Drugs / ARCT-021
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05037097 | Aug 2021 → Dec 2023 | COVID-19 | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04480957 | Aug 2020 → Jan 2021 | Orthocoronavirinae infectious disease | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07390968 | Dec 2026 → Sep 2028 expected | hematopoietic and lymphoid system neoplasm | Fred Hutchinson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04668339 | Jan 2021 → Mar 2022 | COVID-19 | Arcturus Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04728347 | Jan → Dec 2021 | COVID-19 | Arcturus Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-09-19 | Arcturus Therapeutics, Inc. | Results Study Shows Novel sa-mRNA Vaccines Offer Robust, Broad, Enduring Protection Against COVID-19 Variants arcturusrx.com ↗
Current mRNA technologies provide effective initial immunogenicity against COVID-19, but the results of this study show that our sa-mRNA vaccine platform can offer improvements in duration and breadth of protection against new and emerging variants, |
| 2021-05-10 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces First Quarter 2021 Company Overview and Financial Results and Provides New Clinical Data arcturusrx.com ↗
ARCT-021 Phase 2 interim data showed favorable safety profile and greater than 90% seroconversion after a single dose; data supports advancement into Phase 3 |
| 2021-01-04 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States arcturusrx.com ↗ |
| 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 ARCT-021 Phase 1/2 data provide clinical validation for our unique vaccine candidate and suggest that our self-replicating mRNA-based investigational vaccine could have a differentiated clinical profile and may allow vaccination at low doses. |
| 2020-11-09 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Positive Interim ARCT-021 (LUNAR-COV19) Phase 1/2 Study Results for Both Single Shot and Prime-boost Regimens, and Up to $220 Million in Additional Financial Commitments from Singapore arcturusrx.com ↗ |
| 2020-09-04 | Arcturus Therapeutics, Inc. | Results Arcturus Therapeutics Announces Preclinical Publication of its COVID-19 Vaccine Candidate arcturusrx.com ↗
The manuscript provides an in-depth assessment of humoral- and cell-mediated immune activation following a single shot vaccination in mice and shows that LUNAR®-COV19 (ARCT-021) produced robust antibody responses, with neutralizing antibody titers increasing up to day 60. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARCT-021 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04480957 ↗ |
| Modality | Messenger RNA (mRNA) | “ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA” NCT04480957 ↗ |
| Route | Intramuscular | “Study drug (ARCT-021 or control) will be administered as an intramuscular (IM) injection.” NCT04480957 ↗ |