Zilebesiran is an investigational, subcutaneously administered RNAi therapeutic being developed for hypertension with infrequent dosing. It targets hepatic angiotensinogen to modulate the RAAS pathway and has progressed through Phase 2 KARDIA studies into the global Phase 3 ZENITH cardiovascular outcomes trial. Its safety and efficacy have not yet been established by regulatory authorities.
Alnylam Pharmaceuticals entered a $1.23 billion discovery collaboration with Tenaya Therapeutics to identify up to 15 novel genetic targets for heart disease. The agreement includes $10 million upfront and up to $1.13 billion in milestone payments.
The cardiovascular biologics market is projected to reach $4.23 billion by 2033, while the cell therapy market is expected to reach $5.38 billion by 2032, driven by RNA-based therapies and regulatory approvals.
A review in The Lancet highlights emerging long-acting injectable therapies for hypertension that could reduce treatment to two doses annually instead of daily pills, with several candidates now in late-stage clinical trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07553442 |
A Study to Evaluate ALN-AGT01 RVR in Adult Patients With Mild to Moderate Hypertension Pretreated With Zilebesiran |
RECRUITING | PHASE2 |
| NCT07181109 |
Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease |
RECRUITING | PHASE3 |
| NCT06423352 |
A Study to Evaluate Zilebesiran in Japanese Patients With Mild to Moderate Hypertension |
COMPLETED | PHASE1/PHASE2 |
| NCT06272487 |
Zilebesiran as Add-on Therapy in Patients With High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications (KARDIA-3) |
COMPLETED | PHASE2 |
| NCT05103332 |
Zilebesiran as Add-on Therapy in Patients With Hypertension Not Adequately Controlled by a Standard of Care Antihypertensive Medication (KARDIA-2) |
COMPLETED | PHASE2 |
