Drugs / ARCT-810
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | ornithine carbamoyltransferase deficiency | 2020-03-11 | “Filed IND for ARCT-810 with the U.S. Food and Drug Administration (FDA)” arcturusrx.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04442347 | Nov 2020 → Aug 2023 | ornithine carbamoyltransferase deficiency | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04416126 | Jun → Dec 2020 | ornithine carbamoyltransferase deficiency | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06488313 | Nov 2024 → Jun 2026 overdue | ornithine carbamoyltransferase deficiency | Arcturus Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05526066 | Oct 2022 → Oct 2024 | ornithine carbamoyltransferase deficiency | Arcturus Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-06-30 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Positive Interim Phase 2 Multiple Dose Data for Ornithine Transcarbamylase (OTC) Deficiency Program arcturusrx.com ↗
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announces positive Phase 2 interim results in people with OTC deficiency treated with ARCT-810, an mRNA therapeutic candidate designed to replace the OTC enzyme and restore urea cycle activity preventing hyperammonemia crises. |
| 2023-06-01 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for ARCT-810, mRNA Therapeutic Candidate for Ornithine Transcarbamylase Deficiency arcturusrx.com ↗ |
| 2022-08-09 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Second Quarter 2022 Financial Update and Pipeline Progress arcturusrx.com ↗ |
| 2021-07-28 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Announces Regulatory Approval to Proceed with Phase 2 Study of ARCT-810 mRNA Therapeutic Candidate for Ornithine Transcarbamylase (OTC) Deficiency arcturusrx.com ↗
announced today that the Company has received approval from the UK Health Research Authority to initiate a Phase 2 clinical study for ARCT-810, a novel mRNA-based therapeutic candidate for Ornithine Transcarbamylase (OTC) Deficiency. |
| 2020-11-09 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Third Quarter 2020 Financial Results and Positive Clinical Updates for ARCT-810 Phase I Study and Additional ARCT-021 Interim Data arcturusrx.com ↗
The initial ARCT-810 Phase 1/2 study results, showing good tolerability and favorable pharmacokinetics, provide support for the further development of this drug candidate in Ornithine Transcarbamylase (OTC) deficiency, a severe monogenic rare disease where new medicines are urgently needed. |
| 2020-10-05 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Completion of First Three Dose Escalation Cohorts in Phase 1 Study of ARCT-810, Therapeutic Candidate for Ornithine Transcarbamylase (OTC) Deficiency arcturusrx.com ↗
Based on the available preliminary study data, ARCT-810 has been well tolerated at these doses, which are all within the anticipated therapeutic range. |
| 2020-04-13 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Allowance of IND & Approval of Clinical Trial Application (CTA) for ARCT-810, a First-in-Class Investigational mRNA Medicine to Treat Ornithine Transcarbamylase Deficiency arcturusrx.com ↗ |
| 2020-03-11 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Reports Fourth Quarter and Year End 2019 Financial Results arcturusrx.com ↗
Today, we achieved one of our primary goals for 2020, by filing the Investigational New Drug (IND) application for ARCT-810, a potential treatment for ornithine transcarbamylase (OTC) deficiency. |
| 2019-08-15 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Announces Second Quarter Financial Results and Provides a Corporate Update arcturusrx.com ↗
Arcturus receives Orphan Drug Designation from the U.S. FDA for ARCT-810 |
| 2019-06-27 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Orphan Drug Designation from the U.S. FDA for ARCT-810, for Treatment of Ornithine Transcarbamylase (OTC) Deficiency arcturusrx.com ↗
today announced the U.S. Food and Drug Administration ( FDA ) has granted Orphan Drug Designation for the Company’s lead product candidate ARCT-810 to treat ornithine transcarbamylase deficiency (OTCD). |
| 2019-05-20 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Presenting Data for ARCT-810 and the Arcturus mRNA + LUNAR® Technology Platform at the 2019 Annual Meeting of TIDES: Oligonucleotide and Peptide Therapeutics arcturusrx.com ↗
Arcturus is presenting the following OTC program-related data at the 2019 Annual Meeting of TIDES: |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARCT-810 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06488313 ↗ |
| Modality | Messenger RNA (mRNA) | “ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.” NCT04416126 ↗ |
| Route | Intravenous | “Ascending single doses of ARCT-810 administered intravenously” NCT04416126 ↗ |
| Target | OTC | “ARCT-810 is messenger RNA (mRNA) coding for Ornithine Transcarbamylase (OTC) formulated in a lipid nanoparticle (LNP).” NCT05526066 ↗ |