Drugs / zodasiran
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05217667 | Apr 2022 → May 2023 | homozygous familial hypercholesterolemia | Arrowhead Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04832971 | Jun 2021 → Aug 2022 | hyperlipidemia, combined, 2 | Arrowhead Pharmaceuticals | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT07473843 | Aug 2026 → Jul 2028 expected | homozygous familial hypercholesterolemia | Arrowhead Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07037771 | Jun 2025 → Aug 2027 expected | homozygous familial hypercholesterolemia | Arrowhead Pharmaceuticals | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-05-29 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents New Phase 2 Data of Zodasiran in Patients with Mixed Hyperlipidemia arrowheadpharma.com ↗
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced results from the Phase 2b double blind, randomized ARCHES-2 study of investigational zodasiran (formerly ARO-ANG3) in patients with mixed hyperlipidemia. |
| 2024-01-29 | Visirna Therapeutics HK Limited | Regulatory Visirna Announces Breakthrough Therapy Designation Granted for VSA003 for Treatment of Patients with Homozygous Familial Hypercholesterolemia (HoFH) visirna.com ↗
Visirna announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for VSA003 for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH). |
| 2023-11-13 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Phase 2 Data on Plozasiran and Zodasiran at AHA 2023 arrowheadpharma.com ↗ |
| 2023-05-23 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Interim Data from ARO-ANG3 Phase 2 GATEWAY Study in Patients with HoFH arrowheadpharma.com ↗
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented interim data from the ongoing Phase 2 GATEWAY clinical study of ARO-ANG3, the company’s investigational RNAi therapeutic designed to reduce expression of angiopoietin-like protein 3 (ANGPTL3), in patients with homozygous familial hypercholesterolemia (HoFH). |
| 2022-11-07 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Phase 2 Data at AHA 2022 on Cardiometabolic Pipeline arrowheadpharma.com ↗
ARO-ANG3 decreased triglycerides by 59%, LDL-C by 32%, and was associated with a relative reduction in liver fat fraction in patients with mixed dyslipidemia |
| 2021-01-25 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Files IND for Phase 2b Study of ARO-ANG3 for Treatment of Mixed Dyslipidemia arrowheadpharma.com ↗
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 2b dose-finding clinical study of ARO-ANG3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with mixed dyslipidemia. |
| 2020-11-13 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Clinical Data on Cardiometabolic Pipeline at AHA 2020 arrowheadpharma.com ↗
ARO-ANG3 achieved triglyceride reductions of 29-75% and LCL-C reductions of 29-35% |
| 2020-08-31 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Positive New Phase 1/2 Clinical Data on Cardiometabolic Candidates ARO-APOC3 and ARO-ANG3 at European Society of Cardiology Congress 2020 arrowheadpharma.com ↗
These positive results from the healthy volunteer, repeat-dose portion of the Phase 1/2 clinical studies of our cardiometabolic candidates, ARO-APOC3 and ARO-ANG3, strongly support our plans to rapidly advance both drug candidates into later stage development. |
| 2020-02-05 | Arrowhead Pharmaceuticals | Results Arrowhead Reports Interim Clinical Data on Cardiometabolic Candidates ARO-APOC3 and ARO-ANG3 arrowheadpharma.com ↗
The interim results from the multiple-dose portion of the Phase 1 studies of Arrowhead’s cardiometabolic candidates ARO-APOC3 and ARO-ANG3 are highly encouraging and support our belief that RNAi may be the optimal mechanism to inhibit APOC3 and ANGPTL3. |
| 2019-11-18 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Clinical Data on Cardiometabolic Candidates ARO-APOC3 and ARO-ANG3 at AHA Scientific Sessions 2019 arrowheadpharma.com ↗
The data were presented in two late-breaking oral presentations at the American Heart Association (AHA) Scientific Sessions 2019, in Philadelphia. |
| 2019-09-16 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents Initial Top-Line Clinical Data and Preclinical Data on RNAi Candidates ARO-APOC3 and ARO-ANG3 arrowheadpharma.com ↗
These initial clinical data also indicate that ARO-APOC3 and ARO-ANG3 administration led to a long duration of effect that potentially enables once every three-month or once every six-month dosing intervals. |
| 2019-07-16 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-ANG3 arrowheadpharma.com ↗
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ARO-ANG3 for the treatment of homozygous familial hypercholesterolemia (HoFH). |
| 2018-10-15 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-ANG3 arrowheadpharma.com ↗
An application was submitted to an ethics committee in compliance with the Clinical Trial Notification process of the Australian Department of Health and Ageing, Therapeutic Goods Administration. |
| 2018-05-11 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Presents Preclinical Data on Expanding Cardiometabolic Pipeline arrowheadpharma.com ↗
The new preclinical data presented on ARO-APOC3 and ARO-ANG3 included the following:: |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zodasiran | “Zodasiran, an RNAi therapeutic targeting ANGPTL3, for treating patients with homozygous familial hypercholesterolaemia (GATEWAY): an open-label, randomised, phase 2 trial.” PMID 41422812 ↗ Dec 20253“Zodasiran is an RNA interference (RNAi) therapy targeting expression of ANGPTL3 in the liver.” PMID 38809174 ↗ May 2024 |
| Action | Inhibit | “substantial mean dose-dependent decreases from baseline in ANGPTL3 levels were observed with zodasiran” PMID 38809174 ↗ May 2024 |
| Modality | Small interfering RNA (siRNA) | “Zodasiran is an RNA interference (RNAi) therapy targeting expression of ANGPTL3 in the liver.” PMID 38809174 ↗ May 2024 |
| Route | Subcutaneous | “Eligible patients were randomly assigned in a 3:1 ratio to receive subcutaneous injections of zodasiran (50, 100, or 200 mg) or placebo on day 1 and week 12” PMID 38809174 ↗ May 2024 |
| Target | ANGPTL3 | “Zodasiran is an RNA interference (RNAi) therapy targeting expression of ANGPTL3 in the liver.” PMID 38809174 ↗ May 2024 |