Drugs / ZIFCASIRAN
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | clear cell papillary renal cell carcinoma | 2019-12-11 | “submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1b adaptive dose-finding clinical study of ARO-HIF2” arrowheadpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04169711 | Aug 2020 → Jan 2022 | clear cell renal carcinoma | Arrowhead Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-02-17 | Arrowhead Pharmaceuticals | Results Arrowhead Presents New Clinical Data on ARO-HIF2 at ASCO GU 2022 arrowheadpharma.com ↗
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced positive interim results from AROHIF21001, a Phase 1b dose-finding clinical study of ARO-HIF2, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with clear cell renal cell carcinoma (ccRCC). |
| 2021-07-06 | Arrowhead Pharmaceuticals | Results Arrowhead Announces Positive Interim Results from Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma arrowheadpharma.com ↗
In addition, one patient achieved a partial response with tumor shrinkage of approximately 65% and four additional patients in cohort 2 remain on study drug with stable disease. |
| 2019-12-11 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Files IND for Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma arrowheadpharma.com ↗ |
| 2018-10-16 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals Hosts R&D Day on Pipeline of RNAi Therapeutics arrowheadpharma.com ↗
ARO-HIF2 has demonstrated effective tumor delivery and deep HIF2α mRNA knockdown in tumors. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-02-17 | Arrowhead Pharmaceuticals | Arrowhead Presents New Clinical Data on ARO-HIF2 at ASCO GU 2022 arrowheadpharma.com ↗ |
| 2021-07-06 | Arrowhead Pharmaceuticals | Arrowhead Announces Positive Interim Results from Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma arrowheadpharma.com ↗ |
| 2020-08-18 | Arrowhead Pharmaceuticals | Arrowhead Pharmaceuticals Initiates Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma arrowheadpharma.com ↗ |
| 2019-12-11 | Arrowhead Pharmaceuticals | Arrowhead Pharmaceuticals Files IND for Phase 1b Study of ARO-HIF2 for Treatment of Clear Cell Renal Cell Carcinoma arrowheadpharma.com ↗ |
| 2018-10-16 | Arrowhead Pharmaceuticals | Arrowhead Pharmaceuticals Hosts R&D Day on Pipeline of RNAi Therapeutics arrowheadpharma.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZIFCASIRAN | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095465 ↗ |
| Known as | ADS-007 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095465 ↗ |
| Known as | ARO-HIF2 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04169711 ↗ |
| Route | Intravenous | “Multiple doses of ARO-HIF2 by intravenous infusion” NCT04169711 ↗ |