Drugs / ARO-HSD
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | — | NAFLD1 | 2019-12-16 | “Completed regulatory submissions to begin Phase 1 studies of ARO-HSD for the treatment of alcohol and nonalcohol related liver disease” arrowheadpharma.com ↗ “today announced that it has filed an application for approval to begin a Phase 1 clinical trial of ARO-HSD” arrowheadpharma.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04202354 | Mar 2020 → Sep 2021 | metabolic dysfunction-associated steatohepatitis | Arrowhead Pharmaceuticals | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2021-11-12 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Additional Clinical Data on Investigational ARO-HSD Treatment at AASLD Liver Meeting arrowheadpharma.com ↗ |
| 2021-11-01 | Arrowhead Pharmaceuticals | Results Arrowhead Pharmaceuticals to Participate in Upcoming November 2021 Conferences arrowheadpharma.com ↗
Title: ARO-HSD, An Investigational RNAi Therapeutic, Demonstrates Reduction in ALT and Hepatic HSD17B13 mRNA and Protein in Patients with NASH or Suspected NASH |
| 2021-06-23 | Arrowhead Pharmaceuticals | Results Arrowhead Presents Positive Interim Clinical Data on ARO-HSD Treatment in Patients with Suspected NASH at EASL International Liver Congress arrowheadpharma.com ↗
The data demonstrate that ARO-HSD is the first investigational therapeutic to achieve robust reductions in messenger RNA (mRNA) and protein levels of hepatic HSD17B13, leading to reductions in alanine aminotransferase (ALT), a liver enzyme typically elevated in liver diseases including NASH. |
| 2019-12-16 | Arrowhead Pharmaceuticals | Regulatory Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1 Study of ARO-HSD for Treatment of Alcohol and Nonalcohol Related Liver Disease arrowheadpharma.com ↗ |
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARO-HSD | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04202354 ↗ |
| Action | Inhibit | “ARO-HSD is an RNA interference (RNAi) therapeutic designed to selectively reduce expression of HSD17β13 mRNA in hepatocytes.” PMID 36513186 ↗ Dec 2022 |
| Modality | Small interfering RNA (siRNA) | “ARO-HSD is a small-interfering RNA designed to silence HSD17β13 expression” PMID 36513186 ↗ Dec 2022 |
| Route | Subcutaneous | “by subcutaneous (sc) injections” NCT04202354 ↗ |
| Target | HSD17B13 | “selectively reduce expression of HSD17β13 mRNA in hepatocytes” PMID 36513186 ↗ Dec 2022 |