S-892216 / Shionogi - LARVOL DELTA

A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting

Enrollment open • Renal Disease

A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Shionogi

New P1 trial • Renal Disease

The Same and Not the Same: Discovery of S-892216, A Second-Generation Nonpeptidic Covalent 3CL Protease Inhibitor for Oral COVID-19 Therapeutics. (PubMed, J Med Chem) - "Targeting the 3CLpro main protease has been successful in identifying clinical agents; however limited options exist, and improvements are still required to have broader clinical utility. Utilizing the established central scaffold to develop ensitrelvir, both noncovalent and covalent modes of action were leveraged using structural knowledge to identify S-892216 as a potential best-in-class reversible covalent nonpeptidic 3CLpro inhibitor with a superior preclinical profile for treatment of COVID-19 and future pandemic preparedness."

Journal • Infectious Disease • Novel Coronavirus Disease

A Study of S-892216 in Participants With COVID-19 (clinicaltrials.gov) - P2 | N=282 | Completed | Sponsor: Shionogi | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Development of a manufacturing process for S-892216, COVID-19 antiviral (ACS-Fall 2025) - "The process was further refined towards sustainable manufacturing, with the implementation of flow chemistry significantly enhancing reaction efficiency. Overall yield increased from 28% to 62% and PMI decreased from 523 to 210 compared to the discovery stage route, demonstrating the potential for strengthening the COVID-19 therapeutics supply chain with our scalable and streamlined approach."

Infectious Disease • Novel Coronavirus Disease

Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=98 | Not yet recruiting | Sponsor: Shionogi

New P1 trial

Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=98 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting

Enrollment open

Novel Approach to Pre-Exposure Prophylaxis (PrEP) of COVID-19: Development of S-892216 Long-Acting Injectable Suspension. (PubMed, Chem Pharm Bull (Tokyo)) - "The developed injectable suspension was stable for 12 months at 5 and 25°C/60% relative humidity after terminal sterilization by gamma irradiation. Thus, the developed injectable suspension shows potential for further development for human use."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of S-892216 in Participants With COVID-19 (clinicaltrials.gov) - P2 | N=280 | Recruiting | Sponsor: Shionogi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Discovery of the Clinical Candidate S-892216: A Second-Generation of SARS-CoV-2 3CL Protease Inhibitor for Treating COVID-19. (PubMed, J Med Chem) - "S-892216 exhibited antiviral activity against diverse SARS-CoV-2 variants, including major mutations reducing antiviral activities of nirmatrelvir and ensitrelvir. In SARS-CoV-2-infected mice, S-892216 inhibited viral replication in the lungs similar to ensitrelvir, although at a 30-fold lower dose."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of S-892216 in Participants With COVID-19 (clinicaltrials.gov) - P2 | N=280 | Not yet recruiting | Sponsor: Shionogi

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Shionogi | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Shionogi

New P1 trial • Infectious Disease • Novel Coronavirus Disease

In Vitro and in Vivo Antiviral Activity of S-892216, a Second-Generation Oral 3CLpro Inhibitor against SARS-CoV-2 (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease

Therapeutic Effect of Delayed Treatment with a Second-Generation 3CL Protease Inhibitor S-892216 in Hamsters Infected with SARS-CoV-2 (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease

In Vitro Resistance Profiling of S-892216, a Second Generation SARS-CoV-2 3CLpro Inhibitor for the Treatment of COVID-19 (IDWeek 2024) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease

Shionogi Expands its COVID-19 Product Portfolio by Initiating a Phase 1 Clinical Trial in Japan for a Second COVID-19 Antiviral (Shionogi Press Release) - "Shionogi & Co., Ltd....today announced the initiation of a Phase 1 clinical trial in Japan of S-892216, an investigational agent which is being developed as an antiviral against COVID-19, caused by SARS-CoV-2 infection. The first dose in this Phase 1 clinical trial was administered successfully and no safety concerns have been identified."

Japan • New P1 trial • Infectious Disease • Novel Coronavirus Disease