021 → Dec 2023 | essential hypertension | Alnylam Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT04936035 | Jul 2021 → Apr 2023 | hypertensive disorder | Alnylam Pharmaceuticals | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07181109 | Sep 2025 → Sep 2030 expected | atherosclerotic cardiovascular disease, hypertensive disorder | Alnylam Pharmaceuticals | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07553442 Background | Apr 2026 → Apr 2028 expected | hypertensive disorder | Alnylam Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-08-30 | Alnylam Pharmaceuticals | Results Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings alnylam.com ↗
New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control |
| 2026-08-30 | Alnylam Pharmaceuticals | Results Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings alnylam.com ↗
New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control |
| 2026-03-30 | Alnylam Pharmaceuticals | Results New Data Presented at ACC.26 Further Support Benefits of Vutrisiran in ATTR-CM and Potential of Zilebesiran for Hypertension Management alnylam.com ↗
Pooled Phase 2 Safety Data Reinforce Encouraging Safety Profile for Zilebesiran Across a Broad Population of Patients with Hypertension |
| 2026-03-30 | Alnylam Pharmaceuticals | Results New Data Presented at ACC.26 Further Support Benefits of Vutrisiran in ATTR-CM and Potential of Zilebesiran for Hypertension Management alnylam.com ↗
Pooled Phase 2 Safety Data Reinforce Encouraging Safety Profile for Zilebesiran Across a Broad Population of Patients with Hypertension |
| 2024-04-07 | Alnylam Pharmaceuticals | Results 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 ↗ |
| 2024-03-05 | Hoffmann-La Roche | Results 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 ↗
People with mild to moderate hypertension treated with zilebesiran added to a standard of care hypertension medication experienced a clinically and statistically significant reduction in systolic blood pressure at month three. |
| 2024-03-05 | Alnylam Pharmaceuticals | Results 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 ↗
Zilebesiran demonstrated an encouraging safety and tolerability profile when added to these standard of care antihypertensives. |
| 2023-11-11 | Alnylam Pharmaceuticals | Results 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 | Hoffmann-La Roche | Results Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease roche.com ↗
Zilebesiran demonstrated a clinically significant reduction in 24-hour mean systolic blood pressure (SBP) at month three, achieving a placebo-subtracted reduction greater than 15 mmHg with both 300 and 600 mg doses (p < 0.0001). |
| 2023-09-07 | Alnylam Pharmaceuticals | Results 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 ↗
The study results indicate zilebesiran was associated with dose-dependent, potent and durable knockdown of serum AGT levels through Month 6. |
| 2023-07-19 | Alnylam Pharmaceuticals | Results Alnylam Announces Publication of Phase 1 Study Results for Zilebesiran in the New England Journal of Medicine alnylam.com ↗
Zilebesiran also demonstrated an acceptable safety profile supporting continued clinical development; the most frequent treatment-related adverse events were mild, transient injection-site reactions. |
| 2021-11-13 | Alnylam Pharmaceuticals | Results 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 ↗
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive interim results from the ongoing Phase 1 study of zilebesiran (formerly known as ALN-AGT), an investigational subcutaneous RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension. |
All press releases naming this drug 21 releases
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 ↗ |
| 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 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 ↗ |