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Arcturus Therapeutics (ARCT) Drug Pipeline
| Drug Name | Condition | Stage | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Arct-032 | Cystic Fibrosis, Cftr Gene Mutation | Phase II | Recruiting | Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis | Dec 17, 2024 | ― |
| Arct-2304, Control Vaccine Younger Adults, Control Vaccine Older Adults | Influenza, Human | Phase I | Active Not Recruiting | Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults | Sep 16, 2024 | ― |
| Arct-810 | Otc Deficiency, Ornithine Transcarbamylase Deficiency, Otcd | Phase II | Recruiting | A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD | Jun 28, 2024 | ― |
| Influenza Vaccine, Arct-2303, Influenza Vaccine, Adjuvanted | Covid-19 | Phase III | Completed | Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults | Feb 23, 2024 | ― |
| Arct-2138, Licensed Quadrivalent Vaccine For Younger Adults, Licensed Quadrivalent Vaccine For Older Adults | Influenza, Human | Phase I | Completed | Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults | Nov 05, 2023 | ― |
| Arct-032 | Cystic Fibrosis | Phase I | Completed | Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis. | Jan 26, 2023 | ― |
| Arct-810 | Otc Deficiency, Ornithine Transcarbamylase Deficiency, Otcd | Phase II | Terminated | Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810 | Aug 08, 2022 | ― |
| Arct-021, Arct-165, Arct-154 | Covid-19, Sars-Cov-2 Infection, Corona Virus Infection | phase1AndPhase2 | Completed | A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults | Aug 30, 2021 | ― |
| Arct-021 | Sars-Cov-2 | Phase II | Terminated | Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 | Jan 24, 2021 | ― |
| Arct-021 Single Dose Priming, Arct-021 Two Lower Dose Priming, Arct-021 Two Higher Dose Priming, Randomized Booster | COVID19, Sars-Cov Infection, Corona Virus Infection | Phase II | Terminated | A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults | Nov 25, 2020 | ― |
| Drug Name | Stage | Condition | Status | Study Name | Trial Start Date | Article |
|---|---|---|---|---|---|---|
| Arct-032 | Phase II | Cystic Fibrosis, Cftr Gene Mutation | Recruiting | Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis | Dec 17, 2024 | ― |
| Arct-2304, Control Vaccine Younger Adults, Control Vaccine Older Adults | Phase I | Influenza, Human | Active Not Recruiting | Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults | Sep 16, 2024 | ― |
| Arct-810 | Phase II | Otc Deficiency, Ornithine Transcarbamylase Deficiency, Otcd | Recruiting | A Study to Evaluate the Pharmacodynamics and Safety of ARCT-810 in Participants With OTCD | Jun 28, 2024 | ― |
| Influenza Vaccine, Arct-2303, Influenza Vaccine, Adjuvanted | Phase III | Covid-19 | Completed | Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults | Feb 23, 2024 | ― |
| Arct-2138, Licensed Quadrivalent Vaccine For Younger Adults, Licensed Quadrivalent Vaccine For Older Adults | Phase I | Influenza, Human | Completed | Safety and Immunogenicity First-in-human Dose-ranging Study of Self-Amplifying RNA Seasonal Influenza Vaccine in Adults | Nov 05, 2023 | ― |
| Arct-032 | Phase I | Cystic Fibrosis | Completed | Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis. | Jan 26, 2023 | ― |
| Arct-810 | Phase II | Otc Deficiency, Ornithine Transcarbamylase Deficiency, Otcd | Terminated | Study for Adolescents and Adults With Ornithine Transcarbamylase Deficiency to Evaluate Safety and Tolerability of ARCT-810 | Aug 08, 2022 | ― |
| Arct-021, Arct-165, Arct-154 | phase1AndPhase2 | Covid-19, Sars-Cov-2 Infection, Corona Virus Infection | Completed | A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults | Aug 30, 2021 | ― |
| Arct-021 | Phase II | Sars-Cov-2 | Terminated | Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 | Jan 24, 2021 | ― |
| Arct-021 Single Dose Priming, Arct-021 Two Lower Dose Priming, Arct-021 Two Higher Dose Priming, Randomized Booster | Phase II | COVID19, Sars-Cov Infection, Corona Virus Infection | Terminated | A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults | Nov 25, 2020 | ― |
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Arcturus Therapeutics (ARCT) have in its pipeline
Arcturus Therapeutics ARCT is currently developing the following drugs: Arct-032, Arct-2304, Control Vaccine Younger Adults, Control Vaccine Older Adults, Arct-810, Influenza Vaccine, Arct-2303, Influenza Vaccine, Adjuvanted, Arct-2138, Licensed Quadrivalent Vaccine For Younger Adults, Licensed Quadrivalent Vaccine For Older Adults, Arct-021, Arct-165, Arct-154, Arct-021, Arct-021 Single Dose Priming, Arct-021 Two Lower Dose Priming, Arct-021 Two Higher Dose Priming, Randomized Booster. These drug candidates are in various stages of clinical development as the company works toward FDA approval.
