Arcturus Therapeutics Holdings Inc. (ARCT)
Arcturus Therapeutics Holdings Inc. is a biotechnology company focused on RNA-based medicines, developing a pipeline of vaccines for infectious diseases alongside treatments for rare liver and respiratory conditions across the United States. Its notable development programs encompass LUNAR-OTC, designed for ornithine transcarbamylase (OTC) deficiency, and LUNAR-CF, targeting cystic fibrosis lung disease caused by specific CFTR gene mutations. The company also advances vaccine initiatives such as LUNAR-COV19 and LUNAR-FLU. Arcturus has cultivated a range of strategic collaborations, including partnerships with Vinbiocare Biotechnology Joint Stock Company for manufacturing COVID-19 vaccines; Janssen Pharmaceuticals, Inc., to create nucleic acid-based therapies for hepatitis B virus; Ultragenyx Pharmaceutical, Inc., for developing mRNA therapeutics aimed at rare disease targets; CureVac AG, to progress mRNA therapeutic and vaccine candidates across various indications; the Singapore Economic Development Board and Duke-NUS Medical School, specifically for the LUNAR-COV19 vaccine; and Millennium Pharmaceuticals, Inc., focused on discovering siRNA medicines for non-alcoholic steatohepatitis (NASH). Founded in 2013, Arcturus Therapeutics maintains its corporate headquarters in San Diego, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Arcturus Therapeutics Holdings Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults
ARCT-2303, Influenza vaccine
COVID-19
NCT06279871Enrollment1,514StartMar 2024Primary CompletionOct 2024CompletionNov 2024 - Phase 2Terminated
A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
ARCT-021 single dose priming, ARCT-021 two lower dose priming
Covid19, SARS-CoV Infection +1
NCT04668339Enrollment581StartJan 2021Primary CompletionMar 2022CompletionMar 2022 - Phase 2Terminated
Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
ARCT-021
SARS-CoV-2
NCT04728347Enrollment65StartJan 2021Primary CompletionDec 2021CompletionDec 2021 - Phase 2Terminated
Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810
ARCT-810
Ornithine Transcarbamylase Deficiency, OTC Deficiency +1
NCT05526066Enrollment8StartOct 2022Primary CompletionOct 2024CompletionOct 2024 - Phase 2Recruiting
A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD
ARCT-810
OTC Deficiency, Ornithine Transcarbamylase Deficiency +1
NCT06488313Enrollment9StartNov 2024Primary CompletionJun 2026est.CompletionSep 2026est. - Phase 2Recruiting
Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis
ARCT-032
Cystic Fibrosis, CFTR Gene Mutation
NCT06747858Enrollment33StartDec 2024Primary CompletionJun 2027est.CompletionJun 2027est. - Phase 1/2Completed
Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
ARCT-021 Dose 1, ARCT-021 Dose 2
SARS-CoV-2
NCT04480957Enrollment106StartAug 2020Primary CompletionJan 2021CompletionJan 2021 - Phase 1/2Completed
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
ARCT-165, ARCT-154
COVID-19, SARS-CoV-2 Infection +1
NCT05037097Enrollment72StartAug 2021Primary CompletionDec 2023CompletionDec 2023 - Phase 1/2Completed
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
ARCT-2304, Control vaccine younger adults
Influenza, Human
NCT06602531Enrollment212StartDec 2024Primary CompletionJun 2025CompletionDec 2025 - Phase 1Completed
Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects
ARCT-810
Ornithine Transcarbamylase Deficiency
NCT04416126Enrollment30StartJun 2020Primary CompletionDec 2020CompletionDec 2020 - Phase 1Completed
Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency
ARCT-810
Ornithine Transcarbamylase Deficiency
NCT04442347Enrollment16StartNov 2020Primary CompletionAug 2023CompletionApr 2024 - Phase 1Completed
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
ARCT-032
Cystic Fibrosis
NCT05712538Enrollment39StartFeb 2023Primary CompletionJul 2024CompletionJul 2024 - Phase 1Completed
Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults
ARCT-2138, Licensed Quadrivalent Vaccine for younger adults
Influenza, Human
NCT06125691Enrollment139StartJan 2024Primary CompletionAug 2024CompletionJan 2025
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | ARCT-2303, Influenza vaccine | NCT06279871 |
| Phase 2 | Terminated | ARCT-021 single dose priming, ARCT-021 two lower dose priming | NCT04668339 |
| Phase 2 | Terminated | ARCT-021 | NCT04728347 |
| Phase 2 | Terminated | ARCT-810 | NCT05526066 |
| Phase 2 | Recruiting | ARCT-810 | NCT06488313 |
| Phase 2 | Recruiting | ARCT-032 | NCT06747858 |
| Phase 1/2 | Completed | ARCT-021 Dose 1, ARCT-021 Dose 2 | NCT04480957 |
| Phase 1/2 | Completed | ARCT-165, ARCT-154 | NCT05037097 |
| Phase 1/2 | Completed | ARCT-2304, Control vaccine younger adults | NCT06602531 |
| Phase 1 | Completed | ARCT-810 | NCT04416126 |
| Phase 1 | Completed | ARCT-810 | NCT04442347 |
| Phase 1 | Completed | ARCT-032 | NCT05712538 |
| Phase 1 | Completed | ARCT-2138, Licensed Quadrivalent Vaccine for younger adults | NCT06125691 |